Patients underreported their use of common but potentially dangerous over-the-counter pain medications known as NSAIDs, according to research presented at the Annual Scientific Meeting of the American College of Gastroenterology. "This is a serious issue given what we know about the significant risk of injury and bleeding in the GI tract in patients using NSAIDs," said David Johnson, M.D., FACG, one of the researchers and President of the America College of Gastroenterology.
Serious gastrointestinal complications such as bleeding, ulceration and perforation can occur with or without warning symptoms in people who take NSAIDS (non-steroidal anti-inflammatory drugs.) Ulcers and gastrointestinal bleeding are serious health problems in the United States. With millions taking NSAID pain medications every day, it is estimated that more than 100,000 Americans are hospitalized each year and between 15,000 and 20,000 Americans die each year from ulcers and gastrointestinal bleeding linked to NSAID use.
Of particular concern are patients with arthritic conditions. More than 14 million such patients consume NSAIDs regularly. Up to 60 percent will have gastrointestinal side effects related to these drugs and more than 10 percent will cease recommended medications because of troublesome gastrointestinal symptoms.
Dr. Johnson and his colleagues at Eastern Virginia Medical School administered a survey to patients in a private GI practice after a written and verbally confirmed report of current medications to nursing staff. Almost one in five respondents to the survey noted use of an NSAID that had not been reported verbally to nursing staff, including 8 percent who reported daily use. For 22 percent of respondents, they did not think the medications were important enough to list, while 30 percent cited the fact that the drugs were not prescribed by a physician. "This reflects a common misperception that these medications are insignificant or benign when actually their chronic use, particularly among the elderly and those with conditions such as arthritis, is linked to serious and potentially fatal GI injury and bleeding," noted Dr. Johnson.
Physician experts from the American College of Gastroenterology warn that patients who take over-the-counter pain medications on a regular basis should talk with their physician about the potential for ulcers and other GI side effects.
Recent research suggests a role for acid suppression therapy with a proton pump inhibitor (PPI) for patients at risk of developing stomach ulcers due to long-term use of NSAIDs. In another study presented at the American College of Gastroenterology, a VA researcher, Neena S. Abraham, M.D. looked at the burden of cost from hospitalization for GI bleeding related to NSAID use, and conducted a cost benefit analysis of using PPIs to help protect against serious potential injury to the GI tract.
"Our analysis of a large patient population suggests that it is cost beneficial to administer a proton pump inhibitor with NSAIDs and points to significant savings in hospital costs relating to GI injury and bleeding in the Veterans' Administration medical setting," explained Dr. Abraham.
Dr. Abraham and her colleagues reviewed prescription records linked to inpatient, outpatient and death files for the VA medical system and Medicare. In an overall population of almost half a million veterans, Dr. Abraham identified 3,200 events of GI bleeding, of which 36 percent were treated by the VA. A review of their prescription and hospitalization records revealed that half of those with GI bleeding events were hospitalized. Importantly, the one third of patients with GI bleeding events prescribed a PPI were 60 percent less likely to be hospitalized. Their overall median total medical costs were significantly lower than patients who were not prescribed a PPI.
"This reduction in the risk of hospitalization is where significant savings occur due to lower utilization of health resources, endoscopy and surgery, not to mention the impact on patients' quality of life," explained Dr. Abraham. While there are costs to treat patients on NSAIDs prophylactically with PPIs, these findings suggest that reduced hospitalization costs offset higher pharmacy costs.
"These are powerful data, especially because of the high risk for GI bleeding in elderly patients who are in the highest risk category for GI bleeding," according to Dr. Abraham.
The American College of Gastroenterology has educational materials available for consumers that address many important questions relating to the risk of ulcers and bleeding in the gastrointestinal tract relating to NSAID use.
Click here for more information, consumers may access educational materials developed by the College on this Web site.
About the American College of Gastroenterology
Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 10,000 individuals from 80 countries. The College is committed to serving the clinically oriented digestive disease specialist through its emphasis on scholarly practice, teaching and research. The mission of the College is to serve the evolving needs of physicians in the delivery of high quality, scientifically sound, humanistic, ethical, and cost-effective health care to gastroenterology patients.
The ACG is committed to providing accurate, unbiased and up-to-date health information. Visit the ACG Web site American College of Gastroenterology
to access educational resources for patients and their families spanning the broad range of digestive diseases and conditions - both common and not-so-common. Organized by disease, state and organ system, these educational materials, developed by ACG physician experts, are offered for the information and benefit of patients and the public.
Source: Rosanne Riesenman
American College of Gastroenterology
пятница, 28 октября 2011 г.
вторник, 25 октября 2011 г.
GNS Healthcare And Biogen Idec Identify Novel, Patient-Specific Drug Targets For Rheumatoid Arthritis
GNS Healthcare, Inc., (GNS) the leading healthcare analytics company focused on enabling personalized medicine to improve human health, announced the publication of results from a study focused on identifying novel drug targets for the one-third of rheumatoid arthritis patients who do not respond to leading anti-TNF therapies. The paper, titled "Causal Modeling Using Network Ensemble Simulations of Genetic and Gene Expression Data Predicts Genes Involved in Rheumatoid Arthritis," by researchers at GNS Healthcare and Biogen Idec (Nasdaq: BIIB) was published in the journal PLoS Computational Biology. The paper describes the experimental and computational approach used by the researchers to integrate clinical, molecular and genetic data into dynamic models of disease progression and drug response. This approach helped predict individual patients' clinical responses to the shutting down of specific pathways, suggesting that accurate determinations can be made about patients' responses to existing drugs as well as to the inhibition of novel targets and pathways based on DNA sequence and gene expression data from a given patient's blood.
Starting from a patient dataset comprised of genotyping, whole-blood gene expression profiles and clinical measures such as tender joints, swollen joints and C-reactive protein, the researchers used GNS's supercomputer-driven REFS™ (reverse-engineering and forward-simulation) scientific computing platform to construct a comprehensive disease model directly from the raw data. This computer disease model enabled the team to conduct virtual clinical trials, simulating the clinical effect of inhibiting various drug targets and predicting novel and previously known alternative genetic targets to anti-TNFs.
"This project established that a relatively small, heterogeneous clinical trial dataset can be directly utilized to learn novel disease biology if one has access to a significantly powerful computational modeling platform. This is the first time that a patient-data driven, computer model of rheumatoid arthritis has been developed to generate patient-specific predictions to the response to existing drugs and the response to inhibiting novel targets and pathways of the disease," said Colin Hill, CEO and co-founder of GNS Healthcare. "The convergence of multiple layers of rich genomics and molecular profiling data, together with clinical outcomes has reached a tipping point in the evolution of personalized medicine that is now enabling the automated discovery of dynamic disease models of individualized patient outcomes."
The joint GNS-Biogen Idec publication sets forth an approach that may allow researchers to rapidly construct and interrogate computer models of drug and disease biology that reflect probabilistic cause-and-effect relationships directly from genetic, molecular and clinical data without requiring the use of prior biological knowledge. Such models potentially enable patient-specific predictions, accelerating the cycle of bench-to-bedside medicine by bringing bedside data back to the computational "bench" and, in turn, making additional insights available to researchers and clinicians.
About REFS™
REFS is comprised of integrated machine-learning algorithms and software that extract "causal" relationships from complex, multi-dimensional data and enable the simulation of billions of "what if?" hypotheses to explore novel unseen conditions and predictions forward in time. This model-centric discovery and simulation approach represents a paradigm shift in data analysis, leapfrogging existing approaches such as high-dimensional pattern matching. REFS is licensed to GNS Healthcare from its parent company Via Science.
Source:
GNS Healthcare
Starting from a patient dataset comprised of genotyping, whole-blood gene expression profiles and clinical measures such as tender joints, swollen joints and C-reactive protein, the researchers used GNS's supercomputer-driven REFS™ (reverse-engineering and forward-simulation) scientific computing platform to construct a comprehensive disease model directly from the raw data. This computer disease model enabled the team to conduct virtual clinical trials, simulating the clinical effect of inhibiting various drug targets and predicting novel and previously known alternative genetic targets to anti-TNFs.
"This project established that a relatively small, heterogeneous clinical trial dataset can be directly utilized to learn novel disease biology if one has access to a significantly powerful computational modeling platform. This is the first time that a patient-data driven, computer model of rheumatoid arthritis has been developed to generate patient-specific predictions to the response to existing drugs and the response to inhibiting novel targets and pathways of the disease," said Colin Hill, CEO and co-founder of GNS Healthcare. "The convergence of multiple layers of rich genomics and molecular profiling data, together with clinical outcomes has reached a tipping point in the evolution of personalized medicine that is now enabling the automated discovery of dynamic disease models of individualized patient outcomes."
The joint GNS-Biogen Idec publication sets forth an approach that may allow researchers to rapidly construct and interrogate computer models of drug and disease biology that reflect probabilistic cause-and-effect relationships directly from genetic, molecular and clinical data without requiring the use of prior biological knowledge. Such models potentially enable patient-specific predictions, accelerating the cycle of bench-to-bedside medicine by bringing bedside data back to the computational "bench" and, in turn, making additional insights available to researchers and clinicians.
About REFS™
REFS is comprised of integrated machine-learning algorithms and software that extract "causal" relationships from complex, multi-dimensional data and enable the simulation of billions of "what if?" hypotheses to explore novel unseen conditions and predictions forward in time. This model-centric discovery and simulation approach represents a paradigm shift in data analysis, leapfrogging existing approaches such as high-dimensional pattern matching. REFS is licensed to GNS Healthcare from its parent company Via Science.
Source:
GNS Healthcare
суббота, 22 октября 2011 г.
Molecular Response Of Cartilage To Injury Identified By Study
It's an unfortunate fact backed by studies of former professional football and soccer players: injury to joint cartilage escalates the risk of developing of osteoarthritis (OA). However, why this occurs - the details of how joint cartilage cells respond to acute trauma and how this response leads to progressive cartilage degradation - remains open to investigation.
To shed further light on this issue of intense research interest, an international team of rheumatologists and biotechnologists conducted a microarray screening of adult human joint cartilage subjected to injury. Led by Dr. Francesco Dell'Accio, a Clinician Scientist Fellow of the Arthritis Research Campaign, the team reported in the May issue of Arthritis & Rheumatism the full-genome characterization of the moleculer response of adult human articular cartilage to mechanical injury.
The gene expression profile of cartilage explants 24 hours after mechanical injury was compared to that of uninjured control explants using microarray technology. The explants were obtained either from uninvolved cartilage areas of knees affected by OA or from healthy cartilage from one individual who underwent a limb amputation following a road traffic accident. The expression of selected genes was then confirmed using real time PCR and immunohistochemistry.
In the injured samples, a total of 690 genes were significantly either up- or downregulated at least 2-fold compared with expression in the uninjured samples. Significant clusters included genes associated with cell signaling, wound healing, and skeletal development, as well as genes previously found to be differentially expressed in OA cartilage. Members of the WNT, TGF??, and FGF family of signalling molecules were included in the regulated gene list. A targeted analysis of the Wnt signaling pathway in injured cartilage revealed up-regulation of the ligand Wnt-16, down-regulation of the secreted inhibitor FRZB, nuclear accumulation of ??-catenin, and upregulation of several known WNT target genes supporting net activation of this signalling pathway. Wnt-16 and ??-catenin were barely detectable in preserved cartilage from OA joints but dramatically up-regulated in areas of the same joint with moderate to severe OA damage.
This study indicates that several genes encoding signalling molecules are regulated following cartilage injury in adult individuals. Although it is tempting to speculate that some of these genes represent a reparative response, Dr Dell'Accio stresses that at the moment we do not know whether such phenomena are supporting repair (hence representing potential therapeutic tools) or even play a role in the progression of damage (hence potential therapeutic targets). Hence further investigation is needed "to optimally target the respective pathways to promote joint surface cartilage defect repair or to stop further joint surface breakdown, thereby preventing the development of posttraumatic OA."
In a related editorial, Dr. Tonia L. Vincent and Dr. Jeremy Saklatva of Imperial College London raise the question of whether the response of cartilage to injury is relevant to osteoarthritis. As they argue, the findings of Dr. Dell'Accio and his colleagues suggest that Wnt activity may be important in OA, possibly driving bone changes in disease, such as osteophyte formation, but not necessarily directly injury-regulated. Yet, as they also note, studies devoted to unraveling the link between joint injury and OA risk are leading the way toward a better understanding of the tissue processes and the signaling pathways activated in disease. "Further investigation into the pathways revealed in this injury microarray is likely to be highly informative," Dr. Vincent states.
Article: "Identification of the Molecular Response of Articular Cartilage to Injury, by Microarray Screening: Wnt-16 Expression and Signaling After Injury and in Osteoarthritis," Francesco Dell'Accio, Cosimo De Bari, Noha M. Eltawil, Paul Vanhummelen, and Costantino Pitzalis, Arthritis & Rheumatism, May 2008; 58:5 pp. 1410-1421.
Editorial: "Is the Response of Cartilage to Injury Relevant to Osteoarthritis," Tonia L. Vincent and Jeremy Saklatvala, Arthritis & Rheumatism, May 2008; 58:5 pp. 1207-1210.
Source: Sean Wagner
Wiley-Blackwell
To shed further light on this issue of intense research interest, an international team of rheumatologists and biotechnologists conducted a microarray screening of adult human joint cartilage subjected to injury. Led by Dr. Francesco Dell'Accio, a Clinician Scientist Fellow of the Arthritis Research Campaign, the team reported in the May issue of Arthritis & Rheumatism the full-genome characterization of the moleculer response of adult human articular cartilage to mechanical injury.
The gene expression profile of cartilage explants 24 hours after mechanical injury was compared to that of uninjured control explants using microarray technology. The explants were obtained either from uninvolved cartilage areas of knees affected by OA or from healthy cartilage from one individual who underwent a limb amputation following a road traffic accident. The expression of selected genes was then confirmed using real time PCR and immunohistochemistry.
In the injured samples, a total of 690 genes were significantly either up- or downregulated at least 2-fold compared with expression in the uninjured samples. Significant clusters included genes associated with cell signaling, wound healing, and skeletal development, as well as genes previously found to be differentially expressed in OA cartilage. Members of the WNT, TGF??, and FGF family of signalling molecules were included in the regulated gene list. A targeted analysis of the Wnt signaling pathway in injured cartilage revealed up-regulation of the ligand Wnt-16, down-regulation of the secreted inhibitor FRZB, nuclear accumulation of ??-catenin, and upregulation of several known WNT target genes supporting net activation of this signalling pathway. Wnt-16 and ??-catenin were barely detectable in preserved cartilage from OA joints but dramatically up-regulated in areas of the same joint with moderate to severe OA damage.
This study indicates that several genes encoding signalling molecules are regulated following cartilage injury in adult individuals. Although it is tempting to speculate that some of these genes represent a reparative response, Dr Dell'Accio stresses that at the moment we do not know whether such phenomena are supporting repair (hence representing potential therapeutic tools) or even play a role in the progression of damage (hence potential therapeutic targets). Hence further investigation is needed "to optimally target the respective pathways to promote joint surface cartilage defect repair or to stop further joint surface breakdown, thereby preventing the development of posttraumatic OA."
In a related editorial, Dr. Tonia L. Vincent and Dr. Jeremy Saklatva of Imperial College London raise the question of whether the response of cartilage to injury is relevant to osteoarthritis. As they argue, the findings of Dr. Dell'Accio and his colleagues suggest that Wnt activity may be important in OA, possibly driving bone changes in disease, such as osteophyte formation, but not necessarily directly injury-regulated. Yet, as they also note, studies devoted to unraveling the link between joint injury and OA risk are leading the way toward a better understanding of the tissue processes and the signaling pathways activated in disease. "Further investigation into the pathways revealed in this injury microarray is likely to be highly informative," Dr. Vincent states.
Article: "Identification of the Molecular Response of Articular Cartilage to Injury, by Microarray Screening: Wnt-16 Expression and Signaling After Injury and in Osteoarthritis," Francesco Dell'Accio, Cosimo De Bari, Noha M. Eltawil, Paul Vanhummelen, and Costantino Pitzalis, Arthritis & Rheumatism, May 2008; 58:5 pp. 1410-1421.
Editorial: "Is the Response of Cartilage to Injury Relevant to Osteoarthritis," Tonia L. Vincent and Jeremy Saklatvala, Arthritis & Rheumatism, May 2008; 58:5 pp. 1207-1210.
Source: Sean Wagner
Wiley-Blackwell
среда, 19 октября 2011 г.
The International Osteoporosis Foundation Joins ECCEO9 At Leading International Meeting In Athens
Collaboration results in enhanced scientific meeting, greater global perspective
The International Osteoporosis Foundation (IOF) invites clinicians and researchers in the bone health field to attend ECCEO9-IOF, a joint meeting to be held from March 18-21 in Athens, Greece.
Some 4,000 participants are expected at the four-day meeting which will feature an expanded scientific scope as well as a broad spectrum of clinically-oriented 'Meet-the-Professor' sessions. The programme is also enhanced by poster sessions and satellite symposia, and offers clinical insights through special sessions on the management of osteoarthritis and osteoporosis.
A highlight of the stimulating scientific programme is the series of eight plenary lectures, delivered by leading experts in the field:
Implications of improving adherence to osteoporosis treatment,
Stuart Silverman
Secular trends in osteoporosis fracture: myth or reality,
Cyrus Cooper
Imaging of bone microarchitecture and osteoporosis,
Sharmila Majumdar
Clinical and economic aspects of the management of postmenopausal women with osteopenia,
Christian Roux
Role of microdamage in bone fragility,
Clive Lee
Novelties and perspectives in the management of osteoarthritis,
Jean-Pierre Pelletier
Debate: long-term treatment of osteoporosis with bisphosphonates: good, John Bilezikian
Debate: long-term treatment of osteoporosis with bisphosphonates: bad, Socrates Papapoulos
Join us in Athens for an exciting scientific programme, and a special opportunity to meet leading experts from around the world.
Reminder: Paid registrants of the cancelled IOF World Congress on Osteoporosis in Bangkok (December 2008) are offered free registration. Please register through the ECCEO9-IOF website ecceo9/ and under 'special discount' indicate 'IOF WCO FREE'.
ABOUT IOF
The International Osteoporosis Foundation (IOF) is a nongovernmental
umbrella organization dedicated to the worldwide
fight against osteoporosis, the disease known as "the silent
epidemic". IOF's members - committees of scientific researchers,
patient, medical and research societies and industry representatives
from around the world - share a common vision of a world without
osteoporotic fractures. Launched in 1998 with the merger of the
European Foundation for Osteoporosis (EFFO, founded in 1987) and
the International Federation of Societies on Skeletal Diseases, IOF
now represents 191 societies in 91 locations. iofbonehealth
ABOUT ESCEO
The European Society for Clinical and Economic Aspects of
Osteoporosis and Osteoarthritis (ESCEO) is a non-profit organization,
dedicated to a close interaction between clinical scientists dealing
with rheumatic disorders, pharmaceutical industry developing new
compounds in this field, regulators responsible for the registration of
such drugs and health policy makers, to integrate the management of
osteoporosis and osteoarthritis within the comprehensive perspective
of health resources utilization. The objective of ESCEO is to provide
practitioners with the latest clinical and economic information,
allowing them to organize their daily practice, in an evidence-based
medicine perspective, with a cost-conscious perception.
Source: Yolande Piette
International Osteoporosis Foundation
The International Osteoporosis Foundation (IOF) invites clinicians and researchers in the bone health field to attend ECCEO9-IOF, a joint meeting to be held from March 18-21 in Athens, Greece.
Some 4,000 participants are expected at the four-day meeting which will feature an expanded scientific scope as well as a broad spectrum of clinically-oriented 'Meet-the-Professor' sessions. The programme is also enhanced by poster sessions and satellite symposia, and offers clinical insights through special sessions on the management of osteoarthritis and osteoporosis.
A highlight of the stimulating scientific programme is the series of eight plenary lectures, delivered by leading experts in the field:
Implications of improving adherence to osteoporosis treatment,
Stuart Silverman
Secular trends in osteoporosis fracture: myth or reality,
Cyrus Cooper
Imaging of bone microarchitecture and osteoporosis,
Sharmila Majumdar
Clinical and economic aspects of the management of postmenopausal women with osteopenia,
Christian Roux
Role of microdamage in bone fragility,
Clive Lee
Novelties and perspectives in the management of osteoarthritis,
Jean-Pierre Pelletier
Debate: long-term treatment of osteoporosis with bisphosphonates: good, John Bilezikian
Debate: long-term treatment of osteoporosis with bisphosphonates: bad, Socrates Papapoulos
Join us in Athens for an exciting scientific programme, and a special opportunity to meet leading experts from around the world.
Reminder: Paid registrants of the cancelled IOF World Congress on Osteoporosis in Bangkok (December 2008) are offered free registration. Please register through the ECCEO9-IOF website ecceo9/ and under 'special discount' indicate 'IOF WCO FREE'.
ABOUT IOF
The International Osteoporosis Foundation (IOF) is a nongovernmental
umbrella organization dedicated to the worldwide
fight against osteoporosis, the disease known as "the silent
epidemic". IOF's members - committees of scientific researchers,
patient, medical and research societies and industry representatives
from around the world - share a common vision of a world without
osteoporotic fractures. Launched in 1998 with the merger of the
European Foundation for Osteoporosis (EFFO, founded in 1987) and
the International Federation of Societies on Skeletal Diseases, IOF
now represents 191 societies in 91 locations. iofbonehealth
ABOUT ESCEO
The European Society for Clinical and Economic Aspects of
Osteoporosis and Osteoarthritis (ESCEO) is a non-profit organization,
dedicated to a close interaction between clinical scientists dealing
with rheumatic disorders, pharmaceutical industry developing new
compounds in this field, regulators responsible for the registration of
such drugs and health policy makers, to integrate the management of
osteoporosis and osteoarthritis within the comprehensive perspective
of health resources utilization. The objective of ESCEO is to provide
practitioners with the latest clinical and economic information,
allowing them to organize their daily practice, in an evidence-based
medicine perspective, with a cost-conscious perception.
Source: Yolande Piette
International Osteoporosis Foundation
воскресенье, 16 октября 2011 г.
Humira(R) (adalimumab) Receives FDA Approval For Treatment Of Ankylosing Spondylitis
Abbott announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA(R) (adalimumab) for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is an autoimmune disease affecting the spine and large peripheral joints that causes inflammatory back pain and stiffness and also can be associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, AS over time can result in complete spinal fusion, causing extreme physical limitation and reduction in health-related quality of life.
AS is the third of six autoimmune diseases targeted for HUMIRA therapy that has received FDA approval. HUMIRA also is approved by the FDA to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and clinical trials are currently under way evaluating the potential of HUMIRA in other autoimmune diseases. HUMIRA received European approval to treat patients with severe, active AS on June 1, 2006.
"Medications like HUMIRA represent another option in the way we treat ankylosing spondylitis, a painful and potentially disabling disease that tends to strike mostly young adults," said Jane Bruckel, BSN, RN, Spondylitis Association of America co-founder and executive director.
AS affects young adults and commonly develops during the second and third decades of life. Because the pain and stiffness of AS are hard to distinguish from other common causes of back pain, patients may go undiagnosed for many years from the onset of their symptoms. AS is one of the most overlooked causes of persistent back pain in young adults.
The recommended dose of HUMIRA for AS is 40 mg every other week, by subcutaneous injection (a shot beneath the skin), the usual dose recommended for HUMIRA in the treatment of moderate to severe RA and PsA. HUMIRA is available to patients with AS in the United States in a pre-filled syringe. Beginning in August, patients will be able to take advantage of the HUMIRA Pen, a new delivery device for the self-administration of HUMIRA. Approved by the FDA on June 23, 2006, the HUMIRA Pen offers improved ease of use and a less painful experience compared to the HUMIRA pre-filled syringe.
Clinical Trial Results
The approval of HUMIRA for the treatment of patients with active AS is based on data from the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) trial.
ATLAS was a randomized, placebo-controlled, double-blind, Phase III study conducted in Europe and the United States. Results showed that HUMIRA was successful in reducing pain and inflammation in patients with AS after 12 weeks of treatment, the study's primary endpoint. Other findings demonstrated significant improvement in measures of disease activity for many patients treated with HUMIRA that were first observed at week two and maintained through 24 weeks.
ATLAS also explored the impact of HUMIRA on enthesitis, a condition in AS characterized by inflammation of the ligaments that attach to the bone. At week 24, the mean change in the enthesitis symptom score as measured by Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in patients treated with HUMIRA showed significant reduction. MASES is an index that assesses enthesitis in certain locations, such as the rib cage, lower back, and Achilles tendons.
"The approval of HUMIRA in the treatment of ankylosing spondylitis marks an important milestone for Abbott," said Rebecca Hoffman, M.D., divisional vice president, Immunology Development, Abbott. "HUMIRA is now approved to treat three forms of autoimmune rheumatic diseases - all of them chronic, progressive, debilitating diseases where patients have limited treatment options. With its proven efficacy and established safety profile and the convenience of every other week self-administered dosing, HUMIRA offers an outstanding treatment option for the diverse patient populations who suffer from these conditions."
In the ATLAS trial, a similar rate of treatment-emergent adverse events leading to discontinuation of study drug was observed among placebo-treated (1.9 percent) and HUMIRA-treated (1.4 percent) patients. The overall incidence of adverse events reported by patients treated with HUMIRA was higher than the placebo-treated patients. The most common adverse events included nasopharyngitis, injection site reactions and headache.
About Ankylosing Spondylitis
Ankylosing spondylitis, or arthritis of the spine, is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha, has been suggested to play a role in the disease development. AS is a form of arthritis known as spondyloarthritis, which is a group of closely linked rheumatic diseases that can cause pain in the spine and joints as well as ligaments and tendons. A chronic disease, AS primarily affects the spine causing back stiffness and potential deformity over time.
AS is associated with a number of other conditions including peripheral arthritis and enthesitis (inflammation of the muscle-bone insertion). Other associated affected organ systems may include the eyes, intestines and skin.
Important Safety Information
Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four- fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.
The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis and psoriatic arthritis, the safety profile for patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with DMARDs.
HUMIRA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Massachusetts, United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about HUMIRA, including full prescribing information, is available on the Web site rxabbott or in the United States by calling Abbott Medical Information at 1-800-633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
abbott
View drug information on Humira.
AS is the third of six autoimmune diseases targeted for HUMIRA therapy that has received FDA approval. HUMIRA also is approved by the FDA to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and clinical trials are currently under way evaluating the potential of HUMIRA in other autoimmune diseases. HUMIRA received European approval to treat patients with severe, active AS on June 1, 2006.
"Medications like HUMIRA represent another option in the way we treat ankylosing spondylitis, a painful and potentially disabling disease that tends to strike mostly young adults," said Jane Bruckel, BSN, RN, Spondylitis Association of America co-founder and executive director.
AS affects young adults and commonly develops during the second and third decades of life. Because the pain and stiffness of AS are hard to distinguish from other common causes of back pain, patients may go undiagnosed for many years from the onset of their symptoms. AS is one of the most overlooked causes of persistent back pain in young adults.
The recommended dose of HUMIRA for AS is 40 mg every other week, by subcutaneous injection (a shot beneath the skin), the usual dose recommended for HUMIRA in the treatment of moderate to severe RA and PsA. HUMIRA is available to patients with AS in the United States in a pre-filled syringe. Beginning in August, patients will be able to take advantage of the HUMIRA Pen, a new delivery device for the self-administration of HUMIRA. Approved by the FDA on June 23, 2006, the HUMIRA Pen offers improved ease of use and a less painful experience compared to the HUMIRA pre-filled syringe.
Clinical Trial Results
The approval of HUMIRA for the treatment of patients with active AS is based on data from the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) trial.
ATLAS was a randomized, placebo-controlled, double-blind, Phase III study conducted in Europe and the United States. Results showed that HUMIRA was successful in reducing pain and inflammation in patients with AS after 12 weeks of treatment, the study's primary endpoint. Other findings demonstrated significant improvement in measures of disease activity for many patients treated with HUMIRA that were first observed at week two and maintained through 24 weeks.
ATLAS also explored the impact of HUMIRA on enthesitis, a condition in AS characterized by inflammation of the ligaments that attach to the bone. At week 24, the mean change in the enthesitis symptom score as measured by Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in patients treated with HUMIRA showed significant reduction. MASES is an index that assesses enthesitis in certain locations, such as the rib cage, lower back, and Achilles tendons.
"The approval of HUMIRA in the treatment of ankylosing spondylitis marks an important milestone for Abbott," said Rebecca Hoffman, M.D., divisional vice president, Immunology Development, Abbott. "HUMIRA is now approved to treat three forms of autoimmune rheumatic diseases - all of them chronic, progressive, debilitating diseases where patients have limited treatment options. With its proven efficacy and established safety profile and the convenience of every other week self-administered dosing, HUMIRA offers an outstanding treatment option for the diverse patient populations who suffer from these conditions."
In the ATLAS trial, a similar rate of treatment-emergent adverse events leading to discontinuation of study drug was observed among placebo-treated (1.9 percent) and HUMIRA-treated (1.4 percent) patients. The overall incidence of adverse events reported by patients treated with HUMIRA was higher than the placebo-treated patients. The most common adverse events included nasopharyngitis, injection site reactions and headache.
About Ankylosing Spondylitis
Ankylosing spondylitis, or arthritis of the spine, is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha, has been suggested to play a role in the disease development. AS is a form of arthritis known as spondyloarthritis, which is a group of closely linked rheumatic diseases that can cause pain in the spine and joints as well as ligaments and tendons. A chronic disease, AS primarily affects the spine causing back stiffness and potential deformity over time.
AS is associated with a number of other conditions including peripheral arthritis and enthesitis (inflammation of the muscle-bone insertion). Other associated affected organ systems may include the eyes, intestines and skin.
Important Safety Information
Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four- fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.
The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis and psoriatic arthritis, the safety profile for patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with DMARDs.
HUMIRA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Massachusetts, United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about HUMIRA, including full prescribing information, is available on the Web site rxabbott or in the United States by calling Abbott Medical Information at 1-800-633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
abbott
View drug information on Humira.
четверг, 13 октября 2011 г.
Arthritis Foundation And Takeda Launch First-Ever National Gout Public Service Announcement (PSA) Campaign
The Arthritis Foundation and Takeda Pharmaceuticals North America, Inc. announced the launch of a new educational campaign, Gout Living, to help increase understanding and encourage better management of gout. The campaign, which includes the first-ever gout public service announcements (PSAs), aims to encourage those living with the disease to be proactive about their health. The PSAs, which will be available via television, radio and print outlets, emphasize that living with gout doesn't have to mean missing out on life's special moments.
"Gout is a common yet often overlooked arthritic disease, and the Arthritis Foundation is dedicated to improving the lives of those with arthritis and related diseases, including gout," says John Hardin, M.D., vice president of research of the Arthritis Foundation. "GoutLiving provides people with gout and their loved ones with information about ways to manage gout and keep it under control. Learning about this chronic illness is an important first step, and we are excited to be able to offer new and valuable resources to the gout community."
There are more than 100 types of arthritis, and gout, a painful and chronic disease, is one of them. It is actually the most common form of inflammatory arthritis in men and affects an estimated 6 million people in the United States.
"Takeda is committed to increasing understanding of gout and fostering meaningful dialogue about the disease," says Robert Spanheimer, M.D., vice president of medical and scientific affairs at Takeda. "We are pleased to partner with the Arthritis Foundation to provide tools and resources needed to increase gout education and enhance communication around gout management."
About Gout
Gout is a chronic, metabolic disease affecting approximately 6 million Americans and is the most common form of inflammatory arthritis in men. The underlying cause of gout is hyperuricemia, a condition characterized by elevated levels of uric acid in the blood.
A gout attack, or "flare," occurs when excess uric acid in the body begins to form crystals, triggering an inflammatory response in the joints or soft tissue causing extreme discomfort. While gout can affect several different joints, including elbows, knees and wrists, patients most commonly experience attacks in the big toe. The pain of a gout attack may interfere with everyday activities, including work and family events.
In addition to recommended diet and lifestyle changes, experts recognize that achieving and maintaining a healthy uric acid level in the body of less than 6.0 mg/dL can help reduce the risk of future attacks.
About the Arthritis Foundation
The mission of the Arthritis Foundation is to improve lives through leadership in the prevention, control and cure of arthritis and related diseases.
The Arthritis Foundation is the leading health organization addressing the needs of some 46 million Americans living with doctor-diagnosed arthritis, the nation's most common cause of disability.
The Arthritis Foundation pursues its mission through a focus on:
-- Research: The Arthritis Foundation is the largest nonprofit contributor to arthritis research in the world, advancing cutting-edge research in search of a cure for arthritis.
-- Public Health: The Arthritis Foundation aims to increase public awareness of arthritis as the most common cause of disability, to prevent arthritis whenever possible, and to promote early diagnosis and access to the resources people with arthritis need to cope with their disease.
-- Public Policy: The Arthritis Foundation works at both the national and local levels to advance legislative policy issues on behalf of the 46 million adults and approximately 300,000 children in America with doctor-diagnosed arthritis.
The Arthritis Foundation offers resources to people who live with gout and other forms of arthritis through many communications vehicles, such as the magazine Arthritis Today; through local offices across the country that offer resources and programs for people with arthritis;
Source: The Arthritis Foundation
"Gout is a common yet often overlooked arthritic disease, and the Arthritis Foundation is dedicated to improving the lives of those with arthritis and related diseases, including gout," says John Hardin, M.D., vice president of research of the Arthritis Foundation. "GoutLiving provides people with gout and their loved ones with information about ways to manage gout and keep it under control. Learning about this chronic illness is an important first step, and we are excited to be able to offer new and valuable resources to the gout community."
There are more than 100 types of arthritis, and gout, a painful and chronic disease, is one of them. It is actually the most common form of inflammatory arthritis in men and affects an estimated 6 million people in the United States.
"Takeda is committed to increasing understanding of gout and fostering meaningful dialogue about the disease," says Robert Spanheimer, M.D., vice president of medical and scientific affairs at Takeda. "We are pleased to partner with the Arthritis Foundation to provide tools and resources needed to increase gout education and enhance communication around gout management."
About Gout
Gout is a chronic, metabolic disease affecting approximately 6 million Americans and is the most common form of inflammatory arthritis in men. The underlying cause of gout is hyperuricemia, a condition characterized by elevated levels of uric acid in the blood.
A gout attack, or "flare," occurs when excess uric acid in the body begins to form crystals, triggering an inflammatory response in the joints or soft tissue causing extreme discomfort. While gout can affect several different joints, including elbows, knees and wrists, patients most commonly experience attacks in the big toe. The pain of a gout attack may interfere with everyday activities, including work and family events.
In addition to recommended diet and lifestyle changes, experts recognize that achieving and maintaining a healthy uric acid level in the body of less than 6.0 mg/dL can help reduce the risk of future attacks.
About the Arthritis Foundation
The mission of the Arthritis Foundation is to improve lives through leadership in the prevention, control and cure of arthritis and related diseases.
The Arthritis Foundation is the leading health organization addressing the needs of some 46 million Americans living with doctor-diagnosed arthritis, the nation's most common cause of disability.
The Arthritis Foundation pursues its mission through a focus on:
-- Research: The Arthritis Foundation is the largest nonprofit contributor to arthritis research in the world, advancing cutting-edge research in search of a cure for arthritis.
-- Public Health: The Arthritis Foundation aims to increase public awareness of arthritis as the most common cause of disability, to prevent arthritis whenever possible, and to promote early diagnosis and access to the resources people with arthritis need to cope with their disease.
-- Public Policy: The Arthritis Foundation works at both the national and local levels to advance legislative policy issues on behalf of the 46 million adults and approximately 300,000 children in America with doctor-diagnosed arthritis.
The Arthritis Foundation offers resources to people who live with gout and other forms of arthritis through many communications vehicles, such as the magazine Arthritis Today; through local offices across the country that offer resources and programs for people with arthritis;
Source: The Arthritis Foundation
понедельник, 10 октября 2011 г.
NICE Recommends Treatments For Rheumatoid Arthritis After The Failure Of A TNF Inhibitor
In draft final guidance published today, (25 June 2010) NICE recommends rituximab, adalimumab, etanercept, infliximab and abatacept, in certain circumstances, as possible treatments for rheumatoid arthritis after treatment with a tumour necrosis factor (TNF) inhibitor has failed.
Following consultation on the preliminary draft guidance, the independent appraisal committee has made the following recommendations:
-- Rituximab (MabThera, Roche Products), in combination with methotrexate, is recommended as an option for the treatment of adults with severe active rheumatoid arthritis that has responded inadequately to other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs. Treatment with rituximab should not be given more frequently than every six months and should only be continued if there is an adequate response[1].
-- Adalimumab (Humira, Abbott Laboratories), etanercept (Enbrel, Wyeth Pharmaceuticals), infliximab (Remicade, Schering-Plough) and abatacept (Orencia, Bristol-Myers Squibb) are recommended for the treatment of people with severe active rheumatoid arthritis that has responded inadequately to other DMARDs, including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs and who have a contraindication to rituximab or methotrexate, or when either of these two drugs is withdrawn because of an adverse event. Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response1 six months after the start of therapy.
Dr Carole Longson, Director, Health Technology Evaluation Centre at NICE said: "Around 87,000 people in England and Wales have severe rheumatoid arthritis, which can have a major impact on quality of life. Different people respond in different ways to treatment and the committee heard from clinical experts and patients about the importance of having multiple options available.
"We have already recommended the TNF inhibitors adalimumab, etanercept and infliximab for some people with rheumatoid arthritis as options for use after conventional treatments. The focus of this appraisal was to look at treatment options when a TNF inhibitor has not worked or when it has lost its effect. The evidence suggests that rituximab works in this context and is a cost-effective treatment option.
"However, not all patients are able to take rituximab, and so, following consultation, the appraisal committee has recommended that adalimumab, etanercept, infliximab or abatacept may be given in this context if a patient cannot take rituximab. We hope that this wider choice of options will mean that people will be able to manage their rheumatoid arthritis more effectively."
Notes
-- The guidance is available to view at: guidance.nice.uk/TA/WaveR/61 (from 23 June 2010).
-- It is estimated that 580,000 people in England and Wales have rheumatoid arthritis. Of these, approximately 15%, around 87,000, have severe disease.
-- DAS28 is a disease activity scoring system developed in Europe. It is calculated using a formula that includes counts for 28 tender and swollen joints, an evaluation of general health by the patient (on a scale of 0 to 100) and a measure of circulating inflammatory markers. A DAS28 score greater than 5.1 indicates high disease activity, between 3.2 and 5.1 moderate disease activity, and less than 3.2 low disease activity. A score of less than 2.6 indicates disease remission. An improvement in DAS28 score of 0.6 or less is considered a poor response, and improvements greater than 1.2 points indicate a good response.
-- This appraisal combines an evaluation of adalimumab after the failure of a previous TNF inhibitor with reviews of previous NICE guidance on the use of adalimumab, etanercept and infliximab (technology appraisals TA 36) and also rituximab (technology appraisal 126) and abatacept (technology appraisal 141):
- NICE guidance (technology appraisal 36) does not recommend etanercept or infliximab as treatment options for rheumatoid arthritis after the failure of a TNF inhibitor.
- NICE guidance (technology appraisal 126) recommends the use of rituximab after the failure of a TNF inhibitor.
- NICE guidance (technology appraisal 141) does not recommend the use of abatacept after the failure of a TNF inhibitor.
-- NICE has previously recommended adalimumab, etanercept and infliximab as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs (technology appraisal 130)
The annual acquisition costs of the technologies appraised are:
Rituximab - ??3,492 for one course to ??6,984 for two courses per year
Adalimumab - ??9,295
Etanercept - ??9,295
Infliximab - ??10,072 in the first year, ??7,553 - ??8,812 in subsequent years (annual cost will vary depending on patient's weight)
Abatacept - ??10,171 in the first year, ??9,444 in subsequent years (annual cost will vary depending on patient's weight)
Costs may vary in different settings because of negotiated procurement discounts.
[1] An 'adequate response' is defined as an improvement in disease activity score (DAS28) of 1.2 points or more.
Source:
NICE
View drug information on Enbrel; Humira; Orencia.
Following consultation on the preliminary draft guidance, the independent appraisal committee has made the following recommendations:
-- Rituximab (MabThera, Roche Products), in combination with methotrexate, is recommended as an option for the treatment of adults with severe active rheumatoid arthritis that has responded inadequately to other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs. Treatment with rituximab should not be given more frequently than every six months and should only be continued if there is an adequate response[1].
-- Adalimumab (Humira, Abbott Laboratories), etanercept (Enbrel, Wyeth Pharmaceuticals), infliximab (Remicade, Schering-Plough) and abatacept (Orencia, Bristol-Myers Squibb) are recommended for the treatment of people with severe active rheumatoid arthritis that has responded inadequately to other DMARDs, including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs and who have a contraindication to rituximab or methotrexate, or when either of these two drugs is withdrawn because of an adverse event. Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response1 six months after the start of therapy.
Dr Carole Longson, Director, Health Technology Evaluation Centre at NICE said: "Around 87,000 people in England and Wales have severe rheumatoid arthritis, which can have a major impact on quality of life. Different people respond in different ways to treatment and the committee heard from clinical experts and patients about the importance of having multiple options available.
"We have already recommended the TNF inhibitors adalimumab, etanercept and infliximab for some people with rheumatoid arthritis as options for use after conventional treatments. The focus of this appraisal was to look at treatment options when a TNF inhibitor has not worked or when it has lost its effect. The evidence suggests that rituximab works in this context and is a cost-effective treatment option.
"However, not all patients are able to take rituximab, and so, following consultation, the appraisal committee has recommended that adalimumab, etanercept, infliximab or abatacept may be given in this context if a patient cannot take rituximab. We hope that this wider choice of options will mean that people will be able to manage their rheumatoid arthritis more effectively."
Notes
-- The guidance is available to view at: guidance.nice.uk/TA/WaveR/61 (from 23 June 2010).
-- It is estimated that 580,000 people in England and Wales have rheumatoid arthritis. Of these, approximately 15%, around 87,000, have severe disease.
-- DAS28 is a disease activity scoring system developed in Europe. It is calculated using a formula that includes counts for 28 tender and swollen joints, an evaluation of general health by the patient (on a scale of 0 to 100) and a measure of circulating inflammatory markers. A DAS28 score greater than 5.1 indicates high disease activity, between 3.2 and 5.1 moderate disease activity, and less than 3.2 low disease activity. A score of less than 2.6 indicates disease remission. An improvement in DAS28 score of 0.6 or less is considered a poor response, and improvements greater than 1.2 points indicate a good response.
-- This appraisal combines an evaluation of adalimumab after the failure of a previous TNF inhibitor with reviews of previous NICE guidance on the use of adalimumab, etanercept and infliximab (technology appraisals TA 36) and also rituximab (technology appraisal 126) and abatacept (technology appraisal 141):
- NICE guidance (technology appraisal 36) does not recommend etanercept or infliximab as treatment options for rheumatoid arthritis after the failure of a TNF inhibitor.
- NICE guidance (technology appraisal 126) recommends the use of rituximab after the failure of a TNF inhibitor.
- NICE guidance (technology appraisal 141) does not recommend the use of abatacept after the failure of a TNF inhibitor.
-- NICE has previously recommended adalimumab, etanercept and infliximab as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs (technology appraisal 130)
The annual acquisition costs of the technologies appraised are:
Rituximab - ??3,492 for one course to ??6,984 for two courses per year
Adalimumab - ??9,295
Etanercept - ??9,295
Infliximab - ??10,072 in the first year, ??7,553 - ??8,812 in subsequent years (annual cost will vary depending on patient's weight)
Abatacept - ??10,171 in the first year, ??9,444 in subsequent years (annual cost will vary depending on patient's weight)
Costs may vary in different settings because of negotiated procurement discounts.
[1] An 'adequate response' is defined as an improvement in disease activity score (DAS28) of 1.2 points or more.
Source:
NICE
View drug information on Enbrel; Humira; Orencia.
пятница, 7 октября 2011 г.
New Guidelines For Treating Rheumatoid Arthritis
Proven combinations of medicines and the introduction of new anti-arthritis drugs have significantly improved the treatment of rheumatoid arthritis (RA), according to guidelines issued by the American College of Rheumatology and co-authored by physicians at the University of Alabama at Birmingham (UAB).
Lead author Kenneth Saag, M.D., M.Sc., a professor in the UAB Division of Clinical Immunology and Rheumatology, said the new guidelines update strategies for treating RA with the goal of preventing joint damage and disability.
The new recommendations do not strive to replace individualized medical decisions, Saag said. Instead, they are meant to guide rheumatologists and other health care workers toward the most updated recommendations. The last set of American College of Rheumatology RA treatment guidelines was published in 2002.
"The recommendations developed are not intended to be used in a 'cookbook' or prescriptive manner, or to limit a physician's clinical judgment," Saag said. "They provide guidance based on clinical evidence and expert panel input."
The recommendations focus on several classes of anti-arthritic drugs, including a potent group of agents called disease-modifying anti-rheumatic drugs (DMARDs). Newer genetically engineered DMARDs called biologics often work in combination with earlier therapies. Many anti-arthritic drugs are designed to stop damaging inflammation, and biologics work to interrupt the chain of events that leads to inflammation.
Newer biologics called anti-TNF agents adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade) prevent the production of an immunity protein that plays a role in inflammation.
Some of the key recommendations include:
-- Methotrexate or leflunomide therapy is recommended for most RA patients.
-- Anti-TNF agents etanercept, infliximab, or adalimumab along with methotrexate can be used in new or early RA cases with worsening and severe symptoms.
-- Doctors should not initiate or resume treatment with methotrexate, leflunomide, or biologics if RA patients have active bacterial infection, shingles (herpes-zoster), hepatitis B, hepatitis C and active or latent tuberculosis.
-- Doctors should not prescribe anti-TNF agents to patients with a history of heart failure, lymphoma or multiple sclerosis.
The full list of RA treatment recommendations is available at rheumatology by clicking on practice support, then guidelines.
University of Alabama at Birmingham
701 20th St. S, AB 1320
Birmingham, AL 35294-0113
United States
uab
View drug information on Enbrel; Humira; Remicade.
Lead author Kenneth Saag, M.D., M.Sc., a professor in the UAB Division of Clinical Immunology and Rheumatology, said the new guidelines update strategies for treating RA with the goal of preventing joint damage and disability.
The new recommendations do not strive to replace individualized medical decisions, Saag said. Instead, they are meant to guide rheumatologists and other health care workers toward the most updated recommendations. The last set of American College of Rheumatology RA treatment guidelines was published in 2002.
"The recommendations developed are not intended to be used in a 'cookbook' or prescriptive manner, or to limit a physician's clinical judgment," Saag said. "They provide guidance based on clinical evidence and expert panel input."
The recommendations focus on several classes of anti-arthritic drugs, including a potent group of agents called disease-modifying anti-rheumatic drugs (DMARDs). Newer genetically engineered DMARDs called biologics often work in combination with earlier therapies. Many anti-arthritic drugs are designed to stop damaging inflammation, and biologics work to interrupt the chain of events that leads to inflammation.
Newer biologics called anti-TNF agents adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade) prevent the production of an immunity protein that plays a role in inflammation.
Some of the key recommendations include:
-- Methotrexate or leflunomide therapy is recommended for most RA patients.
-- Anti-TNF agents etanercept, infliximab, or adalimumab along with methotrexate can be used in new or early RA cases with worsening and severe symptoms.
-- Doctors should not initiate or resume treatment with methotrexate, leflunomide, or biologics if RA patients have active bacterial infection, shingles (herpes-zoster), hepatitis B, hepatitis C and active or latent tuberculosis.
-- Doctors should not prescribe anti-TNF agents to patients with a history of heart failure, lymphoma or multiple sclerosis.
The full list of RA treatment recommendations is available at rheumatology by clicking on practice support, then guidelines.
University of Alabama at Birmingham
701 20th St. S, AB 1320
Birmingham, AL 35294-0113
United States
uab
View drug information on Enbrel; Humira; Remicade.
вторник, 4 октября 2011 г.
Study Results Suggest Oral Salmon Calcitonin Using Eligen(R) Drug Delivery Technology May Reduce Cartilage And Bone Degradation In Osteoarthritis
Emisphere Technologies, Inc. (OTCBB: EMIS) announced study results in which twice-daily oral salmon calcitonin using Emisphere's proprietary Eligen® Drug Delivery Technology significantly suppressed markers of cartilage and bone degradation versus placebo in men and women with osteoarthritis, the most common form of arthritis. The study, a Phase I, placebo-controlled, double-blind, double-dummy, randomized, gender-stratified clinical trial, was conducted on behalf of Emisphere's partner Novartis Pharma AG by Nordic Bioscience, and published online in the September 2009 issue of Osteoarthritis and Cartilage.
A total of 73 male and female subjects aged 57 to 75 years with painful osteoarthritis of the knee received twice-daily 0.6 mg or 0.8 mg doses of oral salmon calcitonin with the Eligen® Technology or placebo administered over 14 days. Doses of 0.8mg compared with 0.6mg produced significantly higher Cmax and AUC(0-4 hrs), of calcitonin, P=0.03. This resulted in significant reductions in CTX-I and CTX-II which are biochemical markers of bone degradation and of cartilage degradation, respectively. Gender had no observable influence on results. Oral sCT doses were well tolerated; 44 adverse events and no serious adverse events were reported in this study. For further details please consult the original publication which is available online (Karsdal MA et al; The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study; Osteoarthritis and Cartilage; available online September 1, 2009).
"We are pleased that emerging data continue to indicate oral salmon calcitonin in combination with our absorption-enhancing Eligen® Technology may be a potential therapeutic option for women and men with osteoarthritis, which affects more than 20 million people in the United States," said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies. "We look forward to further validating these results in the extensive ongoing Phase III clinical trial program."
Emisphere announced in June 2009 that recruitment had been completed for the planned second multi-center Phase III study exploring the safety and efficacy of oral salmon calcitonin using the Eligen® Technology to treat patients with osteoarthritis of the knee. Enrollment in the first Phase III trial for osteoarthritis was completed in September 2008.
Oral salmon calcitonin using Eligen® Technology is also being investigated in a Phase III study for osteoporosis being conducted by Novartis Pharma AG and Nordic Bioscience.
About Osteoarthritis
Osteoarthritis ("OA") is a clinical syndrome in which low-grade inflammation results in joint pain, caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when the patient bears weight upon the joints, when walking or standing. OA affects nearly 21 million people in the United States, accounting for approximately 15 percent of visits to primary care physicians. It is estimated that 80 percent of the population will have radiographic evidence of OA by age 65.
Bone and cartilage degradation are normally tightly coupled in the pathogenesis of OA, indicating an optimal approach to counter the progression of OA may be to target both bone and cartilage degeneration. Recent preclinical experience and preliminary data from clinical settings suggest that calcitonin may have positive effects on both bone and cartilage.
Source
Emisphere Technologies, Inc.
A total of 73 male and female subjects aged 57 to 75 years with painful osteoarthritis of the knee received twice-daily 0.6 mg or 0.8 mg doses of oral salmon calcitonin with the Eligen® Technology or placebo administered over 14 days. Doses of 0.8mg compared with 0.6mg produced significantly higher Cmax and AUC(0-4 hrs), of calcitonin, P=0.03. This resulted in significant reductions in CTX-I and CTX-II which are biochemical markers of bone degradation and of cartilage degradation, respectively. Gender had no observable influence on results. Oral sCT doses were well tolerated; 44 adverse events and no serious adverse events were reported in this study. For further details please consult the original publication which is available online (Karsdal MA et al; The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study; Osteoarthritis and Cartilage; available online September 1, 2009).
"We are pleased that emerging data continue to indicate oral salmon calcitonin in combination with our absorption-enhancing Eligen® Technology may be a potential therapeutic option for women and men with osteoarthritis, which affects more than 20 million people in the United States," said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies. "We look forward to further validating these results in the extensive ongoing Phase III clinical trial program."
Emisphere announced in June 2009 that recruitment had been completed for the planned second multi-center Phase III study exploring the safety and efficacy of oral salmon calcitonin using the Eligen® Technology to treat patients with osteoarthritis of the knee. Enrollment in the first Phase III trial for osteoarthritis was completed in September 2008.
Oral salmon calcitonin using Eligen® Technology is also being investigated in a Phase III study for osteoporosis being conducted by Novartis Pharma AG and Nordic Bioscience.
About Osteoarthritis
Osteoarthritis ("OA") is a clinical syndrome in which low-grade inflammation results in joint pain, caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when the patient bears weight upon the joints, when walking or standing. OA affects nearly 21 million people in the United States, accounting for approximately 15 percent of visits to primary care physicians. It is estimated that 80 percent of the population will have radiographic evidence of OA by age 65.
Bone and cartilage degradation are normally tightly coupled in the pathogenesis of OA, indicating an optimal approach to counter the progression of OA may be to target both bone and cartilage degeneration. Recent preclinical experience and preliminary data from clinical settings suggest that calcitonin may have positive effects on both bone and cartilage.
Source
Emisphere Technologies, Inc.
суббота, 1 октября 2011 г.
New Surgical Option For Wrist Arthritis
Breaking a fall, such as a tumble on the sidewalk, with your hands and wrists is everyone's natural reflex. But, if you fall hard enough, you'll often fracture your radius bone, or even one of the smaller wrist bones and wrist ligaments. Left untreated, these injuries could lead to disabling wrist arthritis.
For patients who develop wrist arthritis, a new surgical option known as OCRPRC (OsteoChondral Resurfacing in Proximal Row Carpectomy) is available at NewYork-Presbyterian Hospital/Columbia University Medical Center, where it is offered by one of the orthopedic surgeons who originally developed and described the technique -- Dr. Peter Tang. His research shows that the procedure reduces pain and improves hand function.
"I often see patients who had a wrist injury in the past who either did not seek medical attention or whose original injury was not diagnosed. As with most things in medicine, the earlier a diagnosis is made, the better the outcome. So if you continue to have pain after a month, you should make an appointment to see a hand surgeon for an evaluation," says Dr. Tang, who is an orthopedic hand surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of orthopedic surgery at Columbia University College of Physicians and Surgeons.
Because the biomechanics of the wrist is both delicate and complex, an alteration in the normal anatomy can lead to arthritis. Once disabling arthritis develops, surgery cannot simply fix the injured structure, but rather must remove the arthritis and improve wrist function. The two most common operations for wrist arthritis are a partial fusion of the small wrist bones (intercarpal fusion) and excision of the first row of carpal bones (proximal row carpectomy, or PRC). There are various reasons to choose one operation over the other, but PRC has a quicker recovery, may be better for older patients, gives equal grip strength to intercarpal fusion, and usually results in more wrist motion.
Once the three carpal bones are removed during the PRC procedure, the capitate bone becomes the point where the wrist articulates with the arm; as such, it is important that the arthritis has not progressed to the capitate bone.
For these patients whose arthritis has progressed, Dr. Tang has adapted a cartilage-grafting technique that is used effectively in sports medicine treatments for cartilage disorders in the knee, ankle and elbow. The results are promising, according to his study in the Journal of Hand Surgery, with improvement in grip strength and decrease in pain levels.
"The goal of this new procedure is to give the best possible outcome by improving the cartilage status of the capitate bone. Another plus is that we do not have to take the graft from another part of the body. Even though we take out the three carpal bones for arthritis, there is usually one area of the bones where we can find undamaged cartilage for grafting," says Dr. Tang.
The study followed eight patients who underwent osteochondral resurfacing over 18 months. Preoperatively, seven patients described their pain as moderate to severe, while postoperatively, seven patients described their pain as mild to no pain, and one patient described the pain as moderate. Preoperative grip strength increased from 62 percent of their healthy side to postoperatively, 71 percent. Preoperative Mayo wrist score improved from a score of 51, which rates as "poor," to a postoperative score of 68, which rates as "fair."
The Journal of Hand Surgery study is co-authored by Dr. Joseph E. Imbriglia who is clinical professor of orthopaedic surgery and director of the Hand and Upper Extremity Fellowship Program at the University of Pittsburgh School of Medicine, where Dr. Tang did his training. Interestingly, Dr. Imbriglia did both his orthopaedic residency and hand fellowship training at Columbia University College of Physicians and Surgeons.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit cumc.columbia.
NewYork Presbyterian Hospital
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments -- more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit nyp.
NewYork-Presbyterian Hospital
627 W 165th St., SB-621
New York
NY 10032
United States
nyp
For patients who develop wrist arthritis, a new surgical option known as OCRPRC (OsteoChondral Resurfacing in Proximal Row Carpectomy) is available at NewYork-Presbyterian Hospital/Columbia University Medical Center, where it is offered by one of the orthopedic surgeons who originally developed and described the technique -- Dr. Peter Tang. His research shows that the procedure reduces pain and improves hand function.
"I often see patients who had a wrist injury in the past who either did not seek medical attention or whose original injury was not diagnosed. As with most things in medicine, the earlier a diagnosis is made, the better the outcome. So if you continue to have pain after a month, you should make an appointment to see a hand surgeon for an evaluation," says Dr. Tang, who is an orthopedic hand surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of orthopedic surgery at Columbia University College of Physicians and Surgeons.
Because the biomechanics of the wrist is both delicate and complex, an alteration in the normal anatomy can lead to arthritis. Once disabling arthritis develops, surgery cannot simply fix the injured structure, but rather must remove the arthritis and improve wrist function. The two most common operations for wrist arthritis are a partial fusion of the small wrist bones (intercarpal fusion) and excision of the first row of carpal bones (proximal row carpectomy, or PRC). There are various reasons to choose one operation over the other, but PRC has a quicker recovery, may be better for older patients, gives equal grip strength to intercarpal fusion, and usually results in more wrist motion.
Once the three carpal bones are removed during the PRC procedure, the capitate bone becomes the point where the wrist articulates with the arm; as such, it is important that the arthritis has not progressed to the capitate bone.
For these patients whose arthritis has progressed, Dr. Tang has adapted a cartilage-grafting technique that is used effectively in sports medicine treatments for cartilage disorders in the knee, ankle and elbow. The results are promising, according to his study in the Journal of Hand Surgery, with improvement in grip strength and decrease in pain levels.
"The goal of this new procedure is to give the best possible outcome by improving the cartilage status of the capitate bone. Another plus is that we do not have to take the graft from another part of the body. Even though we take out the three carpal bones for arthritis, there is usually one area of the bones where we can find undamaged cartilage for grafting," says Dr. Tang.
The study followed eight patients who underwent osteochondral resurfacing over 18 months. Preoperatively, seven patients described their pain as moderate to severe, while postoperatively, seven patients described their pain as mild to no pain, and one patient described the pain as moderate. Preoperative grip strength increased from 62 percent of their healthy side to postoperatively, 71 percent. Preoperative Mayo wrist score improved from a score of 51, which rates as "poor," to a postoperative score of 68, which rates as "fair."
The Journal of Hand Surgery study is co-authored by Dr. Joseph E. Imbriglia who is clinical professor of orthopaedic surgery and director of the Hand and Upper Extremity Fellowship Program at the University of Pittsburgh School of Medicine, where Dr. Tang did his training. Interestingly, Dr. Imbriglia did both his orthopaedic residency and hand fellowship training at Columbia University College of Physicians and Surgeons.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit cumc.columbia.
NewYork Presbyterian Hospital
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments -- more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit nyp.
NewYork-Presbyterian Hospital
627 W 165th St., SB-621
New York
NY 10032
United States
nyp
среда, 28 сентября 2011 г.
Osteoarthritis Not Relieved By Knee Surgery
In what has been described as a landmark study, scientists in Canada have found that a routine knee operation undergone by many patients with
osteoarthritis does not relieve joint pain or improve knee function.
The study was the work of researchers at the The University of Western Ontario and Lawson Health Research Institute, both in London, Ontario,
Canada, and appears in the September 11th issue of the New England Journal of Medicine, NEJM.
The study was designed by the late Dr Sandy Kirkley, orthopaedic surgeon and arthroscopy specialist, and was coordinated by the Clinical Trials
Group of Robarts Research Institute. A research team comprising orthopaedic surgeons, rheumatologists and physiotherapists, carried out the study
at the Fowler Kennedy Sport Medicine Clinic at London Health Sciences Centre (LHSC).
Co-author Dr Brian Feagan, Clinical Trials Director at the Robarts Research Institute at Western, and a professor in the Departments of Medicine, and
Epidemiology and Biostatistics at Western's Schulich School of Medicine & Dentistry, said:
"This study provides definitive evidence that arthroscopic surgery provides no additional therapeutic value when added to physical therapy and
medication for patients with moderate osteoarthritis of the knee."
Ten per cent of Canadians, and 27 million Americans are living with osteoarthritis, the most common type of arthritis.
Arthroscopic surgery is a minimally invasive surgical operation where the surgeon makes a small incision and inserts an arthroscope (long tube with a
camera on the end and room to pass surgical instruments through as well) in the knee joint and them removes fragments of cartilage and smooths
down the surfaces of the joints.
For the study, which ran from 1999 to 2007, the researchers treated 178 male and female patients of average age 60 who came from the London
area and had moderate to severe arthritis of the knee.
The patients were randomly assigned to receive either surgical lavage and arthroscopic debridement together with optimized physical and medical
therapy (92 treatment group patients) or to receive physical and medical therapy without surgery (86 control group patients).
The patients then completed symptom assessment questionnaires at various points post-treatment, for up to two years. One
questionnaire was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and another questionnaire was the Short Form-36
(SF-36) Physical Component Summary score.
The total WOMAC score ranges from 0 to 2400, with higher scores meaning more severe symptoms. This was the primary outcome measure. The SF-36 Physical Component Summary score can range from 0 to 100, with the higher scores indicating better quality of life. This was part of the
secondary outcome measures.
The results showed that:
Of the 92 patients assigned to surgery, 6 did not have it.
All 86 patients in the control group had physical and medical therapy only, as planned.
After 2 years of follow up, the mean (plus or minus standard deviation) WOMAC score for the surgery group was 874 plus or minus 624,
compared with 897 plus or minus 583 for the control group.
The absolute difference between the surgery group WOMAC score minus the control group WOMAC score at 2 years was a statistically
insignificant -23 plus or minus 605 (95% confidence interval ranged from -208 to 161; P=0.22 after baseline and grade of severity
adjustments).
The SF-36 Physical Component Summary score for the surgery group was 37.0 plus or minus 11.4 and 37.2 plus or minus 10.6 for the control
group at 2 years.
The absolute difference in SF-36 Physical Component Summary scores in the surgery group minus the control group at 2 years was a statistically
insignificant -0.2 plus or minus 11.1 (95% confidence interval ranged from -3.6 to 3.2; P=0.93).
Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show better statistically significant results for the
surgery group.
The authors concluded that:
"Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy. "
"Based on the available evidence, we believe that the resources currently allocated towards arthroscopic surgery for osteoarthritis would be better
directed elsewhere," they said.
In other words, at several stages during the 2 year follow up, the researchers found both patient groups experienced comparable improvements in
joint pain, stiffness, and function, but there was no significant benefit from surgery.
Co-author and orthopaedic surgeon Dr Bob Litchfield, who is also Medical Director of the Fowler Kennedy Sport Medicine Clinic, pointed out that the
study only looked at knee problems that were arthritis related :
"Although this study did not show a significant therapeutic benefit of arthroscopic debridement in this patient population, knee arthroscopy is still
beneficial in many other conditions affecting the knee, such as meniscal repair and resection, and ligament reconstruction."
Litchfield is also a professor in the Department of Surgery at Schulich Medicine & Dentistry and a scientist with the Lawson Health Research Institute.
"As surgeons, we need to know when things are working and when they're not. If this particular technique is not working for this subgroup of patients,
we better come up with something else that does," he added.
An earlier study (the "Moseley study") published in 2002 showing similar results was considered methodologically flawed and rejected by the medical
community and arthroscopic surgery is still routinely performed to treat joint pain and stiffness.
In 2006/2007, Ontario Health Insurance Plan (OHIP) spent 7.9 million dollars on this procedure alone, said the researchers in a press
statement.
"A Randomized Trial of Arthroscopic Surgery for Osteoarthritis of the Knee."
Kirkley, Alexandra, Birmingham, Trevor B., Litchfield, Robert B., Giffin, J. Robert, Willits, Kevin R., Wong, Cindy J., Feagan, Brian G., Donner, Allan,
Griffin, Sharon H., D'Ascanio, Linda M., Pope, Janet E., Fowler, Peter J.
N Engl J Med 2008 359: 1097-1107.
Volume 359, Number 11, pages 1097-1107, September 11, 2008.
Click here for Abstract.
Source: The University of Western Ontario, Journal abstract.
Written by: , PhD
osteoarthritis does not relieve joint pain or improve knee function.
The study was the work of researchers at the The University of Western Ontario and Lawson Health Research Institute, both in London, Ontario,
Canada, and appears in the September 11th issue of the New England Journal of Medicine, NEJM.
The study was designed by the late Dr Sandy Kirkley, orthopaedic surgeon and arthroscopy specialist, and was coordinated by the Clinical Trials
Group of Robarts Research Institute. A research team comprising orthopaedic surgeons, rheumatologists and physiotherapists, carried out the study
at the Fowler Kennedy Sport Medicine Clinic at London Health Sciences Centre (LHSC).
Co-author Dr Brian Feagan, Clinical Trials Director at the Robarts Research Institute at Western, and a professor in the Departments of Medicine, and
Epidemiology and Biostatistics at Western's Schulich School of Medicine & Dentistry, said:
"This study provides definitive evidence that arthroscopic surgery provides no additional therapeutic value when added to physical therapy and
medication for patients with moderate osteoarthritis of the knee."
Ten per cent of Canadians, and 27 million Americans are living with osteoarthritis, the most common type of arthritis.
Arthroscopic surgery is a minimally invasive surgical operation where the surgeon makes a small incision and inserts an arthroscope (long tube with a
camera on the end and room to pass surgical instruments through as well) in the knee joint and them removes fragments of cartilage and smooths
down the surfaces of the joints.
For the study, which ran from 1999 to 2007, the researchers treated 178 male and female patients of average age 60 who came from the London
area and had moderate to severe arthritis of the knee.
The patients were randomly assigned to receive either surgical lavage and arthroscopic debridement together with optimized physical and medical
therapy (92 treatment group patients) or to receive physical and medical therapy without surgery (86 control group patients).
The patients then completed symptom assessment questionnaires at various points post-treatment, for up to two years. One
questionnaire was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and another questionnaire was the Short Form-36
(SF-36) Physical Component Summary score.
The total WOMAC score ranges from 0 to 2400, with higher scores meaning more severe symptoms. This was the primary outcome measure. The SF-36 Physical Component Summary score can range from 0 to 100, with the higher scores indicating better quality of life. This was part of the
secondary outcome measures.
The results showed that:
Of the 92 patients assigned to surgery, 6 did not have it.
All 86 patients in the control group had physical and medical therapy only, as planned.
After 2 years of follow up, the mean (plus or minus standard deviation) WOMAC score for the surgery group was 874 plus or minus 624,
compared with 897 plus or minus 583 for the control group.
The absolute difference between the surgery group WOMAC score minus the control group WOMAC score at 2 years was a statistically
insignificant -23 plus or minus 605 (95% confidence interval ranged from -208 to 161; P=0.22 after baseline and grade of severity
adjustments).
The SF-36 Physical Component Summary score for the surgery group was 37.0 plus or minus 11.4 and 37.2 plus or minus 10.6 for the control
group at 2 years.
The absolute difference in SF-36 Physical Component Summary scores in the surgery group minus the control group at 2 years was a statistically
insignificant -0.2 plus or minus 11.1 (95% confidence interval ranged from -3.6 to 3.2; P=0.93).
Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show better statistically significant results for the
surgery group.
The authors concluded that:
"Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy. "
"Based on the available evidence, we believe that the resources currently allocated towards arthroscopic surgery for osteoarthritis would be better
directed elsewhere," they said.
In other words, at several stages during the 2 year follow up, the researchers found both patient groups experienced comparable improvements in
joint pain, stiffness, and function, but there was no significant benefit from surgery.
Co-author and orthopaedic surgeon Dr Bob Litchfield, who is also Medical Director of the Fowler Kennedy Sport Medicine Clinic, pointed out that the
study only looked at knee problems that were arthritis related :
"Although this study did not show a significant therapeutic benefit of arthroscopic debridement in this patient population, knee arthroscopy is still
beneficial in many other conditions affecting the knee, such as meniscal repair and resection, and ligament reconstruction."
Litchfield is also a professor in the Department of Surgery at Schulich Medicine & Dentistry and a scientist with the Lawson Health Research Institute.
"As surgeons, we need to know when things are working and when they're not. If this particular technique is not working for this subgroup of patients,
we better come up with something else that does," he added.
An earlier study (the "Moseley study") published in 2002 showing similar results was considered methodologically flawed and rejected by the medical
community and arthroscopic surgery is still routinely performed to treat joint pain and stiffness.
In 2006/2007, Ontario Health Insurance Plan (OHIP) spent 7.9 million dollars on this procedure alone, said the researchers in a press
statement.
"A Randomized Trial of Arthroscopic Surgery for Osteoarthritis of the Knee."
Kirkley, Alexandra, Birmingham, Trevor B., Litchfield, Robert B., Giffin, J. Robert, Willits, Kevin R., Wong, Cindy J., Feagan, Brian G., Donner, Allan,
Griffin, Sharon H., D'Ascanio, Linda M., Pope, Janet E., Fowler, Peter J.
N Engl J Med 2008 359: 1097-1107.
Volume 359, Number 11, pages 1097-1107, September 11, 2008.
Click here for Abstract.
Source: The University of Western Ontario, Journal abstract.
Written by: , PhD
воскресенье, 25 сентября 2011 г.
Intelligent Therapies With Virtual Reality For The Psychological Treatment Of Patients Suffering From Fibromyalgia
Researchers of the Labpsictec at the Universitat Jaume I of Castellon (UJI) and the LahHuman Group at the Universidad Politecnica of Valencia (UPV) and the University of Valencia (UVEG) have developed a new therapy based on the use of mobile devices and virtual reality for the psychological treatment of patients suffering from fibromyalgia. This therapy is currently being validated by researchers of the UJI and the University of the Balearic Islands (UIB) with a group of 24 patients and it counts on the essential collaboration of the Rheumatology Department of the Hospital General of Castell??n, supervised by the medical doctor Belmonte.
Fibromyalgia is a complex and chonic pain syndrome which causes generalized pain and deep exhaustion, among other symptoms. It is a serious public health problem, more usual among adult women, and which causes significant negative psychologicla effects. In fact, 35% of affected patients suffer from depressive and anxious syndrome.
"Our aim is to achieve that woman patients learn strategies to face the pain which are an alternative to those they use and which are adaptive in order to improve their physical and mental state and their quality of life", points out Beatriz Rey, researcher of the LabHuman of the UPV.
The method developed by the researchers is made of three applications. The first one is an evaluation system of the chronic pain key factors through mobile devices. It is based on a commercial PDA and a made-to-measure device. The device monitors the degree of psysical activity (accelerometer) and communicates with the PDA via Bluethooth.
The PDA runs an application that offers some questions the patient has to answer three times a week: intensity of pain (on a scale from 0 to 10), intensity of fatigue (on a scale from 0 to 10) and mood (on a scale from 1 to 7; in this case, the application shows a series of emoticons). The answers to each three questions are stored in the PDA. When the user goes to the medical office, the PDA can be synchonized with the computer of the medical and the data can be stored in a server.
It has been designed a new version of the Virtual Reality system EMMA to induce positive emotions on woman patients that works together with this system. "The psychologist supervises the group sessions using a system of unique screen projection", points out Azucena Garc?a-Palacios researcher of the Labpsitec of the UJI.
Those sessions are carefully guided and use contents (texts, sounds, videos, music and images, etc) selected to induce positive emotions. The therapist is present during the session and guides its development. During each session, the system helps the woman patients to consider a feasible objective they must fulfil before taking part on the next one. Woman patients will follow a treatment of three weeks with two sessions a week for making an evaluation of the system.
The therapy also has an application of telepsychology (intelligent therapy) through mobile devices in order patients to continue the treatment out of the doctor's office, such as from home. "The application is run in the PDA and also allows watching videos on the screen. The videos are fragments of the treatment sessions with EMMA, which are used to induce positive emotions along sessions", points Rosa Ba?±os of the UVEG.
Source: Universitat Jaume I
Fibromyalgia is a complex and chonic pain syndrome which causes generalized pain and deep exhaustion, among other symptoms. It is a serious public health problem, more usual among adult women, and which causes significant negative psychologicla effects. In fact, 35% of affected patients suffer from depressive and anxious syndrome.
"Our aim is to achieve that woman patients learn strategies to face the pain which are an alternative to those they use and which are adaptive in order to improve their physical and mental state and their quality of life", points out Beatriz Rey, researcher of the LabHuman of the UPV.
The method developed by the researchers is made of three applications. The first one is an evaluation system of the chronic pain key factors through mobile devices. It is based on a commercial PDA and a made-to-measure device. The device monitors the degree of psysical activity (accelerometer) and communicates with the PDA via Bluethooth.
The PDA runs an application that offers some questions the patient has to answer three times a week: intensity of pain (on a scale from 0 to 10), intensity of fatigue (on a scale from 0 to 10) and mood (on a scale from 1 to 7; in this case, the application shows a series of emoticons). The answers to each three questions are stored in the PDA. When the user goes to the medical office, the PDA can be synchonized with the computer of the medical and the data can be stored in a server.
It has been designed a new version of the Virtual Reality system EMMA to induce positive emotions on woman patients that works together with this system. "The psychologist supervises the group sessions using a system of unique screen projection", points out Azucena Garc?a-Palacios researcher of the Labpsitec of the UJI.
Those sessions are carefully guided and use contents (texts, sounds, videos, music and images, etc) selected to induce positive emotions. The therapist is present during the session and guides its development. During each session, the system helps the woman patients to consider a feasible objective they must fulfil before taking part on the next one. Woman patients will follow a treatment of three weeks with two sessions a week for making an evaluation of the system.
The therapy also has an application of telepsychology (intelligent therapy) through mobile devices in order patients to continue the treatment out of the doctor's office, such as from home. "The application is run in the PDA and also allows watching videos on the screen. The videos are fragments of the treatment sessions with EMMA, which are used to induce positive emotions along sessions", points Rosa Ba?±os of the UVEG.
Source: Universitat Jaume I
четверг, 22 сентября 2011 г.
Results Of Golimumab Clinical Trial For Psoriatic Arthritis Symptoms
Patients with active psoriatic arthritis receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) experienced significant and sustained improvements in the joint and skin manifestations of the disease, according to findings from the largest Phase 3 biologic study ever completed in subjects with psoriatic arthritis. Findings presented at the American College of Rheumatology (ACR) Annual Scientific Meeting showed that at week 14 of the 405-patient study in subjects with active psoriatic arthritis, 51 percent of patients receiving golimumab 50 mg and 45 percent of patients receiving golimumab 100 mg experienced at least 20 percent improvement in arthritis signs and symptoms (ACR 20) compared with 9 percent of patients receiving placebo (P < 0.001 for both comparisons). Golimumab-treated patients maintained significant improvements in arthritis through week 24 and also showed substantial and sustained improvements in skin and nail psoriatic disease (as measured by a 75 percent reduction in Psoriasis Area and Severity Index [PASI 75] in patients with baseline body surface area with psoriasis of at least three percent, and the Nail Psoriasis Severity Index [NAPSI]).
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.
"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' approach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."
Joint and Psoriatic Improvements
Initial improvements as measured by ACR 20 at week 14 persisted through six months. At week 24, 52 percent and 61 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 20, compared with 12 percent of patients receiving placebo (P < 0.001). Significant improvements were observed in ACR 50 and ACR 70 measures at the same time points. At week 14, 30 percent and 28 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 50, compared with 2 percent of patients receiving placebo (P < 0.001). At week 24, the results persisted with 32 percent and 38 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieving ACR 50 as compared with four percent of patients receiving placebo (P < 0.001). ACR 70, a more stringent response criterion, was achieved at week 14 by 12 percent of patients receiving golimumab 50 mg and 17 percent receiving golimumab 100 mg, compared with 1 percent of patients receiving placebo (P < 0.001). At week 24, 19 percent of patients receiving golimumab 50 mg and 21 percent of patients receiving golimumab 100 mg achieved ACR 70 as compared with 1 percent of patients receiving placebo (P < 0.001).
Patients receiving both doses of golimumab also experienced improvements in enthesitis and dactylitis, two common disease manifestations causing pain and swelling. Enthesitis, an inflammation of a tendon, ligament or joint capsule insertion to the bone and dactylitis, a swelling of digits in the hands or feet, are estimated to affect more than one-third of people with psoriatic arthritis. At baseline, 78 percent (placebo group), 75 percent (golimumab 50 mg group) and 79 percent (golimumab 100 mg group) of study subjects presented with enthesitis (at least one tender body enthesitis site) as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index modified for Psoriatic Arthritis; 34 percent (placebo group), 34 percent (golimumab 50 mg group) and 34 percent (golimumab 100 mg group) of subjects presented with dactylitis at baseline.
Both golimumab doses were significantly better than placebo in improvement of enthesitis as measured by percent change in the psoriatic arthritis modified MASES Index.
At week 14, the mean improvement in enthesitis was 44 percent among patients receiving golimumab 50 mg and 33 percent among patients receiving golimumab 100 mg, compared with a 19 percent worsening in patients receiving placebo (P < 0.001). At week 24, the mean improvements in enthesitis were 46 percent for patients receiving golimumab 50 mg and 52 percent among patients receiving golimumab 100 mg, compared with a 13 percent worsening in placebo patients (P < 0.001). The golimumab 100 mg dose significantly improved dactylitis measured by percent change in dactylitis score compared with placebo at week 14 (66 percent versus 5 percent; P = 0.009) and at week 24 (82 percent versus 28 percent; P < 0.001). There was a trend towards improvement in dactylitis for 50 mg golimumab dose at week 14 and 24 but the comparisons with placebo did not reach statistical significance.
In addition to improvements in joint symptoms, a substantial proportion of golimumab-treated patients experienced significant improvement in skin manifestations of the disease. Among a subset of the study population with at least three percent of body surface area involved by psoriasis at baseline, 40 percent and 58 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved PASI 75 at week 14, compared with 3 percent of patients receiving placebo (P < 0.001). At week 24, PASI 75 responses improved to 56 percent (golimumab 50 mg) and 66 percent (golimumab 100 mg), compared with 1 percent of placebo patients (P < 0.001). In additional analyses, patients receiving golimumab 50 mg and golimumab 100 also experienced improvements in nail psoriasis as measured by NAPSI and these improvements were sustained over time.
"These Phase 3 data show that once monthly subcutaneous administrations of golimumab 50 mg and golimumab 100 mg significantly improved articular and psoriatic manifestations in patients with psoriatic arthritis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "We are encouraged by these results and believe golimumab holds great promise as a new anti-TNF-alpha therapy for physicians and patients in need of additional therapeutic options."
Disease Activity and Physical Function Improvements
The majority of golimumab-treated patients in the study were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28), which measures tender and swollen joints and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 14 weeks of treatment, 66 percent of patients receiving golimumab 50 mg were DAS28 responders, as were 67 percent of patients receiving the 100 mg dose, compared with 24 percent of patients receiving placebo (P < 0.001). At week 24, 64 percent and 78 percent of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS28 responders, compared with 24 percent of patients receiving placebo (P < 0.001).
Patients receiving golimumab in the study also experienced significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 14, patients receiving golimumab 50 mg experienced a mean improvement of 0.31 and patients receiving golimumab 100 mg experienced a mean improvement of 0.38 in HAQ score, compared with an improvement of only 0.04 among placebo patients (P < 0.001). At week 24, the improvements were 0.33 and 0.39 in the respective treatment groups, compared with worsening in HAQ score of -0.01 among patients receiving placebo (P < 0.001). HAQ assesses the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). An improvement in HAQ of at least 0.3 indicates clinically meaningful improvement in physical function.
About the GO-REVEAL Trial
The Golimumab -- A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial involved 405 adults with psoriatic arthritis. Subjects with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 cm in diameter were randomly assigned to receive SC injections of placebo or golimumab (50 or 100 mg) at weeks 0, 4, 8, 12, 16 and 20. At week 16, patients with inadequate arthritis response were switched to golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg (patients originally receiving golimumab 50 mg). The primary endpoint was ACR 20 response at week 14 for combined golimumab groups and individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, golimumab was generally well-tolerated, with two percent of golimumab-treated patients experiencing serious adverse events compared with six percent of patients in the placebo group. Injection site reactions occurred in five percent of patients receiving golimumab and three percent of patients receiving placebo. One case of prostate cancer and two cases of basal cell carcinoma were reported in golimumab-treated patients. There were no reports of tuberculosis or opportunistic infections through week 24.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.
About Golimumab
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
About Centocor
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at sec/ or jnj/. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is schering-plough/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of golimumab. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
Source: Brian Kenney
Centocor, Inc.
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.
"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' approach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."
Joint and Psoriatic Improvements
Initial improvements as measured by ACR 20 at week 14 persisted through six months. At week 24, 52 percent and 61 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 20, compared with 12 percent of patients receiving placebo (P < 0.001). Significant improvements were observed in ACR 50 and ACR 70 measures at the same time points. At week 14, 30 percent and 28 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 50, compared with 2 percent of patients receiving placebo (P < 0.001). At week 24, the results persisted with 32 percent and 38 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieving ACR 50 as compared with four percent of patients receiving placebo (P < 0.001). ACR 70, a more stringent response criterion, was achieved at week 14 by 12 percent of patients receiving golimumab 50 mg and 17 percent receiving golimumab 100 mg, compared with 1 percent of patients receiving placebo (P < 0.001). At week 24, 19 percent of patients receiving golimumab 50 mg and 21 percent of patients receiving golimumab 100 mg achieved ACR 70 as compared with 1 percent of patients receiving placebo (P < 0.001).
Patients receiving both doses of golimumab also experienced improvements in enthesitis and dactylitis, two common disease manifestations causing pain and swelling. Enthesitis, an inflammation of a tendon, ligament or joint capsule insertion to the bone and dactylitis, a swelling of digits in the hands or feet, are estimated to affect more than one-third of people with psoriatic arthritis. At baseline, 78 percent (placebo group), 75 percent (golimumab 50 mg group) and 79 percent (golimumab 100 mg group) of study subjects presented with enthesitis (at least one tender body enthesitis site) as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index modified for Psoriatic Arthritis; 34 percent (placebo group), 34 percent (golimumab 50 mg group) and 34 percent (golimumab 100 mg group) of subjects presented with dactylitis at baseline.
Both golimumab doses were significantly better than placebo in improvement of enthesitis as measured by percent change in the psoriatic arthritis modified MASES Index.
At week 14, the mean improvement in enthesitis was 44 percent among patients receiving golimumab 50 mg and 33 percent among patients receiving golimumab 100 mg, compared with a 19 percent worsening in patients receiving placebo (P < 0.001). At week 24, the mean improvements in enthesitis were 46 percent for patients receiving golimumab 50 mg and 52 percent among patients receiving golimumab 100 mg, compared with a 13 percent worsening in placebo patients (P < 0.001). The golimumab 100 mg dose significantly improved dactylitis measured by percent change in dactylitis score compared with placebo at week 14 (66 percent versus 5 percent; P = 0.009) and at week 24 (82 percent versus 28 percent; P < 0.001). There was a trend towards improvement in dactylitis for 50 mg golimumab dose at week 14 and 24 but the comparisons with placebo did not reach statistical significance.
In addition to improvements in joint symptoms, a substantial proportion of golimumab-treated patients experienced significant improvement in skin manifestations of the disease. Among a subset of the study population with at least three percent of body surface area involved by psoriasis at baseline, 40 percent and 58 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved PASI 75 at week 14, compared with 3 percent of patients receiving placebo (P < 0.001). At week 24, PASI 75 responses improved to 56 percent (golimumab 50 mg) and 66 percent (golimumab 100 mg), compared with 1 percent of placebo patients (P < 0.001). In additional analyses, patients receiving golimumab 50 mg and golimumab 100 also experienced improvements in nail psoriasis as measured by NAPSI and these improvements were sustained over time.
"These Phase 3 data show that once monthly subcutaneous administrations of golimumab 50 mg and golimumab 100 mg significantly improved articular and psoriatic manifestations in patients with psoriatic arthritis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "We are encouraged by these results and believe golimumab holds great promise as a new anti-TNF-alpha therapy for physicians and patients in need of additional therapeutic options."
Disease Activity and Physical Function Improvements
The majority of golimumab-treated patients in the study were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28), which measures tender and swollen joints and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 14 weeks of treatment, 66 percent of patients receiving golimumab 50 mg were DAS28 responders, as were 67 percent of patients receiving the 100 mg dose, compared with 24 percent of patients receiving placebo (P < 0.001). At week 24, 64 percent and 78 percent of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS28 responders, compared with 24 percent of patients receiving placebo (P < 0.001).
Patients receiving golimumab in the study also experienced significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 14, patients receiving golimumab 50 mg experienced a mean improvement of 0.31 and patients receiving golimumab 100 mg experienced a mean improvement of 0.38 in HAQ score, compared with an improvement of only 0.04 among placebo patients (P < 0.001). At week 24, the improvements were 0.33 and 0.39 in the respective treatment groups, compared with worsening in HAQ score of -0.01 among patients receiving placebo (P < 0.001). HAQ assesses the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living). An improvement in HAQ of at least 0.3 indicates clinically meaningful improvement in physical function.
About the GO-REVEAL Trial
The Golimumab -- A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial involved 405 adults with psoriatic arthritis. Subjects with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 cm in diameter were randomly assigned to receive SC injections of placebo or golimumab (50 or 100 mg) at weeks 0, 4, 8, 12, 16 and 20. At week 16, patients with inadequate arthritis response were switched to golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg (patients originally receiving golimumab 50 mg). The primary endpoint was ACR 20 response at week 14 for combined golimumab groups and individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, golimumab was generally well-tolerated, with two percent of golimumab-treated patients experiencing serious adverse events compared with six percent of patients in the placebo group. Injection site reactions occurred in five percent of patients receiving golimumab and three percent of patients receiving placebo. One case of prostate cancer and two cases of basal cell carcinoma were reported in golimumab-treated patients. There were no reports of tuberculosis or opportunistic infections through week 24.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.
About Golimumab
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
About Centocor
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at sec/ or jnj/. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is schering-plough/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of golimumab. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
Source: Brian Kenney
Centocor, Inc.
понедельник, 19 сентября 2011 г.
Sixty years young: Arthritis Care Awareness Week 2007
Nine million Britons, including 12,000 children, currently live with
arthritis, the country's biggest single cause of physical disability,
and, as the population ages, that figure can only rise.
In 2025, the number of over-85s is predicted to have mushroomed by
two-thirds, placing the health service under unprecedented strain.
In commemorating its Diamond Jubilee this year, Arthritis Care - the
biggest voluntary organisation dedicated to supporting people with
arthritis - is readying itself for another sixty years in the frontline
of very real challenge.
'There was no NHS when Arthritis Care was founded in 1947. It worked to
help people to understand arthritis, to alleviate the pain, isolation,
and disability it caused, and to support them towards self-management of
what is a long-term and as-yet incurable condition,' said Neil
Betteridge, Arthritis Care's chief executive.
'Today, we have almost come full circle. There is an NHS but there is
still no cure for arthritis. And there is a worrying new sense that
people with arthritis are once again on their own - there is much talk
of healthcare rationing, the postcode lottery, and cutbacks to the
health professions who serve people with arthritis.'
'At the same time, the speed of health service reform means that
Arthritis Care is no less vital to people with arthritis in 2007 than it
was sixty years ago. People still need support, and signposting to
services, and they need more help than ever in getting their voices
heard.'
The message of this year's Arthritis Care Awareness Week is therefore
Much done; much still to do.
'Today we can look back with pride on many achievements, particularly
Arthritis Care's pioneering of self-management training, its
campaigning, its award winning information, and its development of
services for children and young people with arthritis. But we cannot
afford to slacken now - we must keep campaigning for equal access to NHS
care and treatment, keep championing the rights of people with
arthritis, and be vigilant in our efforts to ensure that rheumatology is
not a Cinderella service in future, but one designed to cope with
increasing demands,' said Neil Betteridge.
Arthritis Care was founded in 1947 by Arthur Mainwaring Bowen as the
British Rheumatic Association. Aged 25, and an undergraduate at
Aberystwyth University, 'Waring' as he was known, had developed
inflammation in his foot which spread to his spine. It was ankylosing
spondylitis, a form of arthritis five times more common in men than
women.
His widow Helen says: 'Waring was always very conscious of the isolation
felt by people in his position and this is what led him to form an
association for people with rheumatism. When I look at how many people
have benefited from Arthritis Care, I'm very glad he did.'
People like the many callers to Arthritis Care's free helplines, or this
40 year old man who wrote in:
'I was looking up your web site about arthritis. I was badly bullied as
a child and had my feet stamped on a few times and now after thirty
years I am suffering from osteoarthritis in my big toes. I am in pain
all the time and need a walking stick to help support me as I walk, as
they have the habit of locking up and I can fall down. I am waiting to
see an Orthopaedic Surgeon and god knows when that will be, and I am
getting sick of waiting as the thought of cutting my feet off has
crossed my mind a few times in the last few years. I can't do the things
I love to do like work and hill walking now as I am in too much pain.'
arthritiscare.uk
arthritis, the country's biggest single cause of physical disability,
and, as the population ages, that figure can only rise.
In 2025, the number of over-85s is predicted to have mushroomed by
two-thirds, placing the health service under unprecedented strain.
In commemorating its Diamond Jubilee this year, Arthritis Care - the
biggest voluntary organisation dedicated to supporting people with
arthritis - is readying itself for another sixty years in the frontline
of very real challenge.
'There was no NHS when Arthritis Care was founded in 1947. It worked to
help people to understand arthritis, to alleviate the pain, isolation,
and disability it caused, and to support them towards self-management of
what is a long-term and as-yet incurable condition,' said Neil
Betteridge, Arthritis Care's chief executive.
'Today, we have almost come full circle. There is an NHS but there is
still no cure for arthritis. And there is a worrying new sense that
people with arthritis are once again on their own - there is much talk
of healthcare rationing, the postcode lottery, and cutbacks to the
health professions who serve people with arthritis.'
'At the same time, the speed of health service reform means that
Arthritis Care is no less vital to people with arthritis in 2007 than it
was sixty years ago. People still need support, and signposting to
services, and they need more help than ever in getting their voices
heard.'
The message of this year's Arthritis Care Awareness Week is therefore
Much done; much still to do.
'Today we can look back with pride on many achievements, particularly
Arthritis Care's pioneering of self-management training, its
campaigning, its award winning information, and its development of
services for children and young people with arthritis. But we cannot
afford to slacken now - we must keep campaigning for equal access to NHS
care and treatment, keep championing the rights of people with
arthritis, and be vigilant in our efforts to ensure that rheumatology is
not a Cinderella service in future, but one designed to cope with
increasing demands,' said Neil Betteridge.
Arthritis Care was founded in 1947 by Arthur Mainwaring Bowen as the
British Rheumatic Association. Aged 25, and an undergraduate at
Aberystwyth University, 'Waring' as he was known, had developed
inflammation in his foot which spread to his spine. It was ankylosing
spondylitis, a form of arthritis five times more common in men than
women.
His widow Helen says: 'Waring was always very conscious of the isolation
felt by people in his position and this is what led him to form an
association for people with rheumatism. When I look at how many people
have benefited from Arthritis Care, I'm very glad he did.'
People like the many callers to Arthritis Care's free helplines, or this
40 year old man who wrote in:
'I was looking up your web site about arthritis. I was badly bullied as
a child and had my feet stamped on a few times and now after thirty
years I am suffering from osteoarthritis in my big toes. I am in pain
all the time and need a walking stick to help support me as I walk, as
they have the habit of locking up and I can fall down. I am waiting to
see an Orthopaedic Surgeon and god knows when that will be, and I am
getting sick of waiting as the thought of cutting my feet off has
crossed my mind a few times in the last few years. I can't do the things
I love to do like work and hill walking now as I am in too much pain.'
arthritiscare.uk
пятница, 16 сентября 2011 г.
What You Need to Know About Arthritis Pain Medications
Recent controversy about the safety of pain medications for arthritis has left patients and health care professionals
alike confused about which medications are safe to use. In fact, a recent survey by the Boston-based Rippe Lifestyle
Institute indicated that many people with arthritis are suffering unnecessarily because they have stopped or reduced their
use of pain relievers due to confusion about which drugs are considered safe.
The survey also showed that now, more than ever, those with arthritis need to understand the benefits and possible side
effects associated with all arthritis pain medications. In order to do so, people with arthritis, their caregivers and
families must be familiar with recent news about the two types of drugs most commonly used to treat arthritis pain -
non-selective, non-steroidal anti-inflammatory drugs (NSAIDs), and another group of NSAIDs known as cyclooxygenase-2 (COX-2)
specific inhibitors.
COX-2 specific inhibitors vs. Other NSAIDs
COX-2 specific inhibitors are the newest members of the NSAID class of medications. Available by prescription only, they
became widely used in recent years to reduce joint pain and swelling. COX-2 specific inhibitors work by selectively
blocking, or inhibiting, one of the two enzymes associated with inflammation. Some experts think that this selective
inhibition may be one reason for some of the negative side effects currently associated with COX-2 specific inhibitors.
Non-selective NSAIDs were developed earlier than COX-2 specific inhibitors and have been widely used to relieve arthritis
pain and inflammation for many years. Unlike COX-2 specific inhibitors, non-selective NSAIDs inhibit both major enzymes
involved in the inflammatory process, COX-1 and COX-2. The non-selective NSAID category includes a number of different
medications that are available in both prescription and over-the-counter (OTC) products.
Timeline of Events
To understand the current state of affairs, it is important to understand the sequence of events. The controversy started
when a study published in the October 21, 2004, issue of the New England Journal of Medicine cited the COX-2 specific
inhibitor, Vioxx as potentially causing "major adverse events," including heart attack and stroke, among patients taking the
drug. As a result, Merck (the drug's manufacturer) voluntarily withdrew Vioxx from the market. However, in the months
following, the safety of the other available COX-2 specific inhibitors such as Celebrex and Bextra, as well as other
arthritis pain medications in the non-steroidal anti-inflammatory (NSAID) class, were also called into question.
Consequently, in February 2005, the US Food and Drug Administration (FDA) convened a special Advisory Committee, made up of
members of the Arthritis and Drug Safety Advisory Committees, to review the cardiovascular safety of these arthritis pain
medications.
FDA Directive: Stronger Warning Labels for Some Pain Medications
On April 7, 2005, taking into account the recommendations of the Advisory Committee, the FDA issued the following directives:
-- Bextra, a COX-2 specific inhibitor manufactured by Pfizer, was withdrawn from the market.
-- All prescription NSAIDs must revise their labeling to include a "black box" warning that highlights the potential
increased risk for cardiovascular (CV) events as well as the potentially life threatening gastrointestinal (GI) bleeding
associated with these drugs. Celebrex, the only COX-2 specific inhibitor remaining on the US market, was included in this
directive.
-- All OTC NSAIDs (except aspirin) will be required to revise their labeling to include more specific information about the
potential for GI and CV side effects, a stronger reminder to follow label instructions, as well as a warning about potential
skin reactions.
To further evaluate the potential for increased CV risk, the FDA also announced that all NSAIDs must conduct and submit to
the FDA a comprehensive review and analysis of pertinent safety data from clinical trials.
-- Aleve (naproxen sodium) is supported by clinical studies conducted to gain approval of naproxen as a prescription product
and as OTC that do not provide any evidence of increased risk of cardiovascular events.
Treatment Options: What Should Arthritis Patients Know?
For some people who suffer from pain associated with arthritis, their symptoms can be managed with exercise, heat/cold
therapy, joint protection, assistive devices, weight control, or in some severe cases, surgery. For others, medications are
needed to help manage the symptoms associated with arthritis.
When taken as directed OTC medications such as Aleve provide a safe and effective way to treat mild to moderate pain of minor
arthritis. If patients have questions, they should consult their health care professional about which treatment option is
most appropriate.
Why It's Important to Treat Arthritis
Arthritis affects approximately 66 million Americans and is the nation's leading cause of disability. There are over 100
different types of arthritis, and they all have different symptoms that vary in severity from person to person. The most
common form of arthritis, osteoarthritis, is characterized by the breakdown of cartilage that causes the bones to rub
together, resulting in pain, loss of movements and stiffness [i]. Arthritis is usually a chronic condition.
For more information on Aleve and naproxen, visit the Aleve website at aleve.
For more information on arthritis pain relief, visit arthritis.
View drug information on Bextra; Vioxx.
alike confused about which medications are safe to use. In fact, a recent survey by the Boston-based Rippe Lifestyle
Institute indicated that many people with arthritis are suffering unnecessarily because they have stopped or reduced their
use of pain relievers due to confusion about which drugs are considered safe.
The survey also showed that now, more than ever, those with arthritis need to understand the benefits and possible side
effects associated with all arthritis pain medications. In order to do so, people with arthritis, their caregivers and
families must be familiar with recent news about the two types of drugs most commonly used to treat arthritis pain -
non-selective, non-steroidal anti-inflammatory drugs (NSAIDs), and another group of NSAIDs known as cyclooxygenase-2 (COX-2)
specific inhibitors.
COX-2 specific inhibitors vs. Other NSAIDs
COX-2 specific inhibitors are the newest members of the NSAID class of medications. Available by prescription only, they
became widely used in recent years to reduce joint pain and swelling. COX-2 specific inhibitors work by selectively
blocking, or inhibiting, one of the two enzymes associated with inflammation. Some experts think that this selective
inhibition may be one reason for some of the negative side effects currently associated with COX-2 specific inhibitors.
Non-selective NSAIDs were developed earlier than COX-2 specific inhibitors and have been widely used to relieve arthritis
pain and inflammation for many years. Unlike COX-2 specific inhibitors, non-selective NSAIDs inhibit both major enzymes
involved in the inflammatory process, COX-1 and COX-2. The non-selective NSAID category includes a number of different
medications that are available in both prescription and over-the-counter (OTC) products.
Timeline of Events
To understand the current state of affairs, it is important to understand the sequence of events. The controversy started
when a study published in the October 21, 2004, issue of the New England Journal of Medicine cited the COX-2 specific
inhibitor, Vioxx as potentially causing "major adverse events," including heart attack and stroke, among patients taking the
drug. As a result, Merck (the drug's manufacturer) voluntarily withdrew Vioxx from the market. However, in the months
following, the safety of the other available COX-2 specific inhibitors such as Celebrex and Bextra, as well as other
arthritis pain medications in the non-steroidal anti-inflammatory (NSAID) class, were also called into question.
Consequently, in February 2005, the US Food and Drug Administration (FDA) convened a special Advisory Committee, made up of
members of the Arthritis and Drug Safety Advisory Committees, to review the cardiovascular safety of these arthritis pain
medications.
FDA Directive: Stronger Warning Labels for Some Pain Medications
On April 7, 2005, taking into account the recommendations of the Advisory Committee, the FDA issued the following directives:
-- Bextra, a COX-2 specific inhibitor manufactured by Pfizer, was withdrawn from the market.
-- All prescription NSAIDs must revise their labeling to include a "black box" warning that highlights the potential
increased risk for cardiovascular (CV) events as well as the potentially life threatening gastrointestinal (GI) bleeding
associated with these drugs. Celebrex, the only COX-2 specific inhibitor remaining on the US market, was included in this
directive.
-- All OTC NSAIDs (except aspirin) will be required to revise their labeling to include more specific information about the
potential for GI and CV side effects, a stronger reminder to follow label instructions, as well as a warning about potential
skin reactions.
To further evaluate the potential for increased CV risk, the FDA also announced that all NSAIDs must conduct and submit to
the FDA a comprehensive review and analysis of pertinent safety data from clinical trials.
-- Aleve (naproxen sodium) is supported by clinical studies conducted to gain approval of naproxen as a prescription product
and as OTC that do not provide any evidence of increased risk of cardiovascular events.
Treatment Options: What Should Arthritis Patients Know?
For some people who suffer from pain associated with arthritis, their symptoms can be managed with exercise, heat/cold
therapy, joint protection, assistive devices, weight control, or in some severe cases, surgery. For others, medications are
needed to help manage the symptoms associated with arthritis.
When taken as directed OTC medications such as Aleve provide a safe and effective way to treat mild to moderate pain of minor
arthritis. If patients have questions, they should consult their health care professional about which treatment option is
most appropriate.
Why It's Important to Treat Arthritis
Arthritis affects approximately 66 million Americans and is the nation's leading cause of disability. There are over 100
different types of arthritis, and they all have different symptoms that vary in severity from person to person. The most
common form of arthritis, osteoarthritis, is characterized by the breakdown of cartilage that causes the bones to rub
together, resulting in pain, loss of movements and stiffness [i]. Arthritis is usually a chronic condition.
For more information on Aleve and naproxen, visit the Aleve website at aleve.
For more information on arthritis pain relief, visit arthritis.
View drug information on Bextra; Vioxx.
вторник, 13 сентября 2011 г.
Campaign Launched To Tackle 'Alarming Ignorance' About Rheumatoid Arthritis - Revealed In New Poll
A ComRes poll commissioned by the National Rheumatoid Arthritis Society (NRAS) published today to co-inside with the launch of the '2009 Year of Rheumatoid Arthritis' campaign reveals alarming levels of ignorance about the disease.
62% of people polled thought that rheumatoid arthritis (RA) was caused by the wear and tear of joints over time, exposing a worryingly common misconception about the disease. This figure was worst among young people aged 18-24 (75%).
NRAS revealed the results of the survey at the launch of the '2009 Year of Rheumatoid Arthritis'; a campaign to re-shape people's attitudes to RA and raise awareness about the disease.
RA is an autoimmune disease that is caused when a person's immune system starts attacking healthy joints, most commonly the hands, feet and wrists. Onset of RA can happen at any age. It is very different to osteoarthritis, which is when joints suffer wear and tear damage slowly over many years, most frequently affecting older people.
Commenting on the Poll's findings, NRAS Chief Executive, Ailsa Bosworth said,
"We did not expect the poll to reveal such alarming ignorance about RA and its symptoms. It is shocking how few people understand a condition which affects almost ??million people in the UK. It is especially worrying that young people know so little about RA because early diagnosis and treatment of the disease is vital to prevent joint damage and disability later in life."
73% of those aged 18-24 didn't know that RA is a systemic disease that can affect the whole body including organs such as the heart and lungs and increases the risk of developing cardiovascular disease.
The '2009 Year of RA' campaign aims to raise awareness about the condition especially among young people who may not recognise symptoms such as joint pain and stiffness as indicators of RA and seek advice from their GP. Furthermore, they are unlikely to be aware that lifestyle factors such as smoking increases their risk of developing RA.
Stephanie McCabe age 27 from Manchester, developed joint swelling, stiffness and pain when she was 22 years old but because no-one recognised these as symptoms of RA it took months before she was diagnosed and referred for treatment. The rapid progression of her RA lead to joint damage which she has since had surgery to correct. Speaking about the poll's findings, Stephanie said,
"If I, or my family and friends, had been aware of the symptoms of RA then I would have sought medical advice earlier because I would have known how quickly joint damage can occur when the disease is left untreated. The lack of awareness and understanding about RA revealed by this survey makes it harder for people living with the disease. People, especially young people, don't realise that on-set of RA can begin at any age and the severe impact it can have on your life. "
Launching the 'NRAS Year of RA', Chief Executive Ailsa Bosworth said,
"Throughout 2009, NRAS will be tackling commonly held misconceptions about RA by sharing the experiences of people, such as Stephanie, living with the disease. NRAS want to show how a better common understanding of the condition can help people live, work and manage their RA more effectively."
Theresa May MP, NRAS Patron, said,
"The NRAS team and their network of volunteers are committed to supporting people with RA and their families. However, the findings of this poll demonstrate that much needs to be done to raise awareness about the causes and symptoms of RA, especially among young people. The '2009 Year of RA' campaign aims to challenge and correct common misconceptions about RA to ensure that people experiencing symptoms such as joint pain and stiffness seek early treatment to prevent joint damage and disability later in life."
Notes
1. 2009: The Year of Rheumatoid Arthritis
- The NRAS '2009: Year of RA' campaign aims to challenge common misconceptions about RA through a series of events throughout 2009.
- Increased understanding of RA and its symptoms is crucial for people to recognise the symptoms of the disease and seek swift medical advice and treatment. RA can progress very rapidly therefore the earlier it is diagnosed and treated, the more likely it is that irreversible joint damage and disability can be avoided in the long term.
- Many young people are not aware that they can get RA or that life style factors, such as smoking, can increase their chances of getting the disease.
- RA can severely impact on a person's physical ability to work and do normal everyday tasks. This is made worse when employers and others have a low level of understanding about RA and the severe impact that it can have.
2. About NRAS
- The National Rheumatoid Arthritis Society (NRAS) was launched in October 2001 and is now established as the campaigning voice in the UK for people with Rheumatoid Arthritis.
- NRAS provides a total one-stop-shop with support, information and advocacy for all people in the UK with RA, their carers and families.
- NRAS has a national volunteer network, a group of people with the disease who provide peer to peer support and provide additional resource to help NRAS in many different ways.
- For more information about NRAS and details on how to contact the NRAS volunteer network please go to rheumatoid.uk
3. About ComRes
ComRes interviewed 1013 GB adults by telephone between 6th March and 8th March 2009. Data was weighted to be representative demographically of all GB adults. ComRes is a member of the British Polling Council and abides by its rules.
Source
National Rheumatoid Arthritis Society
62% of people polled thought that rheumatoid arthritis (RA) was caused by the wear and tear of joints over time, exposing a worryingly common misconception about the disease. This figure was worst among young people aged 18-24 (75%).
NRAS revealed the results of the survey at the launch of the '2009 Year of Rheumatoid Arthritis'; a campaign to re-shape people's attitudes to RA and raise awareness about the disease.
RA is an autoimmune disease that is caused when a person's immune system starts attacking healthy joints, most commonly the hands, feet and wrists. Onset of RA can happen at any age. It is very different to osteoarthritis, which is when joints suffer wear and tear damage slowly over many years, most frequently affecting older people.
Commenting on the Poll's findings, NRAS Chief Executive, Ailsa Bosworth said,
"We did not expect the poll to reveal such alarming ignorance about RA and its symptoms. It is shocking how few people understand a condition which affects almost ??million people in the UK. It is especially worrying that young people know so little about RA because early diagnosis and treatment of the disease is vital to prevent joint damage and disability later in life."
73% of those aged 18-24 didn't know that RA is a systemic disease that can affect the whole body including organs such as the heart and lungs and increases the risk of developing cardiovascular disease.
The '2009 Year of RA' campaign aims to raise awareness about the condition especially among young people who may not recognise symptoms such as joint pain and stiffness as indicators of RA and seek advice from their GP. Furthermore, they are unlikely to be aware that lifestyle factors such as smoking increases their risk of developing RA.
Stephanie McCabe age 27 from Manchester, developed joint swelling, stiffness and pain when she was 22 years old but because no-one recognised these as symptoms of RA it took months before she was diagnosed and referred for treatment. The rapid progression of her RA lead to joint damage which she has since had surgery to correct. Speaking about the poll's findings, Stephanie said,
"If I, or my family and friends, had been aware of the symptoms of RA then I would have sought medical advice earlier because I would have known how quickly joint damage can occur when the disease is left untreated. The lack of awareness and understanding about RA revealed by this survey makes it harder for people living with the disease. People, especially young people, don't realise that on-set of RA can begin at any age and the severe impact it can have on your life. "
Launching the 'NRAS Year of RA', Chief Executive Ailsa Bosworth said,
"Throughout 2009, NRAS will be tackling commonly held misconceptions about RA by sharing the experiences of people, such as Stephanie, living with the disease. NRAS want to show how a better common understanding of the condition can help people live, work and manage their RA more effectively."
Theresa May MP, NRAS Patron, said,
"The NRAS team and their network of volunteers are committed to supporting people with RA and their families. However, the findings of this poll demonstrate that much needs to be done to raise awareness about the causes and symptoms of RA, especially among young people. The '2009 Year of RA' campaign aims to challenge and correct common misconceptions about RA to ensure that people experiencing symptoms such as joint pain and stiffness seek early treatment to prevent joint damage and disability later in life."
Notes
1. 2009: The Year of Rheumatoid Arthritis
- The NRAS '2009: Year of RA' campaign aims to challenge common misconceptions about RA through a series of events throughout 2009.
- Increased understanding of RA and its symptoms is crucial for people to recognise the symptoms of the disease and seek swift medical advice and treatment. RA can progress very rapidly therefore the earlier it is diagnosed and treated, the more likely it is that irreversible joint damage and disability can be avoided in the long term.
- Many young people are not aware that they can get RA or that life style factors, such as smoking, can increase their chances of getting the disease.
- RA can severely impact on a person's physical ability to work and do normal everyday tasks. This is made worse when employers and others have a low level of understanding about RA and the severe impact that it can have.
2. About NRAS
- The National Rheumatoid Arthritis Society (NRAS) was launched in October 2001 and is now established as the campaigning voice in the UK for people with Rheumatoid Arthritis.
- NRAS provides a total one-stop-shop with support, information and advocacy for all people in the UK with RA, their carers and families.
- NRAS has a national volunteer network, a group of people with the disease who provide peer to peer support and provide additional resource to help NRAS in many different ways.
- For more information about NRAS and details on how to contact the NRAS volunteer network please go to rheumatoid.uk
3. About ComRes
ComRes interviewed 1013 GB adults by telephone between 6th March and 8th March 2009. Data was weighted to be representative demographically of all GB adults. ComRes is a member of the British Polling Council and abides by its rules.
Source
National Rheumatoid Arthritis Society
суббота, 10 сентября 2011 г.
Passport To Successful Consultations: New Patient Resource Launched At EULAR Congress
Doctors are often unable to recognise patient dissatisfaction and address concerns(1) has prompted EULAR Social Leagues and its campaigning arm, PARE (People with Arthritis/Rheumatism in Europe) Manifesto to develop a tool to improve doctor/patient communications as one of their World Arthritis Day projects under the theme of 'small things matter'.
Studies(1,2,3) further reveal that missed communication opportunities between doctors and patients can impact on key outcomes, such as compliance with treatments and quality of life.
Recognising the need to help improve doctor/patient communications from both perspectives, EULAR Social Leagues have developed a Health Passport. The Health Passport is an A5 booklet, which has been developed by patients in cooperation with doctors to capture the clinical information doctors need, together with a monthly record of the patient's experience of living with their arthritis/rheumatism.
Information gathered in the Health Passport provides a comprehensive record, which can be referenced as an aide memoir both when preparing for a consultation and during the consultation.
The average length of consultations in primary care in Europe is around ten minutes (4). The aim of the Health Passport is to help patients and doctors use these ten minutes effectively.
"Doctors and patients have different needs and expectations from a consultation, but it is important that both are met within the allotted time. The Health Passport is designed to help facilitate more effective communication between doctors and patients and improve satisfaction with the outcomes of the consultation from both perspectives," says Professor Anthony Woolf, medical consultant to the project.
Belgium is the first country to develop the Health Passports in both Dutch and French led by patient organisations ReumaNet and CLAIR respectively. Evaluation forms were provided to both those trying out the passports over a test period and their doctors. Feedback has been very positive from both doctors and patients.
"The passport helps me prepare and remember important questions to ask my doctor. It also helps me evaluate and put into perspective whether my condition is improving or getting worse, as well as providing detailed information about my treatments, medications, activities and emotional control. As such, it can play a key role in my treatment programme and pain management," said Sophie, one of the Belgian patients testing the Health Passport.
"This is a very good initiative. The Health Passport helps patients to be more precise when describing their symptoms and concerns related to their condition. By using the Passport patients learn what kind of information is important for their doctor when making decisions about the treatment," said the rheumatologist of one of the patients using a Health Passport in Belgium.
"The Belgium pilot has demonstrated that Health Passports can make a huge difference to patients and doctors, so we are now calling on other countries to develop their own versions," says Robert Johnstone, Chair of PARE Manifesto and working group that developed the Health Passport.
A copy of the Health Passport can be downloaded in English from the World Arthritis Day website (worldarthritisday) Design templates and support materials will be available for Social Leagues to adapt and translate from the end of June.
EULAR CONGRESS PRESS OFFICE
30 Orange Street
eular
Studies(1,2,3) further reveal that missed communication opportunities between doctors and patients can impact on key outcomes, such as compliance with treatments and quality of life.
Recognising the need to help improve doctor/patient communications from both perspectives, EULAR Social Leagues have developed a Health Passport. The Health Passport is an A5 booklet, which has been developed by patients in cooperation with doctors to capture the clinical information doctors need, together with a monthly record of the patient's experience of living with their arthritis/rheumatism.
Information gathered in the Health Passport provides a comprehensive record, which can be referenced as an aide memoir both when preparing for a consultation and during the consultation.
The average length of consultations in primary care in Europe is around ten minutes (4). The aim of the Health Passport is to help patients and doctors use these ten minutes effectively.
"Doctors and patients have different needs and expectations from a consultation, but it is important that both are met within the allotted time. The Health Passport is designed to help facilitate more effective communication between doctors and patients and improve satisfaction with the outcomes of the consultation from both perspectives," says Professor Anthony Woolf, medical consultant to the project.
Belgium is the first country to develop the Health Passports in both Dutch and French led by patient organisations ReumaNet and CLAIR respectively. Evaluation forms were provided to both those trying out the passports over a test period and their doctors. Feedback has been very positive from both doctors and patients.
"The passport helps me prepare and remember important questions to ask my doctor. It also helps me evaluate and put into perspective whether my condition is improving or getting worse, as well as providing detailed information about my treatments, medications, activities and emotional control. As such, it can play a key role in my treatment programme and pain management," said Sophie, one of the Belgian patients testing the Health Passport.
"This is a very good initiative. The Health Passport helps patients to be more precise when describing their symptoms and concerns related to their condition. By using the Passport patients learn what kind of information is important for their doctor when making decisions about the treatment," said the rheumatologist of one of the patients using a Health Passport in Belgium.
"The Belgium pilot has demonstrated that Health Passports can make a huge difference to patients and doctors, so we are now calling on other countries to develop their own versions," says Robert Johnstone, Chair of PARE Manifesto and working group that developed the Health Passport.
A copy of the Health Passport can be downloaded in English from the World Arthritis Day website (worldarthritisday) Design templates and support materials will be available for Social Leagues to adapt and translate from the end of June.
EULAR CONGRESS PRESS OFFICE
30 Orange Street
eular
среда, 7 сентября 2011 г.
Nutra Pharma Begins Drug Registration Process In Central America For Its Nyloxin Pain Reliever
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), announced today that it has begun the drug registration process in Panama for its Nyloxin pain reliever.
"As an important international business center, Panama offers us an opportunity to introduce our Nyloxin pain reliever in Central America," explained Rik J Deitsch, Chairman and CEO of Nutra Pharma. "We plan to move forward with this drug registration process in conjunction with finalizing our relationship with a prospective local distribution partner that has the resources and capabilities to successfully market and distribute Nyloxin throughout the country," he concluded.
Nyloxin, which was first introduced in November 2009 as a treatment for chronic pain, is currently available in the United States as an oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia, and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis.
In the beginning of June, Nutra Pharma announced its partnership with the healthcare products distributor Henry Schein for distribution of its Nyloxin-branded pain relievers in the United States. Henry Schein, which ranks #339 on the Fortune 500 list, is the largest distributor of healthcare products and services to medical, dental, and veterinary office-based practitioners.
Additionally, the Company recently selected Grupo Farmac?©utico de Tijuana (GFT) as its exclusive distributor for Nyloxin in Mexico. GFT specializes in the distribution of pharmaceutical products to large, national retailers and to over 3,000 pharmacies throughout Mexico.
Source:
Nutra Pharma Corp.
"As an important international business center, Panama offers us an opportunity to introduce our Nyloxin pain reliever in Central America," explained Rik J Deitsch, Chairman and CEO of Nutra Pharma. "We plan to move forward with this drug registration process in conjunction with finalizing our relationship with a prospective local distribution partner that has the resources and capabilities to successfully market and distribute Nyloxin throughout the country," he concluded.
Nyloxin, which was first introduced in November 2009 as a treatment for chronic pain, is currently available in the United States as an oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia, and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis.
In the beginning of June, Nutra Pharma announced its partnership with the healthcare products distributor Henry Schein for distribution of its Nyloxin-branded pain relievers in the United States. Henry Schein, which ranks #339 on the Fortune 500 list, is the largest distributor of healthcare products and services to medical, dental, and veterinary office-based practitioners.
Additionally, the Company recently selected Grupo Farmac?©utico de Tijuana (GFT) as its exclusive distributor for Nyloxin in Mexico. GFT specializes in the distribution of pharmaceutical products to large, national retailers and to over 3,000 pharmacies throughout Mexico.
Source:
Nutra Pharma Corp.
воскресенье, 4 сентября 2011 г.
COX-2 Inhibitors Prescribed To Reduce Gastrointestinal Toxicity Prior To The Market Withdrawals
Nonsteroidal antiinflammatory drugs (NSAIDs) have been the most popular treatment for arthritis - despite their association with gastrointestinal (GI) complications, including bleeding ulcers and death. When selective cyclooxygenase 2 inhibitors (coxibs) were introduced a decade ago, they were widely hailed as a gastroprotective shield for NSAID users. Eventually, they were incorporated into the treatment guidelines of both the American College of Rheumatology and the Arthritis Foundation for patients at increased risk of GI complications. Two gastroprotective strategies for patients prescribed NSAIDs were recommended--either coprescription of a non-selective NSAID with an acid-reducing medication or selection of a COX-2 inhibitor NSAID. Then, clinical studies began to uncover evidence that COX-2 inhibitors and other non-selective NSAIDs may increase the risk of heart attack and stroke. Spurred by these findings and other safety concerns, 2 of the 3 FDA-approved coxibs - rofecoxib, known to consumers as Vioxx, and valdecoxib, known to consumers as Bextra - were withdrawn from the market. Questions regarding the appropriate use of COX-2 inhibitors for arthritis patients - and broader questions regarding prescribing patterns of novel drugs soon after FDA approval - remain.
For answers, a study published in the August 2006 issue of Arthritis Care & Research (interscience.wiley/journal/arthritiscare) examines the prescribing patterns of COX-2 inhibitors and other gastroprotective agents for arthritis patients with varying levels of GI risk. Using the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a team of CORRONA investigators evaluated data on 2,690 rheumatoid arthritis (RA) patients treated between March 1, 2004 and September 30, 2004 - the last day rofecoxib was legally sold in the U.S.
Of the patient sample, 1,833 (68.1 percent) were prescribed NSAID agents, 538 (20 percent) were prescribed aspirin , and 319 (11.9 percent) were prescribed an NSAID and aspirin. In contrast to multiple earlier epidemiologic studies that observed that a minority of NSAID users were prescribed gastroprotection, the majority (75.3%) of the 1,833 patients prescribed NSAIDs in the study were prescribed a gastroprotective strategy; the most frequently prescribed gastroprotective strategy was COX-2 inhibitors (65.8%).
The researchers also stratified their analyses by the number of GI risk factors for each patient. For patients with two or more risk factors, 80.2% were prescribed a gastroprotective strategy, primarily using COX-2 inhibitors (68.6%). High rates of NSAID gastroprotection were also observed for patients with one major GI risk factor. However, the authors also observed that 72.0% without traditional GI risk factors were prescribed NSAID gastroprotection, including 64.1% using COX-2 inhibitors. As the authors pointed out, registries cannot identify all of the considerations and risk factors inherent in patient and physician decision-making. .
"The relative GI safety of the COX-2 inhibitor class represented a major therapeutic advance for patients at increased GI risk who require long-term NSAID therapy," states its leading author, Jeffrey Greenberg, M.D., M.P.H. "The challenges associated with limiting diffusion of novel therapeutic agents to broader patient populations are likely to be challenges that cross subspecialty boundaries within the US health care system."
Clinical trials serve to determine the efficacy of a novel drug compound. However, the patient population for which a drug is prescribed frequently expands after FDA approval. This study underscores the potential value of post-marketing observational registries. "As novel therapeutic classes are introduced, early evaluation of prescribing patterns using arthritis registries can determine the appropriateness of prescribing patterns," Dr. Greenberg notes, "and may improve patient outcomes."
Article: "Assessment of Coxib Ultilization for Nonsteroidal Antiinflammatory Drug Gastroprotection Prior to the Coxib Market Withdrawals," Jeffrey D. Greenberg, Clifton O. Bingham III, Steven B. Abramson, George Reed, Mitsumasa Kishimoto, Kim Hinkle, and Joel Kremer, for the Corrona Investigators, Arthritis Care & Research, August 2006; (DOI: 10.1002/art.22095).
Contact: Amy Molnar
John Wiley & Sons, Inc.
View drug information on Bextra; Vioxx.
For answers, a study published in the August 2006 issue of Arthritis Care & Research (interscience.wiley/journal/arthritiscare) examines the prescribing patterns of COX-2 inhibitors and other gastroprotective agents for arthritis patients with varying levels of GI risk. Using the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a team of CORRONA investigators evaluated data on 2,690 rheumatoid arthritis (RA) patients treated between March 1, 2004 and September 30, 2004 - the last day rofecoxib was legally sold in the U.S.
Of the patient sample, 1,833 (68.1 percent) were prescribed NSAID agents, 538 (20 percent) were prescribed aspirin , and 319 (11.9 percent) were prescribed an NSAID and aspirin. In contrast to multiple earlier epidemiologic studies that observed that a minority of NSAID users were prescribed gastroprotection, the majority (75.3%) of the 1,833 patients prescribed NSAIDs in the study were prescribed a gastroprotective strategy; the most frequently prescribed gastroprotective strategy was COX-2 inhibitors (65.8%).
The researchers also stratified their analyses by the number of GI risk factors for each patient. For patients with two or more risk factors, 80.2% were prescribed a gastroprotective strategy, primarily using COX-2 inhibitors (68.6%). High rates of NSAID gastroprotection were also observed for patients with one major GI risk factor. However, the authors also observed that 72.0% without traditional GI risk factors were prescribed NSAID gastroprotection, including 64.1% using COX-2 inhibitors. As the authors pointed out, registries cannot identify all of the considerations and risk factors inherent in patient and physician decision-making. .
"The relative GI safety of the COX-2 inhibitor class represented a major therapeutic advance for patients at increased GI risk who require long-term NSAID therapy," states its leading author, Jeffrey Greenberg, M.D., M.P.H. "The challenges associated with limiting diffusion of novel therapeutic agents to broader patient populations are likely to be challenges that cross subspecialty boundaries within the US health care system."
Clinical trials serve to determine the efficacy of a novel drug compound. However, the patient population for which a drug is prescribed frequently expands after FDA approval. This study underscores the potential value of post-marketing observational registries. "As novel therapeutic classes are introduced, early evaluation of prescribing patterns using arthritis registries can determine the appropriateness of prescribing patterns," Dr. Greenberg notes, "and may improve patient outcomes."
Article: "Assessment of Coxib Ultilization for Nonsteroidal Antiinflammatory Drug Gastroprotection Prior to the Coxib Market Withdrawals," Jeffrey D. Greenberg, Clifton O. Bingham III, Steven B. Abramson, George Reed, Mitsumasa Kishimoto, Kim Hinkle, and Joel Kremer, for the Corrona Investigators, Arthritis Care & Research, August 2006; (DOI: 10.1002/art.22095).
Contact: Amy Molnar
John Wiley & Sons, Inc.
View drug information on Bextra; Vioxx.
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