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
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