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
среда, 28 сентября 2011 г.
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.
четверг, 1 сентября 2011 г.
Stanford Develops Imaging Technique To Catch Arthritis Early In Onset
You come into a doctor's office with severe knee pain. The physician orders an MRI, which reveals substantial loss of cartilage-osteoarthritis, that is-in your knee joint. At this point, not much can be done beyond gulping down palliatives and trying to keep your weight off the joint. But the damage may have started building as much as 20 years earlier, possibly due to a traumatic injury to the affected joint.
Just ask Garry Gold, MD, an associate professor of radiology at the Stanford University School of Medicine. Now 45, Gold sustained a knee injury 20 years ago while playing in a pickup basketball game. These days, he's starting to wish his house, currently being remodeled, didn't have any stairs.
Gold, who has been diagnosed with osteoarthritis, is working with an imaging technology called sodium MRI to diagnose osteoarthritis as long as decades before the onset of physical symptoms. That may spawn new therapies that could possibly have blocked his disease before it put an end to his basketball days.
Gold is collecting young athletes who've suffered damage to the anterior cruciate ligament, or ACL, in their knee-an injury afflicting several hundred thousand people annually in the United States alone. This knee insult is especially common among female athletes. "A good fraction of the Stanford women's basketball and soccer teams either have torn their ACL sometime in the past or will tear it while they're still at Stanford," Gold said. Even when the initial ligament lesion is repaired surgically, victims remain at almost doubled risk for symptomatic osteoarthritis in the injured knee a decade or two down the road, compared with uninjured people.
Using the new imaging technology, Gold and colleagues have been able to spot, soon after such an injury, telltale signs of cartilage deterioration consistent with the development of osteoarthritis.
MRI now in routine use works by pulsing the area to be observed with electromagnetic energy, at a frequency that preferentially excites the protons in water molecules. As the protons settle back to a relaxed state, they send out an electromagnetic burst of their own, which can be picked up by sensors in the apparatus. Because cartilage has lots of water compared with nearby bone, it shows up on a computer-generated image of the region.
But while standard MRI gives a reasonable display of overall cartilage structure, it doesn't tell a diagnostician much about the quality of that cartilage.
"If you look into a big house and you see that it's standing up," Gold said, "you may assume it's going to be safe in the event of an earthquake. But without closer inspection, you don't know much about the integrity of the structure."
If standard MRI is akin to a view of standing timber in the house, the version Gold is using, called sodium MRI, enables the visualization of dry rot infecting and weakening the wood.
A key structural material in cartilage, called glycosaminoglycan, occurs in a complex with sodium, an elemental metal that has its own set of excitation and relaxation frequencies and is more restricted to cartilage than water is.
Sodium MRI has been around for years, but until recently it couldn't be used in clinical settings. For one thing, the magnets employed to excite sodium atoms were too puny, making crisp resolution possible only with tiny creatures such as mice. Gold and his colleague Brian Hargreaves, PhD, assistant professor of radiology at Stanford, have designed improved magnets and software to scale up the technology for human application.
They're on the right track, said Ari Borthakur, a University of Pennsylvania scientist who is not involved in Gold's research but has done pioneering work with sodium MRI since writing his PhD thesis on it some years ago. "Everything his lab has developed is going to be applicable in the clinics," said Borthakur. "As America ages, we're expecting to see a huge increase in osteoarthritis, and any technique that could be used for its early diagnosis, or that could help developing therapies for curing it, or even slowing the progression of cartilage loss, would be tremendous."
Gold and Hargreaves' project is being conducted with funding from the National Institutes of Health and GlaxoSmithKline, an international pharmaceutical company. Neither researcher owns stock in, or receives consulting fees from, the company.
Working with Hargreaves, Gold has imaged the knees of about a dozen volunteers who have suffered a recent ACL injury. In every case so far, significant losses of glycosaminoglycan can be glimpsed under sodium MRI scanning, despite the absence of any sign of damage to cartilage observed with standard MRI. Almost invariably, sodium MRI scans of the injured knee-but not of the other, uninjured one-reveal glycosaminoglycan deficits within three years of the injury, potentially enabling a vastly accelerated diagnosis.
This ought to speed the development of new therapies, and radically lower the cost of doing so, Gold said. The idea is to be able to use glycosaminoglycan loss as a "surrogate marker" of impending osteoarthritis, much as high LDL levels are used to flag people at risk of heart disease-perhaps years before actual symptoms of heart disease manifest. While not everybody with elevated LDL develops cardiovascular disease, this marker has been sufficiently predictive of that condition that regulatory authorities routinely approve drugs based on their ability to lower LDL.
Catching osteoarthritis during its stealth phase may spur clinical trials that would be prohibitively time-consuming and costly if standard MRI were employed, because of the huge lag from the time of an ACL injury until the time cartilage deterioration can be detected by that old method.
With sodium MRI, cohorts of treated vs. untreated at-risk patients could be imaged over time to see if, within a few years of the injury, a drug or a lifestyle change is reducing or arresting the loss of glycosaminoglycan from the ligament. Once promising drugs or lifestyle changes are identified, they could then be administered to at-risk patients long before symptoms surface, Gold said.
As for Gold himself, he has yet to see what his own damaged knee looks like under sodium MRI. The 6-foot-6 once-avid amateur basketball center's knee is too big for even his improved new experimental apparatus to fit. It's probably too late for any kind of imaging to do Gold much good now, anyway. He already knows he's got arthritis. "I don't even want to look," he said.
Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford.
Stanford University Medical Center
Just ask Garry Gold, MD, an associate professor of radiology at the Stanford University School of Medicine. Now 45, Gold sustained a knee injury 20 years ago while playing in a pickup basketball game. These days, he's starting to wish his house, currently being remodeled, didn't have any stairs.
Gold, who has been diagnosed with osteoarthritis, is working with an imaging technology called sodium MRI to diagnose osteoarthritis as long as decades before the onset of physical symptoms. That may spawn new therapies that could possibly have blocked his disease before it put an end to his basketball days.
Gold is collecting young athletes who've suffered damage to the anterior cruciate ligament, or ACL, in their knee-an injury afflicting several hundred thousand people annually in the United States alone. This knee insult is especially common among female athletes. "A good fraction of the Stanford women's basketball and soccer teams either have torn their ACL sometime in the past or will tear it while they're still at Stanford," Gold said. Even when the initial ligament lesion is repaired surgically, victims remain at almost doubled risk for symptomatic osteoarthritis in the injured knee a decade or two down the road, compared with uninjured people.
Using the new imaging technology, Gold and colleagues have been able to spot, soon after such an injury, telltale signs of cartilage deterioration consistent with the development of osteoarthritis.
MRI now in routine use works by pulsing the area to be observed with electromagnetic energy, at a frequency that preferentially excites the protons in water molecules. As the protons settle back to a relaxed state, they send out an electromagnetic burst of their own, which can be picked up by sensors in the apparatus. Because cartilage has lots of water compared with nearby bone, it shows up on a computer-generated image of the region.
But while standard MRI gives a reasonable display of overall cartilage structure, it doesn't tell a diagnostician much about the quality of that cartilage.
"If you look into a big house and you see that it's standing up," Gold said, "you may assume it's going to be safe in the event of an earthquake. But without closer inspection, you don't know much about the integrity of the structure."
If standard MRI is akin to a view of standing timber in the house, the version Gold is using, called sodium MRI, enables the visualization of dry rot infecting and weakening the wood.
A key structural material in cartilage, called glycosaminoglycan, occurs in a complex with sodium, an elemental metal that has its own set of excitation and relaxation frequencies and is more restricted to cartilage than water is.
Sodium MRI has been around for years, but until recently it couldn't be used in clinical settings. For one thing, the magnets employed to excite sodium atoms were too puny, making crisp resolution possible only with tiny creatures such as mice. Gold and his colleague Brian Hargreaves, PhD, assistant professor of radiology at Stanford, have designed improved magnets and software to scale up the technology for human application.
They're on the right track, said Ari Borthakur, a University of Pennsylvania scientist who is not involved in Gold's research but has done pioneering work with sodium MRI since writing his PhD thesis on it some years ago. "Everything his lab has developed is going to be applicable in the clinics," said Borthakur. "As America ages, we're expecting to see a huge increase in osteoarthritis, and any technique that could be used for its early diagnosis, or that could help developing therapies for curing it, or even slowing the progression of cartilage loss, would be tremendous."
Gold and Hargreaves' project is being conducted with funding from the National Institutes of Health and GlaxoSmithKline, an international pharmaceutical company. Neither researcher owns stock in, or receives consulting fees from, the company.
Working with Hargreaves, Gold has imaged the knees of about a dozen volunteers who have suffered a recent ACL injury. In every case so far, significant losses of glycosaminoglycan can be glimpsed under sodium MRI scanning, despite the absence of any sign of damage to cartilage observed with standard MRI. Almost invariably, sodium MRI scans of the injured knee-but not of the other, uninjured one-reveal glycosaminoglycan deficits within three years of the injury, potentially enabling a vastly accelerated diagnosis.
This ought to speed the development of new therapies, and radically lower the cost of doing so, Gold said. The idea is to be able to use glycosaminoglycan loss as a "surrogate marker" of impending osteoarthritis, much as high LDL levels are used to flag people at risk of heart disease-perhaps years before actual symptoms of heart disease manifest. While not everybody with elevated LDL develops cardiovascular disease, this marker has been sufficiently predictive of that condition that regulatory authorities routinely approve drugs based on their ability to lower LDL.
Catching osteoarthritis during its stealth phase may spur clinical trials that would be prohibitively time-consuming and costly if standard MRI were employed, because of the huge lag from the time of an ACL injury until the time cartilage deterioration can be detected by that old method.
With sodium MRI, cohorts of treated vs. untreated at-risk patients could be imaged over time to see if, within a few years of the injury, a drug or a lifestyle change is reducing or arresting the loss of glycosaminoglycan from the ligament. Once promising drugs or lifestyle changes are identified, they could then be administered to at-risk patients long before symptoms surface, Gold said.
As for Gold himself, he has yet to see what his own damaged knee looks like under sodium MRI. The 6-foot-6 once-avid amateur basketball center's knee is too big for even his improved new experimental apparatus to fit. It's probably too late for any kind of imaging to do Gold much good now, anyway. He already knows he's got arthritis. "I don't even want to look," he said.
Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford.
Stanford University Medical Center
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