Treatment With REMICADE(reg) Improved Bone Erosion Scores in Early RA Study
New data show that more than 55 percent of patients treated with REMICADE(reg) (infliximab) plus methotrexate (REMICADE(reg) regimen) demonstrated improvement in bone erosion scores (a key indicator of joint destruction in rheumatoid arthritis), compared with 26.8 percent for methotrexate alone in early rheumatoid arthritis (RA) patients with progressive disease and bone erosions.
Previously presented data from the ASPIRE trial (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) demonstrated that the REMICADE(reg) regimen prevented the progression of structural damage in the overall patient population, but these new analyses demonstrate improvement in those patients with progressive disease. These new data emerged from a retrospective sub-analysis of the ASPIRE trial and were presented today at The European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.
"The new results from the ASPIRE trial contribute to the growing body of clinical evidence that supports earlier initiation of therapy for RA patients," said Paul Emery, MA, MD, FRCP, ACR professor of rheumatology, Leeds University, and clinical director, rheumatology, Leeds Teaching Hospital Trust, UK. "Our findings clearly demonstrate that early treatment with REMICADE(reg) can prevent the progression of this debilitating disease and can improve bone erosion scores, suggesting that repair may be possible."
About ASPIRE
ASPIRE was a Phase lll, 54 week, randomized, double-blind, active control study involving 1,049 patients with early RA (< or = three years duration) enrolled in 125 centers in North America and Europe evaluating the efficacy and safety of REMICADE(reg) in combination with methotrexate compared with methotrexate alone.
Patients in the ASPIRE study had an average of only seven months of disease duration and more than 80 percent already had evidence of erosive joint destruction. At randomization, all patients received methotrexate and either placebo, REMICADE(reg) 3 mg/kg or REMICADE(reg) 6 mg/kg at weeks zero, two and six and then every eight weeks thereafter. The ASPIRE trial had three co-primary endpoints at one year: reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function.
All three primary endpoints were met, with the REMICADE(reg) regimen being superior to methotrexate alone on all primary and major secondary endpoints.
The most commonly reported adverse events were upper respiratory infection, nausea and headache. Serious adverse events reported were similar to those observed in other controlled clinical trials and clinical experience with REMICADE(reg) as described in the prescribing information.
About the ASPIRE Sub-Analysis
Of 838 patients with an evaluable change in erosion score in the ASPIRE trial, 213 patients had an erosion score of 10.75 or greater at baseline representing the highest quartile. Among patients with a baseline erosion score of 10.75 or greater, the mean change from baseline in erosion score for the combined REMICADE(reg) group at week 54 was -0.75 (improvement), whereas the mean change for the placebo group was 3.57 (worsening) (p 0.5 and experienced no worsening in any joint compared with only 27 percent in the placebo group. No worsening was defined as a radiographic score that was equal to or less than the baseline value.
REMICADE(reg) is currently indicated for use in patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. In April 2004, the Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion recommending approval of expanded labeling for REMICADE(reg) as first line therapy, in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs), for the treatment of early RA patients with severe, active, progressive disease. Centocor, Inc., has filed an sBLA (supplemental Biologics License Application) with the U.S. Food and Drug Administration (FDA) for the use of REMICADE(reg) plus methotrexate in patients with early disease of moderate or greater severity who have not previously demonstrated an adequate response to methotrexate therapy. The sBLA filing is under review by the FDA.
About Early Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, progressive disease and research demonstrates that a critical therapeutic window exists within the first two years of disease onset when the rate of radiographic progression of the disease can be "reset."1,2,3 Radiographic changes occur within two years of disease onset in 50 percent to 70 percent of RA patients.4 The American College of Rheumatology (ACR) suggests control of disease progression should start early to limit joint damage in RA.3 RA is associated with substantial disability and economic losses, and one study showed that one-third of patients in the United Kingdom who were employed became work-disabled within two years of disease onset.5 Rheumatologic disorders also account for 25 percent of Social Security disability payments in the United States.6
About REMICADE(reg)
REMICADE(reg) is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-alpha) on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in RA, ankylosing spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine, and Crohn's disease (CD), a serious gastrointestinal disorder, in addition to a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE(reg) is currently being studied.
REMICADE(reg) is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both RA and CD and, in the European Union, AS. In most countries where it has received marketing authorization, REMICADE(reg), in combination with methotrexate, is indicated for the treatment of patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. REMICADE(reg) is the only biologic indicated for the treatment of patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE(reg) is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In addition, in the European Union, REMICADE(reg) is indicated for the treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
REMICADE(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, REMICADE(reg) is typically received every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE(reg) patients may require as few as six treatments each year. In AS, REMICADE(reg) is administered every six to eight weeks following a standard induction regimen that requires treatment at weeks zero, two and six. The safety and efficacy of REMICADE(reg) have been well established in clinical trials conducted over the past 10 years and through commercial experience, with now more than 500,000 patients treated worldwide.7
Important Information
Many people with heart failure should not take REMICADE(reg); so, prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB your doctor should begin TB treatment before you start REMICADE(reg). If you are prone to or have a history of infections, currently have one, or develop one while taking REMICADE(reg), tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common or if you have or have had a disease that affects the nervous system or if you experience any numbness, weakness, tingling or visual disturbances.
There are also reports of serious infusion reactions with hives, difficulty breathing and low blood pressure. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to infusion such as rash or itchy skin. Please read important information about REMICADE(reg), including full U.S. prescribing information, at www.remicade.com. For a complete copy of REMICADE(reg) E.U. prescribing information, please contact Schering-Plough Corporation at +1-908-298-7616.
About Centocor, Inc.
Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the health care community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.
Centocor, Inc., discovered REMICADE(reg) and has exclusive marketing rights to the product in the United States. Schering-Plough Corporation has rights to market REMICADE(reg) in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.
Johnson & Johnson Disclosure Notice
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 the Company'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(b) of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2003. Copies of this Form 10-K are available online at www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward- looking statements as a result of new information or future events or developments.
1 Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
2 Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis benefit from early second line therapy: five year follow up of a prospective double blind placebo controlled study. J. Rheumatol. 1995;22:2208-2213.
3 American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, 2002 Update.
4 van der Heijde DM. Joint erosions and patients with early rheumatoid arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
5 Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study. Rheumatology. 2000;39:1403-1409.
6 Social Security Disability Insurance Program.
7 Data on file at Centocor, Inc.
View drug information on Remicade.
Tratamentul cu Remicade (REG) os îmbunãtãþit scorurile de eroziune la începutul anului de studiu RA - Treatment With REMICADE(reg) Improved Bone Erosion Scores in Early RA Study - articole medicale engleza - startsanatate