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| |  EULAR: Remicade Shows Positive Results In Rheumatoid Arthritis At One Year GLASGOW, SCOTLAND -- June 7, 1999 -- In one of the largest clinical studies ever conducted in patients with advanced rheumatoid arthritis (RA), Centocor, Inc.’s Remicade(TM) (infliximab) produced significant reductions of signs and symptoms of this painful and chronic condition that were sustained or further reduced from 30 weeks through 54 weeks of therapy. The drug is the first monoclonal antibody to be evaluated for the treatment of RA. A summary of 54-week results from the phase III clinical trial, known as ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), was presented at the European League Against Rheumatism (EULAR) meeting in Glasgow, Scotland. The 30-week results from this study were presented in November 1998 at the American College of Rheumatology (ACR) annual meeting in San Diego. The ATTRACT trial is a double-blind, placebo-controlled, randomised clinical trial of 428 patients at 34 clinical sites in North America and Europe. It was designed to evaluate the efficacy and safety of Remicade in combination with methotrexate in patients with active RA despite treatment with methotrexate. According to the analysis of the one-year study results, 52 percent of all patients treated with Remicade experienced significant reductions in signs and symptoms of RA as measured by ACR 20, a standard assessment of disease activity, compared to 17 percent of patients receiving methotrexate alone. ACR 20 represents a 20 percent reduction in the number of tender and swollen joint counts, as well as other criteria including physician and patient global assessments and a laboratory marker of inflammation and pain. Two other key assessments, ACR 50 and ACR 70, represent 50 and 70 percent reductions in these same benchmarks, respectively. The study presented today also demonstrated the following one-year results: "The rapid and marked improvement in signs and symptoms of rheumatoid arthritis after treatment with Remicade are impressive because patients have now been controlled for one year," said Ravinder Maini, MD, director, Kennedy Institute, London, and a clinical trial investigator who presented the findings today. "The patients in this study had advanced disease and had failed methotrexate treatment, the current standard treatment for RA, which makes these results even more noteworthy.” The majority of patients responding to treatment with Remicade did so within two weeks of infusion and virtually all responding patients (approximately 90 percent) did so within six weeks, indicating rapid onset of action. "These data demonstrate that Remicade could be an important therapeutic option for the treatment of rheumatoid arthritis because of its potential long-term use in moderate to severe patients," said Daniel Furst, MD, clinical professor of medicine, University of Washington, and director of the Arthritis Clinical Research Unit, Virginia Mason Medical Center, Seattle, WA. "It is important to note that these new biologics are intended to be administered by rheumatologists after standard and accepted therapies such as disease-modifying, anti-rheumatic drugs and methotrexate have failed or no longer provide adequate control." The lowest tested dose (3 mg/kg at eight-week intervals) provided improved function, relief of joint tenderness and decreased joint swelling in a significant proportion of patients. It was also observed that an increase in Remicade dosage may provide additional benefits for patients with more severe disease. Other doses of Remicade studied in combination with methotrexate included: 3 mg/kg every four weeks; 10 mg/kg every eight weeks, and 10mg/kg every four weeks. Patients enrolled in the ATTRACT trial were characterised as having disease that was particularly difficult to manage. The median duration of disease in trial patients was 8.4 years and the majority of patients were on methotrexate therapy for three or more years. More than one-third of all0 patients had previous joint surgery, and approximately one half were classified as functional class and/or anatomical stage III or IV, which indicates progressive and advanced disease. After one year, Remicade was generally well tolerated and side effects were minimal. The most common adverse events included upper respiratory tract infection, headache, nausea, sinusitis, rash and cough. There was no increase in the incidence of serious adverse events (17 percent in Remicade-treated patients versus 21 percent of those on placebo), or serious infections (six percent in Remicade-treated patients compared to eight percent of those on placebo) in patients receiving Remicade compared to those on placebo. No serious infusion reactions were observed in the Remicade-treated patients. TNF-alpha is a key inflammatory mediator, or cytokine, in rheumatoid arthritis, Crohn's disease and other autoimmune disorders. Overproduction of TNF-alpha leads to inflammation in these chronic conditions. It is believed that Remicade reduces inflammation in patients with rheumatoid arthritis by binding to and neutralising TNF-alpha on the cell membrane and in the blood.
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