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| |  European Union Approves Remicade (Infliximab) for Rheumatoid Arthritis MALVERN, PA. and MADISON, NJ -- June 28, 2000 -- Centocor, Inc. and Schering-Plough Corporation announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to Remicade® (infliximab) with methotrexate for the reduction of the signs and symptoms of rheumatoid arthritis in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. For the treatment of rheumatoid arthritis, the efficacy and safety of Remicade have been demonstrated only in combination with methotrexate. Commission approval of the centralized Type II variation for Remicade results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The approval follows a positive recommendation by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) in February 2000. In August 1999, the European Commission granted centralized marketing authorization to Remicade for the treatment of Crohn's disease, a serious gastrointestinal disorder. Schering-Plough will market Remicade for rheumatoid arthritis in all countries outside of the United States, except in Japan and parts of the Far East where Remicade will be marketed by Tanabe Seiyaku, Ltd. Centocor has retained exclusive marketing rights to the product in the United States. Roch F. Doliveux, president, Schering-Plough International, said, "This approval of Remicade in Europe for rheumatoid arthritis means that an important new therapy will now be available for patients suffering from this debilitating disease. The ability of Remicade to neutralize TNF-alpha, a key inflammatory mediator, represents an exciting treatment advance in reducing the swollen, inflamed and stiff joints associated with this painful disease." The centralized Type II variation application for Remicade for the reduction of signs and symptoms of rheumatoid arthritis is based on clinical findings from ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), a double-blind, placebo-controlled, randomized clinical trial involving 428 patients at 34 clinical sites. ATTRACT is one of the largest clinical studies ever conducted in patients with advanced rheumatoid arthritis. The dosage for rheumatoid arthritis patients with active disease and an inadequate response to disease-modifying drugs is 3 mg/kg, the lowest dose evaluated in ATTRACT. Infusions are given at two and six weeks following the initial infusion, then every eight weeks thereafter. In the ATTRACT trial at 30 weeks, 50 percent of all patients treated with Remicade and methotrexate, compared to 20 percent of patients receiving methotrexate alone, experienced a reduction in signs and symptoms of rheumatoid arthritis as measured by ACR 20, a standard assessment of disease activity and a primary endpoint of the study. All treated patients had active disease despite methotrexate treatment. Improvement versus methotrexate alone was seen as early as two weeks and was maintained through 54 weeks of treatment. ACR 20 represents a 20 percent reduction in the number of tender and swollen joints, as well as other criteria including physician and patient global assessments and a laboratory marker of inflammation. Two other key assessments, ACR 50 and ACR 70, also showed improvement. These represent 50 percent and 70 percent reductions, respectively, in these same parameters. Patients enrolled in the ATTRACT trial were characterized as having disease that was particularly difficult to manage. The median duration of disease in trial patients was 8.4 years. All patients had been receiving methotrexate therapy, with half having been on methotrexate for three or more years. More than a third of all patients had previous joint surgery, and half were classified as functional class 3 or 4, which indicates progressive and advanced disease. The one-year results from ATTRACT indicate that Remicade was generally well tolerated. The most common adverse events in the ATTRACT trial included upper respiratory tract infections, headache, nausea, sinusitis, rash and cough. Through 54 weeks, there was no increased incidence of serious adverse events (17 percent with Remicade and methotrexate versus 21 percent with methotrexate alone) or serious infections (6 percent with Remicade plus methotrexate versus 8 percent with methotrexate alone). The incidence of infusion reactions was also low in patients receiving Remicade plus methotrexate (5 percent) as compared to patients receiving methotrexate alone (2 percent) at any particular infusion. TNF-alpha mediates inflammation and cellular immune response including response to infection. Serious infections, including sepsis and fatal infections, have been reported in patients receiving TNF-blocking agents. Many of the serious infections in patients treated with Remicade have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn's disease or rheumatoid arthritis, could predispose them to infections. Patients treated with Remicade may have an increased risk of infection. Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infection. Remicade should not be given to patients with a clinically important, active infection. Patients who develop a new infection while undergoing treatment with Remicade should be monitored closely. If a patient develops a serious infection or sepsis, Remicade therapy should be discontinued It is estimated that 2.5 million people -- mostly women -- in Europe are affected by rheumatoid arthritis, which is a chronic and often painful disease characterized by inflammation of the joints. Its initial symptoms include fatigue, fever and anemia. As the disease progresses, joints become swollen, inflamed, painful and stiff. Rheumatoid arthritis usually begins with the hands, wrists, feet, knees and elbows, but often also attacks the shoulders, neck, hips and back. When inflammation persists or does not respond well to treatment, destruction of nearby cartilage, bone, tendons and ligaments can occur and lead to permanent disability. In the United States, Remicade received approval in November 1999 in combination with methotrexate for the reduction of the signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate. In October 1999, Centocor submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Remicade in combination with methotrexate for the prevention of joint damage in patients with rheumatoid arthritis. Remicade is also marketed in the United States for the short-term treatment of active and fistulizing Crohn's disease, a serious gastrointestinal disorder. Remicade is the first of a new class of agents that neutralizes a key inflammatory mediator called TNF-alpha. Overproduction of TNF-alpha leads to inflammation in chronic autoimmune conditions such as rheumatoid arthritis and Crohn's disease. It is believed that Remicade reduces inflammation in patients with rheumatoid arthritis by binding to and neutralizing TNF-alpha on the cell membrane and in the blood. Related Links: Remicade (infliximab), Centocor, Inc. and Schering-Plough Corporation.
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