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| |  FDA Approves Remicade For Crohn's Disease MALVERN, PA -- Aug. 24, 1998 -- The United States Food and Drug Administration has approved Centocor’s Remicade(TM) (infliximab), a treatment for patients with Crohn's disease, a chronic and debilitating disorder of the gastrointestinal tract that can greatly affect a patient's quality of life. Remicade, formerly known as Avakine, is the first of a new class of agents that blocks activity of a key biologic response mediator called tumour necrosis factor alpha (TNF-alpha). It is believed that Remicade reduces intestinal inflammation in patients with Crohn's disease by binding to and neutralising TNF-alpha on the cell membrane and in the blood and by destroying TNF-alpha producing cells. This action may explain why Remicade is a particularly effective inhibitor of TNF-alpha and why Remicade has a rapid and substantial clinical benefit. Remicade is indicated for treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapy. It is also indicated as a treatment for patients with fistulizing Crohn's disease for reduction in the number of draining enterocutaneous fistula(s). The safety and efficacy of Remicade beyond the recommended duration of treatment have not been established. In a clinical trial of 108 patients with moderately to severely active Crohn's disease who did not respond adequately to conventional therapies, 82 percent of patients treated with REMICADE at the recommended dose (5 mg/kg) achieved a clinical response at week four versus 16 percent of patients who received placebo. In this study, 48 percent of patients treated with Remicade went into clinical remission at week four versus four percent of patients who received placebo. Overall, 92 percent of patients enrolled in the trial continued to receive stable doses of corticosteroids, antibiotics, aminosalicylates or other immunomodulators. Remicade was also shown to be effective in reducing the number of open, draining fistulas, a painful complication of Crohn's disease in which deep openings burrow from the bowel wall through the surface of the skin, causing drainage of mucous and/or fecal material. Remicade is the first product documented to reduce the number of open fistulas in a controlled clinical trial. In a clinical study of 94 patients with fistulizing Crohn's disease (42 patients had single fistula and 52 patients had multiple fistulas), 68 percent of those treated at the recommended dose of Remicade experienced closure of at least 50 percent of fistula(s) for four weeks or more compared with 26 percent of placebo-treated patients. More than one-half (55 percent) of patients with single or multiple fistula(s) treated with Remicade experienced a clinical effect demonstrated clinical response to treatment with Remicade developed an abscess in the area of the fistula between eight and 16 weeks after the last infusion. "Remicade represents a significant advance in the treatment of Crohn's disease," said Stephen Hanauer, M.D., University of Chicago Medical Center, department of gastroenterology, and a principal investigator in the clinical trials. "These patients suffer terribly and we physicians now have an important option available to treat them." Approximately five percent of Crohn's disease patients studied discontinued Remicade treatment. The most common reasons for discontinuation were infusion reactions and infections. On rare occasions, these reactions were serious but resolved with standard treatment for hypersensitivity reactions or discontinuation of Remicade therapy. The most common adverse reactions occurring more frequently with Remicade than placebo include nausea, upper respiratory tract infections and abdominal pain. Remicade therapy may result in the development of autoantibodies. However, development of such autoantibodies rarely leads to clinical symptoms or discontinuation of therapy. The dosage for patients with non-fistulizing moderately to severely active Crohn's disease is a single infusion of 5 mg/kg of Remicade. The dosage for patients with fistulizing disease is an initial dose of 5 mg/kg followed with additional doses of 5 mg/kg at two and six weeks after the first infusion. Related Links: Centocor
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