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| |  Remicade Effective For Serious Complication Of Crohn's Disease MALVERN, PA - May 6, 1999 -- The first definitive clinical evidence that a medical therapy can close fistulas, a complication of Crohn's disease, was reported today in The New England Journal of Medicine. Results from this landmark study showed that Centocor, Inc.’s Remicade(TM) (infliximab) can be highly effective in healing fistula(s). "This is a very important study because it is the first to document the beneficial effect of an agent in reducing the number of fistula[s] experienced by individuals with Crohn's disease," said Daniel Present, M.D., lead author of the study and clinical professor of medicine at Mt. Sinai Medical Center in New York. "Many of the patients I have treated with Remicade have experienced a remarkably improved quality of life." Fistula(s) are deep ulcer tracts that burrow through the bowel wall into nearby organs or through the surface of the skin and are experienced by approximately one-third of individuals with Crohn's disease. Up to three-quarters of individuals with Crohn's disease will need surgery at some time during their lives. Results from the randomised, double-blind, placebo-controlled study with 94 patients showed that more than two-thirds of patients receiving Remicade (68 percent) achieved closure of at least half of their draining fistula(s) compared with 26 percent of placebo-treated patients. More than half of patients receiving Remicade (55 percent) experienced closure of all their fistula(s) compared with 13 percent of placebo treated patients. The median time for response was two weeks with median duration of benefit lasting three months. Patients in the study received infusions of 5 mg/kg or 10 mg/kg of Remicade or placebo at weeks zero, two and six at 12 centres in the United States and Europe. The study concluded that the maximum beneficial effect of Remicade can be achieved by the smallest dose tested: 5 mg/kg. The beneficial effect of Remicade treatment was found to be consistent regardless of concomitant therapy with other commonly used Crohn's disease treatments. Only six patients withdrew from the study (four in the placebo group). Reasons for withdrawal included lack of efficacy (three placebo patients), administrative reasons (one placebo patient), withdrawal of consent (one Remicade patient) and adverse events (one Remicade patient). Throughout the trial, the most common adverse reactions included headache, abscess, upper respiratory tract infection and fatigue. Four patients experienced mild dizziness, slight temperature elevation, headache, or chest pain with flushing during or shortly after an infusion. Remicade was approved by the United States Food and Drug Administration on Aug. 24, 1998 for treatment of moderately to severely active Crohn's disease among patients who have an inadequate response to conventional therapy. Remicade was also approved for the treatment of fistula(s). A supplemental Biologics License Application has been submitted to the FDA for Remicade for the treatment of rheumatoid arthritis. Remicade is the first of a revolutionary new class of agents that blocks activity of a key inflammatory mediator called tumour necrosis factor alpha (TNF-(alpha)). Overproduction of TNF-(alpha) leads to inflammation in conditions such as Crohn's, rheumatoid arthritis and other autoimmune diseases. It is believed that Remicade reduces inflammation in patients with Crohn's disease by binding to and neutralising TNF-(alpha) on the cell membrane and in the blood. New studies are also looking at Remicade for the treatment of children with Crohn's disease. Dr. Present and other key investigators will present additional data on Remicade during Digestive Disease Week in Orlando, FL., May 15-21, 1999.
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