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Oct 19, 2006

First Biologic to Induce and Maintain Remission for Both Types of IBD Approved

  • Centocor’s Remicade® (infliximab) has been approved for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response to conventional therapy.

    “The data supporting this indication show that, in addition to helping ulcerative colitis patients achieve remission, Remicade is also effective in maintaining long-term remission and helping patients to discontinue use of corticosteroids,” says Stephen B. Hanauer, M.D., professor of medicine at the University of Chicago Hospitals & Clinic and a study investigator of the ACT 1 trial.

    The one-year data from the ACT 1 randomized, double-blind, multicenter, placebo-controlled clinical trial found that patients receiving Remicade were more than twice as likely to be in clinical remission at week 54 compared to placebo. Centocor also points out that the Remicade group was nearly three times as likely as the placebo group to maintain clinical remission from their symptoms after one year. In addition, 45% of Remicade patients had mucosal healing at week 54 compared to 18% in the placebo group, the company adds.

    Remicade has been on the market for the treatment of Crohn's disease since 1998 and was approved for the treatment of UC in September 2005. With the expanded indication for maintenance therapy in UC, Remicade is now the only biologic indicated for inducing and maintaining clinical remission of both types of inflammatory bowel disease, according to Centocor.



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