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New Analysis Shows Efficacy of REMICADE(R) in Treatment of Ulcerative Colitis in Patients with Recent Disease Onset or Long-Standing Disease
Date:5/20/2008

subjects with disease duration less than three years, and 68 percent versus 34 percent for subjects with disease duration of at least three years; clinical remission: 28 percent versus 8 percent and 35 percent versus 12 percent, respectively; mucosal healing: 56 percent versus 29 percent and 63 percent versus 35 percent, respectively.

At week 30, clinical response, clinical remission and mucosal healing rates for the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were also significantly higher than the placebo group (P < 0.01) regardless of disease duration; clinical response: 49 percent versus 19 percent for subjects with disease duration less than three years, and 54 percent versus 34 percent for subjects with disease duration of at least three years; clinical remission: 28 percent versus 10 percent, and 35 percent versus 15 percent, respectively; mucosal healing: 47 percent versus 20 percent ,and 52 percent versus 32 percent, respectively. A Cochran-Mantel-Haenszel test stratified by baseline corticosteroid refractory status was used to compare REMICADE with placebo within each disease duration subgroup.

Ulcerative colitis is a chronic inflammatory disease of the colon and large intestine that affects approximately half a million Americans and can lead to frequent hospitalizations, surgery and loss of work productivity. Both UC and Crohn's disease are known collectively as inflammatory bowel diseases, or IBD. Approved in 1998 by the U.S. Food and Drug Administration as the first anti-tumor necrosis factor (TNF)-alpha therapy, REMICADE received its initial approval for the treatment of Crohn's disease and has since become the first and only anti-TNF-alpha therapy approved for the treatment of UC and pediatric Crohn's disease. A Phase 3 study evaluating the efficacy and safety of REMICADE for the treatment of pediatric UC is currently ongoing.

Impact of Anti-TNF Therapies on Absence from Work Among Employees with IBD

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