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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

ented today were findings from a separate retrospective analysis using the Human Capital Management Services Research Reference Database. Containing claims from large employers in the U.S. between January 1, 2001 and September 30, 2006 showed the effect of persistence with anti-TNF therapies on work-related absences for employees with IBD (Crohn's disease or UC). Work absences of 294,983 employees without IBD and 1,380 employees with IBD were analyzed. Employees with IBD and treated for less than 48 weeks with anti-TNF therapies had more total health-related absence days (22.5) than those with at least 48 weeks of anti-TNF therapies (10.3). This was true for sick leave days (4.8 vs. 2.3; P = 0.44) and short-term disability days (17.6 vs. 8.0; P = 0.67). Investigators concluded from the analysis that persistence with anti-TNF therapies is associated with a trend toward reduced work absence, including sick leave and short-term disability, and that these indirect costs should be taken into account when considering treatment options available to patients with IBD.

About ACT 1 and ACT 2

ACT 1 and ACT 2 were multicenter, Phase 3, randomized, double-blind, placebo-controlled clinical trials conducted to evaluate the safety and efficacy of REMICADE for the treatment of adult patients with moderately to severely active UC experiencing an inadequate response to conventional therapy. A total of 728 patients with active UC unresponsive to at least one standard therapy, including corticosteroids, other immunosuppressants, or 5-ASAs, were enrolled in ACT 1 (n=364) and ACT 2 (n=364). Patients in ACT 1 and ACT 2 had endoscopic evidence of moderately to severely active UC (total Mayo score of 6 to 12) and an endoscopy sub-score of at least 2. ACT 1 patients received treatment with placebo or REMICADE 5 mg/kg or REMICADE 10 mg/kg at weeks 0, 2 and 6 and then every eight weeks through week 46 and had the last evaluation at week 54. ACT 2 patients received treatment with
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