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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

A Separate Retrospective Analysis of US Employer Claims Suggests a Benefit of Anti-Tumor Necrosis Factor Therapies on Absenteeism Among Employees with

Inflammatory Bowel Disease

SAN DIEGO, May 20 /PRNewswire/ -- Data from a new analysis of the Active Ulcerative Colitis Trials (ACT 1 and ACT 2) showed that at week 8, more than 60 percent of patients with moderately to severely active ulcerative colitis (UC) receiving REMICADE(R) (infliximab) achieved clinical response regardless of disease duration (less than three years versus at least three years). Investigators also reported that at week 30, significant improvements were maintained with nearly half of REMICADE-treated patients having a clinical response. Significant improvements in disease remission and mucosal healing were also reported at weeks 8 and 30 among patients receiving REMICADE and meeting the disease duration criteria. These findings were presented today at the annual Digestive Disease Week(R) (DDW) meeting.

"These data are encouraging because we see that REMICADE is an effective treatment option for patients with active ulcerative colitis, whether recently diagnosed or struggling with the condition for many years," said Dr. Bruce Sands, Associate Professor of Medicine at Harvard Medical School, and study investigator. "Regardless of disease duration, patients receiving REMICADE showed significant improvements in clinical response, remission and mucosal healing, all goals of therapy in the treatment of ulcerative colitis."

In the analysis of 728 patients from ACT 1 and ACT 2, 254 patients had UC for less than three years and 474 patients had UC for at least three years. Clinical response, clinical remission and mucosal healing rates at week 8 for the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were all significantly higher than the placebo group (P < 0.01) regardless of disease duration; clinical response: 62 percent versus 33 percent for
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