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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

placebo or REMICADE 5 mg/kg or REMICADE 10 mg/kg at weeks 0, 2, and 6 and then every eight weeks through week 22 and had the last evaluation at week 30. In these studies, the primary assessments of efficacy were based on clinical response, defined as a decrease from baseline in the Mayo score by at least 30 percent and at least three points, accompanied by a decrease in the rectal bleeding subscore of at least one or a rectal bleeding subscore of 0 or 1, and clinical remission, defined as a Mayo score less than or equal to two points, with no individual subscore greater than 1. Based on this definition, patients in clinical remission will have a rectal bleeding subscore of 0 or 1.

The ACT 1 and ACT 2 studies both met their primary endpoint of clinical response at week 8. In the pooled data from the ACT 1 and ACT 2 studies, 66 percent of patients in the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were in clinical response at week 8, compared with 33 percent in the placebo treatment group (P < 0.001).

The serious adverse events reported in these trials were similar to those reported in previous REMICADE clinical trials. See "Important Safety Information" below.

About Human Capital Management Services

Human Capital Management Services (HCMS) is a research and analysis company that focuses on the Health as Human Capital analytical approach that emphasizes the shift from medical cost management to investment in health as human capital.

About Ulcerative Colitis

Ulcerative colitis (UC), a chronic inflammatory bowel disease affecting nearly 500,000 people in the U.S., is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which causes bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms often lead to unwanted
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