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New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohn's Disease According to First-of-its Kind Study
Date:10/6/2008

, Centre Hospitalier Universitaire Lille, France and lead investigator. "These data reinforce the efficacy and safety profile of REMICADE in the treatment of this chronic inflammatory bowel disease."

Dr. William J. Sandborn, Inflammatory Bowel Disease Clinic, Mayo Clinic, and principal investigator for the SONIC trial will present the results of the SONIC trial on Tuesday, October 7 at the annual meeting of the American College of Gastroenterology.

The SONIC clinical trial, the first of its kind to compare REMICADE, an anti-tumor necrosis factor (TNF)-alpha therapy, with an immunomodulator in patients with moderate to severe Crohn's disease previously failing 5-aminosalicylate (5-ASA) and/or steroids, included more than 500 subjects from clinics across the United States, Europe and Israel. In addition to improved rates of steroid-free remission in patients receiving REMICADE, the data showed that a greater proportion of patients with Crohn's disease achieved mucosal healing, a secondary endpoint of the study, when receiving REMICADE. Results from SONIC revealed that 44 percent of patients receiving REMICADE combination therapy and 30 percent receiving REMICADE monotherapy achieved mucosal healing compared with 17 percent of patients receiving azathioprine alone (P < 0.001 REMICADE with azathioprine vs. azathioprine monotherapy; P = 0.023 REMICADE monotherapy vs. azathioprine monotherapy; P = 0.055 REMICADE with azathioprine vs. REMICADE monotherapy).

The data also showed that the safety profile of REMICADE in combination or as monotherapy was similar to that of azathioprine monotherapy in the study. At week 30, 24 percent of patients receiving azathioprine monotherapy experienced one or more serious adverse events compared with 16 and 14 percent of patients receiving REMICADE monotherapy and REMICADE with azathioprine, respectively. That includes 2 patients receiving azathioprine monotherapy who developed colon cancer, one patient receiving azat
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