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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

Data from SONIC Trial Showed REMICADE Therapy is More Likely to Induce

Steroid-Free Remission and Mucosal Healing Compared with Standard

Immunomodulator, Azathioprine

ORLANDO, Fla., Oct. 6 /PRNewswire/ -- Data presented for the first time from the Phase 3b Study of Patients with Crohn's Disease Naive to Immunomodulators and Biologic Therapy (SONIC) may provide new insights into the approach to care of patients with moderate to severe Crohn's disease. According to findings from the SONIC trial, a significantly greater proportion of patients with moderate to severe Crohn's disease receiving REMICADE(R) (infliximab), either in combination with azathioprine or as monotherapy, experienced steroid-free remission and mucosal healing compared with patients receiving azathioprine alone. Azathioprine is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's disease; however, it is widely used by gastroenterologists and other physicians in the United States to treat patients with Crohn's disease. Azathioprine is approved for the treatment of Crohn's disease in some countries outside the United States. Investigators reported that at week 26, 57 percent of patients receiving REMICADE combination therapy and 44 percent of patients receiving REMICADE monotherapy achieved steroid-free remission, the primary endpoint of the study, compared with 31 percent of patients receiving azathioprine alone (P < 0.001 REMICADE with azathioprine vs. azathioprine monotherapy; P = 0.009 REMICADE monotherapy vs. azathioprine monotherapy; P = 0.022 REMICADE with azathioprine vs. REMICADE monotherapy).

"Findings from the SONIC trial have the potential to challenge the treatment protocol for Crohn's disease as these data show that introducing REMICADE earlier may result in more patients achieving steroid-free remission and complete mucosal healing," said Dr. Jean-Frederic Colombel, Professor of Hepatogastroenterology
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SOURCE Centocor
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