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New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease
Date:6/2/2009

ion and complete mucosal healing, the healing of the lining of the bowel, at week 26. Results from the 26 week data showed that 57 percent of patients receiving REMICADE combination therapy and 44 percent receiving REMICADE monotherapy achieved clinical remission without steroids 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). Additionally, mucosal healing was achieved in 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).

Through the first 26 weeks in SONIC, 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. Two patients receiving azathioprine monotherapy developed colon cancer, one patient receiving azathioprine monotherapy died following a colectomy and one patient receiving REMICADE combination therapy was diagnosed with tuberculosis. Serious infections were reported as follows: 8 in the azathioprine monotherapy group, 4 in the REMICADE monotherapy group and 6 in the REMICADE combination therapy group. There were no deaths, malignancies or reports of tuberculosis during the study extension.

For more information regarding the safety profile for REMICADE, please see "Important Safety Information" below.

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SOURCE Centocor Ortho Biotech Inc.
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