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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

ission among the overall randomized population (N=508), including individuals who did not enter the study extension and were assumed to be non-responders to therapy or not in steroid-free remission at week 50, was 46 percent of patients receiving REMICADE and azathioprine combination therapy, and 35 percent of patients receiving REMICADE monotherapy, compared with 24 percent of patients receiving azathioprine alone (P < 0.001 REMICADE with azathioprine vs. azathioprine monotherapy; P = 0.028 REMICADE monotherapy vs. azathioprine monotherapy; P = 0.035 REMICADE with azathioprine vs. REMICADE monotherapy). In an analysis of only those individuals participating in the extension (N=280), 72 percent of patients receiving REMICADE and azathioprine combination therapy, 61 percent of patients receiving REMICADE monotherapy and 55 percent receiving azathioprine alone achieved steroid-free remission at week 50 (P = 0.010 REMICADE and azathioprine vs. azathioprine monotherapy; P = 0.324 REMICADE monotherapy vs. azathioprine monotherapy; P = 0.065 REMICADE and azathioprine vs. REMICADE monotherapy).

A final safety evaluation for those patients who entered the extension study occurred at week 54. The proportion of patients with 1 or more serious adverse events during the study was 27 percent (n=43) in the AZA monotherapy treatment group, 24 percent (n=39) in the REMICADE monotherapy treatment group, and 15 percent (n=27) in the combined REMICADE and AZA treatment group. No new serious adverse events, such as opportunistic infections, malignancies or death, were reported between weeks 30 and 54.

Dr. William J. Sandborn, Inflammatory Bowel Disease Clinic, Mayo Clinic, and principal investigator for the SONIC trial, will present the results of the SONIC extension trial on Tuesday, June 2 at 3:30 PM at the annual Digestive Disease Week meeting.

In 1998, REMICADE became the first anti-T
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SOURCE Centocor Ortho Biotech Inc.
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