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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

hioprine monotherapy who died following a colectomy and one patient receiving REMICADE combination therapy who 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.

In 1998 REMICADE became the first anti-TNF-alpha therapy approved by the FDA for the treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapy. During the past decade, REMICADE has also become the first and only anti-TNF-alpha therapy that the FDA has approved for the treatment of ulcerative colitis, a related inflammatory bowel disease, and pediatric Crohn's disease.

Crohn's disease is a chronic inflammatory disease of the colon and large intestine that affects approximately 500,000 people in the United States. Crohn's disease can lead to frequent hospitalizations, surgery and loss of work productivity.

About SONIC

SONIC is a multicenter, Phase 3b, randomized, double-blind, controlled clinical trial designed to compare the efficacy and safety of REMICADE monotherapy, azathioprine monotherapy and combination therapy with the 2 drugs in patients with moderate to severe Crohn's disease who were nave to immunomodulator and biologic therapy. A total of 508 patients with Crohn's disease who were naive to both biologics and immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) were enrolled in the study and were randomized into three groups; 170 patients received azathioprine 2.5 mg/kg/day and placebo infusions, 169 patients received REMICADE 5 mg/kg infusions at weeks 0, 2, 6 and every 8 weeks thereafter with placebo capsules and 169 patients received REMICADE 5 mg/kg and azathioprine 2.5 mg/kg through 30 weeks. The primary endpoint of SONIC was to assess the induction of steroid-free remission. Fifty-two perce
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