New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn...( First-of-its-Kind Study Demonstrates ...),Health

First-of-its-Kind Study Demonstrates REMICADE More Likely to Maintain Steroid-Free Remission in Patients Naive to Immunomodulators and BiologicTherapy

CHICAGO, June 2 /PRNewswire/ -- New long-term findings from the Phase 3b study of patients with moderately to severely active Crohn's disease having inadequate response to conventional therapies, but naive to immunomodulators and biologic therapy, were presented at Digestive Disease Week today. Data from the SONIC study showed that a greater proportion of patients receiving REMICADE (infliximab) maintained steroid-free remission at one year, compared with patients receiving azathioprine alone.

"The new, year-long data reinforce earlier 26 week findings from the SONIC trial and support the importance of this first-of-its-kind study for treating Crohn's disease," said Dr. Jean-Frederic Colombel, Professor of Hepatogastroenterology, Centre Hospitalier Universitaire Lille, France, study investigator. "The data further support the use of REMICADE earlier in the treatment of moderate to severe Crohn's disease and its effectiveness in patients maintaining steroid-free remission through one year."

The SONIC clinical trial is the first of its kind to compare REMICADE, an anti-tumor necrosis factor (TNF)-alpha therapy, with an immunomodulator (azathioprine) in patients with moderate to severe Crohn's disease. 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.

Patients participating in the SONIC study through 30 weeks were given the option of continuing in a blinded study extension through 54 weeks. The proportion of patients achieving steroid-free rem
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