Treatment with alemtuzumab (Genzyme Corporation) reduced the accumulation of disability and the frequency of relapses in people with early relapsing-remitting MS, compared to Rebif® (interferon beta-1a, EMD Serono, Inc. and Pfizer, Inc.). Those taking alemtuzumab had a 74% reduction in the risk of MS relapse compared with those on Rebif, and a 71% reduction in the risk for sustained accumulation of disability. Those on alemtuzumab, an immune-suppressing monoclonal antibody, experienced adverse events more frequently, including immune thrombocytopenic purpura (a serious bleeding disorder), thyroid adverse events, and infections. The results, originally reported at medical meetings, have now been published (New England Journal of Medicine 2008 359;17: 30-45), and two Phase 3 trials are currently recruiting participants with relapsing-remitting MS.

Comment: “We are pleased to see potential new treatment options move positively through the MS pipeline,” said John R. Richert, MD, executive vice president for research and clinical programs at the National MS Society. “We look forward to results from the Phase 3 studies now getting underway, which will help determine if this treatment can be used safely and effectively in people with MS.”

Two Phase 3 trials of alemtuzumab, supported by Genzyme Corporation and Bayer Healthcare Pharmaceuticals, are currently recruiting participants.

National Multiple Sclerosis Society
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