Sanofi and Genzyme announced results from its CARE-MS 1 study of Lemtrada (alemtuzumab) for the treatment of multiple sclerosis. CARE-MS 1 is the first of two randomized, Phase 3 trials comparing Lemtrada to the approved MS therapy Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing-remitting MS (RRMS). The study showed that two annual cycles of alemtuzumab treatment resulted in a 55% reduction in relapse rate compared to Rebif over the two years of the study (P<0.0001), achieving its first primary endpoint. Statistical significance was not achieved for the second primary endpoint–time to six month sustained accumulation of disability–as compared with Rebif. At the two-year time point, 8% of alemtuzumab-treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared with 11% of those who received Rebif (HR 0.70, P=0.22).
Alemtuzumab is a recombinant, humanized monoclonal antibody (CD52). It is currently marketed as Campath in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
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