Efficacy and safety of Alemtuzumab in treatment-naive patients with relapsing-remitting multiple sclerosis: Four-year follow-up of the Care-MS I study

• Published in: Multiple sclerosis and related disorders 2014-11, Vol.3 (6), p.761-762
• Main Authors: Montalban, X, Inshasi, J.S, Coles, A.J, Hartung, H.P, Havrdova, E, Selmaj, K.W, Margolin, D.H, Palmer, J, Oyuela, P
• Format: Article
• Language: English
• Subjects: Neurology
• ISSN: 2211-0348
• DOI: 10.1016/j.msard.2014.09.207

Background/objectives Alumtzumab is approved in over 30 countries for relapsing-remitting multiple sclerosis. In the 2-year, phase 3 CARE-MS I study (NCT00530348), Alemtuzumab significantly reduced relapses compared with subcutaneous interferon beta-1a, with manageable safety in treatment-naive patients with active relapsing-remitting multiple sclerosis. Durable efficacy of Alemtuzumab was demonstrated at 3-year follow-up. Here we report results for years 3 and 4 after Alemtuzumab initiation, and for years 1 and 2 after Alemtuzumab initiation in patients initially treated with subcutaneous interferon beta-1a (crossover cohort). Design and methods In CARE-MS I, patients received Alemtuzumab (12 mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later) or subcutaneous interferon beta-1a (44 μg 3 times/week). In the extension study (NCT00930553), patients could receive as-needed Alemtuzumab re-treatment (12 mg/day on 3 consecutive days) ≥1 year apart or other disease-modifying therapy. Crossover patients received 2 Alemtuzumab courses (5 days then 3 days) 12 months apart. Results The extension enrolled 349 (95%) eligible patients from the core study Alemtuzumab arm. Through 4 years, 73% of these patients received only 2 annual courses, while 21% and 5% received 1 or 2 additional courses, respectively;