Abstract

Alemtuzumab (Lemtrada®) is an anti-CD52 monoclonal antibody approved in the EU for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS). In phase 3 trials in patients with active RRMS, intravenous alemtuzumab was more effective than subcutaneous interferon β-1a in terms of decreasing relapse rates (in treatment-naïve or -experienced patients) and disability progression (treatment-experienced patients). Treatment benefits were maintained over up to 9 years of follow-up, with ≈ 50% of patients not requiring retreatment. The efficacy of alemtuzumab in patients with highly active disease was generally similar to that in the overall population. Alemtuzumab has an acceptable tolerability profile, with infusion-associated reactions, infections and autoimmunity being the main safety and tolerability issues. Current evidence indicates that alemtuzumab is an effective treatment option for adults with highly active RRMS, with an acceptable safety and tolerability profile and convenient treatment regimen.

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