BACKGROUND: In the 2-year CARE-MS I and II trials, alemtuzumab 12 mg administered on 5 consecutive days at core study baseline and on 3 consecutive days 12 months later significantly improved outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing-remitting multiple sclerosis patients. Here, we present the final 6-year CARE-MS extension trial results (CAMMS03409), and compare outcomes over 6 years in patients randomized to both treatment groups at core study baseline. METHODS: Over a 4-year extension, alemtuzumab patients (alemtuzumab-only) received as-needed additional alemtuzumab (⩾12 months apart) for disease activity after course 2. SC IFNB-1a patients who entered the extension discontinued SC IFNB-1a and received 2 alemtuzumab 12 mg courses (IFN-alemtuzumab), followed by additional, as-needed, alemtuzumab. RESULTS: Through year 6, 63% of CARE-MS I and 50% of CARE-MS II alemtuzumab-only patients received neither additional alemtuzumab nor other disease-modifying therapy, with lasting suppression of disease activity, improved disability, and slowing of brain volume loss (BVL). In CARE-MS I patients (treatment-naive; less disability; shorter disease duration), disease activity and BVL were significantly reduced in IFN-alemtuzumab patients, similar to alemtuzumab-only patients at year 6. Among CARE-MS II patients (inadequate response to prior treatment; more disability; longer disease duration), alemtuzumab significantly improved clinical and magnetic resonance imaging outcomes, including BVL, in IFN-alemtuzumab patients; however, disability outcomes were less favorable versus alemtuzumab-only patients. Safety profiles, including infections and autoimmunities, following alemtuzumab were similar between treatment groups. CONCLUSION: This study demonstrates the high efficacy of alemtuzumab over 6 years, with a similar safety profile between treatment groups. CLINICALTRIALSGOV IDENTIFIERS: NCT00530348; NCT00548405; NCT00930553.

Center of Clinical Neuroscience Carl Gustav Carus University Hospital Dresden Germany

Cerevance Inc Boston MA USA

Department of Biomedical Engineering Cleveland Clinic Cleveland OH USA

Department of Clinical Neurosciences University of Cambridge Box 165 Addenbrooke's Hospital Cambridge CB2 0QQ UK

Department of Clinical Neurosciences University of Cambridge Cambridge UK

Department of Neurology and Center for Clinical Neuroscience 1st Medical Faculty Charles University Prague Czech Republic

Department of Neurology University of Warmia and Mazury Olsztyn Poland

Immunovant Inc New York NY USA

Instituto de Investigación Biomédica de Málaga Málaga Spain

Neurology Center of San Antonio San Antonio TX USA

NeuroRx Research Montréal Québec Canada

Sanofi Cambridge MA USA

The Boster MS Center Columbus OH USA

The University of British Columbia Vancouver British Columbia Canada

Vertex Pharmaceuticals Inc Boston MA USA

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ClinicalTrials.gov
NCT00548405, NCT00530348, NCT00930553