Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial

Autor: Alasdair J. Coles, Douglas L. Arnold, Ann D. Bass, Aaron L. Boster, D. Alastair S. Compston, Óscar Fernández, Eva Kubala Havrdová, Kunio Nakamura, Anthony Traboulsee, Tjalf Ziemssen, Alan Jacobs, David H. Margolin, Xiaobi Huang, Nadia Daizadeh, Madalina C. Chirieac, Krzysztof W. Selmaj
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Therapeutic Advances in Neurological Disorders, Vol 14 (2021)
Druh dokumentu: article
ISSN: 1756-2864
17562864
DOI: 10.1177/1756286420982134
Popis: 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. ClinicalTrials.gov identifiers: NCT00530348; NCT00548405; NCT00930553
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