Alemtuzumab trial data

A
Montalban X, Inshasi JS, Coles AJ, Hartung HP, Havrdova E, Selmaj KW, Margolin DH, Palmer J, Oyuela P.Efficacy and safety of Alemtuzumab in treatment-naive patients with relapsing-remitting multiple sclerosis: Four-year follow-up of the Care-MS I study.Mult Scler Relat Disord. 2014;3(6):761-2.


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 (12mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later) or subcutaneous interferon beta-1a (44μg 3 times/week). In the extension study (NCT00930553), patients could receive as-needed Alemtuzumab re-treatment (12mg/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; <5% of patients received another disease-modifying therapy during the extension. Nine patients (3%) discontinued from the study, none due to adverse events. Among patients who received subcutaneous interferon beta-1a in CARE-MS I, 144 (83%) entered the extension and 132 (92%) received 2 courses of Alemtuzumab. There were 8 withdrawals (6%) in the crossover group during the 2-year extension period, none due to adverse events.
CONCLUSIONS: Most patients receiving Alemtuzumab during the core study required no re-treatment during the 2-year extension period; few sought alternative therapies or withdrew from the study. Among crossover patients, most received both treatment courses and remained in the study.





Kieseier BC, Sahraian MA, Coles AJ, Hartung HP, Havrdova E, Selmaj KW, Margolin DH, Palmer J, Oyuela P. Efficacy and safety of alemtuzumab in patients with relapsing-remitting multiple sclerosis who relapsed on prior therapy: Four-year follow-up of the Care-MS II study. Mult Scler Relat Disord. 2014 Nov;3(6):756. 


BACKGROUND/OBJECTIVES:Alemtuzumab is approved in over 30 countries for relapsing-remitting multiple sclerosis. In the 2-year, phase 3 CARE-MS II study (NCT00548405), alemtuzumab had superior efficacy over subcutaneous interferon beta-1a and manageable safety over 2 years; follow-up at Year 3 showed durable efficacy of alemtuzumab. 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 II, patients with active relapsing-remitting multiple sclerosis who relapsed on prior therapy received 2 courses of alemtuzumab (12mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later) or subcutaneous interferon beta-1a (44?g 3 times/week). In the extension study (NCT00930553), alemtuzumab-treated patients could receive as-needed re-treatment (12mg/day intravenously 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 393 (93%) eligible patients from the core study alemtuzumab arm. Through 4 years, 68% received the first 2, but no additional courses; 24% and 7% received 1 or 2 additional courses, respectively; 5% received another disease-modifying therapy during the extension. Twenty-five patients (6%) discontinued study, none from adverse events. Among former interferon beta-1a patients, 146 (83%) entered the extension; 131 (90%) received 2 alemtuzumab courses. Seven extension withdrawals (5%) occurred in crossover patients, 1 from an adverse event. Efficacy and safety data will be reported.
CONCLUSIONS: Most patients receiving alemtuzumab in the core study required no re-treatment during the first 2 extension years; few received alternative therapies or withdrew from study. Among crossover patients, most received both treatment courses and remained in the study.


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