P058 - Efficacy and safety of Alemtuzumab in treatment-naive patients with relapsing-remitting multiple sclerosis: Four-year follow-up of the Care-MS I study

Abstract

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; <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. Efficacy and safety data will be reported. 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. 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). 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. 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. Efficacy and safety data will be reported. 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.