Coles et al. Alemtuzumab Slows Brain Volume Loss Over 4 Years Despite Most Relapsing-Remitting Multiple Sclerosis Patients Not Receiving Treatment for 3 Years (P7.263). Neurology April 6, 2015 vol. 84 no. 14 Supplement P7.263
OBJECTIVE: Examine alemtuzumab’s effect on brain volume change over 4 years in patients who participated in the CARE-MS studies and ongoing extension.
BACKGROUND: In 2 phase 3, head-to-head trials in active relapsing-remitting multiple sclerosis (RRMS) patients, alemtuzumab had superior efficacy versus subcutaneous interferon beta-1a (SC IFNB-1a), including a 42% greater reduction in brain volume loss than SC IFNB-1a over 2 years in treatment-naive patients (CARE-MS I; NCT00530348) and 24% greater reduction than SC IFNB-1a in patients who relapsed on prior therapy (CARE-MS II; NCT00548405).
DESIGN/METHODS: Core study patients randomized to alemtuzumab received 12 mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later. In the extension (NCT00930553), alemtuzumab-treated patients could receive as-needed retreatment >1 year after previous course. Magnetic resonance imaging scans were acquired at baseline and yearly thereafter. Brain volume loss was measured by brain parenchymal fraction (BPF) change.
RESULTS: 349 (95.1%) CARE-MS I and 393 (92.9%) CARE-MS II alemtuzumab patients entered the extension phase; data are available through 4 years from first treatment with ongoing follow-up. Among CARE-MS I patients, 20.9% received 1 and 4.6% received 2 additional courses during the extension. Median rate of BPF loss decreased progressively over time in CARE-MS I (Year 1: -0.59%, Year 2: -0.25%, Year 3: -0.19%, Year 4: -0.15%). Among CARE-MS II patients, 24% received 1 and 7% received 2 additional courses during the extension. Median rate of BPF loss progressively slowed over 3 years in CARE-MS II and remained low in Year 4 (Year 1: -0.48%, Year 2: -0.22%, Year 3: -0.10%, Year 4: -0.19%).
CONCLUSIONS: Slowing of brain volume loss with alemtuzumab was maintained over 4 years despite most patients receiving last treatment 3 years prior. These findings support alemtuzumab’s durable efficacy in RRMS.
Study Supported by: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals
CoI: multiple