Alemtuzumab Slows Brain Volume Loss Over 4 Years Despite Most Relapsing-Remitting Multiple Sclerosis Patients Not Receiving Treatment for 3 Years (P7.263)

Abstract

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[percnt] greater reduction in brain volume loss than SC IFNB-1a over 2 years in treatment-naive patients (CARE-MS I; NCT00530348) and 24[percnt] 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 蠅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[percnt]) CARE-MS I and 393 (92.9[percnt]) 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[percnt] received 1 and 4.6[percnt] received 2 additional courses during the extension. Median rate of BPF loss decreased progressively over time in CARE-MS I (Year 1: -0.59[percnt], Year 2: -0.25[percnt], Year 3: -0.19[percnt], Year 4: -0.15[percnt]). Among CARE-MS II patients, 24[percnt] received 1 and 7[percnt] 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[percnt], Year 2: -0.22[percnt], Year 3: -0.10[percnt], Year 4: -0.19[percnt]). 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

Disclosure: Dr. Coles has received personal compensation for activities with Genzyme as a speaker. Dr. Arnold has received personal compensation for activities with Acorda, Bayer Healthcare, Biogen Idec, Merck Serono, Genentech, Genzyme, GlaxoSmithKline, Medimmune, Novartis, Receptos, Inc., Roche, Sanofi-Aventis, and Teva. Dr. Cohen has received personal compensation for activities with Biogen Idec, Eli Lilly, Novartis, and Vaccinex as a consultant and/or speaker. Dr. Fox has received personal compensation for activities Acorda Therapeutics, Bayer Pharmaceuticals Corporation, Biogen Idec, Eli Lilly & Company, EMD Serono, Genzyme Corporation, GlaxoSmithKline, and Novartis. Dr. Hartung has holds stock and/or stock options from Opexa Therapeutics. Dr. Havrdova has received research support from the Czech Ministries of Education and Health. Dr. Selmaj has received personal compensation for activities with Genzyme Corporation, Novartis, Ono Pharmaceutical, Roche Diagnostics Corporation, Synthon, Teva Neuroscience, and Biogen Idec. as a consultant and/or speaker. Dr. Margolin has received personal compensation for activities with Genzyme as an employee., Dr. Kasten's employer has received research support from Genzyme. Dr. Panzara has received personal compensation for activities with Genzyme as an employee. Dr. Compston has received personal compensation for activities with Genzyme and Lundbeck Research USA, Inc.