Alemtuzumab Reduces MS Disease Activity in Active Relapsing-Remitting Multiple Sclerosis Patients Who Had Disease Activity on Prior Therapy (P07.093)

OBJECTIVE: Compare efficacy of alemtuzumab and subcutaneous interferon beta-1a (SC IFNB-1a) on MS disease activity. BACKGROUND: In the Phase 3 study CARE-MS II, alemtuzumab reduced the relapse rate over 2 years compared with SC IFNB-1a by 49% (0.26 vs. 0.52; p DESIGN/METHODS: CARE-MS II was a 2-year, randomized, rater-blinded trial comparing alemtuzumab to IFNB-1a in active, RRMS patients who had relapsed on prior therapy. Alemtuzumab was administered intravenously 12mg on 5 days at study start and 3 days 12 months later. IFNB-1a was administered subcutaneously 44mcg 3-times weekly for 24 months. Expanded Disability Status Scale (EDSS) was assessed by blinded rater at baseline, quarterly, and for suspected relapses. 6-month sustained accumulation of disability (SAD) was defined as an increase of >=1 EDSS point (>=1.5 point if baseline EDSS=0) sustained for 6 months. Magnetic resonance imaging with and without gadolinium occurred annually. MS disease activity-free was defined as no relapse, no SAD, no new gadolinium enhancing lesions or new/enlarging T2 hyperintense lesions. RESULTS: Through Year 1, alemtuzumab patients were more likely to be MS disease activity-free (44.0%) than IFNB-1a patients (27.3%) (odds ratio [OR]: 2.10 [95% CI: 1.44, 3.07], p=0.0001). Through end of study, alemtuzumab patients were more likely to be MS disease activity-free (32.2%) than IFNB-1a patients (13.6%) (OR: 3.03 [95% CI: 1.89, 4.86], p CONCLUSIONS: Alemtuzumab was more effective at reducing overall MS disease activity than IFNB-1a in active RRMS patients who had relapsed on prior therapy. Supported by: Genzyme, a Sanofi company and Bayer Healthcare Pharmaceuticals. Disclosure: Dr. Vollmer has received personal compensation for activities with Genzyme Corporation, Acorda Therapeutics, Accelerated Cure Projects for MS, Bristol-Myers Squibb Company, Teva Neuroscience, Biogen Idec, Novartis, and Hoffman-LaRoche. Dr. Vollmer has received research support from Teva Neuroscience, Genzyme Corporation, Ono Pharmaceutical, Biogen Idec, Janssen, and the National Institutes of Health. Dr. Arnold has received personal compensation or research support from Bayer Healthcare, Biogen Idec, Genetech, NeuroRx Research, Roche, Schering, Serono, and Teva Neuroscience. Dr. Arnold has received personal compensation or research support for Bayer Healthcare, Biogen Idec, Genetech, NeuroRx Research, Roche, Schering, Serono, and Teva Neuroscience. Dr. Cohen has received personal compensation for activities with Biogen Idec, Eli Lilly & Company, Novartis, and Vaccinex. Dr. Cohen9s institution has received research support from Biogen Idec, BioMS, Genzyme Corporation, Novartis, Synthon, and Teva Neuroscience. Dr. Coles has received personal compensation for activities with Genzyme Corporation, GlaxoSmithKline, Inc., and Merck Serono as a consultant and/or speaker. Dr. Coles has received research support from Genzyme Corportation. Dr. Confavreux has received personal compensation for activities with Biogen Dompe, Biogen Idec, Gemacbio, Genzyme Corporation, Hertie Foundation, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, UCB Pharma, Bayer Schering, and Merck Serono. Dr. Confavreux has received research support from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Fox has received personal compensation from Bayer, Biogen Idec, EMD Serono, Genzyme Corporation, Novartis, Opexa Therapeutics, and Teva Neuroscience. Dr. Fox has received research support from Biogen Idec, Eli Lilly & Company, EMD Serono, Genzyme Corporation, GlaxoSmithKline, Inc., Novartis, Ono Pharmaceutical, Roche Diagnostics Corporation, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Hartung has received personal compensation for activities with Biogen Idec, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Bayer, Novartis, and Merck Serono. Dr. Havrodova has received personal compensation for activities with Bayer, Biogen Idec, Genzyme Corporation, GlaxoSmithKline, Inc., Novartis, Merck & Co., Inc., Sanofi-Aventis Pharmaceuticals, Inc., Serono, and Teva Neuroscience. Dr. Selmaj has received personal compensation for activities with Biogen Idec, Genzyme, Ono Pharmaceutical, Novartis, Bayer, Hoffmann LaRoche, Merck, Serono and Synthon. Dr. Weiner has received personal compensation for activities with Biogen Idec, Novartis, Serono, Inc., Teva Neuroscience, GlaxoSmithKline, Inc., Nasvax, Xenoport and Genzyme Corporation as a consultant, speaker and/or participant on an advisory board. Dr. Weiner has received research support from Merck Serono. Dr. Twyman has received personal compensation for activities with Genzyme Corporation. Dr. Twyman has received research support from Genzyme Corporation. Dr. Miller has received personal compensation for activities with Allergan, Bayer, Biogen Idec, Eli Lilly, EMD Serono, Forest, Novartis, Sanofi Aventis, and Teva as a speaker. Dr. Miller has received research support from Allergan, Biogen Idec, Genzyme, Elan, Teva, Novartis, Ono, Sanofi Aventis, EMD Serono, and Roche-Genetech. Dr. Lake receives personal compensation as an employee of Genzyme. Dr. Margolin has received personal compensation for activities with Genzyme Corporation as an employee. Dr. Panzara has received personal compensation for activities with Genzyme an employee. Dr. Panzara holds stock options in Genzyme. Dr. Compston has received personal compensation for activities with Genzyme Corporation as a speaker. Dr. Compston has received research support from Genzyme Corporation.