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Durable Efficacy of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Who Participated in the CARE-MS Studies: Three Year Follow-Up (S41.001)

2013; Lippincott Williams & Wilkins; Volume: 80; Issue: 7_supplement Linguagem: Inglês

10.1212/wnl.80.7_supplement.s41.001

1526-632X

Edward Fox, Douglas L. Arnold, Jeffrey Cohen, Alasdair Coles, Christian Confavreux, Hans Hartung, Eva Havrdová, Krzysztof Selmaj, Howard L. Weiner, Cary Twyman, Anton Vladić, David Margolin, Pedro Oyuela, Michael Panzara, Alastair Compston,

Chronic Myeloid Leukemia Treatments

OBJECTIVE: To examine durability of alemtuzumab9s efficacy in relapsing-remitting multiple sclerosis (RRMS) patients who participated in the pivotal phase 3 CARE-MS trials and continued in the extension study. BACKGROUND: Two 2-year phase 3 trials comparing alemtuzumab to subcutaneous interferon beta-1a in RRMS patients who were treatment naive (CARE-MS I) and who had relapsed on prior therapy (CARE-MS II) found significant positive treatment effects for alemtuzumab on relapses (both studies) and accumulation of disability (CARE-MS II). DESIGN/METHODS: During the extension study, patients originally treated with alemtuzumab received safety monitoring and were eligible to receive additional alemtuzumab upon evidence of resumed disease activity (≥1 relapse or ≥2 new or enlarging brain or spinal lesions on MRI). Retreatment courses were 12 mg alemtuzumab intravenously infused once daily for 3 days. Disability was assessed quarterly by blinded raters with the Expanded Disability Status Scale (EDSS). Relapses were assessed by blinded raters as-needed. Year 1 extension data are reported. RESULTS: 349 CARE-MS I and 386 CARE-MS II alemtuzumab patients enrolled in the extension. Annualized relapse rates during Extension Year 1 were 0.13 for both CARE-MS I and CARE-MS II alemtuzumab patients. The mean EDSS scores for the CARE-MS I study were Baseline: 2.0; Month 24: 1.9; Extension Baseline: 1.8, and Extension Year 1: 1.9. The mean EDSS scores for the CARE-MS II study was Baseline: 2.7; Month 24: 2.5; Extension Baseline: 2.5, and Extension Year 1: 2.6. Retreatment data will also be presented. Safety experience during the extension was consistent with previously reported adverse events, including thyroid, immune thrombocytopenia and anti-glomerular basement membrane disease. Updated safety results will be reported. CONCLUSIONS: Efficacy was maintained through the first year of the extension study. Low annualized relapse rates were observed for alemtuzumab patients from both studies. EDSS remained stable in the patients during the first year of the extension period. Supported by: Genzyme, a Sanofi company and Bayer Healthcare Pharmaceuticals. Disclosure: 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. 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. 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. Vladic has nothing to disclose. Dr. Margolin has received personal compensation for activities with Genzyme Corporation as an employee. Dr. Oyuela has received personal compensation from 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.