Efficacy of Alemtuzumab in Patients With Active Relapsing-Remitting Multiple Sclerosis Who Received Retreatment Due to Disease Activity After the Initial Two Courses: Results From the CARE-MS II Extension (P6.363)

Objective: To evaluate efficacy of as-needed alemtuzumab retreatment in CARE-MS II patients. Background: In CARE-MS II (NCT00548405), alemtuzumab 12 mg/day (2 courses, baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a over 2 years in patients with relapsing-remitting MS and inadequate response to prior therapy. In an extension (NCT00930553), durable efficacy was observed over 4 additional years, despite 50% not receiving alemtuzumab retreatment or another disease-modifying therapy (DMT). Design/Methods: In the extension, patients could receive alemtuzumab retreatment (12 mg/day, 3 consecutive days; ≥12 months apart) as needed for relapse and/or MRI activity or receive another DMT per investigator’s discretion. Assessments 12 months before alemtuzumab Course 3 (C3) and up to 3 years after C3 were compared: annualized relapse rate (ARR); improved/stable Expanded Disability Status Scale (EDSS) score (versus core study baseline); 6-month confirmed disability improvement (CDI). Patients receiving another DMT were excluded. Analyses included patients who received ≥1 retreatment, with data for those receiving Course 4 censored at the time of the second retreatment. Results: Through Year 6, 344/393 (88%) patients entering the extension remained on study, with 178/393 (45%) receiving ≥1 retreatment. ARR decreased following retreatment, from 0.85 (12 months before C3) to 0.20 (12 months after C3; rate ratio [95% CI], 0.24 [0.17–0.34]; P P =0.0126). In patients re-treated due to relapse only, outcomes were similar to those in patients re-treated due to relapse and/or MRI activity. Conclusions: These findings, from CARE-MS II patients who were re-treated due to relapse and/or MRI activity after the initial 2 courses, demonstrate continued alemtuzumab efficacy after C3 with reduced relapses and stable or improved disability. Study Supported by: Sanofi and Bayer HealthCare Pharmaceuticals. Disclosure: Dr. Singer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Sanofi Genzyme, and Teva. Dr. Singer has received research support from Acorda, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi Genzyme. Dr. Boster has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Novartis genzyme Genetech Teva medtronic. Dr. Boster has received research support from Biogen, Teva, Novartis, Genetech, Actellion, Roche. Dr. Bass has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Mallinckrodt, Novartis, Roche-Genentech, Sanofi, and Teva Neuroscience. Dr. Bass has received research support from Biogen, Mallinckrodt, Novartis, Roche-Genentech, Sanofi, and Teva Neuroscience. Dr. Berkovich has nothing to disclose. Dr. Comi has nothing to disclose. Dr. Fernandez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lecturer or participation in advisory boards for: Biogen-Idec, Merck Serono, Teva, Novartis, and Almirall. Dr. Fernandez has received personal compensation in an editorial capacity for Editor of: Revista Espanola de Esclerosis Multiple. Dr. Kim has nothing to disclose. Dr. Limmroth has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva, with approval by the HR-Department, Cologne General Hospital, and University of Cologne. Dr. Lycke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi Genzyme, Merck, Novartis, Teva. Dr. Lycke has received research support from Novartis, Teva. Dr. Macdonell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva. Dr. Macdonell has received research support from Biogen, Merck, Novartis, Sanofi, and Teva. Dr. Sharrack has nothing to disclose. Dr. Vermersch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Servier, and Teva. Dr. Vermersch has received research support from Almirall, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Servier, and Teva. Dr. Wiendl has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, Actelion, Alexion, Biogen, Cognomed, Evgen, F. Hoffmann-La Roche Ltd, MedDay Pharmaceuticals, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, TEVA. Dr. Wiendl has received research support from Biogen, GlaxoSmithKline GmbH, Roche Pharma AG, Sanofi-Genzyme. Dr. Ziemssen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Biogen, Bayer, Merck, Novartis, Roche, Sanofi, Teva for the consulting and speaking services. Dr. Ziemssen has received research support from Bayer, Biogen, Novartis, Teva, Sanofi Aventis. Dr. Melanson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Daizadeh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Traboulsee has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Chugai, F. Hoffmann-La Roche Ltd, Novartis, Sanofi Genzyme and Teva. Dr. Traboulsee has received research support from F. Hoffmann-La Roche Ltd.