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• W2800702435 abstract "Objective: Evaluate 6-year efficacy of alemtuzumab in patients with disease activity (relapse) between Courses 1 and 2. Background: Patients with active relapsing-remitting MS and an inadequate response (≥1 relapse) to prior therapy (CARE-MS II; NCT00548405) demonstrated improved clinical/MRI outcomes with alemtuzumab versus SC IFNB-1a that were durable through 6 years (extension study: NCT00930553). The majority of patients were relapse-free after alemtuzumab Course 1; however, some relapsed before Course 2. Design/Methods: Patients received 2 courses of alemtuzumab 12 mg (baseline: 5 days; Month 12: 3 days) in CARE-MS II, and as-needed alemtuzumab for relapse/MRI activity in extension; another disease-modifying therapy was allowed per investigator discretion. Annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW) and improvement (CDI), and brain volume loss (BVL) derived by relative change in brain parenchymal fraction were assessed in patients who relapsed between Course 1 and 2 (Months 6–12). Results: Among the 14% (62/435) of patients who relapsed 6–12 months after Course 1, ARR over this 6-month period was 2.4. In the year after Course 2, their ARR declined to 0.6, and further declined through Year 6 (Years 3–6: 0.4, 0.3, 0.3, 0.1, respectively). Most patients remained free of 6-month CDW from Year 1 (88%) through Year 6 (61%), and proportion with CDI increased from Year 1 (24%) to Year 6 (39%). Median percent yearly BVL (Year 1: −0.53%) durably declined in Years 2–6 (−0.10%, −0.14%, −0.18%, −0.27%, −0.10%, respectively). After Course 2, efficacy in this cohort was comparable with overall CARE-MS II alemtuzumab 12 mg population. Conclusions: Although the majority of patients did not relapse 6–12 months after initiating alemtuzumab, clinical and MRI outcomes in those who did relapse markedly improved over the subsequent 5 years. These findings support the importance of administering the 2-course regimen of alemtuzumab to achieve optimal and durable clinical benefit. Study Supported by: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals. Disclosure: Dr. Singer has received personal compensation for activities with Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Sanofi Genzyme, and Teva CNS as a speaker and/or consultant. Dr. Singer has received research support from Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genzyme. Dr. Wiendl has received personal compensation for activities with Bayer Healthcare, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi Aventis, Bayer Vital GmbH, Bayer Schering AG, Biogen Idec, and CS. Dr. Wiendl has received research support from Bayer HealthCare, Biogen Idec, the German Ministry for Education and Research, Deutsche Forschungsgesellschaft, and the Else Kroner Fresenius Foundation Dr. Broadley has nothing to disclose. Dr. Freedman has received personal compensation for activities with Bayer HealthCare, Biogen Idec, EMD Canada, Novartis, Sanofi, Teva Canada Innovation, Chugai, Merck Serono, Novartis, Opexa for honoraria, consulting or participating on a advisory board. Dr. Izquierdo has received personal compensation for activities with Biogen Idec, Merck Serono, Sanofi Pharmaceuticals, Teva Neuroscience, Novartis, Genzyme Corporation, Almirall and Roche Diagnostics Corporation as a speaker and consultant. Dr. Lycke has received personal compensation for activities with Novartis as a lecturer. Dr. Pozzilli has received personal compensation for activities with Almirall, Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva as a speaker and consultant. Dr. Pozzilli has received research support from Almirall, Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva. Dr. Steingo has received personal compensation for activities with Biogen, TEVA, Novartis, EMD Serono, Acorda, Sanofi Genzyme, Mallinckrodt as as speaker and/or advisor. Dr. Steingo has received research support from Sanofi Genzyme, Novartis, Mallinckrodt, and MedDay. Dr. Margolin has received personal compensation for activities with Sanofi Genzyme as an employee. Dr. Santra has received personal compensation for activities with Sanofi Genzyme as a consultant. Dr. Thangavelu has received personal compensation for activities with Sanofi Genzyme as an employee. Dr. Boster has received personal compensation for activities with Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi Genzyme, and Teva for consulting or non-CME services. Dr. Investigators has nothing to disclose." @default.
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• W2800702435 date "2017-04-18" @default.
• W2800702435 modified "2023-09-22" @default.
• W2800702435 title "Durable Efficacy of Alemtuzumab in CARE-MS II Patients With RRMS With Disease Activity (Relapse) Between Courses 1 and 2 (P5.349)" @default.
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