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• W2224907029 abstract "OBJECTIVE: To assess the efficacy of 150mg subcutaneous daclizumab high-yield process (DAC HYP) after 3 years of treatment in patients with relapsing-remitting multiple sclerosis (RRMS). BACKGROUND : SELECT was a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of subcutaneous DAC HYP versus placebo; SELECTION was an extension study of SELECT. Subcutaneous DAC HYP 150mg every 4 weeks reduced clinical and radiological MS disease activity in patients with RRMS over 1 to 2 years of treatment. DESIGN/METHODS: SELECTED is an ongoing, single-arm, open-label extension study to evaluate the long-term safety and efficacy of subcutaneous DAC HYP 150mg every 4 weeks for up to 6 years in patients who completed SELECTION. At enrollment, patients had received 1-2 years DAC HYP treatment. An interim analysis was performed on January 20, 2014 (covering the first 3 years of treatment) for patients continuously treated with DAC HYP 150mg. RESULTS: 410 (90[percnt] of patients who completed SELECTION) enrolled in SELECTED. At the time of the data cut, 94 patients had received continuous daclizumab HYP 150mg for at least 3 years. The adjusted annualized relapse rate (95[percnt] CI) analyzed at 6-month intervals was 0.089 (0.033, 0.244) for Weeks >96-120 and 0.047 (0.012, 0.187) for Weeks >120-144. In Year 3, the adjusted mean (95[percnt] CI) number of new/newly enlarging T2 hyperintense lesions was 0.56 (0.24, 1.32) and the mean (median) annualized change in brain volume was -0.3[percnt] (-0.3[percnt]). The efficacy of DAC HYP in Year 3 in SELECTED was similar to that observed in Years 1 and 2, while brain atrophy rate was further reduced in Year 3 from Years 1 and 2. CONCLUSIONS : The effects of daclizumab HYP on clinical and radiological MS disease activity were sustained over 3 years of total treatment in patients with RRMS. Study Supported by : Biogen Idec and AbbVie Biotherapeutics. Disclosure: Dr. Radu has received personal compensation for activities with Actelion, Basilea Pharmaceutica, Bayer Schering, Biogen Idec, Merck Serono, and Novartis. Dr. Giovannoni has received personal compensation for activities with AbbVie, Biogen Idec, Canbex Therapeutics, Genzyme Sanofi, Ironwood Pharmaceuticals Inc., Novartis, Merck, Merck Serono, Roche, Synthon, Teva, Vertex, and Bayer Schering Pharma as a scie Dr. Gold has received personal compensation for activities with Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. 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. Havrdovahas received personal compensation for activities with Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals Inc., Genzyme Corp., and Teva Neuroscience. Dr. Stefoski has received personal compensation for activities with Biogen Idec, Acorda Therapeutics, Serono, Inc., Teva Neuroscience, EMD Serono, and Elan. Dr. Sprenger9s institution has received research support from Novartis, ElectroCore, Genzyme, Actelion, Mitsubishi Pharma Europe, and Biogen Idec. Dr. Montalban has received personal compensation for activities with Bayer, Biogen Idec, EMD, Genentech, Genzyme, Merck Serono, Neurotec, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, and Almirall. Dr. Wu has received personal compensation for activities with Biogen Idec as an employee. Dr. Ozen holds stock and/or stock options in Biogen Idec. Dr. Robinson has received personal compensation for activities with AbbVie as an employee. Dr. Beatty holds stock and/or stock options in Biogen Idec." @default.
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• W2224907029 date "2015-04-06" @default.
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• W2224907029 title "Long-Term Efficacy of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis: 3 Year Results from the SELECTED Extension Study (P7.226)" @default.
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