Proportion of Disease-Activity Free Patients with Relapsing-Remitting Multiple Sclerosis Following 1 Year of Treatment with Daclizumab High-Yield Process in the SELECT Study (P07.105)

OBJECTIVE: To evaluate the proportion of 9disease-activity free9 patients following 1 year of treatment with monthly subcutaneous daclizumab high-yield process (DAC HYP) versus placebo. BACKGROUND: The development of targeted biologic therapies has made remission of disease activity a realistic goal. DAC HYP is a humanized monoclonal antibody that binds the α-subunit (CD25) of the interleukin-2 receptor (IL-2R) and inhibits high-affinity IL-2R signalling. DESIGN/METHODS: SELECT was a randomized, double-blind, multicenter study of DAC HYP 150mg, DAC HYP 300mg, or placebo administered subcutaneously every 4 weeks for 52 weeks in relapsing-remitting MS (RRMS) patients. Efficacy outcomes were similar between doses in the trial, so the dose groups were pooled for this analysis. Disease-activity free was defined as completion of the study through Week 52 without relapses or confirmed 3-month disability progression, with no new or enlarging T2 hyperintense lesions and no new Gd+-enhancing lesions. The primary analysis was based on logistic regression controlling for baseline characteristics (age [≤35 vs >35 years], Expanded Disability Status Scale (EDSS) [≤2.5 vs >2.5], number of lesions, and number of relapses in previous year). RESULTS: A greater proportion of DAC HYP-treated patients (n=404) versus placebo (n=196) were disease-activity free (39% vs. 11%, respectively; odds ratio [95% confidence interval], 6.18 [3.71-10.32]; P P P P CONCLUSIONS: DAC HYP treatment for 1 year resulted in a meaningful increase in the proportion of RRMS patients who were disease-activity free versus placebo. Supported by: Biogen Idec and Abbott Biotherapeutics. Disclosure: 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. Giovannoni has received personal compensation for activities with Merck Serono, Biogen Idec, Vertex Pharmaceuticals, Bayer Schering Pharma, Pfizer Inc, Teva Pharmaceutical Industries Ltd, and Sanofi. Dr. Giovannoni has received research support from Biogen Idec, Merck Serono, Novartis, and Ironwood. Dr. Stefoski has received personal compensation for activities with Biogen Idec, Acorda Therapeutics, Serono, Teva Neuroscience, EMD Serono, and Elan Corporation. Dr. Stefoski has received royalty payments from Acorda Therapeutics. Dr. Stefoski has received research support from Biogen Idec, Novartis, Serono, and Pfizer Inc. Dr. Umans has received personal compensation for activities with Biogen Idec. Dr. Umans9 family member holds stock and/or stock options in Sinovac Biotech Ltd. Dr. Greenberg has received personal compensation for activities with Abbott Biotherapeutics as an employee. Dr. Mehta has received personal compensation for activities with Biogen Idec as an employee. Dr. Elkins has received personal compensation for activities with Biogen Idec as an employee. Dr. Elkins holds stock and/or stock options in Biogen Idec.