Gold et al. BMC Neurology (2016) 16:117 DOI 10.1186/s12883-016-0635-y

RESEARCH ARTICLE

Open Access

Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study Ralf Gold1*, Ernst-Wilhelm Radue2, Gavin Giovannoni3, Krzysztof Selmaj4, Eva Havrdova5, Dusan Stefoski6, Till Sprenger2,7, Xavier Montalban8, Stanley Cohan9, Kimberly Umans10, Steven J. Greenberg11, Gulden Ozen10 and Jacob Elkins10

Abstract Background: Daclizumab is a humanized monoclonal antibody against CD25 that modulates interleukin 2 signaling. The SELECT TRILOGY of clinical studies (SELECT/SELECTION/SELECTED) evaluated the safety and efficacy of daclizumab in patients with relapsing-remitting multiple sclerosis (RRMS). We report the long-term safety and efficacy of daclizumab 150 mg subcutaneous every 4 weeks in patients with RRMS in the SELECTED open-label extension study. Methods: An interim intent-to-treat analysis of all enrolled patients was performed in January 2014 for this ongoing study. Results: The SELECTED study enrolled 90 % of patients who completed SELECTION. In the safety and efficacy analysis (N = 410), median treatment time in SELECTED was 25 months (range,