Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study

Ralf Gold, Ernst-Wilhelm Radue, Gavin Giovannoni, Krzysztof Selmaj, Eva Havrdova, Dusan Stefoski, Till Sprenger, Xavier Montalban, Stanley Cohan, Kimberly Umans, Steven J. Greenberg, Gulden Ozen, Jacob Elkins

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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, = 10 %), excluding MS relapse, were nasopharyngitis (12 %) and upper respiratory tract infection (12 %). Most commonly reported SAEs (in >= 3 patients), excluding MS relapses, were increased serum hepatic enzymes, pneumonia, ulcerative colitis, and urinary tract infection (
Idioma originalAnglès
Número d’article117
Nombre de pàgines10
RevistaBMC Neurology
Volum16
DOIs
Estat de la publicacióPublicada - 26 de jul. 2016

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