Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis : 6-year results from the SELECTED open-label extension study
Gold, Ralf (Ruhr-University Bochum)
Radue, Ernst-Wilhem (University Hospital Basel (Basilea, Suïssa))
Giovannoni, Gavin (Queen Mary University of London)
Selmaj, Krzysztof. (University of Warmia and Mazury)
Havrdova, Eva Kubala (Charles University)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Stefoski, Dusan (Rush University Medical Center)
Sprenger, Till (DKD Helios Klinik Wiesbaden)
Robinson, Randy R. (AbbVie Inc.)
Fam, Sami (Biogen)
Smith, Jonathan (Biogen)
Chalkias, Spyros (Biogen)
Giannattasio, Giorgio (Biogen)
Lima, Gabriel (Biogen)
Castro-Borrero, Wanda (Biogen)
Universitat Autònoma de Barcelona

Date:	2020
Abstract:	Objective: SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED. Methods: Eligible participants who completed 1-2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION. Results: Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0-24 was 0. 21 (0. 16-0. 29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17. 4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time. Conclusions: The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED. Trial registration: Clinicaltrials. gov NCT01051349; first registered on January 15, 2010.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Clinical trial ; Daclizumab beta ; Relapsing-remitting multiple sclerosis ; SELECTED
Published in:	Journal of Neurology, Vol. 267 Núm. 10 (january 2020) , p. 2851-2864, ISSN 1432-1459

DOI: 10.1007/s00415-020-09835-y
PMID: 32451615

14 p, 1.0 MB

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