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Journal of Neurology
Published in: Journal of Neurology 10/2020

Open Access 01-10-2020 | Multiple Sclerosis | Original Communication

Long-term safety and efficacy of daclizumab beta in relapsing–remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study

Authors: Ralf Gold, Ernst-Wilhelm Radue, Gavin Giovannoni, Krzysztof Selmaj, Eva Kubala Havrdova, Xavier Montalban, Dusan Stefoski, Till Sprenger, Randy R. Robinson, Sami Fam, Jonathan Smith, Spyros Chalkias, Giorgio Giannattasio, Gabriel Lima, Wanda Castro-Borrero

Published in: Journal of Neurology | Issue 10/2020

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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.
Appendix
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Metadata
Title
Long-term safety and efficacy of daclizumab beta in relapsing–remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study
Authors
Ralf Gold
Ernst-Wilhelm Radue
Gavin Giovannoni
Krzysztof Selmaj
Eva Kubala Havrdova
Xavier Montalban
Dusan Stefoski
Till Sprenger
Randy R. Robinson
Sami Fam
Jonathan Smith
Spyros Chalkias
Giorgio Giannattasio
Gabriel Lima
Wanda Castro-Borrero
Publication date
01-10-2020
Publisher
Springer Berlin Heidelberg
Published in
Journal of Neurology / Issue 10/2020
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-020-09835-y

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