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

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.

• 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
• Journal: Journal of neurology (J Neurol) Vol. 267 Issue 10 Pg. 2851-2864 (Oct 2020) ISSN: 1432-1459 [Electronic] Germany
• PMID: 32451615 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Antibodies, Monoclonal, Humanized
• Immunoglobulin G
• Immunosuppressive Agents
• Daclizumab

Topics

• Adult
• Antibodies, Monoclonal, Humanized
• Daclizumab (adverse effects, therapeutic use)
• Female
• Humans
• Immunoglobulin G
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Male
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting (drug therapy)