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Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study.
- Source :
-
Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2018 May; Vol. 24 (6), pp. 795-804. Date of Electronic Publication: 2017 May 09. - Publication Year :
- 2018
-
Abstract
- Background: Cognitive impairment is common in multiple sclerosis (MS), with cognitive processing speed being the most frequently affected domain.<br />Objective: Examine the effects of daclizumab beta versus intramuscular (IM) interferon (IFN) beta-1a on cognitive processing speed as assessed by Symbol Digit Modalities Test (SDMT).<br />Methods: In DECIDE, patients with relapsing-remitting multiple sclerosis (RRMS) (age: 18-55 years; Expanded Disability Status Scale (EDSS) score 0-5.0) were randomized to daclizumab beta ( n = 919) or IM IFN beta-1a ( n = 922) for 96-144 weeks. SDMT was administered at baseline and at 24-week intervals.<br />Results: At week 96, significantly greater mean improvement from baseline in SDMT was observed with daclizumab beta versus IM IFN beta-1a ( p = 0.0274). Significantly more patients treated with daclizumab beta showed clinically meaningful improvement in SDMT (increase from baseline of ⩾3 points ( p = 0.0153) or ⩾4 points ( p = 0.0366)), and significantly fewer patients showed clinically meaningful worsening (decrease from baseline of ⩾3 points ( p = 0.0103)). Odds representing risk of worsening versus stability or improvement on SDMT were significantly smaller for daclizumab beta ( p = 0.0088 (3-point threshold); p = 0.0267 (4-point threshold)). In patients completing 144 weeks of treatment, the effects of daclizumab beta were generally sustained.<br />Conclusion: These results provide evidence for a benefit of daclizumab beta versus IM IFN beta-1a on cognitive processing speed in RRMS.<br />Trial Registration: ClinicalTrials.gov identifier NCT01064401 (Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis (DECIDE)): https://clinicaltrials.gov/ct2/show/NCT01064401 .
- Subjects :
- Adjuvants, Immunologic therapeutic use
Adult
Female
Humans
Interferon beta-1a therapeutic use
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting psychology
Young Adult
Cognition drug effects
Daclizumab therapeutic use
Immunosuppressive Agents therapeutic use
Multiple Sclerosis, Relapsing-Remitting drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1477-0970
- Volume :
- 24
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Multiple sclerosis (Houndmills, Basingstoke, England)
- Publication Type :
- Academic Journal
- Accession number :
- 28485186
- Full Text :
- https://doi.org/10.1177/1352458517707345