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Clinical Trial
. 2018 May;24(6):795-804.
doi: 10.1177/1352458517707345. Epub 2017 May 9.

Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study

Ralph Hb Benedict  1 , Stanley Cohan  2 , Sharon G Lynch  3 , Katherine Riester  4 , Ping Wang  4 , Wanda Castro-Borrero  4 , Jacob Elkins  4 , Guido Sabatella  4
Affiliations
Clinical Trial

Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study

Ralph Hb Benedict et al. Mult Scler. 2018 May.

Abstract

Background: Cognitive impairment is common in multiple sclerosis (MS), with cognitive processing speed being the most frequently affected domain.

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).

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.

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.

Conclusion: These results provide evidence for a benefit of daclizumab beta versus IM IFN beta-1a on cognitive processing speed in RRMS.

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 .

Keywords: Clinical trial; cognitive impairments; daclizumab; interferon beta-1a; multiple sclerosis; phase III; randomized controlled trial.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: R.H.B.B. has received consulting fees from Biogen, Genentech, Genzyme, and Novartis; consulting fees for continuing medical education from EMD Serono; and research support from Acorda, Biogen, Mallinckrodt, and Novartis. S.C. has received consulting fees from and served on advisory boards for Biogen, Genzyme, Mallinckrodt, and Novartis; served on speaker bureaus for Acorda, Biogen, Genzyme, and Novartis; and received research support from Biogen, Genzyme, Mallinckrodt, Novartis, Opexa, and Roche. S.G.L. has participated in clinical trials for Acorda, Actelion, Artielle, Bayer HealthCare, Biogen, Genentech, Genzyme, the National Institutes of Health, the National Multiple Sclerosis Society, Novartis, Opexa, Roche, Sun, and Teva. K.R., W.C-B., J.E., and G.S. are employees of and hold stock/stock options in Biogen. P.W. holds stock in Biogen.

Figures

Figure 1.
Figure 1.
Mean change from baseline in Symbol Digit Modalities Test (SDMT) score at weeks 24, 48, 72, 96, and 144. Patients with available data for baseline covariates were included. Analyses were based on observed data with no imputation for missing data. IFN: interferon; IM: intramuscular; SD: standard deviation.
Figure 2.
Figure 2.
Percentage of patients with (a) ⩾3-point improvement or (b) ⩾4-point improvement in Symbol Digit Modalities Test score at weeks 24, 48, 72, 96, and 144. Patients with available data for baseline covariates were included. Analyses were based on observed data with no imputation for missing data. IFN: interferon; IM: intramuscular.
Figure 3.
Figure 3.
Percentage of patients with (a) ⩾3-point decline or (b) ⩾4-point decline in Symbol Digit Modalities Test score at weeks 24, 48, 72, 96, and 144. Patients with available data for baseline covariates were included. Analyses were based on observed data with no imputation for missing data. IFN: interferon; IM: intramuscular.
Figure 4.
Figure 4.
Percentage of patients with worsened, stable, or improved Symbol Digit Modalities Test score at week 96 using (a) a 3-point threshold or (b) a 4-point threshold. Patients with available data for baseline covariates were included. Analyses were based on observed data with no imputation for missing data. CI: confidence interval; IFN: interferon; IM: intramuscular; OR: odds ratio.
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