Evidence map›Paper›PMID 28485186›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2018

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

Ralph Hb Benedict, Stanley Cohan, Sharon G Lynch, Katherine Riester, Ping Wang, Wanda Castro-Borrero, Jacob Elkins, Guido Sabatella

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01064401 (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process), which is not on this map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01064401 phase3completednot on this map

Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorBiogenRan2010 to 2014Enrolled1,841ConditionsRelapsing-Remitting Multiple SclerosisArmsBIIB019 (Daclizumab High Yield Process), Interferon beta-1a Placebo, Interferon beta-1a, Daclizumab High Yield Process Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ralph Hb BenedictUBMD Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.
Stanley CohanProvidence Multiple Sclerosis Center, Providence Brain and Spine Institute, Portland, OR, USA.
Sharon G LynchDepartment of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.
Katherine RiesterBiogen, Cambridge, MA, USA.
Ping WangBiogen, Cambridge, MA, USA.
Wanda Castro-BorreroBiogen, Cambridge, MA, USA.
Jacob ElkinsBiogen, Cambridge, MA, USA.
Guido SabatellaBiogen, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

objectiveExamine the effects of daclizumab beta versus intramuscular (IM) interferon (IFN) beta-1a on cognitive processing speed as assessed by Symbol Digit Modalities Test (SDMT).

methodsIn 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.

resultsAt 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.

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

trial registrationClinicalTrials.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 .

Indexed as

Adjuvants, ImmunologicAdultCognitionDaclizumabFemaleHumansImmunosuppressive AgentsInterferon beta-1aMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingYoung AdultAdjuvants, ImmunologicDaclizumabdaclizumab HYPImmunosuppressive AgentsInterferon beta-1aClinical trialcognitive impairmentsdaclizumabinterferon beta-1amultiple sclerosisphase IIIrandomized controlled trial

Identifiers

PMID28485186
PMCPMC5971365

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.