Evidence map›Paper›PMID 33737954›Full record

ArticleTherapeutic advances in neurological disorders2021

Safety and efficacy of daclizumab beta in patients with relapsing multiple sclerosis in a 5-year open-label study (EXTEND): final results following early termination.

Ludwig Kappos, Stanley Cohan, Douglas L Arnold, Randy R Robinson, Joan Holman, Sami Fam, Becky Parks, Shan Xiao, Wanda Castro-Borrero

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in neurological disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01797965 (A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 31% of its field
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.

NCT01797965 phase3terminatednot on this map

A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301

TypeinterventionalSponsorBiogenRan2013 to 2018Enrolled1,501ConditionsRelapsing-Remitting Multiple Sclerosis, Multiple SclerosisArmsBIIB019 (Daclizumab)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. What Have Failed, Interrupted, and Withdrawn Antibody Therapies in Multiple Sclerosis Taught Us?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  3. Review
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

9 authors at 5 institutions in 3 countries.

Ludwig KapposResearch Center Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research, and Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Petersgaben 4, Basel, CH-4031, Switzerland.ORCID https://orcid.org/0000-0003-4175-5509
Stanley CohanProvidence Multiple Sclerosis Center, Providence Brain and Spine Institute, Providence St. Joseph Health, Portland, OR, USA.
Douglas L ArnoldMontreal Neurological Institute, McGill University, Montreal, QC, Canada NeuroRx Research, Montreal, QC, Canada.
Randy R RobinsonAbbVie Inc., Redwood City, CA, USA.
Joan HolmanAbbVie Inc., North Chicago, IL, USA.
Sami FamBiogen, Cambridge, MA, USA.
Becky ParksBiogen, Cambridge, MA, USA.
Shan XiaoBiogen, Cambridge, MA, USA.
Wanda Castro-BorreroBiogen, Cambridge, MA, USA.
Biogen (United States) · USAbbVie (United States) · USNeuroRx Research (Canada) · CAProvidence College · USUniversity of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEXTEND (NCT01797965), an open-label extension study, evaluated the safety and efficacy of daclizumab beta in participants with relapsing multiple sclerosis (MS) who had completed the randomized DECIDE study.

methodsEligible participants who received either daclizumab beta or interferon beta-1a in DECIDE received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 5 years in EXTEND, followed by 24 weeks of post-dosing follow-up. Safety and tolerability were evaluated, as were clinical efficacy and magnetic resonance imaging (MRI). EXTEND was terminated ahead of schedule by the sponsors.

resultsThe total safety population (

conclusionResults from the combined DECIDE-EXTEND study elucidate outcomes of longer-term treatment with daclizumab beta in the clinical trial setting and underscore the importance of pharmacovigilance with immunomodulatory therapies in the real-world setting.

Indexed as

autoimmunitydaclizumabencephalitismultiple sclerosis

Identifiers

PMID33737954
PMCPMC7934044
OpenAlexW3135190823

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.