Evidence map›Paper›PMID 30706431›Full record

ArticleNeurology and therapy2019

Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes.

Jinny Min, Stanley Cohan, Enrique Alvarez, Jacob Sloane, J Theodore Phillips, Anneke van der Walt, Irene Koulinska, Fang Fang, Catherine Miller, Andrew Chan

Registry-linked trialAbstract read
In one paragraph

Article in Neurology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02776072 (A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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.

NCT02776072 completednot on this map

A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)

TypeobservationalSponsorBiogenRan2016 to 2016Enrolled2,978ConditionsMultiple Sclerosis
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Observational
  13. Article
  14. Nursing Management of Gastrointestinal Adverse Events Associated With Delayed-Release Dimethyl Fumarate: A Global Delphi Approach.The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses · 2020
    Article
  15. Article
  16. Article
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

10 authors.

Jinny MinBiogen, Cambridge, MA, USA.
Stanley CohanProvidence Multiple Sclerosis Center, Providence Brain and Spine Institute, Providence St Joseph Health, Portland, OR, USA.
Enrique AlvarezRocky Mountain Multiple Sclerosis Center, University of Colorado, Aurora, CO, USA.
Jacob SloaneBeth Israel Deaconess Medical Center, Boston, MA, USA.
J Theodore PhillipsDepartment of Neurology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
Anneke van der WaltMultiple Sclerosis Research Unit, Royal Melbourne Hospital, Parkville, VIC, Australia.
Irene KoulinskaBiogen, Cambridge, MA, USA.
Fang FangCytel Inc, Cambridge, MA, USA.
Catherine MillerBiogen, Cambridge, MA, USA. Catherine.miller@biogen.com.
Andrew ChanDepartment of Neurology, Inselspital-Bern University Hospital, University of Bern, Bern, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDelayed-release dimethyl fumarate (DMF) is an effective treatment for multiple sclerosis (MS). Some patients experience gastrointestinal (GI) adverse events (AEs) that may lead to premature DMF discontinuation. This study characterized the impact of site-specific GI management strategies on the occurrence of GI events and discontinuation patterns.

methodsData on GI events and DMF persistence were retrospectively abstracted from medical records of patients treated with DMF in routine medical practice in the EFFECT study (NCT02776072). GI management strategies were assessed via a study site questionnaire. Discontinuation rates were analyzed according to counseling patterns.

resultsOf 826 DMF-treated patients at 66 sites, 809 from 65 sites were eligible for the GI analysis; of these, 27% experienced GI AEs. Within 1 year of treatment, 14% (118/826) of patients discontinued DMF, 5% (44/809) due to GI events. Most sites (92%) reported that patients were very likely (> 75% of the time) to be counseled about GI events at/before DMF treatment initiation and/or to be recommended that DMF be taken with food (86%); 48% of sites reported to be very likely to recommend using symptomatic therapies for GI AEs. Lower discontinuation rates were reported at sites very likely versus not very likely (≤ 75% of the time) to (1) provide counseling; (2) provide specific details regarding GI events; or (3) recommend taking DMF with food, and/or using symptomatic GI therapies.

conclusionCounseling and other GI management strategies at initiation of DMF treatment appear to reduce the burden of GI events, and a variety of GI management strategies may improve DMF persistence.

trial registrationNCT02776072.

fundingBiogen (Cambridge, MA, USA).

Indexed as

Gastrointestinal eventsMultiple sclerosisRetrospective studyTecfidera

Identifiers

PMID30706431
PMCPMC6534646

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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.