Evidence map›Paper›PMID 27260297›Full record

Observational studyJournal of neurology2016

Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study.

A Miclea, V I Leussink, H P Hartung, R Gold, R Hoepner

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06385197 (Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.2field-weighted citation impact, top 6% 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.

NCT06385197 nacompletednot on this mapstarted 2022, after this paper: background citation

Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate (DRF) for Patients With Multiple Sclerosis by Chronobiology

TypeinterventionalSponsorHadassah Medical OrganizationRan2022 to 2023Enrolled8ConditionsMultiple SclerosisArmsApp randomizing dosing regimen
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 38 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Observational
  9. 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
  10. The Search for Disease-Modifying Therapies in Pulmonary Hypertension.Journal of cardiovascular pharmacology and therapeutics · 2019
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Observational
  17. Review
  18. Article
  19. Article
  20. 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

5 authors at 3 institutions in 1 country.

A MicleaDepartment of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.
V I LeussinkDepartment of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
H P HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
R GoldDepartment of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany. ralf.gold@rub.de.
R HoepnerDepartment of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.
Heinrich Heine University Düsseldorf · DESt. Josef-Hospital · DERuhr University Bochum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dimethyl fumarate (DMF) was recently approved for treating patients with relapsing-remitting multiple sclerosis (RRMS) based on two phase III clinical trials demonstrating its efficacy. This prompts the need for demonstrating the clinical efficacy and safety of DMF in the real world. By retrospective analysis of medical records at two German MS centers, 644 MS patients treated with DMF were identified. All were included in a safety analysis, and a subgroup of patients with available efficacy data during previous MS therapies (n = 352) was further analyzed for annualized relapse rate and disability progression assessed by the EDSS. In the overall DMF population studied, the annualized relapse rate decreased from 0.52 at baseline to 0.35, and the annualized disability progression from 0.15 to 0.10. Patients who were switched from interferons or glatiramer acetate to DMF revealed a greater benefit, whereas patients pretreated with more potent immunotherapies did not respond that well. Interestingly, patients with a lymphocyte count ≥2000/µl after 0.52 years (mean, SD 0.2) of DMF treatment did not benefit compared to those with lower lymphocyte counts. In total, 22.2 % of the patients withdrew from DMF due to side effects, with gastrointestinal discomfort (12.7 %) and lymphopenia (5.3 %) as most frequently reported reasons. Our study corroborates that DMF is an overall safe and effective drug that reduces relapse rate as well as disability progression in MS patients. Further prospective studies are warranted to establish the additional parameters predicting DMF response, especially in patients switching from other first-line immunotherapies.

Indexed as

Treatment OutcomeAdultDimethyl FumarateDisability EvaluationFemaleFollow-Up StudiesHumansImmunosuppressive AgentsLymphocyte CountMaleMiddle AgedMultiple SclerosisRetrospective StudiesStatistics, NonparametricDimethyl FumarateImmunosuppressive AgentsAnnualized relapse rateDimethyl fumarateEDSS progressionLymphopeniaSafety

Identifiers

PMID27260297
OpenAlexW2413775172

What OpenQuestion holds

Textmetadata
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.