Evidence map›Paper›PMID 31611264›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2019

Dimethyl fumarate decreases neurofilament light chain in CSF and blood of treatment naïve relapsing MS patients.

Tobias Sejbaek, Helle Hvilsted Nielsen, Natasha Penner, Tatiana Plavina, Jason P Mendoza, Nellie Anne Martin, Maria Louise Elkjaer, Mads Henrik Ravnborg, Zsolt Illes

Open access · hybridAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 3 pooled it
9.5field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 3 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
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  11. Review
  12. Fluid and Imaging Biomarkers in Huntington's Disease.Current neurology and neuroscience reports · 2026
    Review
  13. Article
  14. Neurofilament Light Chain in Cerebrospinal Fluid and Blood Identifies Patients With Minimal and Overt Hepatic Encephalopathy.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
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  16. Review
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19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 3 countries.

Tobias SejbaekNeurology, Odense Universitetshospital, Odense, Denmark Tobias.Sejbaek.Mathiesen@rsyd.dk.ORCID 0000-0002-7682-2188
Helle Hvilsted NielsenNeurology, Odense Universitetshospital, Odense, Denmark.
Natasha PennerValue Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.
Tatiana PlavinaValue Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.
Jason P MendozaValue Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.
Nellie Anne MartinDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.
Maria Louise ElkjaerNeurology, Odense Universitetshospital, Odense, Denmark.
Mads Henrik RavnborgNeurology, Odense Universitetshospital, Odense, Denmark.
Zsolt IllesNeurology, Odense Universitetshospital, Odense, Denmark.ORCID 0000-0001-9655-0450
University of Southern Denmark · DKBiogen (United States) · USOdense University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIn a prospective phase IV trial of the first-line oral treatment dimethyl fumarate (DMF), we examined dynamics of neurofilament light (NFL) chain in serum, plasma and cerebrospinal fluid (CSF) samples collected over 12 months from relapsing-remitting multiple sclerosis (RRMS) patients. NFL changes were related to disease activity.

methodsWe examined NFL levels by single-molecule array in 88 CSF, 348 plasma and 131 sera from treatment-naïve RRMS patients (n=52), healthy controls (n=23) and a placebo group matched by age, sex and NFL (n=52). Plasma/sera were collected at baseline, and 1, 3, 6 and 12 months after DMF. CSF samples were collected at baseline and 12 months after DMF.

resultsNFL concentration in CSF, plasma and serum correlated highly (p<0.0001 for all), but plasma levels were only 76.9% of paired serum concentration. After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively). Significant reduction in blood was observed after 6 and 12 months treatment compared with baseline (p<0.01 and p<0.0001, respectively) and to placebo (p<0.0001). Patients with NFL above the 807.5 pg/mL cut-off in CSF had 5.0-times relative risk of disease activity (p<0.001).

conclusionsThis study provides Class II evidence that first-line DMF reduces NFL in both blood and CSF after 6 months and normalises CSF levels in 73% of patients. High NFL concentration in CSF after a year reflected disease activity. NFL levels were higher in serum than in plasma, which should be considered when NFL is used as a biomarker.

Indexed as

AdultBiomarkersDimethyl FumarateFemaleHumansIntermediate FilamentsMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingNeurofilament ProteinsProspective StudiesTreatment OutcomeBiomarkersDimethyl FumarateNeurofilament Proteinsbiomarkercerebrospinal fluiddimethyl fumaratedisease modifying therapydrug responsemultiple sclerosisneurofilament

Identifiers

PMID31611264
PMCPMC6902070
OpenAlexW2979502567

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.