Evidence map›Paper›PMID 31680631›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2020

Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study.

Robert T Naismith, Jerry S Wolinsky, Annette Wundes, Christopher LaGanke, Douglas L Arnold, Dragana Obradovic, Mark S Freedman, Mark Gudesblatt, Tjalf Ziemssen, Boris Kandinov and 10 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06319339 (Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing 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.

NCT06319339 early_phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

TypeinterventionalSponsorUniversity of NebraskaRan2024 to 2026Enrolled20ConditionsPeripheral Artery Disease, Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Arterial Occlusive DiseaseArmsVumerity, Placebo
3 · Its place in the literature

Who cites it

37 citing papers in PubMed.

  1. Trial
  2. Trial
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  5. Article
  6. Rethinking MS Therapeutics: From Disease Pathogenesis Mechanisms to AI-Driven Drug Discovery.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2026
    Review
  7. Article
  8. Article
  9. Article
  10. Observational
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Updates and advances in multiple sclerosis neurotherapeutics.Neurodegenerative disease management · 2023
    Review
  19. Article
  20. Diroximel fumarate for multiple sclerosis.Australian prescriber · 2022
    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

20 authors.

Robert T NaismithWashington University School of Medicine, St. Louis, MO, USA.
Jerry S WolinskyDepartment of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.ORCID 0000-0002-8197-2762
Annette WundesDepartment of Neurology, University of Washington Medical Center, Seattle, WA, USA.
Christopher LaGankeNorth Central Neurology Associates, Cullman, AL, USA.
Douglas L ArnoldMontreal Neurological Institute, McGill University, Montreal, QC, Canada/NeuroRx Research Inc., Montreal, QC, Canada.
Dragana ObradovicDepartment of Neurology, Military Medical Academy, Belgrade, Serbia.
Mark S FreedmanUniversity of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Mark GudesblattSouth Shore Neurologic Associates, Patchogue, NY, USA.
Tjalf ZiemssenCenter of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.ORCID 0000-0001-8799-8202
Boris KandinovAlkermes Inc, Waltham, MA, USA.
Ilda BidollariAlkermes Inc, Waltham, MA, USA.
Maria Lopez-BresnahanAlkermes Inc, Waltham, MA, USA.
Narinder NangiaAlkermes Inc, Waltham, MA, USA.
David RezendesAlkermes Inc, Waltham, MA, USA.
Lili YangBiogen, Cambridge, MA, USA.
Hailu ChenBiogen, Cambridge, MA, USA.
Shifang LiuBiogen, Cambridge, MA, USA.
Jerome HannaBiogen, Maidenhead, UK.
Catherine MillerBiogen, Cambridge, MA, USA.
Richard Leigh-PembertonAlkermes Inc, Waltham, MA, USA.

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167
6 · The paper itself

Abstract

backgroundDiroximel fumarate (DRF) is a novel oral fumarate for patients with relapsing-remitting multiple sclerosis (RRMS). DRF and the approved drug dimethyl fumarate yield bioequivalent exposure to the active metabolite monomethyl fumarate; thus, efficacy/safety profiles are expected to be similar. However, DRF's distinct chemical structure may result in a differentiated gastrointestinal (GI) tolerability profile.

objectiveTo report interim safety/efficacy findings from patients in the ongoing EVOLVE-MS-1 study.

methodsEVOLVE-MS-1 is an ongoing, open-label, 96-week, phase 3 study assessing DRF safety, tolerability, and efficacy in RRMS patients. Primary endpoint is safety and tolerability; efficacy endpoints are exploratory.

resultsAs of March 2018, 696 patients were enrolled; median exposure was 59.9 (range: 0.1-98.9) weeks. Adverse events (AEs) occurred in 84.6% (589/696) of patients; the majority were mild (31.2%; 217/696) or moderate (46.8%; 326/696) in severity. Overall treatment discontinuation was 14.9%; 6.3% due to AEs and <1% due to GI AEs. At Week 48, mean number of gadolinium-enhancing lesions was significantly reduced from baseline (77%;

conclusionInterim data from EVOLVE-MS-1 suggest DRF is a well-tolerated treatment with a favorable safety/efficacy profile for patients with RRMS.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDimethyl FumarateFumaratesHumansImmunosuppressive AgentsDimethyl FumarateFumaratesImmunosuppressive Agentsclinical trialdiroximel fumaratedisease-modifying therapyefficacymonomethyl fumaratemultiple sclerosisRelapsing–remitting multiple sclerosissafety

Identifiers

PMID31680631
PMCPMC7604551

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.