Evidence map›Paper›PMID 40229470›Full record

SynthesisNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2025

Safety and effectiveness of diroximel fumarate in relapsing forms of multiple sclerosis: a systematic review and meta-analysis.

Haneen Sabet, Mohamed Ahmed Zanaty, Abdelfattah Arafa, Mohamed El-Moslemani, Shereen Mohamed Olama, Mahmoud G A Saleh, Abdallah Abbas, Ahmed Z Obeidat

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

8 authors.

Haneen SabetFaculty of Medicine, South Valley University, Qena, Egypt. haninsabet225@gmail.com.ORCID http://orcid.org/0009-0001-9449-5707
Mohamed Ahmed ZanatyFaculty of Medicine, South Valley University, Qena, Egypt.
Abdelfattah ArafaFaculty of Medicine, Al-Azhar University, Damietta, Egypt.
Mohamed El-MoslemaniFaculty of Medicine, Al-Azhar University, Damietta, Egypt.
Shereen Mohamed OlamaDepartment of Internal Medicine, College of Medicine, Northern Border University, Arar, Saudi Arabia.
Mahmoud G A SalehDepartment of Chemistry, College of Science, Northern Border University, Arar, Saudi Arabia.
Abdallah AbbasFaculty of Medicine, Al-Azhar University, Damietta, Egypt.
Ahmed Z ObeidatDepartment of Neurology, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and efficacy of Diroximel Fumarate (DRF) in patients with different relapsing forms of MS (RMS) through systematic review and meta-analysis.

methodsA systematic review and meta-analysis adhering to PRISMA guidelines was conducted. Scopus, PubMed, and Cochrane CENTRAL databases were searched until December 6, 2024, for clinical trials and observational studies on DRF in RMS. Eligibility criteria included studies evaluating DRF's safety or efficacy, excluding case reports and non-clinical outcomes. The risk of bias was assessed using the Newcastle-Ottawa Scale and ROBINS-I tools. Statistical analyses were performed using OpenMetaAnalyst, focusing on pooled mean differences and incidence rates with 95% confidence intervals.

resultsSeven studies with 3,075 participants were included. The overall persistence rate was 75.6% (95% CI: 63.5%, 87.7%). The discontinuation rate due to safety concerns was 6.1% (95% CI: 4.1%, 8.1%). Lymphocyte count decreased significantly by -355.02 cells/µL (95% CI: -636.71, -73.32). Mild adverse events (AEs) occurred in 33% (95% CI: 18.6%, 47.4%), moderate in 30% (95% CI: -9.9%, 69.9%), and severe in 5% (95% CI: -3.8%, 13.7%). Gastrointestinal (GI) AEs were observed in 17.4% (95% CI: 6%, 28.8%), flushing in 18.5% (95% CI: 5.7%, 31.3%), and lymphopenia in 24.3% (95% CI: 10.2%, 38.4%). The relapse rate was 7.1% (95% CI: -4.8%, 19%).

conclusionDRF demonstrates efficacy in reducing relapse rates and offers an improved safety profile compared to its predecessor, Dimethyl Fumarate (DMF), particularly in GI tolerability. However, lymphopenia requires monitoring. Further research is recommended to evaluate long-term safety and efficacy in diverse populations.

Indexed as

Immunosuppressive AgentsMultiple Sclerosis, Relapsing-RemittingFumaratesHumansdiroximel fumarateFumaratesImmunosuppressive AgentsDiroximel fumarateDisease-modifying therapiesMultiple sclerosisRelapsing–remitting multiple sclerosis

Identifiers

PMID40229470
PMCPMC12267325

What OpenQuestion holds

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LicenceCC BY
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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.