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Updated: May 13, 2025
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
Safety and effectiveness of diroximel fumarate in relapsing forms of multiple sclerosis: a systematic review and
Haneen Sabet1, Mohamed Ahmed Zanaty2, Abdelfattah Arafa3
1Faculty of Medicine, South Valley University, Qena, Egypt. haninsabet225@gmail.com.
Objective:
To evaluate the safety and efficacy of Diroximel Fumarate (DRF) in patients with different relapsing forms of MS (RMS) through systematic review and meta-analysis.
Methods:
A 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.
Results:
Seven 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%).
Conclusion:
DRF 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.
Insights
Diroximel fumarate (DRF) shows efficacy in reducing multiple sclerosis relapses with a better safety profile than dimethyl fumarate (DMF). Monitoring for lymphopenia is advised, with further research needed for long-term outcomes.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
- Relapsing forms of MS (RMS) are characterized by unpredictable exacerbations.
- Diroximel fumarate (DRF) is an oral fumarate ester approved for treating RMS.
Purpose of the Study:
- To systematically review and meta-analyze the safety and efficacy of Diroximel Fumarate (DRF) in patients with relapsing forms of MS (RMS).
- To compare the safety and efficacy profile of DRF with its predecessor, Dimethyl Fumarate (DMF).
Main Methods:
- Systematic review and meta-analysis adhering to PRISMA guidelines.
- Searched Scopus, PubMed, and Cochrane CENTRAL databases for clinical trials and observational studies.
- Assessed risk of bias using Newcastle-Ottawa Scale and ROBINS-I tools; performed statistical analyses using OpenMetaAnalyst.
Main Results:
- Seven studies with 3,075 participants were included.
- Overall persistence rate was 75.6%; discontinuation due to safety concerns was 6.1%.
- Significant decrease in lymphocyte count (-355.02 cells/µL); common adverse events included GI issues (17.4%) and lymphopenia (24.3%).
Conclusions:
- Diroximel fumarate (DRF) is effective in reducing relapse rates in RMS patients.
- DRF exhibits an improved safety profile, particularly in gastrointestinal tolerability, compared to Dimethyl Fumarate (DMF).
- Monitoring for lymphopenia is crucial; further research on long-term outcomes in diverse populations is recommended.
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