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Diroximel fumarate in patients with relapsing-remitting multiple sclerosis: Final safety and efficacy results from the phase 3 EVOLVE-MS-1 study. | LitMetric

AI Article Synopsis

  • Diroximel fumarate (DRF) is a medication approved for treating relapsing forms of multiple sclerosis (MS), showing fewer gastrointestinal side effects compared to similar drugs.
  • The EVOLVE-MS-1 study assessed DRF’s safety and effectiveness over 96 weeks, with around 75.7% of participants completing the trial and most adverse events being mild or moderate.
  • Results showed a significant reduction in disease activity, indicating that DRF is a well-tolerated treatment option for patients with relapsing-remitting multiple sclerosis.

Article Abstract

Background: Diroximel fumarate (DRF) is approved for adults with relapsing-remitting multiple sclerosis (RRMS) in Europe and for relapsing forms of MS in the United States. DRF and dimethyl fumarate (DMF) yield bioequivalent exposure of the active metabolite monomethyl fumarate. Prior studies indicated fewer gastrointestinal (GI)-related adverse events (AEs) with DRF compared with DMF.

Objective: To report final outcomes from EVOLVE-MS-1.

Methods: EVOLVE-MS-1 was an open-label, 96-week, phase 3 study assessing DRF safety, tolerability, and efficacy in patients with RRMS. The primary endpoint was safety and tolerability; efficacy endpoints were exploratory.

Results: Overall, 75.7% (800/1057) of patients completed the study; median exposure was 1.8 (range: 0.0-2.0) years. AEs occurred in 938 (88.7%) patients, mostly of mild (28.9%) or moderate (50.3%) severity. DRF was discontinued due to AEs in 85 (8.0%) patients, with < 2% discontinuing due to GI or flushing/flushing-related AEs. At Week 96, mean number of gadolinium-enhancing lesions was significantly reduced from baseline (72.7%; < 0.0001); adjusted annualized relapse rate was 0.13 (95% confidence interval: 0.11-0.15).

Conclusion: DRF was generally well tolerated over 2 years, with few discontinuations due to AEs; radiological measures indicated decreased disease activity from baseline. These outcomes support DRF as a treatment option in patients with RRMS.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687803PMC
http://dx.doi.org/10.1177/13524585231205708DOI Listing

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