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Diroximel fumarate in patients with relapsing-remitting multiple sclerosis: Final safety and efficacy results from
Barry A Singer1, Douglas L Arnold2,3, Jelena Drulovic4
1The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.
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%; p < 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.
Insights
Diroximel fumarate (DRF) demonstrated good tolerability and safety over two years in patients with relapsing-remitting multiple sclerosis (RRMS). The study showed reduced disease activity, supporting DRF as a viable treatment option.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Diroximel fumarate (DRF) is approved for relapsing-remitting multiple sclerosis (RRMS) and shows bioequivalent active metabolite exposure to dimethyl fumarate (DMF).
- Prior studies suggest DRF may have fewer gastrointestinal (GI) adverse events (AEs) compared to DMF.
Purpose of the Study:
- To report the final safety, tolerability, and efficacy outcomes of diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis (RRMS).
- To assess the long-term results from the EVOLVE-MS-1 phase 3 study.
Main Methods:
- EVOLVE-MS-1 was an open-label, phase 3 study involving patients with RRMS over 96 weeks.
- The study primarily assessed the safety and tolerability of DRF, with exploratory efficacy endpoints.
Main Results:
- Over 75% of patients completed the 96-week study, with a median exposure of 1.8 years.
- Adverse events (AEs) occurred in 88.7% of patients, mostly mild or moderate; only 8.0% discontinued due to AEs, with <2% for GI or flushing-related issues.
- Significant reductions in gadolinium-enhancing lesions (72.7%) and a low adjusted annualized relapse rate (0.13) were observed by Week 96.
Conclusions:
- Diroximel fumarate (DRF) was generally well-tolerated over two years in RRMS patients, with limited AEs leading to discontinuation.
- Radiological assessments indicated a decrease in disease activity, supporting DRF's role as a treatment option for RRMS.
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