Related Experiment Video
Updated: Jan 4, 2026
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results
Robert T Naismith1, Jerry S Wolinsky2, Annette Wundes3
1Washington University School of Medicine, St. Louis, MO, USA.
Background:
Diroximel 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.
Objective:
To report interim safety/efficacy findings from patients in the ongoing EVOLVE-MS-1 study.
Methods:
EVOLVE-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.
Results:
As 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%; p < 0.0001) and adjusted annualized relapse rate was low (0.16; 95% confidence interval: 0.13-0.20).
Conclusion:
Interim data from EVOLVE-MS-1 suggest DRF is a well-tolerated treatment with a favorable safety/efficacy profile for patients with RRMS.
Insights
Diroximel fumarate (DRF) shows promising safety and efficacy in relapsing-remitting multiple sclerosis (RRMS) patients. Interim results from the EVOLVE-MS-1 study indicate good tolerability and a reduced lesion count.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Diroximel fumarate (DRF) is an oral fumarate treatment for relapsing-remitting multiple sclerosis (RRMS).
- DRF is bioequivalent to dimethyl fumarate, suggesting similar efficacy and safety.
- DRF's unique structure may offer improved gastrointestinal (GI) tolerability.
Purpose of the Study:
- To assess the interim safety, tolerability, and efficacy of DRF in RRMS patients.
- To report findings from the ongoing EVOLVE-MS-1 Phase 3 study.
Main Methods:
- An ongoing, open-label, 96-week Phase 3 study (EVOLVE-MS-1).
- Assessed safety, tolerability, and efficacy endpoints in RRMS patients treated with DRF.
- Interim analysis based on data collected as of March 2018.
Main Results:
- 696 patients enrolled with a median exposure of 59.9 weeks.
- 84.6% of patients experienced mild to moderate adverse events (AEs); 6.3% discontinued due to AEs, with <1% due to GI AEs.
- Significant reduction in gadolinium-enhancing lesions (77%) and a low annualized relapse rate (0.16) by Week 48.
Conclusions:
- Interim data suggest DRF is well-tolerated in RRMS patients.
- DRF demonstrates a favorable safety and efficacy profile.
- The EVOLVE-MS-1 study provides early evidence of DRF's therapeutic potential.
Related Concept Videos
01:11Clinical Trials: Overview
01:29Chemotherapy-Induced Nausea and Vomiting: Dopamine Receptor Antagonists
Phenothiazines, such as prochlorperazine...
01:24Rational Dosage Regimen: Maintenance Dose and Loading Dose
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
01:20Antiepileptic Drugs: Potassium Channel Activators
Ezogabine has gained approval as an adjunctive treatment...