Back to Search Start Over

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

Authors :
Singer, Barry A
Arnold, Douglas L
Drulovic, Jelena
Freedman, Mark S
Gold, Ralf
Gudesblatt, Mark
Jasinska, Elzbieta
LaGanke, Christopher C
Naismith, Robert T
Negroski, Donald
Oh, Jiwon
Hernandez Perez, Miguel Angel
Selmaj, Krzysztof
Then Bergh, Florian
Wundes, Annette
Ziemssen, Tjalf
Castro-Borrero, Wanda
Chen, Hailu
Levin, Seth
Scaramozza, Matthew
Source :
Multiple Sclerosis Journal; Dec2023, Vol. 29 Issue 14, p1795-1807, 13p
Publication Year :
2023

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%; 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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
13524585
Volume :
29
Issue :
14
Database :
Complementary Index
Journal :
Multiple Sclerosis Journal
Publication Type :
Academic Journal
Accession number :
173949037
Full Text :
https://doi.org/10.1177/13524585231205708