Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study.

BACKGROUND

Diroximel fumarate (DRF) is a novel oral fumarate approved for relapsing forms of multiple sclerosis (MS). DRF demonstrated significantly improved gastrointestinal (GI) tolerability

METHODS

A

RESULTS

In total, 504 patients (DRF,

CONCLUSIONS

The improved GI tolerability with DRF translated into clinically meaningful benefits to QoL, as patients experienced less impact on daily life and work and required less concomitant symptomatic medication use.

TRIAL REGISTRATION

[ClinicalTrials.gov identifier: NCT03093324].

Informations de copyright

© The Author(s), 2021.

Déclaration de conflit d'intérêts

Conflict of interest statement: AW reports advisor fees from Biogen and AbbVie; and research support from AbbVie, Alkermes, and Biogen. SW reports consulting fees from Biogen, EMD Serono, Genentech-Roche, Sanofi-Genzyme; speaker bureaus for Biogen, EMD Serono, Genentech/Roche, and Sanofi-Genzyme; and research support from Alkermes, Biogen, Celgene, Genentech/Roche, Novartis, Sanofi-Genzyme, and TG. RG reports honoraria from Bayer, Biogen, Merck Serono, Novartis, and Teva Neuroscience; and research support from Bayer, Biogen, Merck Serono, Novartis, and Teva Neuroscience. BAS reports speaker/consulting fees from AbbVie, Alexion, Bayer, Biogen, Bristol Myers Squibb, EMD Serono, Genentech, Novartis, Roche, Sanofi-Genzyme, Teva, and TG; and research support from AbbVie, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi-Genzyme. EJ reports advisory boards for Biogen; and speaker fees from Adamed, Allergan, Novartis, Polpharma, Roche, and Teva. TZ reports advisory boards for Bayer, Biogen, Genzyme, Merck Serono, Novartis, Synthon, and Teva; speaker fees from Almirall, Bayer, Biogen, Genzyme, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Sanofi, and Teva; and research support from Bayer, Biogen, Genzyme, Novartis, Sanofi, and Teva. JDS reports honoraria from Biogen for advisory boards and consulting. PR reports speaker/consulting fees from Alexion, Biogen, Celgene, EMD Serono, Medison, Novartis, Roche, Sanofi-Genzyme, and Viela Bio. HC, JH, JM, and CM are employees of and hold stock/stock options in Biogen. RTN reports advisor/speaker/consulting fees from Alexion, Alkermes, Bayer, Biogen, Celgene, EMD Serono, Genentech, Lundbeck, NervGen, Novartis, Sanofi-Genzyme, Third Rock, and Viela Bio. The Editor-in-Chief of Therapeutic Advances in Neurological Disorders is an author of this paper, therefore, the peer review process was managed by alternative members of the Board and the Editor was not involved in the decision-making process.