Dimethyl Fumarate Delays MS in Those With Radiologically Isolated Syndrome

Results from the ARISE study (NCT02739542), published in the Annals of Neurology, demonstrated that dimethyl fumarate (Tecfidera; Biogen, Cambridge, MA) delayed the development of multiple sclerosis (MS) in individuals with radiologically isolated syndrome (RIS). Individuals treated with dimethyl fumarate were 82% less likely to experience a first clinical demyelinating event after 96 weeks. Twenty-six percent of participants in the dimethyl fumarate group experienced new and/or newly T2-weighted hyperintense MRI lesions compared with 31% in the placebo group. 

ARISE study is a multicenter, randomized, double-blinded, and placebo-controlled study which enrolled 87 participants with RIS from 12 US centers from 2016 through 2019. Participants did not have clinical symptoms commonly associated with MS but did have incidental brain MRI anomalies consistent with central nervous system (CNS) demyelination. Participants were assigned to treatment with either oral dimethyl fumarate 240 mg twice daily or a placebo. 

During the study, more moderate adverse reactions occurred in the dimethyl fumarate group (32%) than in the placebo group (21%), but the number of severe events reported were similar between the two groups (5% for the dimethyl fumarate group; 9% for the placebo group).