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The following is a summary of “Safety, tolerability, and efficacy of diroximel fumarate in a cohort of Black patients with multiple sclerosis from the phase 3 EVOLVE-MS-1 study,” published in the September 2024 issue of Neurology by Hunter et al.     

Multiple sclerosis (MS) is often underrepresented in clinical trials involving racial and ethnic minorities, which can hinder effective treatment.  

Researchers conducted a prospective study investigating the safety and efficacy of diroximel fumarate (DRF) in Black patients with relapsing-remitting multiple sclerosis (RRMS).  

They evaluated the safety and efficacy of DRF in Black patients with RRMS in the EVOLVE-MS-1 study over 96 weeks.  

The results showed 1,057 patients, 72 (6.8%) were Black, with 90% of Black patients and 89% of non-Black patients reporting AEs, predominantly mild or moderate. Gastrointestinal AEs were reported in 36% of Black patients and 32% of non-Black patients, with no Black patients discontinuing due to gastrointestinal AEs compared to 7 (0.7%) non-Black patients. The mean absolute lymphocyte count decreased by 15% in Black and 29% in non-Black by week 48, while the adjusted annualized relapse rate was reduced by 78.2% (54.6−89.5; P<0.0001) in Black patients and 81.7% (78.5−84.5%; P<0.0001) in non-Black patients. By week 48, 93.4% of Black patients were free from confirmed disability progression, decreasing to 86.2% by week 96, compared to 90.4% of non-Black patients.  

They concluded that DFR was a safe and effective treatment option for Black patients with RRMS, showing consistent efficacy with non-Black patients.  

Source: msard-journal.com/article/S2211-0348(24)00488-7/fulltext