Safety, Efficacy of Dimethyl Fumarate for Multiple Sclerosis in Minority Groups

Dimethyl fumarate (DMF) is a safe and effective treatment for Black/African American and Hispanic/Latino patients with multiple sclerosis (MS), according to a real-world evidence study presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) held from June 1-4, in National Harbor, Maryland.

Researchers conducted a 5-year, international, multicenter, phase 4, real-world evidence study (ESTEEM) to assess the efficacy and safety of DMF treatment according to ethnicity in patients with relapsing-remitting multiple sclerosis (RRMS).

In this study, 220 Black/African American, 5031 non-Black/non-African American, 105 Hispanic/Latino, and 5146 non-Hispanic/non-Latino patients received at least 1 DMF treatment. Primary outcome measures included annualized relapse rate (ARR) and adverse events (AEs) over 5 years.

Black/African American and Hispanic/Latino patients demonstrated lower unadjusted ARRs of 0.054 (95% CI, .038- .078) and 0.069 (95% CI, .043-.112), respectively. In contrast, the non-Black/non-African American and non-Hispanic/non-Latino patients demonstrated higher ARRs of .077 (95% CI, .072-.081) and .076 (95% CI, .072-.081), respectively.

During the 5-year study, ARRs declined between 90.6% to 92.1% following DMF treatment compared with ARRs during the 12 months prior to study initiation (P <.0001 for all subgroups).

Reported AEs included gastrointestinal disorders and decreasing lymphocyte levels. Most discontinuation of DMF resulted from gastrointestinal side effects.

Median lymphocyte counts declined by 24.4% and 28.2% in Black/African American and Hispanic/Latino patients, respectively. In contrast, the non-Black/non-African American and non-Hispanic/non-Latino patients demonstrated greater lymphocyte declines by 35.8% and 35.6%, respectively. The researchers strongly suggested cautious interpretation of these results given the original intent of this study was not to compare lymphocyte level changes.

“Evidence suggests that MS clinical course and disability outcomes may vary according to ethnicity and race,” the researchers concluded. “These data demonstrate real-world treatment benefit of DMF in Black/African American and Hispanic/Latino patients.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. The study was supported by industry.

Reference

Williams MJ, Amezcua L, Chinea A, et al. Real-world effectiveness and safety after 5 years of dimethyl fumarate treatment in Black/African American and Hispanic/Latino American patients with multiple sclerosis in ESTEEM. Presented at: CMSC 2022 Annual Meeting; June1-4, 2022; National Harbor, Maryland. Abstract DMT46.