August 18, 2022
2 minute read
Williams MJ, et al. Real-world efficacy and safety after 5 years of dimethyl fumarate treatment in black/African American and Hispanic/Latino patients with multiple sclerosis in ESTEEM. Presented at the annual meeting of the Consortium of Multiple Sclerosis Centers; June 1-4, 2022; National Harbor, Maryland
Disclosures: Williams reports financial relationships with Biogen, Celgene, EMD Serono, Genentech, Sanofi Genzyme and Teva Neuroscience.
Dimethyl fumarate was safe and reduced relapse rates for up to 5 years in black and Hispanic/Latino patients with relapsing-remitting multiple sclerosis, according to a poster at the Consortium of Multiple Sclerosis Centers annual meeting.
“Evidence suggests that the clinical course and disability outcomes associated with multiple sclerosis may vary by ethnicity and race,” Mitzi J. Williams, MD, of the Joi Life Wellness Group MS Center in Smyrna, Georgia, Healio told. “Dimethyl fumarate has previously been shown to be effective in a small sample of black and Hispanic/Latino patients in the DEFINE/CONFIRM studies and in a retrospective chart review.”
While dimethyl fumarate (DMF) has been shown to be effective over 3 years in this patient population, Williams and colleagues sought to assess the drug’s long-term efficacy and safety in blacks, non- Black, Hispanic/Latino, and non-Hispanic/non-Latino patients with relapsing-remitting multiple sclerosis.
The researchers included 10,502 people (220 black, 5,031 non-black, 105 Hispanic/Latino, and 5,146 non-Hispanic/non-Latino) who received at least one newly prescribed dose of DMF at approximately 390 clinical practice sites across the world and have been monitored for 5 years.
Outcomes of interest included the incidence of serious adverse events and the efficacy and safety of DMF, which were assessed in a post hoc subgroup analysis among black, non-black, Hispanic/Latino, and non-Black participants. Hispanic/non-Latino. The researchers assessed annualized relapse rates (ARR) by a negative binomial model.
The results showed the following unadjusted ARRs up to 5 years – Black = 0.054 (95% CI, 0.038-0.078), Non-Black = 0.077 (95% CI, 0.072-0.081), Hispanic/Latino = 0.069 (95% CI, 0.043-0.112) and non-Hispanic/non-Latino = 0.076 (95% CI, 0.072-0.081). Compared to the AARs obtained 12 months before inclusion in the study, these values represent reductions ranging from 90.6% to 92.1% for all subgroups. The percentage of patients without relapse at 5 years was 80% to 85%.
Median lymphocyte counts also fell during the first year, with researchers reporting a drop of 24.4% in black patients, 35.8% in non-blacks, 28.2% in Hispanic/Latino and 35.6% among non-Hispanics/non-Latinos, then remained stable.
The most common reason for treatment discontinuation in the Black and Hispanic/Latino subgroups was gastrointestinal disorders.
“These data provide insight into the real therapeutic benefits of dimethyl fumarate in black and Hispanic/Latino patients,” Williams told Healio. “Specifically, the annualized relapse rate was significantly lower up to 5 years after starting dimethyl fumarate compared to 12 months before starting dimethyl fumarate, and the safety profile in these subgroups was consistent with the overall ESTEEM population.”