Why carry out this study?

The oral multiple sclerosis (MS) therapy delayed-release dimethyl fumarate (DMF) has demonstrated clinically meaningful, sustained efficacy and a favorable benefit–risk profile in patients with relapsing forms of MS.

ESTEEM is an ongoing, 5-year, multinational, prospective study evaluating long-term safety and effectiveness of DMF in patients with MS.

Black or African American (AA) patients with MS are reported to exhibit greater disease severity compared with non-black/non-AA patients.

MS clinical trials have included low numbers of non-white patients. This interim analysis from ESTEEM evaluated real-world safety and effectiveness of DMF in the largest subgroup of DMF-treated black or African American (black/AA) patients studied to date.

What was learned from the study?

The safety profile of DMF in black/AA patients was consistent with that in the non-black/non-AA ESTEEM population, although lymphocyte decrease was less pronounced in black/AA patients.

Relapse rates remained low in black/AA patients, consistent with non-black/non-AA patients.

Overall, these analyses demonstrate the real-world treatment benefit of DMF in black/AA patients, consistent with findings in the overall ESTEEM population.