To evaluate the representation of non-White pMS in phase III trials of approved disease-modifying therapies (DMTs) and how race and ethnicity are reported in medical journals and on manufacturer websites. 

Black and Hispanic people with MS (pMS) have been found to have different disease courses and/or worse MS outcomes compared to White pMS. They are also more likely to be negatively impacted by social determinants of health, further worsening disparities in outcomes. As these disparities may affect treatment response, non-White pMS must be included in trials for greater generalizability of research and therefore, more inclusive treatment plans. 

We conducted a systematic review of the PubMed database from 1995 to June 2020 to identify manufacturer-sponsored phase III trials for FDA-approved MS DMTs and analyzed how race and ethnicity were reported in trial publications. We also analyzed representation of non-White pMS compared to multinational census data. Additionally, we reviewed patient- and healthcare provider (HCP)-facing websites of available DMTs to assess the dissemination of racial and ethnic representation in trials.

44 phase III trial publications were reviewed, representing 45 trials, among which 17 (37.8%) did not report race or ethnicity, 14 (31.1%) reported race and ethnicity representing White pMS only, and 14 (31.1%) reported two or more races/ethnicities. Compared to multinational census data, non-White pMS were significantly underrepresented in MS trials. Due to lack of data, trends in representation of other races and ethnicities could not be assessed. No patient- nor HCP-facing DMT websites reported data on race and ethnicity in pivotal trials.

Race and ethnicity are underreported in MS DMT trial publications, and race and ethnic representation are omitted from manufacturer websites. Data show that non-White pMS are significantly underrepresented in MS trials. Availability of this information is crucial for patients, together with their HCPs, to make informed decisions about their care.