Although multiple sclerosis (MS) affects many different races and ethnicities and may even be more aggressive in some of these patient populations, minority representation in MS clinical trials remains critically low.
Black patients made up only a fraction of the total enrollment in large-scale Phase 3 trials for three now-approved MS therapies, according to a recent editorial written by Jagannadha Avasarala, MD, PhD, in the journal CNS Spectrums.
Specifically, Blacks comprised just 5.3% of patients in the OPERA 1 and 2 studies (NCT01247324 and NCT01412333) investigating Ocrevus (ocrelizumab).
The proportions of Blacks in other trials were even lower. The EXPAND trial (NCT01665144) testing Mayzent (siponimod) had 0.6% Blacks, while the RADIANCE trial (NCT02047734) for Zeposia (ozanimod) involved 0.5%. Among the participants in the ORATORIO trial (NCT01194570), also for Ocrevus, 1.9% were Black.
The U.S. Food and Drug Administration’s drug trials snapshot of Zeposia, approved in 202o, supports Avasarala’s findings, indicating that the U.S. regulatory agency could not determine how the treatment would affect minority patients because there weren’t enough people of other races enrolled.
The lack of racial diversity in clinical trials is a huge issue across all medical disorders, but it’s especially a roadblock for the MS community given that people of color often have worse disease manifestations. Having little trial data can lead to the development of therapies that have unknown side effects or efficacy for these populations.
“The disease characteristics and [manifestations] of MS or [neuromyelitis optica spectrum disorder] among Blacks and Hispanics are typically aggressive and for this reason alone, if not for any other metric, there needs to [be] a radical shift in allotment of funds devoted to promoting drug research in minority populations,” wrote Avasarala, director of multiple sclerosis and neuroimmunology at the Kentucky Neuroscience Institute.
For example, he noted, more data may need to be collected on Mayzent and its metabolism in the presence of certain gene variants that are more prevalent in Black/Hispanic populations. These variants were not included in the trials and therefore not studied. As a result, it is still unknown how Mayzent affects these patients.
Improving the proportion of minorities represented in clinical trials is a challenge, but doctors, patients, and researchers alike say it is worth overcoming. And there is hope.
Genentech, the maker of Ocrevus, launched a Phase 4 trial (NCT04377555) called Characterization of Ocrelizumab in Minorities with Multiple Sclerosis (CHIMES) in 2020 to better understand how the therapy, first approved by the FDA in 2017, responds in Black and Hispanic populations. The open-label study is recruiting up to 150 participants at sites across the U.S.
“We still have a long way to go, but things are definitely moving in the right direction,” Mitzi Joi Williams, MD, lead investigator of the CHIMES trial, said in a Zoom interview with Multiple Sclerosis News Today.
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