Minority Representation in MS Research Still Lacking, but There Is Hope

Hawken Miller avatar

by Hawken Miller |

Share this article:

Share article via email
Minority Representation in MS Research

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 2020, 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.

A ‘justice issue’

When Williams, the CEO and medical director of the Joi Life Wellness group, which delivers MS care, put together her talk on MS in the African American population for Black History Month in March, she said she could fit research on that particular group in one three-ring binder.

“If the evidence base doesn’t include everybody, then the evidence is going to be biased,” Hollie Schmidt, vice president of the Accelerated Cure Project for Multiple Sclerosis, the nonprofit organization behind the MS Minority Research Engagement Partnership Network (MREPN), said in a phone interview with MS News Today. 

The MREPN is a group of diverse stakeholders, including nonprofits and pharmaceutical companies, who are working to increase minority and ethnic participation in MS research.

Avasarala, who started his residency in the MS field at the Washington University in St. Louis in 2000, has been looking into how the disease manifests in people of color for the past 12 years. His previous research has shown that MS among that group is far more severe than for whites. People of color go to nursing homes on average six years earlier than their white counterparts and have a greater number of lesions in their brain and spinal cord, he says.

Black people also tend to have a stronger antibody response, causing more severe cases of MS, Avasarala said. Researchers haven’t exactly figured out why on a deeper, genetic level. Because of differentiating disease presentations among white, Black, Hispanic, and Native American populations, Avasarala argues MS should be studied by race.

It’s also why he says they should have better participation in clinical trials.

“If you do not treat your toughest cases, what good does it do to them, and how do we quantitate what a medication does in those patient cohorts?” Avasarala said in an emailed statement to MS News Today.

A researcher toolkit created by the MREPN, notes a handful of reasons why minority turnout for clinical trials is low, including concerns about being taken advantage of, safety hesitations, lack of trust, legal and financial risk, cost and travel demands, and cultural beliefs.

According to survey results the network published in January, Blacks were twice as likely to have concerns about being used by trial investigators, while Hispanics were concerned about their legal, employment, and health insurance status.

Ebony Capers, a Black woman with MS who created the Women of Color with Multiple Sclerosis Facebook page, says that some people don’t think the system will help them.

The biggest question for her is, “What are you hoping to make happen by participating in these clinical trials?” In other cases, Capers said some are comfortable with the treatment path they are already on or think new therapies may make them worse off.

Avasarala, from a provider perspective, sees a similar phenomenon. But some of the responsibility falls on the doctors themselves, he said. If they are dismissive of what a patient is saying, assuming the condition they think they have is impossible to treat, that’s a problem. He wants them to have an open mind and stay up to date on the most current research, throwing out a dogmatic approach that relies on opinion rather than facts.

Williams also added it’s important for doctors to simply ask if their patients are interested in clinical trials, carefully walking them through informed consent before they join a trial and assessing their own implicit biases.

“When we frame it like a lack of participation, we kind of put all the onus and responsibility on the patients,” Williams said. “But there are also institutional and provider barriers that keep people from being involved.”

Those institutional barriers, Williams said, can include not being able to take a day off from work for financial reasons, restricting people who have co-existing medical conditions from participating, and a lack of researchers who are part of the Black and Hispanic community.

More than simply being able to treat patients with a better base of knowledge of how MS manifests in minority populations, Schmidt says it’s a justice issue, especially when it comes down to research questions and informing drug development decisions.

Being part of the solution

For Capers, founding and being part of the Women of Color with Multiple Sclerosis group has helped her manage her own symptoms while educating her peers, whom she calls “sisters,” on how to navigate their life with MS. That includes open discussion of issues that include signing up for clinical trials and helping others advocate for themselves.

“It’s a safe space, where we can process or talk about what we’re going through without fear of judgment,” Capers said.

Incentives also may improve study participation, Capers said. While she hates to admit it, that might drive the most people, regardless of race, to sign up for clinical trials.

And in the future, when data becomes more available on race and MS, treatment could in turn help those minority communities that are more severely affected by the disease.

“I can treat them well, and treat them better, instead of, you know, giving them some wishy-washy drugs with minimal efficacy,” Avasarala said in a later phone interview.

To help make a change, he suggests putting pressure on biotech companies to conduct more trials with minority participation. In a more drastic approach, he said the FDA could threaten to reduce public funds for research projects that don’t have proportionate levels of minority participation.

“We have a responsibility to make this happen. I think that’s just pushing it in the right direction,” Avasarala said.

But building that knowledge base and continually learning about the disease is equally as important. Capers hosts virtual presentations by doctors on issues like COVID-19 and MS on her page, helping foster trust and a connection between the provider and minority community.

She isn’t the only patient advocate working to bridge the gap between the research and patient communities.

Damian Washington, who is Black and living with MS, is using his platform as a video blogger on his YouTube channel, NoStressMS, to help spread awareness and inform the public about the disorder. He’s also working to build a virtual MS community.

“You do not know who is in the audience,” Washington, 39, a voiceover actor living in Los Angeles, told MS News Today in a Zoom interview. “If people in the audience have some bit of them in you, it’s important to be as best as you can be so those other people are reflected and feel more comfortable doing more with themselves and their condition.”

In a sponsored video by Genentech, Washington explains the importance of minority representation in clinical trials and how to get involved.

“If these clinical trials are going to be developing therapies for the populations, it should be inclusive of all populations and should certainly include the population that the data shows you have faster disease progression and more severe disease activity,” he said.

In addition to her other work on improving minority representation in MS research, Williams, who also is part of the minority partnership network, has been working for the past three years on the first National African American Multiple Sclerosis Registry.

Sponsored by Providence St. Joseph Health and in collaboration with three other doctors across the U.S., the registry launched in September 2020 and has enrolled 200 people so far. Williams’ goal is for it to eventually hit 20,000 people enrolled.

“There’s so much more to do, but with so many people working on it, I feel pretty, pretty good about the future,” Schmidt said.