Life with MS

Why Is Inclusion Important in Multiple Sclerosis?

By Annette Okai, MD

Multiple sclerosis has historically been considered a disease mostly affecting people of Northern European descent. Over time, the face of MS has changed. A review of newly diagnosed MS patients’ charts showed that the incidence of MS varies by ethnicity, meaning some groups are diagnosed at a higher rate than others. African Americans actually had the highest rate at 10.2, followed by 6.94 in Caucasians and 2.9 for Hispanics. The review also showed up to a 40 percent increase risk of MS in African American women. Hispanic Americans had a 50 percent lower risk and Asian Americans had 80 percent lower risk for MS compared to their Caucasian counterparts.

There have also been differences observed between ethnic groups when it comes to the different measures of disease manifestation and progression in MS. MS-specific mortality trends show distinctive differences by race/ethnicity and age, suggesting there is an unequal burden of disease in non-Caucasians with MS.

Effects of MS on minority populations

A review of 136 articles published on minorities in MS show they tend to have a more serious clinical course and worse outcome. Hispanic Americans are diagnosed at a younger age and demonstrate a high frequency of optic neuritis and transverse myelitis at presentation. The disease progresses at a faster rate and more severely compared to Caucasians. African Americans are also more likely to present with optic neuritis and transverse myelitis. The course is severe. They have frequent relapses, incomplete recovery from relapses and more severe in impairment in walking abilities when compared to Caucasians. There are also findings that linked difficulties with cognition to loss of brain tissue on MRI. This finding is more rapid in African Americans. (For more on these differences, see Diversity of MS Presentation Across Ethnicity and Race on page 16 of this issue: Winter 2021)

Research with Minorities

Most of the information gathered on minority patients with MS has been retrospective – where researchers take a look back at previous records and analyze the data to draw conclusions. While these observations have been made, the fact is, the information is scant. There has not been a large-scale, forward-looking study to address the findings. Per United States census data, the two largest minority groups in the U.S. are Hispanics, representing approximately 18 percent, and African Americans at approximately 14 percent of the US population respectively. Yet non-Caucasian MS patients comprise less than 10 percent of clinical trials participants.

It is well recognized there are barriers to diversity in clinical trials. Federal regulators have instituted nonbinding guidelines on improving enrollment of under-represented to populations in clinical trials. Despite this, enrollment remains low and efforts to end this trend have not been an enduring success.

Why is inclusion important in multiple sclerosis research:

The primary goal of research trials is to have results that can be generalized to the group for whom the research was intended. The practice of multiple sclerosis today, especially when it comes to the non-Caucasian population is based on this small retrospective data that is impossible to generalize. Unfortunately, these observations have been taken as dogma and integrated into clinical practice. As the diagnosis of MS increases in non-Caucasian patients, it is important that research trials include a diverse group of patients that represent the current face of MS. A diverse patient group in research can also help widen the knowledge base of the specific disease process, such as multiple sclerosis. This improved knowledge can lead to better treatment outcomes. It can help identify if there are specific efficacy and safety issues early on during the time that a drug is being developed.

If the research trial does not include a diverse group, it may result in a response to treatment that may not be beneficial for everyone involved. Trials that have patients included from all backgrounds are important for patient education. If there is awareness of inclusive trials, the likelihood of participation is increased. There are different aspects of awareness. Those include education regarding the nature of the disease, how the effect of the disease affects a patient, specifically the biology and treatment response that occur in specific groups.

It is also important that awareness is raised on how clinical trials are conducted, the process of collecting scientific data and how the findings affect the entire community. A sense of community is an important cultural pillar in under-represented groups. Research trials that demonstrate a diverse subject group and show results that reflect the intended population are a powerful tool for advocacy. Advocacy is important to raise awareness, challenge barriers to inclusion, and improve policies to support and empower on an equal basis. When information is inclusive, it allows for empowerment of under-represented groups to actively take part in decision making processes affecting their lives. Armed with quality information, efforts can be made to achieve equal access to health for all and provide benefits to the group for which the research was intended. For MS in particular, this knowledge can be used to advocate for access to important services such as rehabilitation services, access to specialized care and testing, and social services that they may not qualify for otherwise.

Quality research results can also be used to advocate for intentional inclusion in further research trials. The total effect of quality research can influence research design, strategy for recruiting and keeping underrepresented groups in clinical trials, along with influencing policy change to maintain a positive trend of inclusion.

In summary

The demographics of multiple sclerosis have changed over time. The diagnosis of MS in non-Caucasian populations has significantly increased. It has been observed that non-Caucasian patients have more severe disease course and early progression to ambulatory impairment than to their Caucasian counterparts. Although the face of MS has changed over time, research trials in multiple sclerosis have not seen a similar trend.

This raises the question of whether the data obtained from these trials can be applied to this changing population. A diverse patient group in MS research improves the knowledge base of the disease. It can also lead to development of effective treatment for the intended population, identifying the differences in how each group responds to treatment, and early identification of important safety concerns, if any. An inclusive trial also enhances patient education which in turn can lead to increased participation.

A diverse and inclusive clinical trial group requires the efforts and collaboration of all the parties involved: groups that design and conduct research, patients who participate, the community, and regulatory groups that provide oversight regarding the safety and efficacy of the research trials. An inclusive trial that provides quality data improves the quality of scientific information. That has the potential to influence change on multiple levels, including how policies are made, the extent of patient involvement, and access to quality care.