A new study to characterize the response to ocrelizumab (Ocrevus; Genentech, South San Francisco, CHIMES (NCT04377555) in individuals from traditionally underrepresented groups was announced at MSVirtual2020 conference. This is the first prospective clinical trial for multiple sclerosis developed in collaboration with people who have MS, patient-advocacy groups, and investigators. The study will examine the treatment response among African-American, Hispanic- and Latinx-American participants. The study is sponsored by Genentech.
There is a growing body of knowledge showing that African-Americans, Hispanic- and Latinx-Americans with MS have a worse course of disease compared with white individuals. For African Americans, this difference in prognosis includes increased walking disability, earlier need for assistive walking devices (up to 6 years), and earlier admittance to nursing homes.
It is unknown whether these differences in disease course are related to social determinates of health or to underlying biologic differences in disease course that correlate with different populations. Among the reasons why this is unknown is the fact that clinical trials have traditional and still have very low enrollment of people from the African-American, Hispanic- and Latinx-American communities. On average, participation from these communities 2% to 8%, creating very low sample sizes for any subgroup evaluation.
One of the goals of this controlled prospective trial is to have a large enough number of African-American, Hispanic- and Latinx-American participants to understand treatment efficacy in these groups at a statistically significant level. The trial is using ocrelizumab, which targets B cells, because there is evidence that suggests there is greater B-cell-mediated disease activity in African-Americans with MS compared with whites with MS. Another goal is simply to better understand the course of disease in African-Americans, Hispanic- and Latinx-Americans.
This is an open-label, 12-month, phase 4 study with an optional 1-year extension in the US. There will be 2 parallel arms: people with MS who self-identify as African-American and people who self-identify as Hispanic- or Latinx-American. Both arms will receive ocrelizumab treatment on an open-label basis. The primary outcome is efficacy, based on annualized relapse rate (ARR). Secondary measures include both MRI and disability measures of disease progression. There is also an optional substudy to examine a variety of biomarkers in cerebrospinal fluid (CSF). Inclusion and exclusion criteria have been relaxed for this study to adjust for the higher rates of comorbidities found in African-Americans, Hispanic- and Latinx-Americans because of disparities in US health care.
"I think it is really exciting because the trial may give us a glimpse of how MS behaves in these populations. It will hopefully give us a key to understanding the biology of MS in these populations, how it may differ from their white counterparts, and how we can use this to guide treatment," said Dr. Mitzi Joi Williams, MD, Medical Director of the Joi Life Wellness MS Center and lead investigator of the study. "We want to be able to treat people appropriately. As we move toward personalized medicine, we need more diverse data. This is a small step to improve our understanding and work to make personalized medicine available to our patients."
Jill M. Giordano Farmer, DO
Peter McAllister, MD
James Geyer, MD, and Paul Cox