DXM05
Demographics and Baseline Disease Characteristics of Black and Hispanic Patients with Multiple Sclerosis in the Chimes Trial
Objectives: To present the baseline demographics and disease characteristics of Black and Hispanic patients with relapsing multiple sclerosis (RMS) enrolled in the CHIMES trial (NCT04377555).
Methods: The CHIMES trial was specifically designed to address barriers to trial inclusion for Black and Hispanic patients by including accessible study sites, tailoring eligibility criteria, translating patient materials and enhancing scheduling flexibility. Baseline demographics and disease characteristics in this study were evaluated against the benchmark of the existing data from other OCR studies.
Results: The demographics and baseline disease characteristics of patients in the CHIMES trial were overall similar to those observed in the broader OCR clinical trial population. Potential distinguishing factors included younger age, higher BMI, greater T2 burden, shorter duration of disease and time to diagnosis despite similar disease activity than patients from other OCR studies.
Conclusions: Underrepresentation of Black and Hispanic patients in clinical trials limits the understanding of MS and hinders the collection of pathophysiology, safety and efficacy data related to therapies in inclusive patient populations. Data from the CHIMES trial, the first MS trial to focus on Black and Hispanic patients, indicate some differences in demographics and baseline disease characteristics between Black and/or Hispanic and White patients; however, these differences alone do not justify nor explain the lack of representation of Black and Hispanic patients in clinical research.
