DXM05
Demographics and Baseline Disease Characteristics of Black and Hispanic Patients with Multiple Sclerosis in the Chimes Trial

Thursday, June 2, 2022: 3:50 PM
Potomac C (Gaylord National Resort & Convention Center)
Lilyana Amezcua, MD , Keck School of Medicine, University of Southern California, Los Angeles, CA
Annette F Okai, MD , North Texas Institute of Neurology & Headache, Plano, TX
Anne H Cross, MD , Washington University School of Medicine, St. Louis, MO
Nancy L Monson, PhD , University of Texas Southwestern Medical Center, Dallas, TX
Ben W Thrower, MD , Crawford Research Institute, Shepherd Center, Atlanta, GA
Anthony T Reder, MD , University of Chicago Medicine, Chicago, IL
Jeffrey B English, MD , Multiple Sclerosis Center of Atlanta, Atlanta, GA
Gregory F Wu, MD, PhD , Washington University School of Medicine, St. Louis, MO
Evanthia Bernitsas, MD , Wayne State University School of Medicine, Detroit, MI
Shereen Yap, MSc , Genentech, Inc., South San Francisco, CA
Jugena Ndrio, PharmD , Genentech, Inc., South San Francisco, CA
Jinglan Pei, PhD , Genentech, Inc., South San Francisco, CA
Ellen M Mowry, MD, MCR , Dept. of Neurology, Johns Hopkins School of Medicine, Baltimore, MD
Fabio Magrini, MD , Genentech, Inc., South San Francisco, CA
Mitzi J Williams, MD , Joi Life Wellness Group MS Center, Smyrna, GA


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Background: Black and Hispanic patients with multiple sclerosis (MS) have greater disease severity, faster disease progression and a greater risk of disability than White patients yet they are underrepresented in clinical research. This lack of representation of Black and Hispanic patients in clinical trials is due to multiple factors including systemic, financial, cultural and logistical barriers. A key objective of the CHIMES trial is to evaluate both disease characteristics and ocrelizumab (OCR) treatment responses in Black and Hispanic patients.

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.