Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial.

TitleDemographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial.
Publication TypeJournal Article
Year of Publication2023
AuthorsWilliams MJ, Okai AF, Cross AH, Monson NL, Vartanian T, Thrower BW, Reder AT, English JB, Wu GF, Bernitsas E, Yap S, Ndrio J, Pei J, Mowry EM, Magrini F, Acosta J, Amezcua L
Corporate AuthorsCHIMES investigators
JournalMult Scler Relat Disord
Volume76
Pagination104794
Date Published2023 Aug
ISSN2211-0356
KeywordsAdolescent, Adult, Aged, Black or African American, Demography, Hispanic or Latino, Humans, Middle Aged, Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Young Adult
Abstract

BACKGROUND: Black/African American patients with multiple sclerosis (BpwMS) and Hispanic/Latino patients with multiple sclerosis (HpwMS), who historically have been underrepresented in multiple sclerosis (MS) clinical trials, exhibit greater disease severity and more rapid disease progression than White patients with MS (WpwMS). The lack of diversity and inclusion in clinical trials, which may be due to barriers at the system, patient and study levels, impacts the ability to effectively assess risks, benefits and treatment responses in a generalized patient population.

METHODS: CHIMES (Characterization of Ocrelizumab in Minorities With Multiple Sclerosis), an open-label, single-arm, multicenter, phase IV study of self-identified BpwMS and HpwMS aged 18-65 years with relapsing MS and an Expanded Disability Status Score (EDSS) of ≤5.5, was developed in collaboration with patients with MS, national advocacy groups and clinical researchers. Patients were enrolled at study centers across the US, including Puerto Rico, and 1 site in Kenya.

RESULTS: A total of 182 patients enrolled in CHIMES: 113 (62.1%) were BpwMS, and 69 (37.9%) were HpwMS; the mean (SD) baseline EDSS score was 2.4 (1.4), and 62.6% of patients were treatment naive. Using the pooled non-BpwMS/HpwMS group in the OPERA ocrelizumab trials as a reference population, patients enrolled in CHIMES were younger, had a higher mean body mass and had a greater T2 lesion volume but similar T2 lesion number on MRI.

CONCLUSION: BpwMS and HpwMS have been consistently underrepresented in clinical trials, limiting the understanding of disease biology and response to treatment in this population. Data from the CHIMES study revealed differences in demographics and some baseline disease characteristics and disease burden between BpwMS and HpwMS vs WpwMS. These differences could have an impact when assessing clinical outcomes in BpwMS and HpwMS.

GOV IDENTIFIER: NCT04377555.

DOI10.1016/j.msard.2023.104794
Alternate JournalMult Scler Relat Disord
PubMed ID37356256

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