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

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.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MJ Williams has received consulting fees from Alexion, Biogen Idec, Bristol Myers Squibb, EMD Serono, Genentech, Inc., Janssen, Novartis, Sanofi Genzyme and TG Therapeutics and serves on speakers bureaus for Biogen, Bristol Myers Squibb, EMD Serono, Janssen, Genentech and TG Therapeutics. AF Okai has received consulting fees from Alexion, Biogen, Bristol Myers Squibb, EMD Serono, Greenwich Biosciences, Novartis, Roche, Genentech, Inc., Sanofi Genzyme and TG Therapeutics and serves on speakers bureaus for Alexion, Biogen, EMD Serono and Sanofi Genzyme. AH Cross has, in the past year, received fees or honoraria for consulting for Biogen, EMD Serono, F. Hoffmann-La Roche Ltd, Genentech, Inc., Horizon Therapeutics, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Novartis and TG Therapeutics. NL Monson has received consulting fees from EMD Serono and Genentech, Inc.; is a founder of GenRab; and holds patent US 8,394,583 B2 on MSPreciseTM, a diagnostic tool for predicting conversion to multiple sclerosis. T Vartanian reports personal compensation for consulting, speaking or serving on steering committees or advisory boards for Biogen Idec, Novartis, Genentech, Inc., EMD Serono, the National Multiple Sclerosis Society and the National Institutes of Health. BW Thrower serves on speakers bureaus for Biogen, Horizon Therapeutics, Genentech, Inc. and Bristol Myers Squibb. AT Reder has received consulting fees from Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Merck Serono, Novartis and TG Therapeutics; is an editor for MedLink; and has received unrestricted research grant support from Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Mallinckrodt, Merck Serono and Novartis. JB English has received consulting fees from Biogen, EMD Serono, Sanofi Genzyme, Bristol Myers Squibb and IT Therapeutics, contracted research support from Biogen, EMD Serono, Novartis and Genentech, Inc. and serves on speakers bureaus for Biogen, EMD Serono, Sanofi Genzyme and Bristol Myers Squibb. GF Wu has received honoraria for consulting from Novartis and Genentech, Inc. and research funding from Biogen, EMD Serono and F. Hoffmann-La Roche Ltd. E Bernitsas has received grant support from F. Hoffmann-La Roche Ltd, Genentech, Inc., Sanofi Genzyme, MedImmune, Novartis, EMD Merck Serono, Chugai, Mallinckrodt and TG Therapeutics; is a Chief Editor for the “Brain Sciences” Neuroimaging section; and has received consulting fees/honoraria from Biogen, Merck Serono, Bristol Myers Squibb, Horizon, Janssen Pharmaceuticals and Genentech, Inc. S Yap is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd. J Ndrio is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd. J Pei is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd. EM Mowry has received grant support from Biogen, Genentech and Teva and royalties for editorial duties from UpToDate and has participated in data safety monitoring boards for the NIAID and TRIM trials. F Magrini was an employee of Genentech, Inc., at the time of the study. J Acosta is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd. L Amezcua reports personal compensation for consulting or serving on steering committees or advisory boards for Biogen Idec, Novartis, Genentech, Inc. and EMD Serono and has received research support from the National Multiple Sclerosis Society, NIH NINDS and Biogen.
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