Two Years of Ocrelizumab Treatment in Black and Hispanic People with Multiple Sclerosis in CHIMES: A Single-Arm Clinical Trial
Abstract
Objective: To evaluate the effectiveness and safety of ocrelizumab in self-identified black and Hispanic people with relapsing multiple sclerosis.
Methods: The Characterization of Ocrelizumab in Minorities with Multiple Sclerosis (CHIMES) trial, a prospective, open-label, single-arm, phase 4 study, intentionally recruited underrepresented populations in the US, Puerto Rico, and Kenya. Black and Hispanic people with relapsing multiple sclerosis aged 18-65 years with Expanded Disability Status Scale score 0-5.5 received ocrelizumab for 2 years. The primary endpoint was the proportion of participants with no evidence of disease activity in 3 components at week 48: protocol-defined relapse, 24-week confirmed disability progression, and disease activity on magnetic resonance imaging.
Results: Of 113 black and 69 Hispanic people with relapsing multiple sclerosis, most were women (72%), with a mean age of 35.5 (SD 10.5) years, body mass index of 31.0 (SD 7.4) kg/m2, and Expanded Disability Status Scale score of 2.4 (SD 1.4). Genetic ancestry aligned with self-identified race or ethnicity. At week 48, 50.5% of CHIMES participants had no evidence of disease activity, including 94.5% free from 24-week confirmed disability progression, 95.1% free from relapse, 95.6% free from T1-contrast-enhancing lesions, and 52.7% free from new/enlarging T2 lesions. Serious adverse events were experienced by 8.2%, and 2.2% discontinued treatment. Infusion-related reactions were more frequent in…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 69 participants or records.
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