An Interim Analysis of Efficacy and Safety Data in Black and Hispanic Patients With Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial
Evanthia Bernitsas1, Anthony Reder2, Angel Chinea3, Craig Herrman4, Barbara O'Brien5, Richard Sater6, Lilyana Amezcua7, Mitzi Williams8, Gregory Wu9, Timothy Vartanian10, Jinglan Pei11, Juan Acosta11, Nancy Monson12
1Wayne State University School of Medicine, 2University of Chicago Medicine, 3San Juan MS Center, 4JWM Neurology, 5Baptist Memorial Hospital-Collierville, 6Cone Health Medical Group, 7Keck School of Medicine, University of Southern California, 8Joi Life Wellness MS Center, 9Washington University in St Louis, 10Brain and Mind Research Institute, Weill Cornell Medicine, Cornell University, 11Genentech, Inc., 12University of Texas Southwestern
Objective:
To analyze the interim efficacy and safety data for ocrelizumab (OCR) treatment in Black and Hispanic patients with relapsing multiple sclerosis (pwRMS).
Background:
Black and Hispanic patients are underrepresented in MS trials, and these patients may have higher MS incidence, faster disease progression and/or an increased risk of progression to disability vs White patients. The CHIMES trial (NCT04377555) was designed to evaluate disease activity and OCR response in Black and Hispanic patients.
Design/Methods:
This prospective, open-label, single-arm, Phase IV study included pwRMS who self-identified as Black or Hispanic, were aged 18-65 years and had Expanded Disability Status Scale (EDSS) scores of 0-5.5 points at screening. Patients received two 300-mg OCR infusions 14 days apart, and 600 mg every 24 weeks for 1 year, with an optional 3-year extension. The interim data cutoff was March 30, 2022, with patients who completed 1-year OCR treatment. The primary outcome was no evidence of disease activity (NEDA), defined as the proportion of patients free from a protocol-defined event at Week 48.
Results:
This interim analysis included 49/182 patients enrolled, 36 (73.5%) Black and 13 (26.5%) Hispanic. Mean (SD) age was 33.3 (8.1) years, weight was 90.6 (23.9) kg and 85.7% of patients were female. Patients had a mean (SD) time since first MS symptoms of 3.8 (5.1) years and time since RMS diagnosis was 1.6 (3.4) years. Baseline mean (SD) EDSS score was 2.5 (1.5), Gd-enhancing T1 lesions was 2.5 (3.9) and total T2 lesion volume was 21.7 (21.8) cm3. The proportion of patients with NEDA was 40.8% (95% CI 27.0%–55.8%). Overall, 38 patients experienced ≥1 AE, 3 had a serious AE and 22 had a non-serious infusion-related reaction. No deaths occurred.
Conclusions:
The CHIMES interim analysis provides essential preliminary data for OCR treatment response among Black and Hispanic patients.