One-year Analysis of Efficacy and Safety Data from Black/African American and Hispanic/Latino People with Relapsing Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial
Lilyana Amezcua1, Nancy Monson2, Mitzi Williams3, Timothy Vartanian4, Anthony Reder5, Krupa Pandey6, Kottil Rammohan7, Barry Hendin8, Gregory Wu9, Rikisha Parekh10, Jinglan Pei10, Ibraheem Abioye10, Juan Acosta10, Evanthia Bernitsas11
1Keck School of Medicine, University of Southern California, 2University of Texas Southwestern Medical Center, 3Joi Life Wellness MS Center, 4Brain and Mind Research Institute, Weill Cornell Medicine, Cornell University, 5University of Chicago Medicine, 6Hackensack Meridian School of Medicine, Hackensack University Medical Center, 7University of Miami Health System, 8Banner Health, University Medical Center Phoenix, 9Washington University in St Louis, 10Genentech, Inc., 11Wayne State University School of Medicine
Objective:
CHIMES (NCT04377555) was designed to evaluate the efficacy and safety of ocrelizumab in Black/African American and Hispanic/Latino people with relapsing multiple sclerosis (BpwRMS; HpwRMS).
Background:

Black/African American and Hispanic/Latino individuals are understudied in clinical trials but may have higher MS incidence, faster disease progression and/or increased risk of disability progression vs White individuals.

Design/Methods:

This prospective, open-label, single-arm, Phase IV study included BpwRMS and HpwRMS aged 18–65 years with baseline Expanded Disability Status Scale (EDSS) scores of 0–5.5. Participants received two 300-mg ocrelizumab infusions 14 days apart and 600 mg every 24 weeks for 1 year, with an optional 3-year extension. The primary endpoint was 48-week no evidence of disease activity (NEDA), defined as proportion of pwRMS free from protocol-defined events (relapse, 24-week confirmed disability progression [24W-CDP], T1 gadolinium-enhancing lesions [Gd+L] or new/enlarging T2 lesions [NET2Ls]). Safety (eg, adverse events [AE]) was also assessed.

Results:

Results: Of 182 pwRMS, 113 (62%) were Black/African American and 69 (38%) were Hispanic/Latino. Mean (SD) age was 35.5 (10.5) years, BMI was 31.0 (7.4) kg/m2 and 72.5% were female. The mean (SD) times since first MS symptoms and RMS diagnosis were 4.9 (5.7) and 2.9 (4.5) years, respectively. Baseline mean (SD) EDSS score was 2.4 (1.4). Approximately half of BpwRMS (46.0%) and HpwRMS (58.0%) achieved 48-week NEDA. Most BpwRMS and HpwRMS had no relapses (94.7% and 95.7%, respectively), 24W-CDP (94.7% and 94.2%) or Gd+L (94.7% and 97.1%). No NET2Ls were observed in 46.0% of BpwRMS and 63.8% of HpwRMS. No deaths occurred; 80.2% experienced ≥1 AE, 5.5% had ≥1 serious AE and 29.1% had infusion-related reactions.

Conclusions:
Approximately half of CHIMES participants achieved NEDA, and no new safety signals were reported. These results are consistent with prior studies and suggest ocrelizumab is a suitable treatment in this understudied population.
10.1212/WNL.0000000000205282