Interim results from the CHIMES clinical trial (NCT04377555) presented at the 9th joint meeting of the European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) demonstrated the safety and efficacy of Ocrevus (ocrelizumab; Genentech, South San Francisco, CA) in Black and Hispanic patients for the treatment of relapsing multiple sclerosis (RMS).

CHIMES, a prospective, open-label, single-arm, phase 4 study assessing disease activity and biomarkers of neuronal damage in Ocrevus-treated minority patients with RMS, is being conducted at 30 sites in the United States, 1 site in Puerto Rico, and 1 site in Kenya. Participants include self-identifying Black (n=113) and Hispanic (n=69) individuals with RMS aged 18 to 65 years with Expanded Disability Status Scale (EDSS) scores of 0 to 5.5 points at screening. All participants received 2 300 mg Ocrevus infusions 14 days apart, followed by 600 mg Ocrevus infusions every 24 weeks for 1 year.

In all, 46% of Black patients and 58% of Hispanic patients achieved the primary endpoint—no evidence of disease activity (NEDA), defined as the proportion of patients at week 48 free from a protocol-defined event (relapse, confirmed disability progression at week 24, T1 gadolinium [Gd]-enhancing [+] lesion or new/enlarging T2 lesions).

Secondary outcomes also were presented and included the following:

• No relapses in a majority of participants (Black, 94.7%; Hispanic, 95.7%)
• No 24-week confirmed disability progression (Black, 94.7%; Hispanic, 94.2%)
• No T1 Gd+ lesions (Black, 94.7%; Hispanic, 97.1%)
• No new/enlarging T2 lesions (Black, 46.0%; Hispanic, 63.8%)

With respect to safety findings, 80.2% of patients experienced at least 1 adverse event (AE), 5.5% had at least 1 serious AE, and 29.1% had an infusion-related reaction. No deaths occurred.

These results are consistent with the safety and efficacy data reported in other Ocrevus clinical studies. Although Black and Hispanic individuals comprise almost 20% of the MS patient population, they are underrepresented in clinical research.

As lead trial investigator Mitzi Joi Williams, MD, notes, “The CHIMES trial is a critical step in breaking the cycle of health inequity…[and] unlocks new insights into the role of social determinants of health in the recruitment and retention of these populations in clinical trials.”