Is Ocrelizumab Safe, Effective for Black and Hispanic Patients With Relapsing MS?

Ocrelizumab is effective and has no new safety signals for the treatment of relapsing multiple sclerosis (MS) among Black and Hispanic patients, according to study results presented at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.

In clinical trials, Black and Hispanic populations are understudied. However, Black and Hispanic patients vs White patients may have increased incidence of multiple sclerosis (MS), a faster disease progression, and higher risk for progression of disability.

The CHIMES study (ClinicalTrials.gov Identifier: NCT04377555) was a prospective, open-label, single-arm, phase 4 trial designed to assess the safety and efficacy of ocrelizumab among minority populations.

Patients (N=182; mean age, 35.5; women 72.5%; body mass index [BMI], 31.0 kg/m²) aged 18 to 65 who were Black (n=113) or Hispanic (n=69) and had an Expanded Disability Status Scale (EDSS) of 0 to 5.5 at baseline received two 300 mg ocrelizumab infusions 2-weeks apart followed by 600 mg ocrelizumab every 24 weeks for one year with an optional 3-year extension.

The primary efficacy outcome was no evidence of disease activity (NEDA) at 48 weeks, defined as freedom from relapse, 24-week confirmed disability progression (24W-CDP), T1 gadolinium-enhancing lesions (Gd+L), and new or enlarging T2 lesions (NET2Ls).

The average time since first MS symptoms was 49 years and time since relapsing MS diagnosis was 2.9 years.

At baseline, patients had an average EDSS score of 2.4 points.

Nearly half of Black patients (46.0%) and more than half of Hispanic patients (58.0%) with relapsing MS achieved NEDA at 48 weeks.

Most Black and Hispanic patients had no relapse (94.7% and 95.7%), 24W-CDP (94.7% and 94.2%), or Gd+L (94.7% and 97.1%) events, respectively. For NET2L events, 46.0% of Black patients and 63.8% of Hispanic patients were free from the NTE2L outcome during follow-up.

Most patients (80.2%) experienced 1 or more adverse event, 5.5% experienced 1 or more serious adverse event, 29.1% had an infusion-related reaction, and no deaths occurred during the study.

“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,” the researchers concluded.

Disclosures: This research was supported by Genentech, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.