Ocrelizumab Maintains Efficacy and Safety in a Diverse Relapsing MS Patient Population at 1-Year

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In a new analysis of the CHIMES trial, ocrelizumab displayed a trend toward improved work productivity among minority patients with relapsing multiple sclerosis.

Lilyana Amezcua, MD  (Credit: University of Southern California)

Lilyana Amezcua, MD

(Credit: University of Southern California)

New findings from the phase 4 CHIMES (NCT04377555) trial showed effective control of multiple sclerosis (MS) disease activity among Black/African American and Hispanic/Latino patients with relapsing MS after 1 year of ocrelizumab (Ocrevus; Genentech) treatment. The data was consistent with safety findings from prior studies and suggest that ocrelizumab is a suitable treatment for this diverse patient population.1

In the analysis, approximately half of Black/African American patients with RMS (46.0%) and more than half of Hispanic/Latino patients with RMS (58.0%) achieved 48-week no evidence of disease activity (NEDA) following treatment with ocrelizumab. A majority of the Black/African American and Hispanic/Latino patients with RMS reported no relapses (94.7%; 95.7%, respectively), 24-week confirmed disability progression (94.7%; 94.2%, respectively), or T1 gadolinium-enhancing lesions (94.7%; 97.1%, respectively). Notably, investigators observed no new/enlarging T2 lesions in 46% of Black/African American patients with RMS and in 63.8% of Hispanic/Latino patients with RMS.

These results were presented by lead author Lilyana Amezcua, MD, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine, at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held May 29 to June 2, in Nashville, Tennessee. The trial consisted of 182 participants, 113 (62%) of which were Black/African American and 69 (38%) Hispanic/Latino. The mean age of participants was 35.5 years (SD, 10.5), the average body mass index was 31 kg/m2 (SD, 7.4), and 72.5% of the patients were women. Mean times since first MS symptoms and RMS diagnosis were 4.9 (SD, 5.7) and 2.9 (SD, 4.5) years, respectively. Authors noted that the mean baseline Expanded Disability Status Scale (EDSS) score was 2.4 among the participants (SD, 1.4).

CHIMES is a prospective, open-label, single-arm, phase 4 study that included Black/African American patients with RMS and Hispanic/Latino patients with RMS aged 18 to 65 years with baseline EDSS scores of 0 to 5.5. In the trial, patients received 2 ocrelizumab infusions of 300-mg 14 days apart and 600 mg ocrelizumab infusions every 24 weeks for 1 year, with an optional 3-year extension. The primary end point was 48-week NEDA, defined as proportion of patients free from protocol-defined events. Investigators also assessed safety outcomes and had patients periodically surveyed with the Work Productivity and Activity Impairment Questionnaire (WPAI) during the study.

READ MORE: Ofatumumab Positively Impacts Neurofilament Light, NEDA Status Regardless of Race or Ethnic Background

Top Clinical Takeaways

  • Ocrelizumab treatment resulted in 48-week no evidence of disease activity in nearly half of Black and Hispanic patients with RMS.
  • The majority of patients reported no relapses, confirmed disability progression, or T1 gadolinium-enhancing lesions after one year of treatment.
  • Safety findings from the CHIMES trial were consistent with previous studies, supporting the use of ocrelizumab in a diverse patient population with RMS.

Among participants treated with ocrelizumab, researchers reported reductions in Work Productivity and Activity Impairment (WPAI) scores, signifying less impairment, for each domain. This included mean changes of −5.5 for absenteeism (SD, 27.2), −1.6 for presenteeism (SD, 27.4), −5.5 for work productivity (SD, 30.5), and −6.1 for activity impairment (SD, 28.5). Although the trial had no reports of death, 80.2% of participants had at least 1 adverse event, 5.5% had at least 1 serious adverse, and 29.1% had infusion-related reactions.

A published narrative review in 2021 conducted by Amezcua and colleagues concluded that racial and ethnic health disparities and care inequities in MS and neuromyelitis optica spectrum disorder (NMOSD) put Black, Hispanic, and Latinx individuals at a disadvantage in receiving adequate care in the US compared with White individuals.2 Thus, further research is necessitated to investigate how social determinants of health (SDOH) mechanisms and structures contribute to these inequities for underrepresented populations, primarily lower rates of education, income, and access to specialty care.

Investigators found a limited number of studies evaluating inequities between these populations as the role of SDOH in MS and NMOSD. However, Black, Hispanic, and Lantinx patients with MS or NMOSD were found to have increased mortality, as well as unequal access to and utilization of health care, which was impacted by SDOH. These patients also experienced higher levels of mistrust, which were similar to experiences in stroke and other neurological conditions, investigators noted.

Black, Hispanic, and Latinx patients with specific SDOH such as a lower income, lower health literacy, lower education levels, and negative perceptions of illness in MS were associated with greater health disparities compared with White patients with MS and NMOSD. It was further concluded that Black individuals had a higher risk of developing both diseases, as well as a higher risk of associated mortality.

Investigators noted limitations to the narrative review, which included limited selection to underrepresented populations in the US, as well as the potential for subjective sampling bias. Additionally, a quality assessment of the studies was not conducted due to the heterogeneity of the included studies and the variability in how race and ethnicity were defined. Future research should include increased representation of these populations in clinical trials, as well as additional training for health care professionals on evaluating SDOH.

Click here for more coverage of CMSC 2024.

REFERENCES
1. Amezcua L, Monson NL, Williams MJ, et al. One-Year Analysis of Ocrelizumab Treatment in Black/African American and Hispanic/Latino Patients With Relapsing Multiple Sclerosis From the CHIMES Trial. Presented at: 2024 CMSC Annual Meeting; May 29-June 2; Nashville, TN. Abstract DMT33
2. Amezcua L, Rivera VM, Vazquez TC, Baezconde-Garbanati L, Langer-Gould A. “Health disparities, inequities, and social determinants of health in multiple sclerosis and related disorders in the US: A review.” JAMA Neurol. Published online October 4, 2021. doi:10.1001/jamaneurol.2021.3416
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