Ocrevus effective in halting MS disease activity for Black, Hispanic patients at 1 year

Key takeaways:

• A study evaluated 182 Black and Hispanic individuals with MS given infusions of Ocrevus for 1 year.
• By week 48, 58% of Hispanic and 46% of Black participants saw no evidence of disease activity.

Ocrevus infusions were effective in halting disease activity in Black and Hispanic individuals with relapsing forms of multiple sclerosis after 1 year, according to a study presented at ECTRIMS 2023.

"Historically, Black and Hispanic / Latinx populations have been underserved and underrepresented in clinical trial research. These communities often experience more severe disease and greater disability in MS and we did not have enough data to understand why," Mitzi Joi Williams, MD, of the Joi Life Wellness MS Center in Atlanta, told Healio in an email. "Exacerbating the issue, people who identify as Black or Hispanic/Latinx make up less than 5% and 1% of people enrolled in clinical trials."

Williams and fellow researchers conducted the CHIMES trial, intended to evaluate disease activity as well as safety and efficacy of Ocrevus (ocrelizumab, Hoffman-LaRoche) treatment in Black and Hispanic patients with relapsing forms of MS.

The prospective, open-label, single-arm, phase 4 study included 182 individuals (62% Black; mean age 35.5 years; 72.5% female) who recorded Expanded Disability Status Scale scores of 0 to 5.5 points at initial screening. They subsequently received two 300 mg infusions of ocrelizumab 14 days apart and 600 mg every 24 weeks for 1 year, with an optional 3-year extension. The primary outcome for the trial was no evidence of disease activity, defined as proportion of patients at week 48 free from a protocol-defined event (relapse, confirmed disability progression at week 24, T1 gadolinium-enhancing lesion or new/enlarging T2 lesions), with secondary outcomes clinical evaluations along with number, type and severity of adverse events.

Results showed that 46% of Black participants and 58% of Hispanic participants showed no evidence of disease activity by week 48.

Additionally, 94.7% of Black and 95.7% of Hispanic enrollees had no relapses, a significant majority registered no 24-week confirmed disability progression (Black, 94.7%; Hispanic, 94.2%) or T1 Gd+ lesions (Black, 94.7%; Hispanic, 97.1%), and no new or enlarging T2 lesions were observed in 46% of Black and 63.8% of Hispanic individuals.

Adverse events were logged in 80.2% of patients, 5.5% of the study population recorded at least one serious adverse event, 29.1% had an infusion-related reaction and no deaths occurred.

"As the first-ever clinical trial exclusively in Black and Hispanic/Latinx people with MS we now have clinical evidence that Ocrevus is an effective treatment option in these populations," Williams told Healio. "With CHIMES we have also expanded our understanding of how we can recruit and run clinical trials to ensure equitable and inclusive care in MS and beyond, establishing a new blueprint for the future of clinical trial research."