ENSEMBLE Study Results, Ocrelizumab as Promising Early Treatment for MS: Robert A. Bermel, MD

WATCH TIME: 6 minutes

“We've always had this knowledge that early treatment is better in MS, that once processes start off early in the disease, they're really hard to stop and they leave permanent damage. So early treatment is good, but I think it is only an extension of that early effective treatment that would be even better, probably.”

Ocrelizumab (Ocrevus; Genentech), an anti-CD20 monoclonal antibody, has been approved by the FDA for relapsing multiple sclerosis (MS) and primary progressive MS for some time. In 2020, the agency approved a shorter 2-hour infusion time for the treatment based on results from ENSEMBLE-PLUS, a prospective substudy of the open-label, single-arm, phase 3b ENSEMBLE trial (NCT03085810).

New findings from the ENSEMBLE study investigating ocrelizumab in patients with relapsing-remitting MS showed stable or improved disability progression in most patients treated up to 4 years.¹ These results were presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, by lead author Robert Bermel, MD, staff neurologist and director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic.

The patient cohort featured individuals aged 18 to 55 years, who had Expanded Disability Status Scale (EDSS) scores between 0 and 3.5, had 1 relapse or T1-weighted contrast enhancing lesion in the prior 12 months, and were treatment-naïve. In the trial, patients received ocrelizumab 300 mg intravenously on days 1 and 15 for the first dose, followed by 600 mg IV every 24 weeks for 4 years.

Bermelsat down with NeurologyLive® in an interview at the meeting to provide an overview of the ENSEMBLE study. He also talked about the importance of early treatment in MS and how it relates to the use of highly effective therapies. Bermel spoke about the findings from the trial and how the treatment compares with other agents for patients with MS. In addition, he mentioned some of the potential implications of the study such as how it might inform future research and clinical practice.

REFERENCES
1. Bermel R, Hatung H, Brochet B, et al. Low disease activity over 4 years of ocrelizumab therapy in treatment-naïve patients with early-stage relapsing-remitting multiple sclerosis: the phase 3b ENSEMBLE study. Presented at: 2023 AAN Annual Meeting; April 22-27; Boston, MA. Abstract 001928