Ocrelizumab Safe and Effective for Early-Stage Relapsing-Remitting MS

Relapsing-remitting Multiple sclerosis diagnosis in form.
In this interim analysis, researchers reported the 1-year efficacy and safety data of ocrelizumab in treatment-naïve patients with early-stage relapsing-remitting multiple sclerosis.
The following article is part of conference coverage from the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held October 25-28 2021, in Orlando, Florida. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the 2021 CMSC Annual Meeting.

Ocrelizumab is a safe and effective treatment option for treatment-naïve patients with recently diagnosed early-stage relapsing-remitting multiple sclerosis (RRMS), according to study results presented at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held October 25 to 28, 2021 in Orlando, Florida.

ENSEMBLE is a phase 3b study to evaluate ocrelizumab in treatment-naïve early-stage patients with RRMS and the objective of the current interim analysis was to report the 1-year efficacy and safety data of the treatment.

The study included 678 adults (64.6% women) aged 18 to 55 years with Expanded Disability Status Scale score ≤ 3.5, disease duration ≤ 3 years, and clinical or radiographic active disease within 12 months of enrollment. All participants were treated with ocrelizumab 600 mg every 24 weeks.

No evidence of disease activity, defined as absence of protocol-defined relapses, disability progression, T1-weighted contrast-enhancing and new/enlarging T2-weighted lesions, was reported for 91.2% (618 of 678 subjects) of patients at week 24, and for 84.8% (545 of 643 subjects) of patients at week 48.

At week 48, adjusted annualized relapse rate was 0.005 (95% CI, 0.003-0.009).  Disability, measured by Expanded Disability Status Scale, improved significantly from 1.71 at baseline to 1.55 at week 48 (P = .002). Furthermore, age-adjusted serum neurofilament light levels decreased from geometric mean of 10.5 picogram per milliliter at baseline to 4.55 picogram per milliliter at week 48, compared with 4.12 picogram per milliliter in age-matched healthy controls.

No new safety issues emerged with ocrelizumab.

“Treatment-naïve patients with early-stage RRMS in ENSEMBLE responded consistently well to ocrelizumab treatment based on clinical, MRI, and biomarker measures; no new safety signals were observed,” concluded the researchers.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

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Vollmer T, Freedman MS, Killestein J, et al. Recently diagnosed early-stage relapsing-remitting multiple sclerosis: NEDA, annualized relapse rate, disability progression, serum neurofilament, and safety: 1-year interim data from the ocrelizumab phase 3b ENSEMBLE study.  Presented at: CMSC 2021 Annual Meeting. October 25-27, 2021; Orlando, Florida. Abstract DMT07.