Ocrelizumab is safe and effective in early relapsing MS

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

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

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

At week 24, 91.2% (618 of 678 patients) of patients had no evidence of disease activity, defined as the absence of protocol relapses, disability progression, T1-weighted contrast enhancement, and new / enlarging T2-weighted lesions. and for 84.8% (545 of 643 patients) of patients at week 48.

At week 48, the adjusted annualized recurrence rate was 0.005 (95% CI, 0.003-0.009). Disability, as measured using the expanded disability status scale, improved significantly from 1.71 at baseline to 1.55 at week 48 (P = 0.002). In addition, age-adjusted serum neurofilament light levels decreased from the geometric mean of 10.5 picograms per milliliter at baseline to 4.55 picograms per milliliter at week 48, compared to 4.12 picograms per milliliter in age-adjusted healthy controls.

There were no new safety issues with ocrelizumab.

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

Disclosure: Some study authors stated links with biotech, pharmaceutical, and / or device companies. For a full list of the author’s disclosures, see the original reference.

Head to the Neurology Advisor meeting section for full coverage of the CMSC 2021.


T. Vollmer, MS Freedman, J. Killestein 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 ocrelizumab phase 3b ENSEMBLE study. Presented at: CMSC Annual Meeting 2021. 25.-27. October 2021; Orlando Florida. Summary DMT07.

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