Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 300 mg/10 ml) |
Drug Class | CD20-directed cytolytic antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- Indicated for the treatment of primary progressive MS in adults.
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Summary
- Ocrevus (ocrelizumab) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, as well as for the treatment of primary progressive MS in adults.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Ocrelizumab demonstrated superiority in delaying disease progression in Progressive MS (PMS) and was one of the most efficacious treatments for both 3-month and 6-month confirmed disability progression in Relapsing MS (RMS) populations.
- In Relapsing MS (RMS), ocrelizumab was associated with a significantly lower relapse rate compared to interferon beta-1a (RR 0.61, 95% CI 0.52 to 0.73) and showed a reduction in the number of participants with gadolinium-enhancing T1 lesions (RR 0.27, 95% CI 0.22 to 0.35) and new or enlarging T2-hyperintense lesions (RR 0.63, 95% CI 0.57 to 0.69).
- Ocrelizumab showed superior performance in the Timed 25-Foot Walk (T25FW) test, although with low certainty, and demonstrated a significant reduction in the annualized relapse rate (ARR) compared to placebo in the general MS population.
- Ocrelizumab showed little to no difference in the number of participants with SAEs compared to placebo and interferon beta-1a.
- Ocrelizumab had a higher rate of AEs compared to placebo in PPMS (RR 1.06, 95% CI 1.01 to 1.11), but little to no difference compared to interferon beta-1a in RRMS.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ocrevus (Ocrelizumab) Prescribing Information. | 2024 | Genentech USA, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Ocrelizumab (Ocrevus®) protocol for the treatment of relapsing multiple sclerosis (RMS). | 2020 | Health Service Executive |
UK consensus on pregnancy in multiple sclerosis: ‘Association of British Neurologists’ guidelines. | 2019 | Practical Neurology |