Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 150 mg/6 mL single-dose vials) |
Drug Class | CD20-directed cytolytic antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
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Summary
- Briumvi (ublituximab-xiiy) 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.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Ublituximab was among the top three most effective monoclonal antibody therapies for reducing the annualized relapse rate (ARR), with a significant effect size favoring ublituximab (Cohen's d = -0.17, P = 0.006).
- Ublituximab demonstrated significant reductions in MRI outcomes at week 96, showing less disease activity in T1 lesions (Cohen's d = -0.43, P < 0.00001) and T2 lesions (Cohen's d = -0.55, P < 0.00001) compared to Teriflunomide.
- The likelihood of achieving no evidence of disease activity (NEDA) by two years post-initiation was significantly higher with ublituximab, with an odds ratio of 3.33 (P < 0.00001).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Briumvi (ublituximab-xiiy) Prescribing Information. | 2022 | TG Therapeutics, Inc., Morrisville, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Comparative efficacy of therapies for relapsing multiple sclerosis: A systematic review and network meta-analysis. | 2023 | Journal of Comparative Effectiveness Research |
Outcomes of Ublituximab compared to Teriflunomide for relapsing multiple sclerosis: A meta-analysis. | 2022 | Multiple sclerosis and related diseases |