Ublituximab-xiiy

(Briumvi®)

Briumvi®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 150 mg/6 mL single-dose vials)
Drug ClassCD20-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
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  • 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 TitleYearSource
Briumvi (ublituximab-xiiy) Prescribing Information. 2022TG Therapeutics, Inc., Morrisville, NC

Systematic Reviews / Meta-Analyses