Drug updated on 4/18/2024
| 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.
Summary
- Ublituximab-xiiy (Briumvi) is indicated for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- Two studies compared Briumvi's safety and effectiveness to other disease-modifying therapies (DMTs).
- It was among the three most efficacious treatments for reducing the annualized relapse rate when compared with a placebo. Additionally, it demonstrated significant efficacy in controlling MRI-detected lesions.
- Compared to other monoclonal antibody therapies such as ocrelizumab, alemtuzumab, and ofatumumab used for treating RMS, ublituximab shows competitive efficacy, particularly in managing the annualized relapse rates.
- A study that included data from two randomized controlled trials showed that Briumvi significantly reduced T1 and T2 lesions on MRI scans at week 96 post-initiation when compared with teriflunomide.
- While specific population types or subgroup considerations are not detailed within these studies, based on its wide-ranging efficacy across different measured outcomes like ARR reduction and lesion activity control on MRIs, it can be inferred that ublituximab may be broadly effective for adults suffering from various forms of MS.
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 |