Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous:100 mg/10 mL (10 mg/mL) solution in a single-dose vial) |
| Drug Class | CD19-directed cytolytic antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Summary
- Inebilizumab-cdon (Uplizna) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
- Two systematic reviews/meta-analyses were reviewed, providing insights into the efficacy and safety of Uplizna compared to other treatments for NMOSD.
- The first review found that both FDA-approved monoclonal antibodies like Uplizna and off-label drugs significantly lower risk of relapse than standard treatments, with hazard ratios indicating a 13% and 16% risk respectively.
- This same study also noted that FDA-approved monoclonal antibodies had a 20% lower risk of relapse than off-label drugs, although this difference was not statistically significant.
- The second review highlighted Rituximab's superiority over other therapies including Azathioprine in improving disability degree, annual relapse rate, time to first relapse and fewer adverse events during treatment time among NMOSD patients aged 18 or older following Wingerchuck criteria; however it did acknowledge the high effectiveness and safety profile of new molecules such as Eculizumab, Tocilizumab,and Satralizumab which includes Uplinzna (inebiluzimamb).
- Despite these findings suggesting potential benefits from using monoclonal antibodies like Uplinzna (inebiluzimamb), it was suggested that alternatives such as Azathioprine may be useful where access to these newer medications is limited due to their worse risk-benefit ratio but still effective nature against NMOSD according to one study.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Uplizna (inebilizumab-cdon) Prescribing Information. | 2021 | Horizon Therapeutics USA, Inc., Deerfield, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis. | 2023 | Frontiers in neurology |
| Effectiveness of treatments in Neuromyelitis optica to modify the course of disease in adult patients. Systematic review of literature. | 2021 | Multiple sclerosis and related disorders. |