Drug updated on 9/4/2024
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
- Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
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Summary
- Uplizna (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Uplizna (inebilizumab) significantly reduced the annualized relapse rate (ARR) compared to standard treatments, with a mean difference of -0.31 (-0.46 to -0.16), and exhibited a lower risk of relapse (HR 0.13, 95% CI 0.07 to 0.24).
- In terms of relapse rate, Uplizna was superior to satralizumab (lnOR -24.86, 95% CrI -73.75 to -1.93) but ranked below tocilizumab.
- Uplizna led to a reduction in Expanded Disability Status Scale (EDSS) scores, with a mean change of -0.51 (95% CI -0.92 to -0.11, P=0.01).
- Uplizna (inebilizumab) demonstrated a reduction in serious adverse events (RR 0.59, 95% CI 0.37 to 0.96, P=0.03), with no significant differences in total adverse events or mortality compared to placebo.
- No specific safety concerns or adverse effects were identified for particular subgroups, including those based on AQP4-IgG serostatus, for inebilizumab.
- The majority of patients (84.7%) were AQP4-IgG seropositive, with Eculizumab potentially more effective in reducing relapse risk for this subgroup; no specific safety concerns were noted for any particular subgroups with inebilizumab.
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 |
Different monoclonal antibodies and immunosuppressants administration in patients with neuromyelitis optica spectrum disorder: a Bayesian network meta-analysis. | 2023 | Journal of 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 |
Efficacy and safety of monoclonal antibody therapy in neuromyelitis optica spectrum disorders: evidence from randomized controlled trials. | 2020 | Multiple Sclerosis and Related Disorders |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
International Delphi consensus on the management of AQP4-IgG+ NMOSD: Recommendations for eculizumab, inebilizumab, and satralizumab. | 2023 | Neuroimmunology and Neuroinflammation |