Drug updated on 5/17/2024
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.
Latest News
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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. It has shown significant efficacy in reducing the risk of relapse, improving annualized relapse rates, and impacting disability progression.
- Four studies were reviewed, focusing on therapeutic options for NMOSD with particular emphasis on monoclonal antibodies, including Uplizna compared to other treatments.
- The safety analysis favored monoclonal antibodies like Uplizna, indicating a lower risk of serious adverse events compared to other treatments. A superior safety profile was observed with these new treatments, highlighting overall tolerability.
- Subgroup considerations suggest that eculizumab might offer an advantage in decreasing on-trial relapse risk among AQP4 positive patients, suggesting a potential preference within this subset of NMOSD patients.
- Accessibility and cost-related concerns associated with FDA-approved monoclonal antibodies such as Uplizna have been raised, suggesting off-label alternatives may serve as viable first-line options in resource-limited settings.
- While direct comparisons between Uplizna and other monoclonals like eculizumab or rituximab are scarce within the studies, grouped analysis favors the use of FDA-approved drugs, including Uplizna, due to their superior efficacy and safety despite higher costs.
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 |