Drug updated on 12/11/2024
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
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Relapse Reduction: Monoclonal antibodies, including inebilizumab (Uplizna), demonstrated significant effectiveness in reducing relapse rates in patients with neuromyelitis optica spectrum disorder (NMOSD). Food and Drug Administration (FDA)-approved monoclonal antibodies (MABs) showed a hazard ratio (HR) of 0.13 (95% confidence interval (CI): 0.07-0.24) for relapse risk reduction, while off-label mAbs had an HR of 0.16 (95% CI: 0.07-0.37), although the difference between FDA-approved and off-label mAbs was not statistically significant.
- Annualized Relapse Rate (ARR): Inebilizumab and other mAbs significantly reduced ARR compared to standard treatments, with ARRs of -0.27 (95% CI: -0.37, -0.16) for FDA-approved mAbs and -0.31 (95% CI: -0.46, -0.16) for off-label mAbs. In specific comparisons, rituximab (RTX) ranked highest in ARR reduction compared to azathioprine (AZA) and mycophenolate mofetil (MMF).
- Subgroup Findings: Eculizumab showed greater effectiveness in reducing on-trial relapse risk among aquaporin-4 (AQP4)-immunoglobulin G (IgG) seropositive patients compared to other monoclonal antibodies.
- Serious Adverse Events (SAE): Monoclonal antibody therapy, including inebilizumab, was associated with a reduction in SAE (relative risk (RR): 0.59, 95% CI: 0.37-0.96, P = 0.03) compared to other treatments. However, specific data on the types of SAEs for FDA-approved and off-label mAbs were not provided.
- Total Adverse Events (AEs): Mycophenolate mofetil (MMF) had the fewest AEs, followed by rituximab (RTX), with both showing significantly fewer AEs compared to azathioprine (AZA) and corticosteroids. No significant differences in total adverse events or mortality were observed in other analyses.
- AQP4-IgG Seropositive Patients: In a subgroup analysis where 84.7% of patients were AQP4-IgG seropositive, eculizumab showed a potential advantage in reducing on-trial relapse risk compared to other monoclonal antibodies.
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 inNeurology |
Different monoclonal antibodies and immunosuppressants administration in patients with neuromyelitis optica spectrum disorder: a Bayesian network meta-analysis | 2023 | Journal of Neurology |
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 |
---|---|---|
Update on the diagnosis and treatment of neuromyelitis optica spectrum disorders (NMOSD) - revised recommendations of the Neuromyelitis Optica Study Group (NEMOS). Part II: Attack therapy and long-term management | 2024 | Journal of Neurology |
International Delphi Consensus on the Management of AQP4-IgG+ NMOSD | 2023 | Neurology: neuroimmunology & neuroinflammation |