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Inebilizumab-cdon

(Uplizna®)

Uplizna®

Drug updated on 10/28/2024

Dosage FormInjection (intravenous; 100 mg/10 mL [10 mg/mL] solution in a single-dose vial)
Drug ClassCD19-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
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  • 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 NMOSD (neuromyelitis optica spectrum disorder). FDA (Food and Drug Administration)-approved mAbs showed a hazard ratio (HR) of 0.13 (95% CI (confidence interval): 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 AQP4 (aquaporin-4)-IgG seropositive patients compared to other monoclonal antibodies.
  • Serious Adverse Events (SAE): Monoclonal antibody therapy, including inebilizumab, was associated with a reduction in serious adverse events (SAE) (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 adverse events (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.