Inebilizumab-cdon

(Uplizna®)

Inebilizumab-cdon

Drug updated on 9/4/2024

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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  • 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.