Inebilizumab-cdon

(Uplizna®)

Inebilizumab-cdon

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Drug updated on 5/17/2024

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.

Summary
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  • 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.