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Real-world safety assessment of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis - PubMed

4 hours ago
  • #Avacopan Safety
  • #AAV Treatment
  • #Real-World Evidence
  • Study assessed real-world safety of avacopan in AAV patients using FDA Adverse Event Reporting System data.
  • Identified 3150 adverse event reports with 8 significant system-level and 92 specific signals, including 34 new events.
  • Median time to onset was 48 days, overall pattern suggested early failure, and age ≥65 increased cumulative incidence risk.
  • Hepatobiliary events were most common, especially in female and elderly patients (≥65 years old).
  • Conclusion: Avacopan showed favorable safety overall, but age and specific event risks call for individualized monitoring.