Vasculitis & polymyalgia rheumatica
Real-world safety assessment of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis
Authors' conclusion
Avacopan demonstrated a favourable safety profile in patients with AAV in real-world settings. The overall AE risk increased with age, while hepatobiliary events were particularly more frequent among geriatric and female patients. Our study uncovered previously unrecognised AEs as well.
Study context
- Population
- Reports of avacopan-related adverse events (AEs) in patients with antibody-associated vasculitis (AAV), Food and Drug Administration (FDA) Adverse Event Reporting Systemreports
- Participants
- 3,150 reports
- Outcome
- Avacopan-related AEs (disproportionality signals at SOC and PT levels)
Methodological detailsdisproportionality analysis of the FDA Adverse Event Reporting System, system organ class (SOC) and PT levels, time-to-onset and Weibull shape parameter analysis, cumulative incidence analysis, subgroup analyses by gender and age
- Disproportionality analysis of the FDA Adverse Event Reporting System
- SOC and PT levels
- Time-to-onset and Weibull shape parameter analysis
- Cumulative incidence analysis
- Subgroup analyses by gender and age
Main finding
As reported in the abstract
Avacopan-related AE signals
Positive SOC signals
8
Positive PT signals
92
Previously unrecognised preferred terms (PTs)
34
Further findings
Time to onset
- Median time-to-onset (TTO) (days)
- 48
- Overall Weibull shape parameter (WSP) analyses suggested an early failure type pattern; event-specific analyses heterogeneous
Subgroups by age and gender
- Patients aged ≥65 years had a higher cumulative incidence of AEs
- Hepatobiliary events leading, predominantly in female and geriatric (≥65 years) patients
Original publication
Real-world safety assessment of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis. RMD Open. Published 25 March 2026. doi:10.
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