Vasculitis & polymyalgia rheumatica
Hepatotoxicity of Avacopan: Real‐World Incidence and Confirmed Cases of Severe Drug‐Induced Liver Injury in a US National Rheumatology Registry
Authors' conclusion
Hepatic enzyme elevations during avacopan therapy were infrequent in this US cohort, yet severe DILI occurred.
Study context
- Population
- Patients with antibody-associated vasculitis (AAV) treated with avacopan, Rheumatology Informatics System for Effectiveness registry (US)
- Participants
- 238 patients
- Outcome
- Incidence of hepatic enzyme elevations (AST or ALT >3 × ULN, Alk Phos >2 × ULN, total bilirubin >2 mg/dL) during avacopan treatment
Methodological detailsregistry-based, Roussel Uclaf Causality Assessment Method (RUCAM) causality assessment
- Registry-based
- RUCAM causality assessment
Main finding
As reported in the abstract
Hepatic enzyme elevations during treatment, incidence rate per 100 person-years
Elevated AST: 5 patients; incidence rate per 100 person-years
4.24
95% CI 1.77–10.19
Elevated ALT: 3 patients; incidence rate per 100 person-years
2.67
95% CI 0.86–8.27
Elevated Alk Phos: 4 patients; incidence rate per 100 person-years
3.56
95% CI 1.34–9.49
Elevated total bilirubin: 2 patients; incidence rate per 100 person-years
1.80
95% CI 0.45–7.19
Observational data: associations, not effects.
Further findings
- Median time to first hepatic enzyme screening (days)
- 32
- Testing interval, average (days)
- 125
Safety
- Drug-induced liver injury (DILI) cases
- 2 (0.8%)
- Histologically confirmed severe hepatocellular injury
- 1
- Both with RUCAM scores of 9 (highly probable causality)
Original publication
Hepatotoxicity of Avacopan: Real‐World Incidence and Confirmed Cases of Severe Drug‐Induced Liver Injury in a US National Rheumatology Registry. Arthritis Rheumatol. Published 24 August 2026. doi:10.
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