Vasculitis & polymyalgia rheumatica
Immune checkpoint inhibitor-associated aortitis and classical large-vessel vasculitis: Clinical characterization and pharmacovigilance analysis using FDA Adverse Event Reporting System (FAERS)
Authors' conclusion
This FAERS analysis identified disproportionate reporting signals for ICI-associated aortitis and classical large-vessel vasculitis.
Study context
- Population
- FAERS reports 2011 Q1 to 2025 Q3 of aortitis, GCA and Takayasu's arteritis (MedDRA Preferred Terms)ICI-associated reports
- Participants
- 83 reports
- Exposure
- ICI exposure vs all other FAERS reports
- Outcome
- Disproportionality signals for ICI-associated aortitis and classical LVV
Methodological detailsretrospective disproportionality analysis of FAERS, disproportionality analysis (reporting odds ratio (ROR), proportional reporting ratio, information component, empirical Bayesian geometric mean), subgroup analyses by ICI class, individual agent, regimen and event subtype
- Retrospective disproportionality analysis of FAERS
- Disproportionality analysis (ROR, proportional reporting ratio, information component, empirical Bayesian geometric mean)
- Subgroup analyses by ICI class, individual agent, regimen and event subtype
Main finding
As reported in the abstract
Disproportionality signal, aortitis and classical LVV
ROR (95% CI)
ICIs overall
4.45(3.57–5.55)
Anti-PD-1 agents
4.32(3.27–5.71)
Observational data: associations, not effects.
Further findings
Event subtypes
- Aortitis and GCA showed positive signals, whereas Takayasu's arteritis was rarely reported
Clinical characteristics of ICI-associated cases
- Median age (years)
- 68
- Male
- 57.8%
- Median time to onset (days), reports with onset data
- 105.5
Hospitalization and death among ICI-associated cases
- Hospitalization
- 34.9%
- Death
- 2.4%
Original publication
Immune checkpoint inhibitor-associated aortitis and classical large-vessel vasculitis: Clinical characterization and pharmacovigilance analysis using FAERS. Semin Arthritis Rheum. Published 18 August 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →