Immune checkpoint inhibitor-associated eosinophilic fasciitis: A FAERS pharmacovigilance analysis of a rare rheumatic immune-related adverse event
Main finding · EF signal, ICIs as a classResult — go to the resultROR 46.89 95% CI 34.70–63.35Authors' conclusion
ICI-associated EF appears to be an uncommon but potentially serious delayed rheumatic immune-related adverse event.
Study context
- Population
- FAERS reports Q1 2011 to August 2025 with an ICI coded as primary or secondary suspect drugreports of ICI-associated eosinophilic fasciitis (EF)
- Participants
- 69 participants
- Exposure
- Immune checkpoint inhibitors (ICIs) vs all other drugs in FAERS
- Outcome
- Eosinophilic fasciitis (Preferred Term "Eosinophilic fasciitis") reporting disproportionality
Methodological detailsdisproportionality analysis (reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), empirical Bayesian geometric mean (EBGM)), FAERS database, sensitivity analysis with expanded preferred term set
- Disproportionality analysis (ROR, PRR, IC, EBGM)
- FAERS database
- Sensitivity analysis with expanded preferred term set
Main finding
EF signal, ICIs as a class
ROR
46.89
95% CI 34.70–63.35
ICIsvs all other drugs in FAERS (disproportionality)
ROR 46.89 (95% CI 34.70–63.35)
As reported in the abstract
Observational data: associations, not effects.
Further findings
Age and time to onset
- Overall median age (years)
- 61
- Median time to onset (days)
- 319
Sensitivity analysis (expanded fibrosing/scleroderma-spectrum term set)
- Number of reports
- 83
- Overall direction of findings remained stable, particularly for PD-1 inhibitors
Original publication
Immune checkpoint inhibitor-associated eosinophilic fasciitis: A FAERS pharmacovigilance analysis of a rare rheumatic immune-related adverse event. Semin Arthritis Rheum. Published 7 July 2026. doi:10.
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