Lupus & antiphospholipid syndrome
Characterisation of systemic lupus erythematosus associated with immune checkpoint inhibitors: a pharmacovigilance study using FAERS database
Authors' conclusion
This first pharmacovigilance study identified a significant association between ICI use and SLEs, suggesting ICIs may constitute a novel class of drug-induced SLE triggers.
Study context
- Population
- Adverse event reports of patients with cancer with SLE, FAERS database (Q1 2011-Q4 2024)209 SLE cases
- Participants
- 146,066 ICI-related adverse events
- Exposure
- Immune checkpoint inhibitors (ICIs) vs other drugs
- Outcome
- Association between ICIs and SLE (disproportionality signals)
Methodological detailsdisproportionality analysis of FAERS database, reporting OR and information component, adjusted reporting OR (ROR) via logistic regression
- Disproportionality analysis of FAERS database
- Reporting OR and information component
- Adjusted ROR via logistic regression
Main finding
As reported in the abstract
SLE signals associated with ICIs
- Positive signals of SLEs identified, predominantly cutaneous lupus and SLE
- 8
Observational data: associations, not effects.
Further findings
Risk factors for ICI-related SLE
- Risk significantly higher in females than males
- Age and chemotherapy not significant risk factors
- Risk higher with anti-PD-1 vs other ICI therapies
- Lung cancer, melanoma or breast cancer appeared at higher risk
Characteristics of SLE cases
- Age, median (IQR), years
- 63 (55.3-71.7)
- Female
- 106 (51%)
Mortality among ICI-related SLE cases
- Mortality rate
- 4.31% (nine cases)
- Most patients experienced serious outcomes
Original publication
Characterisation of systemic lupus erythematosus associated with immune checkpoint inhibitors: a pharmacovigilance study using FAERS database. Lupus Sci Med. Published 29 September 2025. doi:10.
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