Evaluation of the real-world safety of Canakinumab in the treatment of systemic juvenile idiopathic arthritis in children aged 0–16: a comprehensive analysis based on FDA Adverse Event Reporting System (FAERS) data
Authors' conclusion
This FAERS-based pharmacovigilance study provides preliminary safety data on the use of Canakinumab in children aged 0-16 years with sJIA, confirming several known adverse reactions and revealing additional potential risks.
Study context
- Population
- Children aged 0–16 years with systemic juvenile idiopathic arthritis (sJIA) receiving canakinumab, FAERS reports 2014–2023439 adverse events (AEs)
- Outcome
- AEs associated with canakinumab (disproportionality signals)
Methodological detailsdisproportionality analysis of FAERS data, FDA Adverse Event Reporting System (FAERS), 2014–2023, disproportionality analysis: Reporting odds ratio (ROR), proportional reporting ratio (PRR), MGPS, Bayesian confidence propagation neural network (BCPNN), Weibull shape parameter test for time to AE
- Disproportionality analysis of FAERS data
- FDA Adverse Event Reporting System (FAERS), 2014–2023
- Disproportionality analysis: ROR, PRR, MGPS, BCPNN
- Weibull shape parameter test for time to AE
Main finding
As reported in the abstract
AE signals for canakinumab in sJIA, ages 0-16
- Positive signals for labelled adverse reactions: inappropriate schedule of product administration, incorrect dose administered, rash, illness, gastroenteritis, thrombocytopenia, lymphadenopathy, leukopenia, transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased
- Potential adverse reactions not on the label: hemophagocytic lymphohistiocytosis, COVID-19, nasal congestion, increased serum ferritin
Original publication
Evaluation of the real-world safety of Canakinumab in the treatment of systemic juvenile idiopathic arthritis in children aged 0–16: a comprehensive analysis based on FAERS data. Pediatr Rheumatol Online J. Published 22 November 2025. doi:10.
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