Long-term safety of canakinumab in patients with systemic juvenile idiopathic arthritis: 5-year results from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry
Authors' conclusion
Overall, no changes were observed in the safety profile with long-term use of canakinumab in pediatric patients with SJIA.
Study context
- Population
- Patients with sJIA aged ≥ 2 and < 18 years at treatment initiation, CARRA Registry, August 2015 to June 2022, followed ≥5 years
- Participants
- 90 / 39 / 51 / 87
- Exposure
- Canakinumab vs alternative therapy
- Overall canakinumabn = 90
- Canakinumab incident usersn = 39
- Canakinumab prevalent usersn = 51
- Alternative treatmentn = 87reference
- Outcome
- Serious adverse events (SAEs) and pre-specified events of special interest (ESIs)
- Follow-up
- Minimum of 5 years
Methodological detailslong-term, descriptive; no hypothesis testing
- Long-term
- Descriptive; no hypothesis testing
Main finding
As reported in the abstract
SAE incidence rate per 100 patient-years
Observational data: associations, not effects.
Further findings
- On-label canakinumab dosing at some point during first 5 years — Overall canakinumab
- 72.2%
Safety
Events
- Macrophage activation syndrome (ESI) — Overall canakinumab
- 5
- Infections treated with IV anti-infectives (ESI) — Overall canakinumab
- 1
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Long-term safety of canakinumab in patients with systemic juvenile idiopathic arthritis: 5-year results from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry. Pediatr Rheumatol Online J. Published 21 October 2025. doi:10.
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