Incidence, Risk Factors and Management of Adverse Events in Contemporary Real‐World Care of Children with Juvenile Idiopathic Arthritis
Authors' conclusion
In this real-practice JIA cohort, AAEs were reported in 2 of 5 patients and most were mild events related to NSAID and MTX. SAEs were rare with no deaths and few major complications.
Study context
- Population
- Children with newly diagnosed Juvenile Idiopathic Arthritis (JIA) enrolled within 3 months of diagnosis in the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry, Canada2,046 patient-years (PY) of follow-up
- Participants
- 964 children
- Outcome
- Frequency, risk factors, severity and management of actionable and serious adverse events (AAE and SAE)
Methodological detailsKaplan-Meier and Cox regression analysis, adjusted analyses
- Kaplan-Meier and Cox regression analysis
- Adjusted analyses
Main finding
As reported in the abstract
Actionable and serious adverse events
- Patients with AAEs
- 39.0%
- AAE rate per 100 PY
- 34.9
- Patients with SAEs
- 3.4%
- SAE rate per 100 PY
- 2.0
- GI symptoms linked to non-steroidal anti-inflammatory drugs (NSAID) and methotrexate (MTX) (most common AAEs)
- 56.4%
Observational data: associations, not effects.
Further findings
Risk factors for first AAE (adjusted)
| HR | P value | |
|---|---|---|
| Subcutaneous MTXAdjusted analyses | 3.27 | P < 0.001 |
| Oral MTXAdjusted analyses | 2.08 | P < 0.001 |
| NSAIDAdjusted analyses | 2.17 | P < 0.001 |
| bDMARDsDecreased risk · adjusted analyses | 0.46 | P < 0.001 |
- Active disease associated with increased AAE risk
Safety
- Total SAEs
- 40
- Infections with hospitalisation
- 16
- Malignancy
- 1
- Deaths, demyelinating conditions, opportunistic infections
- 0
- Mostly in patients not receiving biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs)
Original publication
Incidence, Risk Factors and Management of Adverse Events in Contemporary Real‐World Care of Children with Juvenile Idiopathic Arthritis. Arthritis Care Res (Hoboken). Published 14 September 2026. doi:10.
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