Long-term efficacy and safety of upadacitinib in patients with polyarticular-course juvenile idiopathic arthritis: 48 week results from the SELECT-YOUTH open-label study
Authors' conclusion
In the SELECT-YOUTH trial, bodyweight-based dosing of upadacitinib maintained efficacy in pediatric patients with pcJIA, and its safety profile was consistent with established safety profile.
Study context
- Population
- Pediatric patients with pcJIA, aged 2 to < 18 yearspatients who received at least one dose of upadacitinib
- Participants
- 122 patients
- Outcome
- JIA-ACR response rates
- Follow-up
- 48 weeks
Methodological detailsopen-label, second interim analysis, as observed and non-responder imputation methods
- Open-label
- Second interim analysis
- As observed and non-responder imputation methods
Main finding
As reported in the abstract
- JIA-ACR30
- 96.3%
- JIA-ACR50
- 93.6%
- JIA-ACR70
- 89.0%
- JIA-ACR90
- 72.5%
- JIA-ACR100
- 57.8%
Further findings
Low disease activity (JADAS-27 [CRP] ≤ 3.8) · 48 weeks
- Low disease activity achieved
- 79.4%
- Inactive disease status (JADAS-27 [CRP] ≤ 1)
- 49.5%
C-HAQ change from baseline · week 48
- C-HAQ change from baseline (n = 108)
- −0.64
Pain · week 12 through 48 weeks
- Rapid improvement in pain evident by week 12 and persisted throughout 48 weeks
Safety
Treatment-emergent adverse events · up to 156 weeks
- Treatment-emergent adverse events (E/100 PY; n = 122), generally mild to moderate
- 499.6
Most frequent events of special interest (per 100 PY)
- Hepatic disorders
- 7.5
- Bone fractures
- 4.3
- CPK elevation
- 3.5
Deaths
- No deaths occurred
Original publication
Long-term efficacy and safety of upadacitinib in patients with polyarticular-course juvenile idiopathic arthritis: 48 week results from the SELECT-YOUTH open-label study. Rheumatology (Oxford). Published 13 November 2026. doi:10.
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