Tofacitinib for the Treatment of Juvenile Idiopathic Arthritis: Patient‐Reported Outcomes in a Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Withdrawal Trial
Authors' conclusion
Tofacitinib improved a range of PROs in patients with JIA, suggesting potential HRQoL benefits.
Study context
- Population
- Patients with juvenile idiopathic arthritis (JIA)173 randomised in part 2
- Participants
- 225 patients
- Comparison
- Tofacitinib continuation vs switch to placebo after open-label tofacitinib
- Primary endpoint
- PROs: parent/guardian Childhood HAQ (disability, arthritis pain, overall well-being) and Child Health Questionnaire (CHQ)
Methodological detailsdouble-blind, open-label phase (part 1; weeks 0-18), 1:1 randomisation (part 2; weeks 18-44)
- Double-blind
- Open-label phase (part 1; weeks 0-18)
- 1:1 randomisation (part 2; weeks 18-44)
Primary result
As reported in the abstract
PROs during open-label tofacitinib (part 1), least-squares (LS) mean: baseline vs week 18
- Disability score, baseline → week 18
- mean 1.04 (SE 0.05) → mean 0.57 (SE 0.05)
- Arthritis pain score, baseline → week 18
- mean 5.53 (SE 0.20) → mean 2.46 (SE 0.18)
- Overall well-being score, baseline → week 18
- mean 5.07 (SE 0.20) → mean 2.47 (SE 0.18)
- Child Health Questionnaire (CHQ) physical summary score, baseline → week 18
- mean 29.51 (SE 1.15) → mean 42.70 (SE 0.98)
- CHQ psychological summary score, baseline → week 18
- mean 47.24 (SE 0.85) → mean 51.53 (SE 0.80)
Further findings
Patient-reported outcomes (PROs) in part 2 · week 44
- Improvements were generally maintained to week 44 in part 2
Original publication
Tofacitinib for the Treatment of Juvenile Idiopathic Arthritis: Patient‐Reported Outcomes in a Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Withdrawal Trial. Arthritis Rheumatol. Published 19 December 2025. doi:10.
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