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Tofacitinib for the Treatment of Juvenile Idiopathic Arthritis: Patient-Reported Outcomes in a Phase 3, Randomized,

Hermine I Brunner1, Ekaterina Alexeeva2, Marcia Bandeira3

  • 1Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.

Arthritis & Rheumatology (Hoboken, N.J.)
|October 31, 2025
PubMed

Insights

Tofacitinib significantly improved patient-reported outcomes, including disability and pain, in children with juvenile idiopathic arthritis (JIA). These findings suggest tofacitinib offers potential benefits for health-related quality of life (HRQoL) in JIA patients.

Area of Science:

  • Rheumatology
  • Pediatrics
  • Clinical Trials

Background:

  • Juvenile idiopathic arthritis (JIA) negatively impacts health-related quality of life (HRQoL).
  • Patient-reported outcomes (PROs) are crucial for assessing JIA management.
  • Tofacitinib is a Janus kinase inhibitor being investigated for JIA treatment.

Purpose of the Study:

  • To evaluate the effect of tofacitinib on PROs in patients diagnosed with JIA.
  • To assess changes in disability, pain, and overall well-being.
  • To determine the impact on the Child Health Questionnaire (CHQ) scores.

Main Methods:

  • Post hoc analysis of a Phase 3 randomized, double-blind, placebo-controlled withdrawal trial.
  • Patients received open-label tofacitinib initially, followed by randomization to tofacitinib or placebo.
  • PROs assessed included the Childhood Health Assessment Questionnaire and CHQ.

Main Results:

  • Tofacitinib treatment led to numerical improvements in disability, arthritis pain, and overall well-being scores.
  • Child Health Questionnaire physical and psychological summary scores also showed numerical improvements.
  • These improvements were generally sustained during the double-blind phase of the study.

Conclusions:

  • Tofacitinib demonstrated a positive impact on multiple PROs in patients with JIA.
  • The drug suggests potential for improving the health-related quality of life in this population.
  • Further research may confirm these HRQoL benefits in JIA management.
Abstract

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