Clinically Inactive Disease and Remission in Patients With Juvenile Idiopathic Arthritis Receiving Tofacitinib: Post Hoc Analysis of a Phase III Trial

J Rheumatol. 2025 Sep 1;52(9):919-926. doi: 10.3899/jrheum.2024-0536.

Abstract

Objective: To evaluate rates of clinically inactive disease (CID) and remission in patients with juvenile idiopathic arthritis (JIA) receiving tofacitinib using the 2021 Juvenile Arthritis Disease Activity Score (JADAS) thresholds and American College of Rheumatology (ACR) criteria.

Methods: This post hoc analysis included patients with active JIA (polyarticular-course JIA, psoriatic arthritis, or enthesitis-related arthritis) enrolled in a phase III randomized withdrawal study of tofacitinib. In part 1 (weeks 0-18), patients received open-label tofacitinib. In part 2 (weeks 18-44), patients who achieved ACR improvement ≥ 30% were randomized to tofacitinib or placebo for 26 weeks or until JIA flare. Disease activity was assessed using the JADAS in 10 joints (JADAS10) based on C-reactive protein, with interpretation according to 2021 polyarthritis thresholds. JADAS10 remission was defined as ≥ 24 continuous weeks of JADAS10 CID (JADAS10-CID). ACR CID (ACR-CID) and ACR clinical remission were also assessed.

Results: Of 225 patients with JIA in part 1, 173 (76.9%) were randomized in part 2 to continue tofacitinib or switch to placebo. Rates of JADAS10-CID and ACR-CID increased throughout part 1 to 30.5% and 15.8% (week 18), respectively. In part 2, these were sustained with tofacitinib (week 44: 35.2% [JADAS10-CID], 25% [ACR-CID]) and decreased when patients switched to placebo (week 44: 25.9% [JADAS10-CID], 15.3% [ACR-CID]). A small proportion of patients achieved JADAS10 remission at week 44 (tofacitinib: 14.8%; placebo: 7.1%).

Conclusion: In patients with JIA receiving tofacitinib, JADAS10-CID and ACR-CID rates improved rapidly and were sustained over time, and a small proportion of patients achieved JADAS10 remission. Inactive disease is a feasible treatment target in patients receiving tofacitinib. (ClinicalTrials.gov: NCT02592434).

Keywords: arthritis; biological therapy; disease activity score; juvenile idiopathic arthritis; outcomes; pediatric rheumatic diseases.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Antirheumatic Agents* / therapeutic use
  • Arthritis, Juvenile* / drug therapy
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Piperidines* / therapeutic use
  • Protein Kinase Inhibitors* / therapeutic use
  • Pyrimidines* / therapeutic use
  • Remission Induction
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • tofacitinib
  • Pyrimidines
  • Piperidines
  • Protein Kinase Inhibitors
  • Antirheumatic Agents

Associated data

  • ClinicalTrials.gov/NCT02592434