Impact of Concomitant Methotrexate Use and Prior Biologic Disease-Modifying Antirheumatic Drug Exposure on Tofacitinib Efficacy and Safety in Patients with Polyarticular Course Juvenile Idiopathic Arthritis: Post Hoc Analysis of a Phase 3 Randomized Withdrawal Trial.

ABSTRACT:

Objective

We evaluate tofacitinib efficacy and safety in patients with juvenile idiopathic arthritis (JIA) stratified by concomitant methotrexate and prior biologic disease-modifying antirheumatic drug (bDMARD) treatment.

Methods

In this two part, double-blind, randomized withdrawal Phase 3 trial (NCT02592434), patients (2-<18 years) with JIA received open-label tofacitinib (5 mg twice daily/weight-based equivalent) in Part 1 (Day 1-Week 18). Those eligible were randomized to continue tofacitinib or switch to placebo in Part 2 (Weeks 18-44). In this post hoc analysis, patients were stratified by concomitant methotrexate (MTX+/-) and prior bDMARD treatment (bDMARD+/-). Efficacy outcomes included JIA disease flare, JIA/American College of Rheumatology (ACR) 50/70 response rate

SUBMITTER: Ruperto N 

PROVIDER: S-EPMC12504799 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature