ArticleACR open rheumatology2025
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.
Article in ACR open rheumatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02592434 (EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Efficacy, safety and tolerability of tofacitinib for treatment of polyarticular course juvenile idiopathic arthritis (jia) in children and adolescent subjects
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Authors and funding
26 authors.
Funding
Abstract
objectiveWe 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.
methodsIn 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 rates, and JIA/ACR clinical inactive disease (CID). Safety was assessed throughout the trial.
resultsOf 225 patients in Part 1, 147 (65.3%) were MTX+; 85 (37.8%) were bDMARD+. Across subgroups, JIA flare rate at Week 44 was lower with tofacitinib than placebo: patients who were MTX+ (29.8% vs 47.5%), patients who were MTX- (32.3% vs 73.1%), patients who were bDMARD+ (29.0% vs 70.4%), patients who were bDMARD- (31.6% vs 48.3%). Greater JIA/ACR50/70 and JIA/ACR-CID responses with tofacitinib than with placebo were observed across subgroups. In tofacitinib-treated patients, adverse events (AEs) were more common in the subgroups of patients who were MTX- (85.9%) and patients who were bDMARD+ (81.2%) than the subgroups of patients who were MTX+ (74.1%) and patients who were bDMARD- (76.4%). Similar findings were observed with serious AEs/discontinuations due to AEs.
conclusionTofacitinib was efficacious for patients regardless of baseline concomitant MTX treatment or prior bDMARD exposure; MTX may have a protective effect for flare upon tofacitinib withdrawal. Safety was consistent with the known tofacitinib profile, and no new risks were identified in these subgroups.
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