Baricitinib Effective in JIA Subsets Save
A phase 3 trial assessed a selective Janus kinase 1/2-inhibitor, baricitinib, in patients with juvenile idiopathic arthritis (JIA), demonstrating it's efficacy and safety compared to placebo.
A multicenter, multinational trial was a randomised, double-blind, placebo-controlled, trial with an open-label run in and blinded withdrawal. They enrolled JIA patients (aged 2 to <18 years) diagnosed with polyarticular JIA (seropositive or negative), extended oligoarticular JIA, enthesitis-related arthritis (ERA), or juvenile psoriatic arthritis (jPsA), if they had an inadequate response (after ≥12 weeks of treatment) or intolerance to one or more conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs).
The trial consisted of a 2-week safety and pharmacokinetic period, a 12-week open-label lead-in period (10 weeks for the safety and pharmacokinetic subcohort), with only responders being enrolled in a 32-week placebo-controlled double-blind withdrawal period where they received either BARI or placebo. The week 12 response included those meeting Juvenile Idiopathic Arthritis-American College of Rheumatology (JIA-ACR) 30 criteria (JIA-ACR30 responders). The primary endpoint was time to disease flare during the double-blind withdrawal period.
A total of 219 patients (69% girls; median 14 years) initiated baricitinib in the open-label period, and after 12 weeks 74% (163) were JIA-ACR30 responders; responders were randomized to either placebo (n=81) or baricitinib (n=82) in the double-blind withdrawal period.
Time to disease flare was significantly shorter with placebo versus baricitinib (hazard ratio 0·241) with a median placebo time to flare of 27 weeks, and no certain flare time in the BARI group as <50% had a flare event.
Few serious adverse events were seeb in the open-label lead-in period (3%) and the double-blind withdrawal period (5% BARI, 4% PBO), with only one pulmonary embolism in the baricitinib group in the double-blind withdrawal period, (thought to be related to study drug).
Baricitinib appears to be safe and effective in JIA patients whohave had an inadequate response or intolerance to standard therapy.