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Baricitinib for Treatment of Juvenile Idiopathic Arthritis

In patients with an inadequate response or intolerance to standard therapy used for the management of juvenile idiopathic arthritis, baricitinib was efficacious with an acceptable safety profile, a study shows. The phase 3 trial included participants with polyarticular juvenile idiopathic arthritis, extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis.

At 75 centers in 20 countries, 220 children and adolescents aged 2 to less than 18 years with an inadequate response after 12 or more weeks of treatment or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs) entered a 2-week safety and pharmacokinetic period and a 12-week open-label lead-in period (10 weeks for the safety and pharmacokinetic subcohort). Participants meeting Juvenile Idiopathic Arthritis-American College of Rheumatology (JIA-ACR) 30 criteria (JIA-ACR30 responders) continued to a 32-week placebo-controlled double-blind withdrawal period with age-based dosing of barcitinib.

Based on a primary endpoint of time to disease flare during the double-blind withdrawal period, the study showed the following: “Time to disease flare was significantly shorter with placebo versus baricitinib (hazard ratio 0.241 [95% CI 0.128–0.453], P <0.0001). Median time to flare was 27.14 weeks (95% CI 15.29–not estimable) in the placebo group, and not evaluable for patients in the baricitinib group (<50% had a flare event). Six (3%) of 220 patients had serious adverse events during the safety and pharmacokinetic period or open-label lead-in period. In the double-blind withdrawal period, serious adverse events were reported in four (5%) of 82 patients (incidence rate [IR] 9.7 [95% CI 2.7–24.9] per 100 patient-years at risk) in the baricitinib group and three (4%) of 81 (IR 10.2 [2.1–29.7]) in the placebo group. Treatment-emergent infections were reported during the safety and pharmacokinetic or open-label lead-in period in 55 (25%) of 220 patients, and during the double-blind withdrawal period in 31 (38%) of 82 (IR 102.1 [95% CI 69.3–144.9]) in the baricitinib group and 15 (19%) of 81 (IR 59.0 [33.0–97.3]) in the placebo group. Pulmonary embolism was reported as a serious adverse event in one patient (1%; IR 2.4 [95% CI 0.1–13.3]) in the baricitinib group in the double-blind withdrawal period, which was judged to be related to study treatment.”

Source: Lancet