JUNIPERA

Time to flare in Treatment Period 2 in biologic-naive patients with JPsA and ERA (primary end point)⁹

• 72% risk reduction in time to flare vs placebo (N=75) (HR=0.28, 95% CI: 0.13-0.63)

The median time to disease flare was not reached in the COSENTYX group and was 453 days in the placebo group (KM estimate).⁹

JUNIPERA study design

JUNIPERA was a 2-year, 3-treatment-period, phase 3, double-blind, placebo-controlled, event-driven, randomized-withdrawal study in 86 biologic-naive patients 2 years to <18 years of age with active JPsA or ERA as diagnosed based on modified ILAR JIA classification criteria. Treatment Period 1 consisted of all patients receiving open-label treatment with COSENTYX until Week 12. Responders (achieving JIA ACR30 response) at Week 12 entered Treatment Period 2, a double-blind, randomized period in which patients were randomized 1:1 to continue treatment with COSENTYX or begin treatment with placebo. Treatment Period 3 consisted of open-label COSENTYX. Patients were treated subcutaneously with COSENTYX 75 mg if weighing <50 kg or COSENTYX 150 mg if weighing ≥50 kg (Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter). The primary end point was time to flare in Treatment Period 2. Disease flare was defined as a ≥30% worsening in ≥3 of the 6 JIA ACR response criteria, and ≥30% improvement in ≤1 of the 6 JIA ACR response criteria and ≥2 active joints. Secondary end points were based on descriptive analyses.^1,9

ACR, American College of Rheumatology; CI, confidence interval; ERA, enthesitis-related arthritis; HR, hazard ratio; ILAR, International League of Associations for Rheumatology; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; KM, Kaplan-Meier.