EFFICACY AND SAFETY OF SECUKINUMAB IN ENTHESITIS-RELATED ARTHRITIS AND JUVENILE PSORIATIC ARTHRITIS: PRIMARY RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT WITHDRAWAL, PHASE 3 STUDY (JUNIPERA)
Authors: N. Ruperto et al.
Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) represent two categories of juvenile idiopathic arthritis and represent the pediatric correlate of axial spondyloarthritis and adult psoriatic arthritis. In this 2-year study patients (aged 2 until < 18 years) received open-label secukinumab (SEC) (weight adjusted with 75mg < 50kg and 150mg > 50kg) weekly from baseline until week 4 and then every four weeks. Patients who achieved an at least JIA ACR30 response at week 12 were randomized into the double-blind second phase of the trial and continued with SEC or placebo every 4 weeks until flare (primary endpoint was the time to flare) or up to week 100. At the end of trial phase 1, 90.4% of patients achieved JIA ACR30 and 69.9% achieved an JIA ACR70 response. In trial phase 2, there was a 72% risk of flare reduction with SEC in comparison to placebo (HR 0.28; 95%CI 0.13-0.63, p < 0.001). Time to flare was significantly longer with SEC.
This trial has been conducted according to a design that is most often used in pediatric studies: start with an open-label treatment phase and randomize the patients who responded. The results are remarkable as the efficacy spectrum of SEC seems to extend to the juvenile diseases. The open-label first part shows that the majority of children responded and strengthens the view that ongoing treatment is required to maintain the benefit.