Secukinumab significantly increased the time to flare and reduced the number of flares in children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) compared with placebo. The safety profile of secukinumab in this population is congruent with the known safety profile of the drug. These were the main results of the phase 3 randomised, double-blind JUNIPERA trial 104 weeks after treatment initiation.
Efficacy and safety of secukinumab, a human monoclonal antibody targeting IL-17, has been demonstrated in adult PsA and radiographic and non-radiographic axial spondyloarthritis patients. The current study aimed to evaluate the efficacy and safety of secukinumab in ERA and JPsA patients (aged 2–18) with a history of inadequate response or intolerance to ≥1 NSAID or ≥1 DMARD. If patients (n=86) reached juvenile idiopathic arthritis (JIA) ACR 30 at the end of a 12-week open-label secukinumab 75/150 mg subcutaneous first treatment period (TP) (qw first 4 weeks, then q4w), they were randomised to secukinumab q4w (n=37) or placebo (n=38).
After the occurrence of a flare in the second TP, the patient was moved to another open-label secukinumab TP. The primary endpoint was time to disease flare of patients on secukinumab versus placebo in the second TP. Time to flare was significantly longer in the secukinumab arm compared with the placebo arm (HR 0.28; 95% CI 0.13-0.63; p<0.001).
The number of flares was lower in the treatment arm (secukinumab 10 vs placebo 21) and JIA ACR 30 was maintained more often for secukinumab-treated patients (89.2%) than for placebo patients (64.9%) after the second TP. Dr Nicola Ruperto (IRCCS Istituto G. Gaslini, Italy) argued that the median time to flare of 453 days in the placebo arm indicated a prolonged biological effect of the first TP.
Complete resolution of enthesitis occurred in 73.9% of the ERA patients after TP 1. Adverse events (AEs) were reported in 91.7% of the secukinumab patients and 92.1% of the placebo patients, including 7 and 4 non-fatal serious AEs, respectively.
Ruperto N, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind, Placebo-controlled, Treatment Withdrawal, Phase 3 Study (JUNIPERA). LB0004, EULAR 2021 Virtual Congress, 2-5 June.