JUNIPERA Study - Secukinumab in Juvenile PsA & ERA Save
JUNIPERA study evaluated secukinumab (SEC) in children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) and was found to be safe and effective in patients with active ERA and JPsA who previous failed to respond to conventional therapy.
This double-blind, placebo-controlled, treatment-withdrawal, phase 3 trial, enrolled 86 biologic-naïve patients (aged 2 to <18 years) with active disease ERA or JPsA and treated them with open-label subcutaneous (SEC) (weight based dosing either 75 or 150 mg) for 12 weeks. Responders (JCR30 response) at at week 12 were randomised to either SEC or placebo up to 100 weeks. Primary endpoint was time to disease flare in the blinded withdrawal study phase.
SEC had a significantly longer time to disease flare in ERA and JPsA (27% vs 55%, HR, 0.28) versus placebo. No new or unexpected safety signals emerged and the safety profile of SEC in children is consistent with that seen with adult psoriatic arthritis and axial spondyloarthritis.
Conventional synthetic disease-modifying antirheumatic drugs, glucocorticoids and non-steroidal anti-inflammatory drugs provide limited efficacy in these patients, especially with long-term use. The addition of an effective IL-17 inhibitor for patients with ERA or JPsA is a welcomed option.