Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial
Primary result · Disease flare in TP2Result — go to the resultHazard ratio 0.28 95% CI 0.13–0.63Authors' conclusion
Secukinumab demonstrated significantly longer time to disease flare than placebo in children with ERA and JPsA with a consistent safety profile with the adult indications of psoriatic arthritis and axial spondyloarthritis.
Study context
- Population
- Biologic-naïve patients aged 2 to <18 years with active enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) with inadequate response to conventional therapy75 TP1 responders randomised
- Participants
- 86 patients
- Comparison
- Secukinumab vs placebo after open-label secukinumab run-in (TP1) in juvenile idiopathic arthritis (JIA) ACR30 responders
- Primary endpoint
- Time to disease flare in TP2
Methodological detailsdouble-blind, placebo-controlled, treatment-withdrawal, phase 3
- Double-blind
- Placebo-controlled
- Treatment-withdrawal
- Phase 3
Primary result
Disease flare in TP2
Hazard ratio
0.28
95% CI 0.13–0.63
P < 0.001
By group
Secukinumabvs Placebo
HR 0.28 (95% CI 0.13–0.63); P < 0.001
As reported in the abstract
Safety
Adverse events, exposure-adjusted incidence rate (per 100 patient-years (PY)), overall JIA population (total patients)
- Exposure-adjusted incidence rate of AEs, total patients
- 290.7/100 PY (95% CI 230.2 to 362.3)
Serious adverse events, exposure-adjusted incidence rate (per 100 PY), overall JIA population (total patients)
- Exposure-adjusted incidence rate of SAEs, total patients
- 8.2/100 PY (95% CI 4.1 to 14.6)
Original publication
Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Ann Rheum Dis. Published 12 August 2022. doi:10.
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