Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial
| Autor: | Hermine I Brunner, Ivan Foeldvari, Ekaterina Alexeeva, Nuray Aktay Ayaz, Inmaculada Calvo Penades, Ozgur Kasapcopur, Vyacheslav G Chasnyk, Markus Hufnagel, Zbigniew Żuber, Grant Schulert, Seza Ozen, Adelina Rakhimyanova, Athimalaipet Ramanan, Christiaan Scott, Betul Sozeri, Elena Zholobova, Ruvie Martin, Xuan Zhu, Sarah Whelan, Luminita Pricop, Alberto Martini, Daniel Lovell, Nicolino Ruperto |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | ANNALS OF THE RHEUMATIC DISEASES r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/ard-2022-222849 |
| Popis: | BackgroundTreatment options in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are currently limited. This trial aimed to demonstrate the efficacy and safety of secukinumab in patients with active ERA and JPsA with inadequate response to conventional therapy.MethodsIn this randomised, double-blind, placebo-controlled, treatment-withdrawal, phase 3 trial, biologic-naïve patients (aged 2 to ResultsA total of 86 patients (median age, 14 years) entered open-label secukinumab in TP1. In TP2, responders (ERA, 44/52; JPsA, 31/34) received secukinumab or placebo. The study met its primary end point and demonstrated a statistically significant longer time to disease flare in TP2 for ERA and JPsA with secukinumab versus placebo (27% vs 55%, HR, 0.28; 95% CI 0.13 to 0.63; pConclusionsSecukinumab 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.Trial registration numberNCT03031782. |
| Databáze: | OpenAIRE |
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