LB0004 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)

Abstract

Scientific Abstracts 201 of rituximab, when clinically feasible, seems to be reasonable to improve vaccine induced immunogenicity. Holding treatment with abatacept and MMF may be considered on an individual basis. Background: Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are two ILAR categories of juvenile idiopathic arthritis (JIA) and represent paediatric correlates of axial spondyloarthritis (axSpA) and adult psoriatic arthritis (PsA), respectively. 1,2 Secukinumab (SEC) has demonstrated efficacy and safety in adult patients (pts) with PsA, ankylosing spondylitis and non-radi-ographic axSpA. 3-5 Objectives: Evaluate efficacy and safety of SEC using a flare prevention design in pts with active ERA and JPsA. Methods: This 2-yr study consisted of an open-label (OL) s.c. SEC (75/150 mg in pts <50/ ≥50 kg) at baseline (BL), and at Weeks (Wk) 1, 2, 3, 4, 8 and 12 in treatment-period (TP) 1. Responder pts who achieved at least JIA ACR 30 response at Wk 12 were randomised into the double blinded TP2 to continue SEC or placebo (PBO) q4w until a disease flare, or up to Wk 100. Pts (aged 2 to <18 yrs) classified as ERA or JPsA according to ILAR criteria of ≥6 months duration with active disease were included. Primary endpoint was time to flare in TP2 and key secondary endpoints were JIA ACR 30/50/70/90/100, inactive disease , JADAS, enthesitis count and safety. Analysis of time to flare in TP2 included proportion of disease flare, Kaplan-Meier (KM) estimate