OP0221 EFFICACY OF SECUKINUMAB IN ENTHESITIS-RELATED ARTHRITIS: RESULTS FROM A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT WITHDRAWAL, PHASE 3 STUDY (JUNIPERA)

Background Enthesitis-related Arthritis (ERA) is a category of juvenile idiopathic arthritis (JIA) characterised by heterogeneous and insidious manifestations comprising axial and/or peripheral arthritis, enthesitis. 1 Secukinumab (SEC) demonstrated efficacy safety in both ERA psoriatic (JPsA) the JUNIPERA trial. 2 Objectives To evaluate rate flare risk reduction SEC on patients (pts) with active ERA. Methods pts (2 to <18 years age) disease (both ≥3 joints ≥1 enthesitis site) were included. In open-label (OL) treatment-period (TP)1, s.c. (75/150 mg <50/ ≥50 kg) was administered at baseline (BL), Week (Wk) 1–4, 8 12. Pts who achieved least JIA-ACR30 response Wk 12 randomised into double-blinded TP2 continue or placebo (PBO) every 4 wk until flare, up 100. The primary endpoint time JPsA pts. spondyloarthritis activity Index (JSpADA) assessment tool that contains items measure activity. 3 Evaluation end TP1 experienced these symptoms BL included modified Schober test (lumbar flexion), inflammatory back pain, FABER (Flexion, ABduction, External Rotation) test, JIA-ACR responses, Juvenile Disease Activity Score (JADAS)-27, resolution dactylitis for disease. These outcomes also used assess JIA course TP2. Results A total 52/86 (60.5%) enrolled OL period (mean age, 13.7 years; male, 78.8%). total, 51/52 (98.1%) completed 41/44 (93.2%) At BL, mean JADAS-27 14.8, JSpADA index 3.9, counts 2.7 0.4, respectively, number 6.2 limited range motion 4.9. relative experiencing 55% (HR 0.45, 95% CI: 0.16–1.28, p=0.075) (Figure 1). overall improved over are presented Table 1. TP1, 84.6% (44/52) 30 65.4% (34/52) 70. Clinically relevant functional ability as assessed Childhood Health Assessment Questionnaire (CHAQ) occurred (see Resolution ACR responses Clinical response, (SD) change from (unless otherwise stated ) TP1-Wk End TP2* (N=52 (N=22 PBO −2.4 (1.7) −2.7 −2.3 (2.1) Schöber, % 58.3 100.0 Inflammatory 77.8 50.0 52.6 83.3 sacroiliitis, 53.3 Enthesitis −2.2 (1.9) −2.5 −1.3 (1.8) Dactylitis −0.2 (0.8) (1) −0.1 (0.4) ACR30, 84.6 90.9 68.2 ACR50, 78.8 81.8 ACR70, 65.4 54.5 ACR90, 32.7 45.5 ACR100, 26.9 36.4 Inactive disease, 38.5 CHAQ −0.5 (0.5) −0.6 (0.7) −0.4 CRP, median −1.8 (38.7) −5.8 (38.3) 0 (35.9) −9.6 (7.5) −11.0 (8.9) −7.6 # , 72.3 78.6 50 66.7 *End based individual pts’ last visit (n= 46); (n=5). TP2, no. had presence showed complete TP2: enthesitis, 14, 18; dactylitis, 3, PBO, 0. C-reactive protein Conclusion ERA, longer vs exhibited rapid sustained improvement 104. References [1]Pagnini I, et al. Front Med 2021;8:6673052. [2]Brunner H, Rheumatol 2021;73 (suppl 10). [3]Weiss PF, Care Res 2014;66:1775-82. Disclosure Interests Nicolino Ruperto Speakers bureau: Eli Lilly, GlaxoSmith Kline, Pfizer, SOBI UCB, Paid instructor for: Lilly Consultant of: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers Squibb, Cambridge Healthcare Research (CHR), Celegene, Domain therapeutic, EMD Serono, Idorsia, Janssen, Novartis, Grant/research support from: F Hoffmann-La Roche, Pfizer SOBI, Elena Chertok: None declared, Joke Dehoorne Abbvie, Gerd Horneff MSD, Tilmann Kallinich Ingrid Louw BMS, Amgen Cipla, Sandrine Compeyrot-Lacassagne: Bernard Lauwerys Employee UCB Pharma, Neil Martin: Katherine Marzan Sanofi, William Knibbe Ruvie Martin Shareholder Xuan Zhu sarah whelan Luminita Pricop Alberto Martini EMD, Roche Daniel J Lovell Astra Zeneca, Boehringer Ingelheim, GSK, Hoffman LaRoche, UBC, Hermine Brunner Novartis