OP0163 GOLIMUMAB FOR THE TREATMENT OF POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS – AN UPDATE ON SAFETY AND EFFECTIVENESS FROM THE BIKER REGISTRY

Background Golimumab (GOL) is approved for treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years and older. Data on long-term safety GOL this indication are limited. Objectives To assess effectiveness pJIA patients. Methods In ongoing non-interventional observational study, clinical characteristics, disease activity parameters were analysed using the German Biologics Paediatric Rheumatology (BiKeR) registry. A total 141 pJIA-patients treated with frequency matched by body weight 282 receiving alternative tumor necrosis factor inhibitors (aTNFi) 135 biologic–naïve methotrexate (MTX). Results Baseline (measured number active joints JADAS10) other anti-TNF cohort was similar. The tended to have a longer duration more previously exposed biologic agents than cohort. Compared MTX cohort, had lower baseline less concomitant systemic steroids use (Table 1). highlighted decrease mean JADAS 10 from 10.7 (±6.5) (baseline) 4.4 (±5.0) at 24 months. By months, minimal (JADAS ≤3.8) reached 50.0% patients, whereas 34.2 % remission ≤1) PedACR 30/50/70/90 response rates 73.7/65.8/60.5/47.4% respectively. 12 SAEs reported, while aTNFi 25 5 observed One serious infectious event (SI) 6 SIs one SI observed. few incident autoimmune events reported: 4 (1 uveitis, psoriasis, 1 inflammatory bowel (IBD)), (6 IBD) 7 celiac disease) Among preexisting uveitis baseline, out 39 32 flares, there no MTX-cohort. No malignancies reported any Conclusion Our interim results show an acceptable profile therapy, comparable or MTX. AE infection between three cohorts comparable. new signals identified. Available data supports pJIA. Table 1. Patient demographic adverse N=141 N=282 N=135 Gender female ° 116 (82.3) 215 (76.2) 104 (77.0) Age (yrs)# 12.6±3.5 12.1±4.0 11.3±4.3 Disease 7.1±4.4 4.2±3.8 1.0±2.3 RF neg. Polyarthritis 76 (53.9) 142 (50.4) 85 (63.0) pos. 8 (5.7) 40 (14.2) 22 (16.3) Extended Oligoarthritis 53 (37.6) 88 (31.2) 23 (17.0) Psoriatic (2.8) (4.3) (3.7) Pretreatment bDMARD 113 (80.1) 61 (21.6) 0 Concomitant steroids° (15.6) 69 (24.5) 60 (44.4) Active joint count # 4.1±4.9 5.1±6.4 9.7±7.1 CHAQ DI 0.4±0.5 0.5±0.6 0.6±0.6 JADAS10 10.7±6.5 12.2±6.2 16.8±6.1 month ## ±5.0 - * 17295.8 (82.5-111.2) 50385.1 (78.0-92.9) 20093.7 (81.6-107.7) SAE 126.7 (3.8-11.8) 254.2 (2.9-6.3) 52.3 (1.0-5.6) Serious infections 10.6 (0.1-4.0) 61.0 (0.5-2.3) 10.5 (0.1-3.3) Autoimmune process 42.2 (0.8-5.9) 101.7 (0.9-3.1) 73.3 (1.6-6.9) Patients flare baseline+ (of 39) 32) 0) Rheumatoid (RF), modifying antirheumatic drug (bDMARD), childhood health assessment questionnaire disability index (CHAQ Di), (JADAS), (AE), patient year (PY), n (%) mean±SD mean±SD, n, rate/100PY (95% CI), + patients). Acknowledgements authors thank Zhiping Huang, also Rainer Berendes, Michael Borte, Ivan Földvari, Tilman Geikowski, Hermann Girschick, Johannes-Peter Haas, Maria Haller, Boris Hügle, Bernd-Ulrich Keck, Hans Kössel, Rolf-Michael Küster, Kirsten Minden, Prasad Oommen, Jürgen Quietzsch, Bettina Rogalski, Rühlmann, Angelika Thon, Ralf Trauzeddel, Andreas Urban, Frank Weller-Heinemann, Daniel Windschall contributing BIKER-Registry all their families. Disclosure Interests Angela Zimmer: None declared, Ariane Klein: Dressler Speakers bureau: Abbvie, Novartis Pfizer, Consultant of: Mylan, Jasmin Kuemmerle-Deschner: Markus Hufnagel: Toni Hospach Consulting fees: Novartis, SOBI, Dirk Foell Sobi, Biontech, Werfen, Boehringer, Grant/research support from: Normi Brueck: Nils Onken: Fasshauer: Gerd Horneff MSD, Lilly, Roche.