OP0165 LONG-TERM SAFETY OF BIOLOGICS VS CONVENTIONAL SYNTHETIC TREATMENTS IN SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS PATIENTS

Background The better understanding of systemic Juvenile Idiopathic Arthritis (sJIA) pathogenesis and availability new drugs, such as biologic disease-modifying anti-rheumatic drugs (bDMARDs) specifically dedicated to sJIA, have led treatment advances that ameliorated the disease outcome reduced use glucocorticoids. However, published evidence on long term safety data regarding therapies in sJIA is still limited. Objectives objective study was compare adverse events (AEs) at least moderate intensity serious AEs patients treated with biologics compared a cohort csDMARDs (conventional synthetic drugs) Methods Patients classified according International League Associations for Rheumatology (ILAR), enrolled Pharmachild Registry since 2011 followed up until 31 December 2022 were included. All had received one bDMARDs or csDMARDs. Those who switched more than during period observation assigned only group longest time drug exposure. are reported latest release Medical Dictionary Regulatory Activities (MedDRA, Version 23.1) grouped into highest “System Organ Classes” (SOCs). Frequency SOCs analysed. Events repeated same SOC patient counted once analysis. Results A total 980 enrolled, 353 627 distribution demographic similar both cohorts, exception prescription frequent other continents Europe. As shown Table 1, developed frequently infections infestations (41.4%), skin subcutaneous tissue disorders (11.3%) general administration site conditions (8.2%) (all p<0.0001). On hand, endocrine (7.3%, p=0.03). between children csDMARDsA. Conclusion bDMARD higher prevalence manifestations when cohort. 1. Demographics characteristics, number frequencies complete set. Data presented n (%). frequency > 30 by overall presented. AEs: events; SOC: system organ class; bDMARDs: drugs; conventional drugs. bDMARDsN=353 N=627 OverallN=980 p-value Male 175 (49.6%) 279 (44.5%) 454 (46.3%) - Mean (SD) age onset (years) 6.21 (4.24) 5.77 (4.04) 5.92 (4.12) Age groups <2 65 (18.4%) 115 (18.3%) 180 ≥2 12 242 (68.6%) 444 (70.8%) 686 (70.0%) ≥12 18 46 (13.0%) 68 (10.9%) 114 (11.6%) ≥ 0 (0%) diagnosis 6.56 (4.3) 6.17 (4.13) 6.31 (4.2) final visit 12.05 (5.4) 12.41 (5.13) 12.28 (5.2) Disease duration 5.84 (4.61) 6.65 (4.63) 6.36 (4.64) Origin- Europe 320 (90.7%) 466 (74.3%) 786 (80.2%) Other 33 (9.3%) 161 (25.7%) 194 (19.8%) Concomitant steroid therapy (≥6 months) 165 (46.7%) 414 (66.0%) 579 (59.1%) <0.0001 Infections 146 (41.4%) 176 (28.1%) 332 Gastrointestinal 51 (8.1%) 84 0.6 Injury, poisoning procedural complications 28 (7.9%) 50 (8.0%) 78 0.99 Skin 40 27 (4.3%) 67 Blood lymphatic 25 (7.1%) 42 (6.7%) 0.9 Endocrine 13 (3.7%) (7.3%) 59 0.03 Immune 14 (4%) 36 (5.7%) 0.3 Musculoskeletal connective 37 (5.9%) 0.2 General 29 17 (2.7%) Investigations 16 (4.5%) (4.6%) 45 Nervous 15 (4.2%) (2.6%) Acknowledgements This work partially supported Fundación Española de Reumatología (FER). Disclosure Interests Ana Isabel Rebollo Giménez: None declared, Luca Carlini: Yulia Vyzhga: Ekaterina Alexeeva Speakers bureau: from Roche, Novartis Pfizer., Grant/research support from: Pfizer, Centocor, Eli Lilly, AbbVie, Bristol-Myers Squibb, MSD, Sanofi, Amgen Novartis., Charlotte Myrup: Silvia Magni-Manzoni: Maria Trachana: Valda Stanevicha: Constantin Ailioaie: Elena Tsitsami: V Cochino: Chiara Pallotti: Scala: Angela Pistorio: Sebastian Vastert SOBI Novartis, Institutional Grant privat-public grant opportunity ZonMW, Joost F. Swart: Nicolino Ruperto NR has honoraria consultancies speaker bureaus following pharmaceutical companies past 3 years: 2 Bridge, Amgen, AstraZeneca, Aurinia, Bayer, Brystol Myers Celgene, inMed, Cambridge Healthcare Research, Domain Therapeutic, EMD Serono, Glaxo Smith Kline, Idorsia, Janssen, Sobi, UCB., IRCCS Istituto Giannina Gaslini (IGG), where works full-time public employee contributions industries last Bristol Eli-Lilly, F Hoffmann-La Sobi. funding been reinvested research activities hospital fully independent manner, without any commitment third parties.