OP0161 24 MONTH RESULTS ON EFFECTIVENESS AND SAFETY OF A COMPARATIVE STUDY OF TOCILIZUMAB VERSUS TUMOUR NECROSIS FACTOR INHIBITION IN POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS

Objectives To evaluate 24-month effectiveness and tolerability/safety of tocilizumab (TCZ) versus tumour necrosis factor inhibitor (TNFi), analysing predictors JADAS remission minimal disease activity (MDA), comparing 1 st 2 nd line TCZ. Methods BIKER WA 29358 is a 5-year multi-centre prospective, observational cohort study including polyarticular juvenile idiopathic arthritis (JIA) patients in Germany starting treatment between 2015 2020 with TCZ matched an approved TNFi such as etanercept, adalimumab or golimumab. Clinical (JADAS), MDA/remission at 24 months, safety drug adherence were assessed compared cohorts. Results The analysis set consisted 342 participants data (TCZ, n=171; TNFi, n=171) (Table 1). Therefore, on older had longer duration to patients. Efficacy was demonstrated by marked comparable decrease the JADAS10 upon both from 14.6+/-6.6 14.6+/-6.2 baseline 2.5+/-3.4 2.7+/-3.6 month 24. used 2nd biologic majority (84%) while mostly biologics (86%). In last observation carried forward analysis, TCZ/TNFi achieved 84.6%/76.9% users 62.3/66.7% users. MDA 100%/87.9% 84.4%/91.7% TCZ/TNFi. After months residual measured (mean +/SD) lower (1.0+/-1.2 vs. 2.7+/-3.6), (2.7+/-3.8 2.5+/-2.6). Safety based adverse events reporting. 113 (66%) 105 (61%) reported higher rate (89 73/100 patient years (PY), RR 1.2 (95%CI 1.0-1.5), p=0.029, Wald-test) well serious (10 3/100 PY; p=0.045). Cytopenias more common (13 1; p=0.010) injection site reactions 6/100 PY, p=0.089). There no case death opportunistic infection. cohorts, 71 (42%)/72 (42%) discontinued treatment, 43/30 due lack efficacy, 14/22 7/6 intolerance, respectively. Conclusion this interim targets reached similar frequency after TNFi. predominantly biologic. Higher rates observed More but new signals noted. Observation ongoing. Table 1. Baseline patients’ characteristics Tocilizumab, N=171 Matched controls, P-value Age therapy start, mean (SD) 12.1 (3.5) 10.0 (4.4) <0.001 Disease Duration, years, 5.4 (4.0) 3.2 (3.1) Rheumatoid-factor negative poly JIA, n (%) 115 (67%) 97 (57%) n.s. positive 17 (10%) 22 (13%) Extended oligoarthritis, 39 (23%) 52 (30%) Prior bDMARD, 143 24(14%) Concomitant systemic steroids, 43 (25%) 42 MTX, 93 (54%) 133 (78%) Number active joints, 6.3 (6.9) 5.6 (4.8) CHAQ-DI, 0.61 (0.62) 0.63 JADAS-10, 14.6 (6.6) 14,6 (6.2) Month 12 3.5 (4.6) 3.8 (5.4) JADAS-MDA (≤6) -LOCF population 72.7% 77.4% JADAS-remission (≤2.7) 60.9% 57.9% 2.7 (3.6) 2.5 (2.6) 87.0% 85.2% 64.9% 69.1% Figure REFERENCES: NIL. Acknowledgements: Disclosure Interests Gerd Horneff Speakers bureau: Chugai, Pfizer, Novartis, Sobi, Grant/research support from: Roche, Angela Zimmer: None declared, Toni Hospach: Fraank Weller-Heinemann: Jasmin Kuemmerle-Deschner Maria Fasshauer: Kirsten Minden Ivan Foeldvari: Daniel Windschall: Markus Hufnagel: Dirk Foell Prasad Oommen: Ariane Klein: declared.