OP0261 TREAT-TO-TARGET DOSE REDUCTION AND WITHDRAWAL STRATEGY OF TNF INHIBITORS IN PSORIATIC ARTHRITIS AND AXIAL SPONDYLOARTHRITIS: A RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL

Background Tumour Necrosis Factor inhibitors (TNFi) are effective in Psoriatic Arthritis (PsA) and axial SpondyloArthritis (axSpA), but associated with a somewhat increased infection risk, patient burden, high costs. Treat-to-target (T2T) tapering might ameliorate these drawbacks, no quality T2T studies have been done PsA axSpA. Objectives To investigate whether strategy is non-inferior to without tapering. Methods We performed pragmatic open-label, monocenter, randomized, controlled non-inferiority (NI) trial on of TNFi. axSpA patients using TNFi ≥6 months stable low disease activity (LDA) were randomized or no-tapering strategy, ratio 2:1 followed-up for 12 months. LDA was defined as Disease Activity Score (PASDAS) ≤3.2 and/or Ankylosing Spondylitis (ASDAS) <2.1 judgement physician patient. Tapering consisted 3-monthly steps (66%, 50%, 0%), re-intensification case flare. Primary endpoint the difference proportion having at months, compared prespecified NI margin 20%. The primary Bayesian analysis adjusted stratification factors (diagnosis csDMARD use). Secondary endpoints included mean percentage Daily Defined Dose (%DDD) month %DDD. Other discontinuing their TNFi, cumulative incidence flares (change from baseline PASDAS≥0.8 ASDAS≥0.9), use concomitant medication (serious) adverse events. Results 122 (N=81 (PsA, N=42, axSpA, N=39); N=41 N=22, N=19)) (Table 1). Proportion group 69% 73%: 5% (Bayesian 95% credible interval: -10% 19%), confirming NI. %DDD respectively 53% 91% (Figure At 58 (72%) successfully tapered, whom 23 (28%) discontinued 85% 78% (p=0.32). Start escalation more frequent group, significantly so NSAID use: csDMARDs (only PsA): 1 (2%) vs. (5%) (p=0.64); NSAIDs: 44 (54%) 10 (24%) (p=0.002); glucocorticoids: 24 (30%) 7 (17%) (p=0.13). For serious events, similar results seen. risks grade 3/4 infections injection site reactions 46% 23% lower than group. Table 1. Baseline characteristics treated Characteristic ) (N=41 Diagnosis, n (% -Psoriatic arthritis 42(52%) 22(54%) -Axial spondyloarthritis 39(48%) 19(46%) Female, 28(35%) 20(49%) Age years inclusion, (SD 50(14) 52(15) duration years, median (IQR 11(5-21) 12(5-21) CASPAR Criteria, 34(81%) 17(77%) ASAS 35(90%) 17(89%) activity, -PASDAS - (64/64 -ASDAS (57/58 1.60(1.26) 1.34(0.87) 1.63(0.98) 1.21(0.61) Duration current bDMARD use, 2(1-6) 2(2-7) Current -Adalimumab 62(77%) 28(68%) -Etanercept 10(12%) 6(15%) -Certolizumab Pegol 2(2%) 1(2%) -Golimumab -Infliximab 5(6%) 5(12%) Figure Mean (A. C.) (B. D.) baseline, 3, 6, 9 12. Conclusion A regard still substantial reduction albeit slightly other medication. Acknowledgements thank all who willing participate this study rheumatologists Sint Maartenskliniek Nijmegen Woerden participation recruitment data collection; S.R. van de Plassche, A.H. Verkerk M. den Broeder collection entering; Roelofs, I. Cillessen, C. Kleinveld, Neste aiding coordination; D. Aggelen, Rotteveel, L. Schiersbergen laboratory implementation procedures; B.J.F. Bemt Flendrie being part safety monitoring board. Disclosure Interests Celia Michielsens: None declared, Nathan Broeder: Frank Hoogen: Elien Mahler: Steven Teerenstra: Désirée der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, L.M. Verhoef: Alfons Grant/research support from: Abbvie, Sanofi, Gilead