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

Autor: C. Michielsens, N. den Broeder, F. van den Hoogen, E. Mahler, S. Teerenstra, D. van der Heijde, L. M. Verhoef, A. den Broeder
Rok vydání: 2022
Předmět:
Zdroj: Annals of the Rheumatic Diseases. 81:172-173
ISSN: 1468-2060
0003-4967
DOI: 10.1136/annrheumdis-2022-eular.1430
Popis: BackgroundTumour Necrosis Factor inhibitors (TNFi) are effective in Psoriatic Arthritis (PsA) and axial SpondyloArthritis (axSpA), but are associated with a somewhat increased infection risk, patient burden, and high costs. Treat-to-target (T2T) tapering might ameliorate these drawbacks, but no high quality T2T tapering studies have been done in PsA and axSpA.ObjectivesTo investigate whether a T2T strategy with tapering is non-inferior to a T2T strategy without tapering.MethodsWe performed a pragmatic open-label, monocenter, randomized, controlled non-inferiority (NI) trial on T2T tapering of TNFi. PsA and axSpA patients using a TNFi with ≥6 months stable low disease activity (LDA) were randomized to a T2T tapering or no-tapering strategy, in a ratio of 2:1 and followed-up for 12 months. LDA was defined as a Psoriatic Arthritis Disease Activity Score (PASDAS) ≤3.2 for PsA and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) Results122 patients were included (N=81 tapering (PsA, N=42, axSpA, N=39); N=41 no-tapering (PsA, N=22, axSpA, N=19)) (Table 1). Proportion of patients in LDA at 12 months for the tapering and no-tapering group was 69% and 73%: adjusted difference 5% (Bayesian 95% credible interval: -10% to 19%), confirming NI. The mean percentage %DDD was respectively 53% and 91% at month 12 (Figure 1). At 12 months, 58 (72%) patients of the tapering group were successfully tapered, of whom 23 (28%) discontinued their TNFi. The cumulative incidence of flares was 85% in the tapering and 78% in the no-tapering group (p=0.32). Start or escalation of concomitant medication was more frequent in the tapering group, significantly so for NSAID use: csDMARDs (only for PsA): 1 (2%) vs. 1 (5%) (p=0.64); NSAIDs: 44 (54%) vs. 10 (24%) (p=0.002); glucocorticoids: 24 (30%) vs. 7 (17%) (p=0.13). For serious adverse events, similar results were seen. The risks of grade 3/4 infections and injection site reactions were respectively 46% and 23% lower in the tapering group than the no-tapering group.Table 1.Baseline characteristics of T2T strategy treated PsA and axSpA patients with or without tapering.CharacteristicT2T with tapering (N=81)T2T without tapering (N=41)Diagnosis, n (%)-Psoriatic arthritis42(52%)22(54%)-Axial spondyloarthritis39(48%)19(46%)Female, n (%)28(35%)20(49%)Age in years at inclusion, mean (SD)50(14)52(15)Disease duration at inclusion, years, median (IQR)11(5-21)12(5-21)CASPAR Criteria, n (%)34(81%)17(77%)ASAS Criteria, n (%)35(90%)17(89%)Disease activity, mean (SD)-PASDAS - (64/64 PsA)-ASDAS - (57/58 axSpA)1.60(1.26) 1.34(0.87)1.63(0.98) 1.21(0.61)Duration of current bDMARD use, years, median (IQR)2(1-6)2(2-7)Current bDMARD use, n (%)-Adalimumab62(77%)28(68%)-Etanercept10(12%)6(15%)-Certolizumab Pegol2(2%)1(2%)-Golimumab2(2%)1(2%)-Infliximab5(6%)5(12%)Figure 1.Mean disease activity and %DDD of T2T strategy treated PsA (A. and C.) and axSpA (B. and D.) patients with or without tapering at baseline, 3, 6, 9 and 12.ConclusionA T2T TNFi tapering strategy is non-inferior to a T2T strategy without tapering with regard to the proportion of patients still in LDA at 12 months and results in a substantial reduction of TNFi use, albeit with slightly more use of other medication.AcknowledgementsWe thank all the patients who were willing to participate in this study and the rheumatologists in the Sint Maartenskliniek Nijmegen and Woerden for participation in patient recruitment and data collection; S.R. van de Plassche, A.H. Verkerk and M. den Broeder for data collection and entering; M. Roelofs, I. Cillessen, C. Kleinveld, I. van Neste for aiding with study coordination; D. van Aggelen, D. Rotteveel, L. Schiersbergen for aiding with laboratory implementation and procedures; B.J.F. van de Bemt and M. Flendrie for being part of the data safety monitoring board.Disclosure of InterestsCelia Michielsens: None declared, Nathan den Broeder: None declared, Frank van den Hoogen: None declared, Elien Mahler: None declared, Steven Teerenstra: None declared, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, L.M. Verhoef: None declared, Alfons den Broeder Grant/research support from: Abbvie, Galapagos, Pfizer, Novartis, Lilly, Sanofi, Gilead
Databáze: OpenAIRE
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