POS0830 BARICITINIB VERSUS TNF-INHIBITORS IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO CSDMARDS: 12 WEEKS RESULTS OF A PRAGMATIC, MULTICENTER, OPEN LABEL, NONINFERIORITY TRIAL

Background The EULAR guidelines for RA recommend that treatment should be aimed at reaching a predefined disease activity target (T2T). If this is not achieved with csDMARD, adding TNFi or JAK-inhibitor are advised options in patients poor prognostic factor, obviously considering contraindications. While randomized clinical trials have provided relevant data on the relative efficacy and safety of JAKi under ideal conditions, extent to which such results can generalized real-life practice conditions remains unclear. Objectives To demonstrate non-inferiority (NI) and, case NI could shown, subsequent superiority T2T strategy csDMARDs refractory subsequently treated baricitinib versus TNFi. Methods Biologic targeted synthetic DMARD-naïve failing respond were eligible if they pretreated according principles, had duration <5 years no contraindications b/tsDMARD. All included open label discretion their attending rheumatologist either (any type) baricitinib. Patients seen baseline 12-weekly until final follow-up (48 weeks). Full assessment was performed each visit. Self-report questionnaires, including PROMs, collected as well. primary endpoint defined proportion achieving ACR50 response week 12, testing shown. For analysis, compared, using 95% confidence intervals calculated Wilson score method. margin set -12%. Results 199 who received first dose (102) (97) included. Baseline characteristics comparable between both groups (see Table 1). At 12 weeks, lower bound interval difference proportions meeting right zero per-protocol intention-to-treat analysis Figure Hence, found non-inferior statistically superior endpoint. Moreover, DAS28 remission (DAS28-CRP <0.6) 74% compared 46% (p<0.001) weeks. Conclusion Baricitinib terms weeks real-world csDMARD patients. Analysis secondary endpoints, across other measurement points, radiology, costs currently ongoing. 1. p N=102 N=97 Age 55.2 (13.4) 54.8 (12.0) 0.833 Gender 0.796 F 68 (66.7%) 62 (63.9%) M 34 (33.3%) 35 (36.1%) Smoking 0.963 never 38 (37.3%) 37 (38.9%) Stopped 39 (38.2%) 36 (37.9%) Yes 25 (24.5%) 22 (23.2%) BMI 27.5 (4.91) 26.5 (5.03) 0.178 Disease (years) 2.00 [1.00;3.00] 0.766 Erosions 0.537 No 71 (69.6%) 74 (76.3%) Unknown (11.8%) 10 (10.3%) 19 (18.6%) 13 (13.4%) CV 0.432 (72.5%) 76 (78.4%) 28 (27.5%) 21 (21.6%) RF 0.576 Neg 33 (32.4%) 27 (27.8%) Pos 67 (65.7%) 66 (68.0%) 2 (1.96%) 4 (4.12%) ACCP 0.262 (36.3%) 65 (63.7%) 70 (72.2%) MTX 1 31 (30.4%) 30 (30.9%) (69.1%) DAS28ESR 4.41 (1.06) 4.43 (1.14) 0.919 DAS28CRP 4.17 (1.02) 4.12 (1.07) 0.741 TJC28 4.00 [2.00;7.00] 0.662 SJC28 3.00 [1.00;5.00] [2.00;4.00] 0.805 BSE 24.0 (19.7) 25.0 (22.1) 0.738 CRP 13.7 (19.1) 12.8 (17.6) 0.728 HAQ 12.2 (5.66) 10.9 (6.35) 0.13 SDAI 21.2 (8.97) 21.1 (9.00) 0.933 REFERENCES: NIL. Acknowledgements: Disclosure Interests Martjin Oude Voshaar: None declared, Peter ten Klooster: Danyta Tedjo: Celine van de Laar: Mart Laar Speakers bureau: Eli Lilly Company, Grant/research support from: Company.