AB0493 THE EFFICACY AND SAFETY OF TOFACITINIB IN THE TREATMENT OF DMARDS NAIVE RHEUMATOID ARTHRITIS PATIENTS (EASTERN STUDY)

Background Janus kinase (JAK) inhibitor is a great addition to the therapeutic options for rheumatoid arthritis (RA). However, clinical efficacy and safety of tofacitinib comparing with methotrexate (MTX) was not elucidated. Objectives We conducted controlled randomized trial in treatment naive (RA) patients explore (TOFA) MTX. Methods In this open-label, randomized, trial, RA at status medium or high disease activity [simplified index (SDAI)>3.3] were 1:1 ratio into TOFA MTX groups. Patients group received 5 mg twice per day 10-15 once week plus betamethasone 1ml muscle injection enrollment. The rate improvement (defined as SDAI decreased >50% against baseline least 10) 12 taken primary outcome. who did achieve transferred other group. Secondary outcomes included rates remission, low (LDA) change scores. Results 100 enrolled study 49 51 much higher than [29.3% (12/41) vs 7.5% (3/40), p=0.025]. remission 4 comparable between two [17.9 (7.3-30.3) 10.8 (5.5-17.4), p=0.062], CDAI [7 (4.8-16) 15 (7.5-26), p=0.011], DAS28-CRP [2.1 (1.2-3.4) 1.4 (0.7-2.1), p=0.010] DAS28-ESR [3.8 (2.5-5.2) 2.7 (1.8-3.9), p=0.005] all more significant total adverse event [28% (14/50) % (4/49), p=0.022]. Considering specific events, liver damage [16% (8/50) 0, p=0.001] dizzy [6% (3/50) p=0.041] Conclusion For patients, can bring activity. References [1]Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations management synthetic biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-99. [2]Li Z, An Y, Su H, Li X, Xu J, Zheng Tofacitinib conventional drugs Chinese arthritis: Patient-reported from Phase 3 trial. Int J 2018;21(2):402-14. [3]Burmester Blanco R, Charles-Schoeman C, Wollenhaupt Zerbini Benda B, (CP-690,550) combination active an inadequate response tumour necrosis factor inhibitors: randomised phase Lancet. 2013;381(9865):451-60. [4]Cohen SB, Pope Haraoui Irazoque-Palazuelos F, Korkosz Diehl Methotrexate withdrawal modified-release 11 daily (ORAL Shift): randomised, 3b/4, non-inferiority Lancet Rheumatology. 2019;1(1):e23-e34. [5]Fleischmann Mease PJ, Schwartzman S, Hwang LJ, Soma K, Connell CA, Efficacy stratified by background dose Clin Rheumatol. 2017;36(1):15-24. [6]Fleischmann Mysler E, Hall Kivitz AJ, Moots RJ, Luo monotherapy, methotrexate, adalimumab Strategy): double-blind, head-to-head, 2017;390(10093):457-68. Acknowledgements Statistical Office Peking University First Hospital appreciated. acknowledged Fangfang Fan Xueying assistance statistics. Yuhang Liu, Xiaojun Meng physical examination, evaluation administration subjects. Disclosure Interests None Declared.