SAT0427 COMPARATIVE EFFECTIVENESS OF TOFACITINIB (TF) AND ADALIMUMAB (ADA) IN PSORIATIC ARTHRITIS (PsA) PATIENTS IN REAL CLINICAL PRACTICE.

Abstract

Background: Tofacitinib (TF) is an oral Janus kinase inhibitor approved for PsA treatment. It has demonstrated comparable to ADA efficacy in RCT in reducing PsA clinical symptoms 1,2. There is currently no data concerning comparative effectiveness of TF and ADA in clinical practice. The Russian PsA RegisTry (RU-PsART) collected data from 43 rheumatology centers of the Russian Federation. Objectives: to study responses to TF or ADA over a period of 6 months (mo) treatment in patients (pts) with active PsA in real clinical practice. Methods: 77 (M/F=43/34) PsA pts fulfilling the CASPAR criteria from the RU-PsART cohort were divided into two groups according to the treatment given. 41pts (M/F=24 (58.5%)/17 (41.5%), mean age 42.4±10,3 years (yrs), median (Me) PsA duration 72 [35;120] mo were treated with TF 5 mg twice daily. 36 pts (M/F=19 (52.8%)/17 (47.2%), mean age 44±11.5 yrs, Me PsA duration 59 [22;102] mo were treated with ADA 40 mg/2 weeks, subcutaneous, as a first-line bDMARD. In TF/ADA groups 89%/52.8% pts accordingly were given combination therapy with Methotrexate (MTX). At baseline (BL) and at 6 mo of therapy PsA activity by DAPSA, BASDAI, the number of pts (NPts) with dactylitis, enthesitis by LEI, BSA, HAQ were evaluated in both groups. At 6 mo of therapy the NPts who achieved remission by DAPSA (≤4)/Low activity (LA)≤14) and Minimal disease activity (MDA, 5 of 7) were calculated in both groups. M±SD, Me [Q25; Q75], Min-Max, %, t-test, Pierson-χ2, Manna-Whitney, Wilcoxon tests were performed. All p<0.05, were considered to indicate statistical significance. Results: At BL TF pts had higher PsA activity by DAPSA compared to ADA group: 44.2[37.8; 55.3]/35.8 [21.1; 52] accordingly (p=0.03). At 6 mo of treatment DAPSA significantly decreased in TF/ADA groups-to 11 [4,3; 17,3]/9,1[6; 19,6] (p<0,001) accordingly. At 6 mo of therapy there were no significant differences between groups in achieving MDA, DAPSA LA/Remission (table 1). At 6 mo of treatment in TF-treated group the NPts with dactylitis significantly decreased from 22 (53,7%) to 5 (13,2%) pts (p<0.001), and in ADA-treated group no significant differences were found in NPts with dactylitis [despite a quantitative decrease from 13 (36,1%) to 6 (20%) pts (p=0.15)]. The NPts with enthesitis in both TF/ ADA groups decreased significantly: from 27 (69,2%) to 12 (30,8%) (p<0,002) and from 16 (72,7%) to 5 (38,5%) (p<0.046) pts accordingly. In TF/ADA-treated pts BASDAI improved from 6 [4.2;7] to 1.4 [0.6; 3.2] (p<0.001)/from 4.4 [1.9;5.8] to 3 [0.8;4.5] accordingly (p<0.046); HAQ significantly decreased from 1 [0.625;1.5] to 0,5 [0; 0.875] and from 0.875 [0.5;1.38] to 0.5 [0; 0.875] accordingly. The NPts with BSA>3% significantly reduced in the TF group: from 20 (51,3%) to 8 (26,7%) pts (p<0,002), but not in the ADA group. Conclusion: In real clinical practice TF and ADA demonstrated comparable effectiveness in all clinical domains of active PsA and showed equal result in achievement of MDA/LA/Remission according to DAPSA.