POS0664 A MULTICENTER RANDOMIZED STUDY IN RHEUMATOID ARTHRITIS TO COMPARE IGURATIMOD, METHOTREXATE, OR COMBINATION: 52 WEEK EFFICACY AND SAFETY RESULTS OF THE SMILE TRIAL

Background: Iguratimod (IGU) has demonstrated efficacy and safety for active rheumatoid arthritis (RA) patients in double-blind clinical trials China Japan as a new disease-modifying anti-rheumatic drug (DMARD). There are no studies evaluating the radiographic progression of structural joint damage IGU treatment RA using mTSS primary endpoint. Objectives: Our study was to evaluate monotherapy combined methotrexate (MTX) compared with MTX monotherapy, including inhibitory effects destruction. Methods: This randomized, double-blind, parallel-controlled, multicenter who have not previously used biological DMARDs (bDMARDs) (ClinicalTrials.gov Identifier NCT01548001 ) carried out China. Patients were randomized 1:1:1 receive 25 mg twice day (bid), 10mg once week(qw) first 4 weeks 15 week 5 52, or (IGU+MTX) 52 weeks. The endpoints assess compare American College Rheumatology 20% (ACR20) response change modified total Sharp scoring (mTSS) score over (Intention-to-treat, ITT analysis). non-inferiority test analyze difference ACR20 at between arms, limit value 10%. comparison IGU+MTX arms. Two-way ANOVA changes each arm baseline (0 week). Results: A 895 25mg bid (n =297), 10-15mg qw(n=293), (n=305). Baseline characteristics comparable arms (Table 1). Table 1. Demographic Other Characteristics (SAS) Number Subjects 297 293 305 Age, mean (SD) years 46.87(10.67) 47.63(10.70) 48.37(10.69) Female/male, % 77.44/22.56 79.18/20.82 78.03/21.97 Duration RA, mean(SD) 11.67±7.16 11.60±7.98 11.67±7.27 CRP, mg/L 2 22.32±35.47 20.67±26.61 19.74±31.38 Tender count, 14.59±9.16 14.83±9.30 14.93±9.88 Swollen 9.81±6.63 9.73±7.20 9.51±6.22 DAS28-CRP, 5.084±0.994 5.102±0.979 5.103±0.956 HAQ score, 15.82±11.25 15.24±10.93 16.06±10.92 SAS: Safety Analysis Set; CRP: C-reactive protein; DAS28: disease activity score; HAQ: Health Assessment Questionnaire met its endpoints. More concretely, found be superior higher 77.44%(230/297, P=0.0019) 77.05%(235/305, P=0.0028) versus 65.87%(193/293) (fig As shown fig 1, remission (ΔmTSS≤0.5) statistically significant (57.4%, P=0.0308) but (55%) (47.8%). Overall incidence adverse events (AEs) leading discontinuation reported 13.8% (41/297) arm, 11.26% (33/293) 11.51% (35/305) arm. reactions (ADR) 11.45% (34/297), 8.53% (25/293) 9.21% (28/305), respectively. one death all indicators among three Conclusion: alone combination acceptable bDMARDs. Disclosure Interests: None declared