SAT0373 EFFECT OF FILGOTINIB ON PATIENT-REPORTED OUTCOMES IN ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM EQUATOR, A RANDOMIZED, PHASE 2 STUDY

Abstract

Background: Filgotinib (FIL) is an oral, selective Janus kinase 1 inhibitor under clinical investigation in a number of inflammatory diseases. FIL significantly improved multiple disease domains vs placebo (PBO) in patients with active psoriatic arthritis (PsA) in the multicenter, double-blind, phase 2 EQUATOR trial (NCT03101670) [1]. Objectives: To evaluate the effect of FIL vs PBO on patient reported outcomes (PROs) in EQUATOR and the extent to which effects on composite disease endpoints translate to clinically relevant improvements for patients. Methods: Patients were randomized 1:1 to FIL 200 mg or PBO once daily for 16 weeks [1]. Patient’s Global Assessment of Disease Activity (PtGADA), pain intensity (visual analog scale), Pruritus Numerical Rating Scale (NRS), Health Assessment Questionnaire Disability Index (HAQ-DI), 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS), and Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F) were assessed at week 16. Analysis of covariance was used to compare changes from baseline in outcomes between groups. Proportions of patients achieving normative PRO scores or minimal clinically important differences (MCIDs) were compared using Cochran-Mantel-Haenszel tests [2, 3]. Results: FIL significantly improved multiple PROs vs PBO at week 16 (Table). Proportions of patients reaching normative PRO values for FACIT-F and SF-36 PCS (=40 or 50, respectively), and achieving MCIDs in HAQ-DI and SF 36 PCS, were significantly greater for FIL vs PBO (Table). Significant improvement in 6/8 SF 36 domains was observed at week 16 with FIL vs PBO (Fig a). Improvement in most individual FACIT F items was also observed (Fig b). Conclusion: In EQUATOR, FIL-treated patients with active PsA reported greater and clinically meaningful improvements in most PROs at week 16 vs PBO, mirroring improvements previously reported with FIL in disease activity measures [1].