SAT0158 EFFICACY AND SAFETY OF FILGOTINIB IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS: FINCH 3 52-WEEK RESULTS

Abstract

Background:Filgotinib (FIL) is a potent, selective JAK 1 inhibitor. FINCH 3 assessed FIL efficacy and safety in methotrexate (MTX)-naïve patients (pts) with rheumatoid arthritis (RA); week (W)24 primary outcome results were previously presented.1Objectives:To report FINCH 3 (NCT02886728) results through W52.Methods:This global, phase 3, double-blind, active-controlled study randomised MTX-naïve pts with moderately to severely active RA 2:1:1:2 to oral FIL 200 mg once daily + MTX ≤20 mg weekly, FIL 100 mg + MTX, FIL 200 mg monotherapy (mono) + placebo (PBO), or PBO + MTX up to W52. Comparisons at W52 were not adjusted for multiplicity. Safety was assessed from adverse events and laboratory abnormalities.Results:Of 1249 treated pts, 975 received study drug through W52. FIL efficacy was sustained up to W52. Treatment with FIL + MTX or FIL mono increased proportions of pts achieving ACR20/50/70 and clinical disease remission by DAS28(CRP) <2.6 (FIL 200 mg + MTX, 53%; FIL mono, 46%), CDAI, SDAI, and Boolean criteria; improved HAQ-DI; and halted radiographic progression vs MTX alone (Table 1 andFigure). Safety was consistent with W24 data (Table 2).Table 1.Efficacy outcomes at week 52FIL 200 mg + MTX (n = 416)FIL 100 mg + MTX (n = 207)FIL 200 mg(n = 210)MTX(n = 416)ACR20, %75.0***73.4**74.8***61.8ACR50, %62.3***59.4**61.4**48.3ACR70, %47.8***40.1*45.2***29.8mTSSa0.21***0.27*0.23**0.74HAQ-DIb−1.00***−0.97−0.95*−0.88aLeast-squares mean change from baseline.bMean change from baseline.*, p <0.05;**, p <0.01;***, p <0.001 vs MTX alone; not adjusted for multiplicity.FIL, filgotinib; mTSS, van der Heijde modified total Sharp score; MTX, methotrexate.Table 2.Safety outcomes through week 52Event, n (%)FIL 200 mg + MTX(n = 416)FIL 100 mg + MTX(n = 207)FIL 200 mg(n = 210)MTX(n = 416)All AEs318 (76.4)164 (79.2)143 (68.1)305 (73.3)Serious AEs26 (6.3)13 (6.3)17 (8.1)28 (6.7)Infection148 (35.6)76 (36.7)75 (35.7)157 (37.7)Serious infection5 (1.2)3 (1.4)5 (2.4)8 (1.9)Herpes zoster6 (1.4)3 (1.4)4 (1.9)4 (1.0)VTE0004 (1.0)MACE (adjudicated)4 (1.0)1 (0.5)2 (1.0)2 (0.5)Malignancya1 (0.2)004 (1.0)NMSC2 (0.5)001 (0.2)Death3 (0.7)b1 (0.5)c00aExcluding NMSC.b1 lupus cardiomyopathy, 1 atypical interstitial pneumonia, 1 non–treatment-emergent cardiovascular death.cDissecting cerebral and vertebral aneurysm.AE, adverse event; FIL, filgotinib; MACE, major adverse cardiovascular event; MTX, methotrexate; NMSC, nonmelanoma skin cancer; VTE, venous thromboembolism.Conclusion:Efficacy of FIL 200 mg + MTX, FIL 100 mg + MTX, and FIL 200 mg mono was sustained through W52, with faster onset1and consistently numerically greater efficacy for FIL 200 vs 100 mg. No new safety signals were observed.