THU0198 EFFICACY AND SAFETY OF FILGOTINIB FOR PATIENTS WITH RHEUMATOID ARTHRITIS WITH INADEQUATE RESPONSE TO METHOTREXATE: FINCH 1 52-WEEK RESULTS

Abstract

Background:Filgotinib (FIL) is an oral, potent, selective JAK1 inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy and safety in patients (pts) with rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX-IR); primary outcome results at week (W)12 and W24 were previously reported.1Objectives:To present FINCH 1 W52 results.Methods:This global, phase 3, double-blind, active- and placebo (PBO)-controlled study randomised MTX-IR pts with active RA on a background of stable MTX 3:3:2:3 to oral FIL 200 mg or FIL 100 mg once daily, subcutaneous adalimumab (ADA) 40 mg every 2W, or PBO up to W52; pts receiving PBO at W24 were rerandomised to FIL 100 or 200 mg. Efficacy was assessed from clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity. Safety endpoints included adverse events (AEs) and laboratory abnormalities.Results:Of 1755 treated pts, 1417 received study drug through W52. The majority (81.8%) were female, mean (standard deviation [SD]) RA duration was 7.8 (7.6) years, and baseline mean (SD) DAS28(CRP) was 5.7 (0.9). FIL efficacy was sustained through W52; 54%, 43%, and 46% of pts receiving FIL 200 and 100 mg and ADA, respectively, had W52 DAS28(CRP) <2.6 (nominal p for FIL 200 vs ADA = 0.024) (Figures 1–2, Table 1). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments (Table 2); 82 pts (4.7%) discontinued treatment due to AEs.Table 1.Efficacy outcomes at week 52FIL 200 mg(n = 475)FIL 100 mg(n = 480)ADA(n = 325)ACR20/50/70, %78/62/4476/59/3874/59/39DAS28(CRP) ≤3.2, %66+5959mTSSa0.18+++0.450.61HAQ-DIb−0.93+−0.85−0.85SF-36 PCSb12.011.512.4FACIT-Fb11.912.211.7aLeast squares mean change from baseline.bMean change from baseline.+p <0.05,+++p <0.001 vs ADA; not adjusted for multiplicity.ADA, adalimumab; FIL, filgotinib; mTSS, modified van der Heijde TSS.Table 2.Treatment-emergent AEs through week 52Event, n (%)FIL 200(n = 475)FIL 100 mg(n = 480)ADA(n = 325)All AEs352 (74.1)350 (72.9)239 (73.5)Serious AEs35 (7.4)40 (8.3)22 (6.8)Infection206 (43.4)194 (40.4)129 (39.7)Serious infection13 (2.7)13 (2.7)10 (3.1)Herpes zoster6 (1.3)4 (0.8)2 (0.6)VTE1 (0.2)01 (0.3)MACE (adjudicated)02 (0.4)1 (0.3)Malignancy (excluding NMSC)2 (0.4)2 (0.4)2 (0.6)NMSC1 (0.2)1 (0.2)0Death3 (0.6)1 (0.2)1 (0.3)Data omitted for patients rerandomised from placebo to FIL.ADA, adalimumab; AE, adverse event; FIL, filgotinib; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; VTE, venous thromboembolism.Conclusion:Through W52, both FIL 200 and 100 mg showed sustained efficacy based on clinical and pt-reported outcomes and radiographic progression and were well tolerated in MTX-IR pts with RA, with faster onset and numerically greater efficacy for FIL 200 vs 100 mg.