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

Abstract

Background/Purpose: Filgotinib (FIL) is an oral, 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.1 These analyses report FINCH 3 (NCT02886728) results through W52. Methods: This global, phase 3, double‐blind, active‐controlled study randomized 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 and Figure). Safety was consistent with W24 data (Table 2). Conclusion: Efficacy of FIL 200 mg + MTX, FIL 100 mg + MTX, and FIL 200 mg mono was sustained through W52, with faster onset1 and consistently numerically greater efficacy for FIL 200 vs 100 mg. No new safety signals were observed.