OA29 Clinical outcomes up to week 48 of filgotinib treatment in an ongoing long-term extension trial of RA patients with inadequate response to methotrexate initially treated with filgotinib or adalimumab during the Phase 3 Parent Trial

Abstract Background/Aims The preferential Janus kinase (JAK)-1 inhibitor filgotinib (FIL) is approved for treatment of moderately to severely active RA in Europe and Japan. We assessed efficacy and safety of FIL in patients (pts) with inadequate response to MTX (MTX-IR) who completed a Phase 3 trial (NCT02889796) and went on to enroll in a long-term extension (LTE; NCT03025308). Methods Pts who completed the parent study (PS) on study drug were eligible to enter the LTE. LTE data cutoff was June 1, 2020, and safety data are reported to that date, with median exposure 2.2 years. Efficacy data to W48 are reported for 4 treatment groups (all with background MTX): pts who received FIL 200mg (FIL200) or FIL 100mg (FIL100) in the PS and continued their dose in LTE (FIL200/FIL200, FIL100/FIL100) and ADA pts who were re-randomized, double blind, to FIL200 or FIL100 for LTE (ADA/FIL200, ADA/FIL100). ACR20/50/70 response rates, DAS28[CRP] ≤3.2 and