Bernard G Combe1,2, Yoshiya Tanaka3, Maya H Buch4, Peter Nash5, Gerd R Burmester6, Alan J Kivitz7, Beatrix Bartok8, Alena Pechonkina8, Katrina Xia8, Kahaku Emoto9, Shungo Kano9, Thijs K Hendrikx10, Robert B M Landewé11, Daniel Aletaha12. 1. Montpellier University, Montpellier, France. b-combe@chu-montpellier.fr. 2. Rheumatology Department, Lapeyronie Hospital, Montpellier University, 34295, Montpellier Cedex 5, France. b-combe@chu-montpellier.fr. 3. The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. 4. NIHR Manchester Biomedical Research Centre, University of Manchester, Manchester, UK. 5. Griffith University of Queensland, Brisbane, Australia. 6. Charité University Hospital Berlin, Berlin, Germany. 7. Altoona Center for Clinical Research, Duncansville, PA, USA. 8. Gilead Sciences, Inc., Foster City, CA, USA. 9. Gilead Sciences K.K., Tokyo, Japan. 10. Galapagos NV, Mechelen, Belgium. 11. Amsterdam Rheumatology and Clinical Immunology Center (amC) and Zuyderland MC, Heerlen, The Netherlands. 12. Medical University of Vienna, Vienna, Austria.
Abstract
INTRODUCTION: This exploratory analysis of FINCH 1 (NCT02889796) examined filgotinib (FIL) efficacy and safety in a subgroup of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX; MTX-IR) who had four poor prognostic factors (PPFs). METHODS: Patients with MTX-IR received placebo up to week (W)24 or FIL200 mg, FIL100 mg, or adalimumab up to W52; all received MTX. Efficacy and safety data were stratified by four PPFs versus fewer than four PPFs: seropositivity, high-sensitivity C-reactive protein (CRP) ≥ 6 mg/L, Disease Activity Score in 28 joints with CRP > 5.1, and erosions on X-rays. RESULTS: At baseline, 687/1755 patients had four PPFs. At W12, whether with four PPFs or fewer than four PPFs, response rates on all American College of Rheumatology (ACR) measures were significantly greater with FIL200 and FIL100 versus placebo. At W52, FIL200 ACR20/50/70 response rates remained at least numerically higher versus adalimumab in both subgroups. At W52, FIL200 reduced modified total Sharp score (mTSS) change versus adalimumab in patients with four or fewer than four PPFs. CONCLUSIONS: In high-risk (four PPFs) patients with MTX-IR RA, FIL200 and FIL100 showed similar reductions in disease activity versus placebo at W12 as in patients with fewer than four PPFs. mTSS in patients receiving FIL200 changed little from W24 to W52, while that in patients receiving FIL100 progressed comparably to patients who received adalimumab. Tolerability was comparable across treatment arms and subgroups.
INTRODUCTION: This exploratory analysis of FINCH 1 (NCT02889796) examined filgotinib (FIL) efficacy and safety in a subgroup of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX; MTX-IR) who had four poor prognostic factors (PPFs). METHODS: Patients with MTX-IR received placebo up to week (W)24 or FIL200 mg, FIL100 mg, or adalimumab up to W52; all received MTX. Efficacy and safety data were stratified by four PPFs versus fewer than four PPFs: seropositivity, high-sensitivity C-reactive protein (CRP) ≥ 6 mg/L, Disease Activity Score in 28 joints with CRP > 5.1, and erosions on X-rays. RESULTS: At baseline, 687/1755 patients had four PPFs. At W12, whether with four PPFs or fewer than four PPFs, response rates on all American College of Rheumatology (ACR) measures were significantly greater with FIL200 and FIL100 versus placebo. At W52, FIL200 ACR20/50/70 response rates remained at least numerically higher versus adalimumab in both subgroups. At W52, FIL200 reduced modified total Sharp score (mTSS) change versus adalimumab in patients with four or fewer than four PPFs. CONCLUSIONS: In high-risk (four PPFs) patients with MTX-IR RA, FIL200 and FIL100 showed similar reductions in disease activity versus placebo at W12 as in patients with fewer than four PPFs. mTSS in patients receiving FIL200 changed little from W24 to W52, while that in patients receiving FIL100 progressed comparably to patients who received adalimumab. Tolerability was comparable across treatment arms and subgroups.
Authors: Veerle Stouten; René Westhovens; Sofia Pazmino; Diederik De Cock; Kristien Van der Elst; Johan Joly; Delphine Bertrand; Patrick Verschueren Journal: Ann Rheum Dis Date: 2021-06-30 Impact factor: 19.103