ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0208

Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Results

Bernard Combe1, Alan Kivitz2, Yoshiya Tanaka3, Désirée van der Heijde4, J-Abraham Simon-Campos5, Herbert S. Baraf6, Uma Kumar7, Franziska Matzkies8, Beatrix Bartok8, Lei Ye8, Ying Guo9, Chantal Tasset10, John S. Sundy8, Angelika Jahreis8, Neelufar Mozaffarian11, Robert Landewé12, Sang-Cheol Bae13, Edward C Keystone14 and Peter Nash15, 1University of Montpellier, Montpellier, France, 2Altoona Center for Clinical Research/Altoona Arthritis and Osteoporosis Center, Duncansville, PA, 3The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 4Leiden University Medical Center, Leiden, Netherlands, 5Köhler & Milstein Research, Mérida, Mexico, 6The Ctr for Rheumatology and Bone Research, Wheaton, MD, 7All India Institute of Medical Sciences, New Delhi, India, 8Gilead Sciences, Inc., Foster City, CA, 9Gilead Sciences, Inc., Foster City, 10Galapagos NV, Mechelen, Belgium, 11Ichnos Sciences, Paramus, 12Amsterdam University Medical Center & Zuyderland Hospital, Amsterdam, Netherlands, 13Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 14Mount Sinai Hospital, Toronto, ON, Canada, 15School of Medicine Griffith University, Brisbane, Queensland, Australia

Meeting: ACR Convergence 2020

Keywords: ,

Session Information

Date: Friday, November 6, 2020

Title: RA – Treatments Poster I: RA Treatments & Their Safety

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy and safety in patients (pts) with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR); primary outcome results at week (W)12 and W24 were previously reported.1 This analysis presents results from the FINCH 1 study through 52 weeks.

Methods: This global, phase 3, double-blind, active- and placebo (PBO)-controlled study randomized 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 rerandomized to FIL 100 or 200 mg. Efficacy was assessed using clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity, and nominal p-values are reported. Safety endpoints included types and rates of 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) (Figure 1, Table 1). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments (Table 2).

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.

  1. Combe et al., Ann Rheum Dis. 2019; 78 (Suppl 2):77–8.

Disclosure: B. Combe, AbbVie, 5, 8, Janssen, 5, Eli Lilly, 2, 5, 8, Novartis, 2, Gilead Sciences, Inc., 5, 8, Roche-Chugai, 5, 8, Sanofi, 5, Pfizer, 2, 8, MSD, 8, Bristol-Myers Squibb, 8; A. Kivitz, Sanofi, 1, 5, 8, Amgen, 1, Gilead, 1, AbbVie, 5, Genzyme, 5, 8, Janssen, 5, Novartis, 8, Regeneron, 5, 8, Boehringer Ingelheim, 5, Celgene, 8, Flexion, 8, Horizon, 8, Merck, 8, Pfizer, 1, 5, 8, Sun Pharma, 5, UCB, 5; Y. Tanaka, AbbVie, 2, 5, 8, UCB, 2, 5, 8, Sanofi, 2, 5, 8, Asahi-kasei, 2, 5, 8, Novartis, 2, 5, 8, GlaxoSmithKline, 2, 5, 8, Astellas, 2, 5, 8, Chugai, 2, 5, 8, Daiichi-Sankyo, 2, 5, 8, Eisai, 2, 5, 8, Eli Lilly, 2, 5, 8, Gilead Sciences, Inc., 2, 5, 8, Janssen, 2, 5, 8, Mitsubishi-Tanabe, 2, 5, 8, Pfizer, 2, 5, 8, Takeda, 2, 5, 8, YL Biologics, 2, 5, 8, Bristol-Myers Squibb, 2, 5, 8; D. van der Heijde, AbbVie, 5, Bristol-Myers Squibb, 5, Cyxone, 5, Galapagos NV, 5, Gilead Sciences, Inc., 5, GlaxoSmithKline, 5, Eli Lilly, 5, Novartis, 5, Pfizer, 5, UCB Pharma, 5, Amgen Inc., 5, Astellas, 5, AstraZeneca, 5, Boehringer Ingelheim, 5, Celgene, 5, Daiichi-Sankyo, 5, Janssen, 5, Merck, 5, Regeneron, 5, Roche, 5, Sanofi, 5, Takeda, 5, Imaging Rheumatology bv, 3, Eisai, 5; J. Simon-Campos, None; H. Baraf, AbbVie, 2, 8, Horizon, 2, 8, Gilead Sciences, Inc., 2, 8, Pfizer, 2, 8, Janssen, 2, 8, Merck, 2, 8; U. Kumar, None; F. Matzkies, Gilead Sciences, Inc., 1, 3; B. Bartok, Gilead Sciences, Inc., 1, 3; L. Ye, Gilead Sciences, Inc., 1, 3; Y. Guo, Gilead Sciences, Inc., 1, 3; C. Tasset, Galapagos, 1, 3; J. Sundy, Gilead Sciences, Inc., 1, 9; A. Jahreis, Gilead Sciences, Inc., 1, 3; N. Mozaffarian, Gilead Sciences, Inc., 1, 3; R. Landewé, AbbVie, 2, 5, 8, AstraZeneca, 5, Bristol-Myers Squibb, 5, 8, Eli Lilly, 5, Galapagos, 5, Novartis, 5, Pfizer Inc, 2, 5, 8, UCB, 2, 5, 8, GlaxoSmithKline, 5, Janssen, 2, 5, 8, Merck, 5, 8, Rheumatology Consultancy BV, 1, Ablynx, 5, Amgen, 2, 5, 8, Celgene, 5, Gilead, 5, Novo Nordisk, 5, Roche, 2, 5, 8, Schering, 2, 5, 8, TiGenix, 5; S. Bae, None; E. Keystone, AbbVie, 2, 5, 8, Celltrion, 2, 5, 8, Eli Lilly, 2, 5, 8, Pfizer Inc, 2, 5, 8, Merck, 2, 5, 8, Sandoz, 2, 5, 8, Samsung Bioepsis, 2, 5, 8, Myriad Autoimmune, 2, 5, 8, Purapharm, 2, 5, 8, Janssen, 2, 5, 8, Sanofi-Genzyme, 2, 5, 8, Amgen, 2, 5, 8, AstraZeneca, 2, 5, 8, Bristol-Myers Squibb, 2, 5, 8, F. Hoffman-La Roche Ltd., 2, 5, 8, Genentech, 2, 5, 8, Gilead, 2, 5, 8, UCB, 2, 5, 8; P. Nash, AbbVie, 2, 5, 8, Bristol Myers Squibb, 2, 5, 8, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Janssen, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Sanofi, 2, 5, 8, UCB, 2, 5, 8.

To cite this abstract in AMA style:

Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon-Campos J, Baraf H, Kumar U, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy J, Jahreis A, Mozaffarian N, Landewé R, Bae S, Keystone E, Nash P. Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Results [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-filgotinib-for-patients-with-rheumatoid-arthritis-with-inadequate-response-to-methotrexate-52-week-results/. Accessed .

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