ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0217

Efficacy and Safety of Filgotinib in Methotrexate-Naïve Patients with Rheumatoid Arthritis: 52-Week Results

Rene Westhovens1, William F. C. Rigby2, Désirée van der Heijde3, Daniel W.T. Ching4, William Stohl5, Jonathan Kay6, Arvind Chopra7, Beatrix Bartok8, Franziska Matzkies8, Zhaoyu Yin8, Ying Guo9, Chantal Tasset10, John S. Sundy8, Angelika Jahreis8, Neelufar Mozaffarian11, Osvaldo Daniel Messina12, Robert Landewé13, Tatsuya Atsumi14 and Gerd Burmester15, 1University Hospitals Leuven, Belgium, Leuven, Belgium, 2Geisel School of Medicine at Dartmouth, Lebanon, NH, 3Leiden University Medical Center, Leiden, Netherlands, 4Timaru Hospital, Timaru, New Zealand, 5University of Southern California Keck School of Medicine, Los Angeles, CA, 6University of Massachusetts Medical School, Worcester, MA, 7Center for Rheumatic Diseases, Pune, India, 8Gilead Sciences, Inc., Foster City, CA, 9Gilead Sciences, Inc., Foster City, 10Galapagos NV, Mechelen, Belgium, 11Ichnos Sciences, Paramus, 12IRO Medical Ctr & Cosme Argerich Hospital, Buenos Aires, Argentina, 13Amsterdam University Medical Center & Zuyderland Hospital, Amsterdam, Netherlands, 14Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapparo, Hokkaido, Japan, 15Charité University Hospital Berlin, Berlin, Germany

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 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.

  1. Westhovens, et al. Ann Rheum Dis. 2019;78(Suppl2):259–60.

Disclosure: R. Westhovens, Celltrion, Inc., 2, 5, Galapagos NV, 2, 5, Gilead Sciences, Inc., 2, 5; W. Rigby, Gilead Sciences, Inc., 5; 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; D. Ching, AbbVie, 2, 5, 8, Gilead Sciences, Inc., 2, Pfizer, 2, 5, Sanofi, 2; W. Stohl, Gilead Sciences, Inc., 2, GlaxoSmithKline, 2, Janssen Research & Development, 5; J. Kay, Pfizer Inc., 9, Alvotech Suisse AG, 1, Arena Pharmaceuticals, Inc., 1, Boehringer Ingelheim GmbH, 1, Celltrion Healthcare Co. Ltd., 1, Mylan Inc., 5, Novartis AG, 5, Samsung Bioepis, 5, Sandoz Inc., 5, Gilead Sciences, Inc., 9; A. Chopra, None; B. Bartok, Gilead Sciences, Inc., 1, 3; F. Matzkies, Gilead Sciences, Inc., 1, 3; Z. Yin, 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; O. Messina, Amgen, 8, Americas Health Foundation, 8, Pfizer, 8; 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; T. Atsumi, AbbVie Inc., 5, 8, 9, UCB Japan Co.,Ltd., 5, 8, Eisai Co., Ltd., 8, Gilead Sciences, Inc., 5, 8, Bristol Myers Squibb Co., 2, 8, Chugai Pharmaceutical Co., Ltd., 2, 8, 9, Mitsubishi Tanabe Pharma Corporation, 8, 9, Eli Lilly Japan K.K., 2, 5, 8, Astellas Pharma Inc., 8, 9, Pfizer Inc., 2, 8, 9, Daiichi Sankyo Company, Limited, 5, 8, 9; G. Burmester, AbbVie, 5, 8, Pfizer, 5, 8, Gilead Sciences, Inc., 5, 8, Eli Lilly, 5, 8, Novartis, 5, Celgene, 5.

To cite this abstract in AMA style:

Westhovens R, Rigby W, van der Heijde D, Ching D, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy J, Jahreis A, Mozaffarian N, Messina O, Landewé R, Atsumi T, Burmester G. Efficacy and Safety of Filgotinib in Methotrexate-Naïve Patients with Rheumatoid Arthritis: 52-Week Results [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-filgotinib-in-methotrexate-naive-patients-with-rheumatoid-arthritis-52-week-results/. Accessed .

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