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Abstract Number: 506

Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: FINCH1 Primary Outcome Results

Bernard Combe1, Alan Kivitz 2, Yoshiya Tanaka 3, Désirée van der Heijde 4, Franziska Matzkies 5, Beatrix Bartok 5, Lei Ye 5, Ying Guo 5, Chantal Tasset 6, John Sundy 5, Neelufar Mozaffarian 5, Robert B.M. Landewé 7, Sang-Cheol Bae 8, Edward Keystone 9 and Peter Nash 10, 1CHU Montpellier, Montpellier University, Montpellier, France, 2Altoona Center for Clinical Research, Duncansville, PA, 3University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 4Leiden University Medical Center, Leiden, Netherlands, 5Gilead Sciences, Inc., Foster City, CA, 6Galapagos NV, Mechelen, Belgium, 7Amsterdam University Medical Center, Amsterdam, Netherlands, 8Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 9Mount Sinai Hospital and University of Toronto, Toronto, ON, Canada, 10University of Queensland, Brisbane, Queensland, Australia

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Disease Activity and methotrexate (MTX), Janus kinase (JAK), RCT, Rheumatoid arthritis (RA)

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Session Information

Date: Sunday, November 10, 2019

Session Title: RA – Treatments Poster I: Novel Treatments

Session Type: Poster Session (Sunday)

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

Background/Purpose: Filgotinib (FIL) is an orally administered, potent and selective inhibitor of Janus kinase 1 (JAK1) that has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objective of this study is to evaluate efficacy and safety of FIL treatment in patients with RA who have had an inadequate response to methotrexate (MTX).

Methods: This phase 3, double-blind, active- and placebo (PBO)-controlled study randomized patients with active RA (3:3:2:3) to FIL 200 mg, FIL 100 mg, active comparator (adalimumab [ADA] 40mg every 2 weeks), or PBO daily for up to 52 weeks; results through week 24 are presented. Patients were also receiving MTX for ≥12 weeks with a stable dose of MTX for ≥4 weeks before initiation of study drug. Primary efficacy endpoint was proportion of patients achieving ACR20 response at week 12; additional clinical assessments were ACR50 and ACR70 responses, DAS28-CRP score ≤3.2 and < 2.6, van der Heijde modified total Sharp score (mTSS), and patient-reported outcomes were HAQ-DI, SF-36 PCS, and FACIT-Fatigue. Safety endpoints included types and rates of adverse events. Logistic regression adjusting for stratification factors with nonresponder imputation was used for superiority test of FIL vs PBO for ACR response and other binary endpoints. Mixed-effect model adjusting for baseline value, stratification factors, treatment, visit, and treatment by visit interaction as fixed effects with observed cases was used for continuous endpoints. Non-inferiority test of FIL to ADA (preserving >50% of ADA response) was performed for DAS28-CRP ≤3.2 and < 2.6.

Results: Of 1,759 patients randomized, 1,755 received study drug and were analyzed, with 475 FIL 200mg; 480 FIL 100mg; 325 ADA; and 475 PBO, of which 89.5%, 90.4%, 88.9%, and 81.3%, respectively, completed week 24 study drug. Most patients (81.8%) were female, mean (standard deviation [SD]) duration of RA was 7.8 (7.6) years, and mean (SD) DAS28-CRP was 5.7 (0.9). At week 12, significantly more patients in the FIL 200mg and 100mg arms achieved an ACR20 response compared to PBO (Table 1). Similarly, compared to PBO, more patients receiving FIL achieved ACR50 and ACR70 responses, DAS28-CRP scores ≤3.2 and < 2.6, had lower radiographic progression, and reported improvements in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Table 1). Non-inferiority of FIL 200mg to ADA was met based on DAS28-CRP ≤3.2. The FIL safety profile was consistent with prior studies through week 24 (Table 2).

Conclusion: The selective JAK1 inhibitor FIL, at doses of 200mg and 100mg led to significant improvement in signs and symptoms of RA, prevented radiographic progression, and improved physical function compared to PBO, and was well tolerated among patients with RA with prior inadequate response to MTX. Efficacy of FIL 200mg was non-inferior to ADA based on DAS28-CRP ≤3.2.


ACR Finch 1 abstract_FINAL_Table 1


ACR Finch 1 abstract_FINAL_Table 2


Disclosure: B. Combe, AbbVie, 5, BMS, 5, 8, Chugai, 5, 8, Eli Lilly, 5, Eli Lilly and Company, 5, 8, Gilead, 5, 8, Gilead Sciences, Inc., 5, 8, Janssen, 5, Lilly, 5, 8, MSD, 2, 5, 8, Novartis, 5, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Roche-Chugai, 5, 8, Sanofi, 5, UCB, 5, USD, 5; A. Kivitz, AbbVie, 5, Amgen, 1, 4, 5, Boehringer Ingeleheim, 5, Boehringer Ingelheim, 5, Celgene, 8, Flexion, 5, 8, Flexion Therapeutics, 8, Genzyme, 5, 8, Gilead, 1, 4, 5, Gilead Sciences, Inc., 4, Horizon, 8, Janssen, 5, Janssen Research & Development, LLC, 2, Merck, 8, Novartis, 1, 4, 8, Pfizer, 1, 4, 5, 8, Regeneron, 1, 5, 8, Sanofi, 1, 4, 5, 8, Sun Pharma, 5, SUN Pharma Advanced Research, 5, UCB, 5; Y. Tanaka, Abbvie, 8, AbbVie, 5, 8, Asahi-kasei, 2, Asahi-Kasei, 2, Asahi-kasei, BMS, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Ono, Pfizer, Sanofi, Takeda, UCB, 2, Astellas, 8, Astellas Pharma, 9, Astellas Pharma, Inc., 2, 3, 5, 8, 9, Astellas, BMS, Chugai, Daiichi-Sankyo, Eli Lilly, Janssen, Mitsubishi-Tanabe, Pfizer, Sanofic, UCB, YL Biologics, 8, BMS, 2, 5, 8, Bristol-Myers, 2, 8, Bristol-Myers Squibb, 2, 8, Chugai, 2, 8, Daiichi-Sankyo, 2, 8, Daiichi-Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, Abbvie, Pfizer, YL Biologics, Bristol-Myers, 8, Eisai, 2, 8, Eli Lilly, 5, 8, Eli Lilly and Company, 8, Genzyme, 5, Glaxo-Smithkline, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen, Asahi-kasei, 8, Janssen, 8, Mitsubishi-Tanabe, 2, 8, Mitsubishi-Tanabe, Bristol-Myers, Eisai, Chugai, Takeda, Abbvie, Astellas, Daiichi-Sankyo, Ono, MSD, Taisho-Toyama., 2, Mitsubishi-Tanabe, Takeda, Daiichi-Sankyo, Chugai, Bristol-Myers, MSD, Astellas, Abbvie, Eisai, 2, Novartis, 8, Ono, 2, Pfizer, 5, 8, Pfizer Inc, 8, Roche, 5, Sanofi, 2, Takeda, 2, 8, Teijin, 8, UCB, 2, YL Biologics, 8; D. van der Heijde, AbbVie, 5, AbbVie, Amgen, Astellas, AstraZeneca, BMS, 5, Amgen, 5, Astellas, 5, 9, Astellas Pharma, 5, AstraZeneca, 5, BMS, 5, Boehringer Ingelheim, 5, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB, 5, Boehringer-Ingelheim, 5, Bristol-Myers Squibb, 5, Celgene, 5, Daiichi, 5, 9, Daiichi Sankyo, 5, Director of Imaging Rheumatology, 6, Director of Imaging Rheumatology bv, 9, Eli Lilly, 5, Eli Lilly and Company, 5, Eli-Lilly, 5, Galapagos, 5, Gilead, 5, Gilead Sciences, Inc., 5, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, GSK, 5, 8, Imaging Rheumatology bv, 9, Imaging Rheumatology BV, 9, Imaging Rheumatology bv., 9, Janssen, 5, 8, Janssen Pharmaceutica, 5, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Pfizer Inc, 5, Regeneron, 5, 8, Rheumatology bv, 4, 9, Roche, 5, 8, Sanofi, 5, 8, Takeda, 5, 8, Takeda Pharmaceutical Company, 5, UCB, 5, 8, UCB Pharma, 5; F. Matzkies, Gilead Sciences, Inc., 1, 3, 4; B. Bartok, Gilead Sciences, Inc., 3, 4; L. Ye, Gilead Sciences, Inc., 3, 4; Y. Guo, Gilead Sciences, Inc., 3, 4; C. Tasset, Galapagos, 1, 3, Galapagos NV, 3, 4; J. Sundy, Gilead Sciences, Inc., 3, 4; N. Mozaffarian, Gilead Sciences, Inc., 1, Glenmark Pharmaceuticals, 3; R. Landewé, Abbott, 2, 5, 8, Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, 8, Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, 2, AbbVie, 5, Abbvie, 5, 8, AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering- Plough, UCB, Wyeth, 5, Ablynx, 5, Amgen, 2, 5, 8, AstraZeneca, 5, BMS, 5, 8, Bristol Myers Squibb, 5, 8, Bristol-Myers Squibb, 5, Celgene, 5, 8, Centocor, 2, 5, 8, Director of Rheumatology Consultancy BV, which is a registered company under Dutch law, 6, Eli Lilly, 5, 8, Eli Lilly and Company, 5, Eli-Lilly, 5, 8, Galapagos, 5, 8, Gilead, 5, 8, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, 8, Janssen, 5, 8, Merck, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Rheumatology bv, 4, Rheumatology Consultancy BV, 9, Roche, 2, 5, 8, Schering-Plough, 2, 5, 8, UCB, 5, 8, UCB Pharma, 2, 5, 8, Wyeth, 2, 5, 8; S. Bae, None; E. Keystone, Abbvie, 2, 5, 8, Amgen, 2, 5, 8, AstraZeneca, 5, Astra-Zeneca, 5, Biotest, 5, BMS, 2, 5, 8, Celltrion, 5, Crescendo, 5, Crescendo Bioscience, 5, F. Hoffmann-La Roche Inc, 2, 5, 8, Genentech, 5, Genentech Inc., 5, Genzyme, 5, Gilead, 2, 5, Gilead Sciences, Inc., 5, Janssen, 2, 5, 8, Lilly, 2, 5, 8, Merck, 5, 8, Pfizer, 2, 5, 8, Pfizer Pharmaceuticals, 2, 5, 8, Roche, 2, 5, 8, Sandoz, 5, Sanofi, 2, 5, 8, Sanofi-Aventis, 2, 8, UCB, 5, 8; P. Nash, AbbVie, 2, 5, 8, Abbvie, 2, 8, Amgen, 2, 5, 8, BMS, 2, 5, 8, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Gilead, 2, 5, 8, Janssen, 2, 5, 8, Lilly, 2, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 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, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy J, 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: FINCH1 Primary Outcome Results [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-filgotinib-for-patients-with-rheumatoid-arthritis-with-inadequate-response-to-methotrexate-finch1-primary-outcome-results/. Accessed June 29, 2022.
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