Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study

Maya Buch¹, Daniel Aletaha², Roberto F. Caporali³, Bernard G. Combe⁴, Hendrik Schulze-Koops⁵, Jacques-Eric Gottenberg⁶, Yoshiya Tanaka⁷, Ricardo Blanco⁸, Tsutomu Takeuchi⁹, Edmund V. Ekoka Omoruyi¹⁰, Katrien Van Beneden¹¹, Vijay Rajendran¹², Chris Watson¹³, Francesco De Leonardis¹⁴ and Paul Emery¹⁵, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians–University Munich, Munich, Germany, ⁶Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁹Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹²Clinical Research, Galapagos NV, Mechelen, Belgium, ¹³Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁴Medical Affairs, Galapagos GmbH, Basel, Switzerland, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Meeting: ACR Convergence 2023

Keywords: clinical trial, Disease-Modifying Antirheumatic Drugs (Dmards), Randomized Trial, Response Criteria, rheumatoid arthritis

Session Information

Date: Tuesday, November 14, 2023

Title: (2141–2176) RA – Treatments Poster III

Session Type: Poster Session C

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

Background/Purpose: In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate response (IR) or intolerance to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (DMARD). Filgotinib (FIL) is a JAK1 preferential inhibitor available in two doses for the treatment of moderate to severe RA. The objective of this analysis was to evaluate long-term efficacy of two doses of FIL in clinically relevant pt populations. Response rates for Boolean remission 2.0 were reported as an exploratory objective.

Methods: In this interim analysis, efficacy (nonresponder imputation) of FIL 200 mg (FIL200) and 100 mg (FIL100) was assessed from long-term extension (LTE) baseline (BL) to Week (W) 156 in patients (pts) with an IR to methotrexate (MTX-IR) and biologics (bDMARD-IR), enrolled from FINCH 1 (NCT02889796) and 2 (NCT02873936) parent studies, respectively, receiving ≥ 1 FIL dose in FINCH 4 (NCT03025308).

Results: Study design, BL characteristics and W48 outcomes for MTX-IR¹ and bDMARD-IR² pts were reported previously. For MTX-IR and bDMARD-IR pts who received FIL200 or FIL100 in the parent study, W156 remission rates using Boolean 1.0 criteria were 20.5% and 15.8%, and 18.2% and 8.9%, respectively. Adopting the Boolean 2.0 criteria slightly increased remission rates for FIL200 and FIL100 at W156: +4.2% and +4.9% for MTX-IR pts, and +1.5% and +2.4% for bDMARD-IR pts, respectively. For pts rerandomized to FIL on entering the LTE, Boolean 2.0 criteria also increased remission rates vs Boolean 1.0. Both MTX-IR (Figure) and bDMARD-IR pts maintained long-term Boolean remission through W156 with FIL200 and FIL100, irrespective of prior FIL. Results for Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) < 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8 and Simplified Disease Activity Index (SDAI) ≤ 3.3, and mean change from parent study BL in Health Assessment Questionnaire–Disability Index (HAQ-DI) and pain are shown (Table). Similar trends in efficacy were seen for LDA and ACR response criteria.

Conclusion: In FINCH 4, both FIL200 and FIL100 showed sustained efficacy up to W156 in clinically relevant pt populations. Boolean 2.0 criteria classified more pts in remission, in line with the range reported in the validation study.³

References:
1. Combe B, et al. Arthritis Rheumatol 2021;73(Suppl 9):POS1697
2. Buch M, et al. Arthritis Rheumatol 2021;73(Suppl 9):POS1696
3. Studenic P, et al. Arthritis Rheumatol 2023;82:74–80

Figure. Boolean remission 1.0 and 2.0 for MTX-IR pts in FINCH 4 LTE through W156 (safety analysis set, nonresponder imputation)

Table. Efficacy in MTX-IR and bDMARD-IR pts through W156 in FINCH 4 (safety analysis set; nonresponder imputation)

Disclosures: M. Buch: AbbVie, 2, 6, 12, All paid to host institution, Boehringer Ingelheim, 2, 6, 12, Paid to host institution, Galapagos, 2, 6, 12, Paid to host institution, Gilead, 2, 5, 6, 12, Paid to host institution, Lilly, 2, 6, 12, All paid to host institution, National Insitute for Health and Care Research (NIHR), 3, 12, Maya H Buch is a National Institute for Health and Care Research (NIHR) Senior Investigator. The views expressed are those of the authors and not nece, Pfizer, 2, 12, Paid to host institution; D. Aletaha: AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Janssen, 2, 6, Lilly, 2, 5, 6, Merck, 2, 6, Novartis, 2, 5, 6, Pfizer, 2, 6, Roche, 2, 5, 6, Sandoz, 2, 6, Sanofi, 5, Sobi, 5; R. Caporali: AbbVie, 2, 6, Amgen, 2, 6, BMS, 2, 6, Celltrion, 2, 6, Fresenius Kabi, 2, Galapagos, 2, 6, Janssen, 2, 6, Lilly, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, Sandoz, 2, 6, UCB, 2, 6; B. Combe: AbbVie, 2, 6, BMS, 6, Celltrion, 2, Eli Lilly, 1, 2, 6, Galapagos, 2, 6, Gilead, 2, Janssen, 2, 6, MSD, 6, Nordic Pharma, 5, Novartis, 1, Pfizer, 6, Roche-Chugai, 2, 6; H. Schulze-Koops: AbbVie, 2, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Pfizer, 2, 6; J. Gottenberg: AbbVie, 2, BMS, 2, 5, Galapagos, 2, Gilead, 2, Lilly, 2, MSD, 2, Novartis, 2, Pfizer, 2, 5; Y. Tanaka: AbbVie, 6, AstraZeneca, 6, BMS, 6, Boehringer-Ingelheim, 6, Chugai, 5, 6, Eisai, 5, 6, Eli Lilly, 6, Gilead, 6, GSK, 6, Mitsubishi-Tanabe, 5, Pfizer, 6, Taiho, 6, Taisho, 5, 6; R. Blanco: AbbVie, 5, 6, Amgen, 6, AstraZeneca, 2, BMS, 6, Eli Lilly, 6, Galapagos, 2, 6, Janssen, 2, 6, MSD, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 5, 6, Sanofi, 6; T. Takeuchi: AbbVie, 2, 5, 6, AYUMI, 5, Bristol-Myers Squibb, 6, Chugai, 2, 5, 6, Daiichi Sankyo, 5, Eisai, 5, 6, Eli Lilly Japan, 2, 6, Gilead, 2, 6, Janssen, 6, Mitsubishi-Tanabe, 2, 5, 6, ONO, 5, Pfizer Japan, 6, Taiho, 2; E. Ekoka Omoruyi: Galapagos, 2, Janssen, 2, UCB, 11; K. Van Beneden: Galapagos, 3, 11; V. Rajendran: Galapagos, 3, 11; C. Watson: Galapagos, 3, 11; F. De Leonardis: Galapagos, 3; P. Emery: Boehringer Ingelheim, 2, Eli Lilly, 2, Novartis, 2.

To cite this abstract in AMA style:

Buch M, Aletaha D, Caporali R, Combe B, Schulze-Koops H, Gottenberg J, Tanaka Y, Blanco R, Takeuchi T, Ekoka Omoruyi E, Van Beneden K, Rajendran V, Watson C, De Leonardis F, Emery P. Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/efficacy-of-filgotinib-in-patients-with-rheumatoid-arthritis-week-156-results-from-a-long-term-extension-study/. Accessed .

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