ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 0281

Clinical Outcomes of Filgotinib in Patients with RA Aged ≥65 Years: A Post Hoc Subgroup Analysis of Phase 2 and 3 Clinical Trials and Ongoing Long-Term Extensions

Maya Buch1, BERNARD COMBE2, Jose A Gomez-Puerta3, Roberto Felice Caporali4, jacques-eric gottenberg5, Paul Van Hoek6, Vijay Rajendran7, Pieter-Jan Stiers6, Katrien Van Beneden6, Daniel Aletaha8, Gerd Burmester9, Rene Westhovens10 and Yoshiya Tanaka11, 1University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, 2Montpellier University, Montpellier, France, 3Hospital Clínic de Barcelona, Barcelona, Spain, 4University of Milan, Milano, Italy, 5Strasbourg University Hospital, Strasbourg, France, 6Galapagos NV, Mechelen, Belgium, 7Galapagos NV, Gent, Belgium, 8Medical University Vienna, Wien, Austria, 9Charité University Medicine Berlin, Berlin, Germany, 10University Hospitals Leuven, Leuven, Belgium, 11University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan

Meeting: ACR Convergence 2022

Keywords: Aging, clinical trial, Cohort Study, Outcome measures, rheumatoid arthritis

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Saturday, November 12, 2022

Title: RA – Treatment Poster I

Session Type: Poster Session A

Session Time: 1:00PM-3:00PM

Background/Purpose: Filgotinib (FIL) is a Janus kinase 1 preferential inhibitor approved for the treatment of moderate to severe active RA.1 It was previously reported that a numerically higher proportion of patients (pts) aged ≥65 vs < 65 y had an adverse event (AE), serious AE, or serious infection in the FIL 200 mg (FIL200) group of the pooled phase 2 and 3 safety studies.2 Here we report updated data on AEs of special interest (AESIs) and efficacy in these age groups.

Methods: This post hoc analysis assessed safety and efficacy in pts aged < 65 and ≥65 y using data from the phase 2 DARWIN 1 (NCT01888874) and 2 (NCT01894516) trials; phase 3 FINCH 1 (NCT02889796), 2 (NCT02873936), and 3 (NCT02886728) trials; and DARWIN 3 (NCT02065700) and FINCH 4 (NCT03025308) long-term extension (LTE) trials. All pts with RA fulfilled 2010 ACR/EULAR criteria. Data were as of Jan 11, 2022 (DARWIN 3) and Jan 31, 2022 (FINCH 4). Analyses were performed on an ad hoc interim analysis data set without additional cleaning. The as-treated analysis set included all available data for pts receiving ≥1 FIL dose (FIL200/FIL 100 mg [FIL100]), including those rerandomized to FIL in the LTE. Censored exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure of AESIs by age category (< 65 vs ≥65 y) are presented. EAIR and 95% confidence intervals (CIs) were calculated. Proportions of pts aged < 65 and ≥65 y achieving a 20, 50 and 70% improvement in ACR criteria (ACR20/50/70) and DAS28-CRP low disease activity (LDA) at Week 144 in FINCH 4, estimated using observed cases, are reported.

Results: In this pooled analysis, pts aged ≥65 y had higher proportions of cardiovascular (CV) risk factors at baseline vs those < 65 y (Table 1). A higher proportion of pts aged < 65 vs ≥65 y were current smokers. A larger proportion of pts in the ≥65 vs < 65 y age group were from North America. EAIRs of AESIs were generally higher in pts aged ≥65 than < 65 y (Table 2). In pts aged ≥65 y, the EAIRs of adjudicated major adverse cardiovascular events, venous thromboembolisms, serious infections, and herpes zoster differed between the 2 FIL doses with partly or largely overlapping CIs. The EAIRs of nonmelanoma skin cancer (NMSC), malignancies (excluding NMSC), and treatment-emergent AE (TEAE) leading to death were numerically higher in the ≥65 y age group, but not in the < 65 y age group, with FIL200 vs FIL100. The most reported fatal outcomes with FIL200 in the ≥65 y age group were malignancies, cardiac disorders, and infections and infestations. ACR20/50/70 and DAS28-CRP LDA rates in pts aged < 65 and ≥65 y in FINCH 4 were maintained or numerically higher with FIL200 to Week 144 (Table 3).

Conclusion: In this post hoc integrated safety analysis, the EAIRs of AESIs were generally higher in pts aged ≥65 y than < 65 y, which is to be expected in an older population. A numerically higher incidence of NMSC, malignancies (excluding NMSC), and TEAEs leading to death was observed in the FIL200 vs FIL100 group in pts aged ≥65 but not < 65 y. In FINCH 4, efficacy was generally maintained in both age groups. Limitations include the ad hoc nature of the analysis, overlapping CIs, lack of comparator data, and potential LTE bias.

References:
1. Jyseleca SmPC. Galapagos NV; May 2022
2. Jyseleca EPAR. Galapagos NV; Sep 2020

Supporting image 1

Table 1. Baseline demographics and disease characteristics by age category (<65 vs ≥65 y)

Supporting image 2

Table 2. AESIs and overview of ≥1 TEAE leading to death by age category (<65 vs ≥65 y; as-treated set)

Supporting image 3

Table 3. ACR20/50/70 and DAS28-CRP LDA response rates through Week 144 in FINCH 4 by age category (<65 vs ≥65 y; observed cases)


Disclosures: M. Buch, AbbVie, Galapagos, Gilead, Pfizer, Eli Lilly, Merck-Serono, Roche, UCB; B. COMBE, AbbVie, Bristol Myers Squibb, Celltrion, Galapagos, Gilead, Janssen, Lilly, MSD, Pfizer, Roche-Chugai, Novartis; J. Gomez-Puerta, GSK, Galapagos, Pfizer, Janssen, Sanofi, AbbVie, Bristol Myers Squibb, Lilly, Novartis, MSD, Roche; R. Caporali, AbbVie, Celltrion, Fresenius-Kabi, Galapagos, Janssen, Pfizer, Roche, UCB, Eli Lilly, Gilead, Sanofi; j. gottenberg, AbbVie, Bristol Myers Squibb, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer; P. Van Hoek, Galapagos; V. Rajendran, Galapagos; P. Stiers, Galapagos; K. Van Beneden, Galapagos; D. Aletaha, Novartis, SoBi, Sanofi, Amgen, Lilly, Merck, Pfizer, Roche, Sandoz, Janssen, AbbVie; G. Burmester, AbbVie, Galapagos, Lilly, MSD, Pfizer, Roche, UCB, Janssen, Gilead Sciences, Inc.; R. Westhovens, Celltrion, Galapagos, Gilead; Y. Tanaka, Lilly, AbbVie, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Pfizer, Mitsubishi Tanabe, GlaxoSmithKline, Asahi Kasei, Takeda, Astellas, Janssen, Novartis, Sanofi, UCB, YL Biologics, MSD, Ono, Taisho Toyama, Celltrion, Gilead, Boehringer-Ingelheim, Corrona, Kowa, Amgen, AstraZeneca, AstraZeneca, Eli Lilly.

To cite this abstract in AMA style:

Buch M, COMBE B, Gomez-Puerta J, Caporali R, gottenberg j, Van Hoek P, Rajendran V, Stiers P, Van Beneden K, Aletaha D, Burmester G, Westhovens R, Tanaka Y. Clinical Outcomes of Filgotinib in Patients with RA Aged ≥65 Years: A Post Hoc Subgroup Analysis of Phase 2 and 3 Clinical Trials and Ongoing Long-Term Extensions [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/clinical-outcomes-of-filgotinib-in-patients-with-ra-aged-%e2%89%a565-years-a-post-hoc-subgroup-analysis-of-phase-2-and-3-clinical-trials-and-ongoing-long-term-extensions/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to ACR Convergence 2022

ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinical-outcomes-of-filgotinib-in-patients-with-ra-aged-%e2%89%a565-years-a-post-hoc-subgroup-analysis-of-phase-2-and-3-clinical-trials-and-ongoing-long-term-extensions/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology