Evidence map›Paper›PMID 38057656›Full record

ArticleRheumatology and therapy2024

Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis.

Jeffrey R Curtis, Paul Emery, Bryan Downie, Yan Zhong, Jinfeng Liu, Ling Han, Rachael E Hawtin, Gerd Rüdiger Burmester

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02873936 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

TypeinterventionalSponsorGilead SciencesRan2016 to 2018Enrolled449ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib, csDMARDs
NCT02886728 phase3completednot on this map

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

TypeinterventionalSponsorGilead SciencesRan2016 to 2019Enrolled1,252ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib, MTX, Placebo to match MTX
NCT02889796 phase3completednot on this map

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

TypeinterventionalSponsorGilead SciencesRan2016 to 2019Enrolled1,759ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib, Adalimumab, Placebo to match adalimumab, MTX
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. JAK-STAT Signaling in Autoimmunity and Cancer.ImmunoTargets and therapy · 2025
    Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, Faculty Office Tower, University of Alabama at Birmingham, 510 20th St S #834, Birmingham, AL, 35294, USA. jrcurtis@uabmc.edu.ORCID http://orcid.org/0000-0002-8907-8976
Paul EmeryLeeds NIHR Biomedical Research Centre, LTHT, and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID http://orcid.org/0000-0002-7429-8482
Bryan DownieGilead Sciences, Inc, Foster City, CA, USA.ORCID http://orcid.org/0000-0001-8278-722X
Yan ZhongGilead Sciences, Inc, Foster City, CA, USA.
Jinfeng LiuGilead Sciences, Inc, Foster City, CA, USA.ORCID http://orcid.org/0000-0002-0343-8222
Ling HanGilead Sciences, Inc, Foster City, CA, USA.
Rachael E HawtinGilead Sciences, Inc, Foster City, CA, USA.
Gerd Rüdiger BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-7518-1131
Gilead Sciences (United States) · USCharité - Universitätsmedizin Berlin · DEUniversity of Alabama at Birmingham Hospital · USUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess cigarette smoking's effects on efficacy of the preferential Janus kinase (JAK) 1 inhibitor filgotinib and drug persistence in patients with rheumatoid arthritis (RA).

methodsEfficacy in non-smokers, former smokers, and current smokers from phase 3 filgotinib trials was analyzed, including patients with inadequate response (IR) to methotrexate (MTX) or biologic disease-modifying antirheumatic drugs (bDMARDs) or who were MTX-naïve. Proportions achieving Disease Activity Score in 28 joints with C-reactive protein (DAS28[CRP]) ≤ 3.2 were compared using logistic regression. Retrospective claims-based switching data were reviewed.

resultsWeek 12 (W12) DAS28(CRP) ≤ 3.2 was achieved by 50, 61, and 62% of MTX-IR non-smokers, former smokers, and current smokers taking filgotinib 200 mg (FIL200) + MTX vs. 23, 16, and 32% taking placebo + MTX (p < 0.001, < 0.001, and 0.001) and 50, 34, and 33% taking adalimumab + MTX (p = 0.97, 0.013, and 0.006 vs. FIL200 + MTX). W12 DAS28(CRP) ≤ 3.2 was achieved by 46, 48, and 32% of bDMARD-IR non-smokers, former smokers, and current smokers taking FIL200 + conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) vs. 16, 23, and 5% taking placebo + csDMARD (p < 0.001, 0.077, and 0.051); 57, 58, and 59% of respective MTX-naïve smoking groups achieved W12 DAS28(CRP) ≤ 3.2 with FIL200 + MTX vs. 28, 37, and 18% with MTX (p < 0.001, 0.026, and < 0.001). Claims data showed former/current smokers were likelier than non-smokers to switch from adalimumab to other biologics or JAK inhibitors.

conclusionsGreater proportions of MTX-IR current/former smokers responded to FIL200 + MTX vs. adalimumab + MTX. In non-smoking MTX-IR, bDMARD-IR, and MTX-naïve patients with RA, FIL200 + MTX demonstrated increased response vs. controls. Current/former smokers were likelier to discontinue adalimumab vs. non-smokers in real-world clinical settings.

trial registrationNCT02889796, NCT02873936, NCT02886728.

Indexed as

ArthritisJAK inhibitorsRheumatoidSmokingTumor necrosis factor inhibitors

Identifiers

PMID38057656
PMCPMC10796882
OpenAlexW4389398222

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.