Evidence map›Paper›PMID 36209441›Full record

ArticleRheumatology and therapy2023

Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study.

Bernard G Combe, Yoshiya Tanaka, Maya H Buch, Peter Nash, Gerd R Burmester, Alan J Kivitz, Beatrix Bartok, Alena Pechonkina, Katrina Xia, Kahaku Emoto and 4 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02889796 (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), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 20% 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.

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

7 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 9 countries.

Bernard G CombeMontpellier University, Montpellier, France. b-combe@chu-montpellier.fr.ORCID http://orcid.org/0000-0003-4002-1861
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Maya H BuchNIHR Manchester Biomedical Research Centre, University of Manchester, Manchester, UK.
Peter NashGriffith University of Queensland, Brisbane, Australia.
Gerd R BurmesterCharité University Hospital Berlin, Berlin, Germany.
Alan J KivitzAltoona Center for Clinical Research, Duncansville, PA, USA.
Beatrix BartokGilead Sciences, Inc., Foster City, CA, USA.
Alena PechonkinaGilead Sciences, Inc., Foster City, CA, USA.
Katrina XiaGilead Sciences, Inc., Foster City, CA, USA.
Kahaku EmotoGilead Sciences K.K., Tokyo, Japan.
Shungo KanoGilead Sciences K.K., Tokyo, Japan.
Thijs K HendrikxGalapagos NV, Mechelen, Belgium.
Robert B M LandewéAmsterdam Rheumatology and Clinical Immunology Center (amC) and Zuyderland MC, Heerlen, The Netherlands.
Daniel AletahaMedical University of Vienna, Vienna, Austria.
Gilead Sciences (United States) · USAltoona Center for Clinical Research · USCharité - Universitätsmedizin Berlin · DEGalapagos (Belgium) · BEGriffith University · AUMedical University of Vienna · ATUniversité de Montpellier · FRUniversity of Manchester · GBUniversity of Occupational and Environmental Health Japan · JPZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis exploratory analysis of FINCH 1 (NCT02889796) examined filgotinib (FIL) efficacy and safety in a subgroup of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX; MTX-IR) who had four poor prognostic factors (PPFs).

methodsPatients with MTX-IR received placebo up to week (W)24 or FIL200 mg, FIL100 mg, or adalimumab up to W52; all received MTX. Efficacy and safety data were stratified by four PPFs versus fewer than four PPFs: seropositivity, high-sensitivity C-reactive protein (CRP) ≥ 6 mg/L, Disease Activity Score in 28 joints with CRP > 5.1, and erosions on X-rays.

resultsAt baseline, 687/1755 patients had four PPFs. At W12, whether with four PPFs or fewer than four PPFs, response rates on all American College of Rheumatology (ACR) measures were significantly greater with FIL200 and FIL100 versus placebo. At W52, FIL200 ACR20/50/70 response rates remained at least numerically higher versus adalimumab in both subgroups. At W52, FIL200 reduced modified total Sharp score (mTSS) change versus adalimumab in patients with four or fewer than four PPFs.

conclusionsIn high-risk (four PPFs) patients with MTX-IR RA, FIL200 and FIL100 showed similar reductions in disease activity versus placebo at W12 as in patients with fewer than four PPFs. mTSS in patients receiving FIL200 changed little from W24 to W52, while that in patients receiving FIL100 progressed comparably to patients who received adalimumab. Tolerability was comparable across treatment arms and subgroups.

Indexed as

AdalimumabFilgotinibMethotrexatePoor prognostic factors

Identifiers

PMID36209441
PMCPMC9931960
OpenAlexW4303859853

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.