Evidence map›Paper›PMID 39331638›Full record

Trial reportRheumatology (Oxford, England)2025

Efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and an inadequate response to methotrexate.

Maya H Buch, David Walker, Christopher J Edwards, Jane Barry, Laura Akroyd, Edmund V Ekoka Omoruyi, Peter C Taylor

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

7 authors.

Maya H BuchCentre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK.ORCID 0000-0002-8962-5642
David WalkerDepartment of Rheumatology, Northumbria Healthcare NHS Foundation Trust, North Shields, UK.
Christopher J EdwardsDepartment of Rheumatology and NIHR Southampton Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK.ORCID 0000-0002-8233-6602
Jane BarryMedical Affairs Inflammation, UK & Ireland, Galapagos Biotech Ltd, Uxbridge, UK.
Laura AkroydMedical Affairs Inflammation, UK & Ireland, Galapagos Biotech Ltd, Uxbridge, UK.
Edmund V Ekoka OmoruyiBiostatistics, Galapagos NV, Mechelen, Belgium.
Peter C TaylorBotnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-7766-6167

Funding

AbbVieGalapagos NVGilead Sciences, Inc.Gilead Sciences, Ltd
6 · The paper itself

Abstract

objectivesClinical trials restricted to moderately active RA are limited. Filgotinib is approved for treating moderate to severe active RA. This post hoc analysis assessed the efficacy and safety of filgotinib in moderately active RA.

methodsIn FINCH 1, patients with active moderate to severe RA and inadequate response to methotrexate received filgotinib 200 mg or 100 mg (FIL200/FIL100) once daily, adalimumab 40 mg every 2 weeks or placebo, all with methotrexate (N = 1755). This subgroup analysis was conducted in patients with a moderate baseline Disease Activity Score in 28 joints using C-reactive protein [DAS28-CRP; >3.2 to ≤5.1; n = 425 (24.2%)].

resultsA higher proportion of patients achieved DAS28-CRP <2.6, Clinical Disease Activity Index (CDAI) remission (≤2.8), low disease activity (LDA) (DAS28-CRP ≤3.2 or CDAI ≤10) and American College of Rheumatology (ACR20/50/70) responses with FIL200 and FIL100 vs placebo at weeks 12 and 24. Week 12 ACR20 response rates (primary end point) were 77.9%, 67.8% and 43.8%, respectively. A total of ∼75% of patients achieved DAS28-CRP LDA by week 24 with either filgotinib dose. FIL200 and FIL100 elicited greater improvements in patient-reported outcomes than placebo. The efficacy of filgotinib, maintained through week 52, was comparable to that of adalimumab. Frequency of adverse events (AEs) was similar with filgotinib and adalimumab. Infections were the most common AEs; incidence rates were 40-53% in active treatment groups.

conclusionIn this subpopulation with moderately active RA, the efficacy and safety of filgotinib were similar to those in the overall FINCH 1 population (patients with active moderate to severe RA).

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT02889796.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidMethotrexatePyridinesTriazolesAdalimumabAdultAgedDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAdalimumabAntirheumatic AgentsGLPG0634MethotrexatePyridinesTriazolesclinical trials and methodsDMARDsimmunosuppressantsinflammationJAK inhibitorsquality of liferheumatoid arthritis

Identifiers

PMID39331638
PMCPMC11963078

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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.