Evidence map›Paper›PMID 33452004›Full record

Trial reportAnnals of the rheumatic diseases2021

Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial.

René Westhovens, William F C Rigby, Désirée van der Heijde, Daniel W T Ching, William Stohl, Jonathan Kay, Arvind Chopra, Beatrix Bartok, Franziska Matzkies, Zhaoyu Yin and 9 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02886728 (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), which is not on this map. Cited by 79 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 7 pooled it
15.2field-weighted citation impact, top 1% 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.

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
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 7 syntheses or guidelines pooled it, 139 citations in OpenAlex.

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19 more citing papers are in PubMed but not listed here.

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

19 authors at 13 institutions in 6 countries.

René WesthovensDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Flanders, Belgium rene.westhovens@uzleuven.be.ORCID 0000-0002-3432-3073
William F C RigbyGeisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
Daniel W T ChingTimaru Medical Specialists Limited, Timaru, New Zealand.
William StohlUniversity of Southern California Keck School of Medicine, Los Angeles, California, USA.
Jonathan KayDivision of Rheumatology, Department of Medicine, UMass Memorial Medical Center, Worcester, Massachusetts, USA.ORCID 0000-0002-8970-4260
Arvind ChopraCentre for Rheumatic Diseases, Pune, India.
Beatrix BartokGilead Sciences, Foster City, California, USA.
Franziska MatzkiesGilead Sciences, Foster City, California, USA.
Zhaoyu YinGilead Sciences, Foster City, California, USA.
Ying GuoGilead Sciences, Foster City, California, USA.
Chantal TassetGalapagos NV, Mechelen, Belgium.
John S SundyGilead Sciences, Foster City, California, USA.
Angelika JahreisGilead Sciences, Foster City, California, USA.
Neelufar MozaffarianIchnos Sciences, New York, New York, USA.
Osvaldo Daniel MessinaCosme Argerich Hospital, Buenos Aires, Argentina.
Robert Bm LandewéDepartment of Rheumatology & Clinical Immunology, Amsterdam University Medical Center, Amsterdam, The Netherlands.ORCID 0000-0002-0577-6620
Tatsuya AtsumiDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany.
Gilead Sciences (United States) · USArgerich Hospital · ARDartmouth–Hitchcock Medical Center · USDuke Medical Center · USGalapagos (Belgium) · BEHokkaido University · JPHumboldt-Universität zu Berlin · DEIchnos Sciences (United States) · USKU Leuven · BELeiden University Medical Center · NLUniversity of Massachusetts Chan Medical School · USUniversity of Southern California · USZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure.

methodsThis 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24.

resultsThe primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (p<0.001). A significantly greater proportion treated with FIL100+ MTX compared with MTX achieved an ACR20 response (80%, p=0.017) at week 24. Significant improvement in Health Assessment Questionnaire-Disability Index was seen at week 24; least-squares mean change from baseline was -1.0 and -0.94 with FIL200+MTX and FIL100+MTX, respectively, versus -0.81 with MTX (p<0.001, p=0.008, respectively). Significantly higher proportions receiving FIL200+MTX (54%) and FIL100+MTX (43%) achieved DAS28(CRP) <2.6 versus MTX (29%) (p<0.001 for both) at week 24. Hierarchical testing stopped for comparison of ACR20 for FIL200 monotherapy (78%) versus MTX (71%) at week 24 (p=0.058). Adverse event rates through week 52 were comparable between all treatments.

conclusionsFIL200+MTX and FIL100+MTX both significantly improved signs and symptoms and physical function in patients with active RA and limited or no prior MTX exposure; FIL200 monotherapy did not have a superior ACR20 response rate versus MTX. Filgotinib was well tolerated, with acceptable safety compared with MTX.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationHumansMethotrexatePyridinesTreatment OutcomeTriazolesAntirheumatic AgentsGLPG0634MethotrexatePyridinesTriazolesantirheumatic agentsarthritisrheumatoidtherapeutics

Identifiers

PMID33452004
PMCPMC8142453
OpenAlexW3118646829

What OpenQuestion holds

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LicenceCC BY-NC
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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.