Evidence map›Paper›PMID 34385364›Full record

Trial reportRMD open2021

Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3.

Daniel Aletaha, René Westhovens, Cecile Gaujoux-Viala, Giovanni Adami, Alan Matsumoto, Paul Bird, Osvaldo Daniel Messina, Maya H Buch, Beatrix Bartok, Zhaoyu Yin and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Efficacy of Janus kinase inhibitors in rheumatoid arthritis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2023
    Review
  9. Article
  10. Article
  11. Review
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

13 authors at 10 institutions in 9 countries.

Daniel AletahaDivision of Rheumatology, Medical University of Vienna, Wien, Austria daniel.aletaha@meduniwien.ac.at.ORCID 0000-0003-2108-0030
René WesthovensDepartment of Development and Regeneration, KU Leuven University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-3432-3073
Cecile Gaujoux-VialaDepartment of Rheumatologie, Centre Hospitalier Universitaire de Nîmes, Nimes, France.
Giovanni AdamiDivision of Rheumatology, University of Verona, Verona, Italy.ORCID 0000-0002-8915-0755
Alan MatsumotoArthritis and Rheumatism Associates PC, Wheaton, Maryland, USA.
Paul BirdSt George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Osvaldo Daniel MessinaDepartment of Rheumatology and Metabolic Bone Diseases, Investigaciones Reumatológicas y Osteológicas srl, Buenos Aires, Argentina.
Maya H BuchCentre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, The University of Manchester, Manchester, UK.ORCID 0000-0002-8962-5642
Beatrix BartokGilead Sciences Inc, Foster City, California, USA.ORCID 0000-0003-1136-4662
Zhaoyu YinGilead Sciences Inc, Foster City, California, USA.
Ying GuoGilead Sciences Inc, Foster City, California, USA.
Thijs HendrikxGalapagos BV, Leiden, The Netherlands.
Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0001-7518-1131
Gilead Sciences (United States) · USArthritis and Rheumatism Associates · USCharité - Universitätsmedizin Berlin · DEGalapagos (Netherlands) · NLInserm · FRKU Leuven · BEMedical University of Vienna · ATSutherland Hospital · AUUniversity of Manchester · GBUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).

methodsThis was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population.

resultsOf 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed.

conclusionFIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidDrug Therapy, CombinationHumansMethotrexatePrognosisPyridinesTreatment OutcomeTriazolesAntirheumatic AgentsGLPG0634MethotrexatePyridinesTriazolesantirheumatic agentsarthritisrheumatoidtherapeutics

Identifiers

PMID34385364
PMCPMC8362717
OpenAlexW3187665402

What OpenQuestion holds

Textmetadata
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.