Evidence map›Paper›PMID 33504485›Full record

Trial reportAnnals of the rheumatic diseases2021

Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial.

Bernard Combe, Alan Kivitz, Yoshiya Tanaka, Désirée van der Heijde, J Abraham Simon, Herbert S B Baraf, Uma Kumar, Franziska Matzkies, Beatrix Bartok, Lei Ye and 10 more

Registry-linked trialOpen access · hybridAbstract 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 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 132 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 8 pooled it
23.6field-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.

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

132 citing papers in PubMed, 8 syntheses or guidelines pooled it, 235 citations in OpenAlex.

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72 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

20 authors at 13 institutions in 9 countries.

Bernard CombeRheumatology, CHU Montpellier, Montpellier, France bernard.combe@umontpellier.fr.ORCID 0000-0003-4002-1861
Alan KivitzAltoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
Yoshiya TanakaFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Désirée van der HeijdeRheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
J Abraham SimonKöhler & Milstein Research, Mérida, Mexico.
Herbert S B BarafThe Center for Rheumatology and Bone Research, Wheaton, Maryland, USA.
Uma KumarRheumatology, All India Institute of Medical Sciences, New Delhi, India.ORCID 0000-0003-3281-7683
Franziska MatzkiesGilead Sciences, Foster City, California, USA.
Beatrix BartokGilead Sciences, Foster City, California, USA.
Lei YeGilead 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.
Mark C GenoveseGilead Sciences, Foster City, California, USA.
Neelufar MozaffarianIchnos Sciences, New York, New York, USA.
Robert B M LandewéRheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam, The Netherlands.ORCID 0000-0002-0577-6620
Sang-Cheol BaeRheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.ORCID 0000-0003-4658-1093
Edward C KeystoneMedicine, University of Toronto, Mount Sinai Hospital, Toronto, Ontario, Canada.
Peter NashGriffith University, Brisbane, Queensland, Australia.ORCID 0000-0002-2571-788X
Gilead Sciences (United States) · USCenter for Rheumatology · USAltoona Center for Clinical Research · USAmsterdam University Medical Centers · NLCentre Hospitalier Universitaire de Montpellier · FRDuke Medical Center · USGalapagos (Belgium) · BEGriffith University · AUHanyang University Seoul Hospital · KRIchnos Sciences (United States) · USLeiden University Medical Center · NLMount Sinai Hospital · CAUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of the Janus kinase-1-preferential inhibitor filgotinib versus placebo or tumour necrosis factor-α inhibitor therapy in patients with active rheumatoid arthritis (RA) despite ongoing treatment with methotrexate (MTX).

methodsThis 52-week, multicentre, double-blind, placebo-controlled and active-controlled phase III trial evaluated once-daily oral filgotinib in patients with RA randomised 3:3:2:3 to filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100), subcutaneous adalimumab 40 mg biweekly, or placebo (through week 24), all with stable weekly background MTX. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Additional efficacy outcomes were assessed sequentially. Safety was assessed from adverse events and laboratory abnormalities.

resultsThe proportion of patients (n=1755 randomised and treated) achieving ACR20 at week 12 was significantly higher for FIL200 (76.6%) and FIL100 (69.8%) versus placebo (49.9%; treatment difference (95% CI), 26.7% (20.6% to 32.8%) and 19.9% (13.6% to 26.2%), respectively; both p<0.001). Filgotinib was superior to placebo in key secondary endpoints assessing RA signs and symptoms, physical function and structural damage. FIL200 was non-inferior to adalimumab in terms of Disease Activity Score in 28 joints with C reactive protein ≤3.2 at week 12 (p<0.001); FIL100 did not achieve non-inferiority. Adverse events and laboratory abnormalities were comparable among active treatment arms.

conclusionsFilgotinib improved RA signs and symptoms, improved physical function, inhibited radiographic progression and was well tolerated in patients with RA with inadequate response to MTX. FIL200 was non-inferior to adalimumab. TRIAL REGISTRATION NUMBER: NCT02889796.

Indexed as

AdalimumabAdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedPyridinesTriazolesAdalimumabAntirheumatic AgentsGLPG0634MethotrexatePyridinesTriazolesantirheumatic agentsarthritisrheumatoidtherapeutics

Identifiers

PMID33504485
PMCPMC8237199
OpenAlexW3124339251

What OpenQuestion holds

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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.