Evidence map›Paper›PMID 29566740›Full record

Trial reportArthritis research & therapy2018

Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: patient-reported outcomes.

Mark Genovese, Rene Westhovens, Luc Meuleners, Annegret Van der Aa, Pille Harrison, Chantal Tasset, Arthur Kavanaugh

2 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
–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.

NCT01888874 phase2completednot on this map

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2013 to 2015Enrolled599ConditionsRheumatoid ArthritisArmsGLPG0634, Placebo
NCT01894516 phase2completednot on this map

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2013 to 2015Enrolled287ConditionsRheumatoid ArthritisArmsGLPG0634, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  8. The application prospects of sacha inchi (Frontiers in pharmacology · 2024
    Review
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  11. Article
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  17. JAK Inhibitors: What Is New?Current rheumatology reports · 2020
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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.

Mark GenoveseDivision of Immunology and Rheumatology, Stanford School of Medicine, Stanford, CA, USA. genovese@stanford.edu.
Rene WesthovensDepartment of Development and Regeneration KU Leuven, Skeletal Biology and Engineering Research Center; Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Luc MeulenersGalapagos NV, Mechelen, Belgium.
Annegret Van der AaGalapagos NV, Mechelen, Belgium.
Pille HarrisonGalapagos NV, Mechelen, Belgium.
Chantal TassetGalapagos NV, Mechelen, Belgium.
Arthur KavanaughUniversity of California San Diego, La Jolla, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim was to assess patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) treated with filgotinib during two phase 2b, 24-week, randomized, placebo-controlled studies.

methodsPatients with moderate-to-severe active RA and an inadequate response to methotrexate (MTX) were randomized to daily placebo or filgotinib 50 mg, 100 mg, or 200 mg as add-on therapy to MTX (NCT01888874) or as monotherapy (NCT01894516). At week 12, nonresponders receiving filgotinib 50 mg in both studies or placebo in the add-on study, and all patients receiving placebo as monotherapy, were re-assigned to filgotinib 100 mg. PROs were measured using the Health Assessment Questionnaire - Disability Index (HAQ-DI) including Patient Pain assessed by visual analog scale, and the Patient Global Assessment of Disease Activity (Patient Global), the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (Version 4), and the 36-Item Short Form Health Survey (SF-36).

resultsAt week 12, improvements in all PROs, apart from the SF-36 mental component in the add-on study, were statistically better with filgotinib than placebo; some improvements were noted as early as the first assessment time point (week 1 or week 4). Filgotinib improved HAQ-DI by 0.58-0.84 points, FACIT-Fatigue by 6.9-11.4 points, Patient Global by 25.2-35.6 mm, and Pain by 24.2-37.9 mm; scores were maintained or improved to week 24. Across all PROs, more patients achieved minimal clinically important differences and normative values with filgotinib 200 mg than placebo. Patients re-assigned to filgotinib 100 mg at week 12 experienced improvements in PROs between weeks 12 to 24.

conclusionsFilgotinib as MTX add-on therapy or as monotherapy demonstrated rapid and sustained (to 24 weeks) improvements in health-related quality of life and functional status in patients with active RA.

trial registrationMTX add-on study: ClinicalTrials.gov , NCT01888874 . Registered on 28 June 2013. Monotherapy study: ClinicalTrials.gov , NCT01894516 . Registered on 10 July 2013.

Indexed as

Patient Reported Outcome MeasuresAntirheumatic AgentsArthritis, RheumatoidDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHumansJanus Kinase 1MaleMethotrexateMiddle AgedProtein Kinase InhibitorsPyridinesTreatment OutcomeTriazolesAntirheumatic AgentsGLPG0634Janus Kinase 1MethotrexateProtein Kinase InhibitorsPyridinesTriazolesFilgotinibJAK inhibitorPatient-Reported Outcome MeasuresRheumatoid Arthritis

Identifiers

PMID29566740
PMCPMC5865354

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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.