Evidence map›Paper›PMID 31624837›Full record

Trial reportRheumatology (Oxford, England)2020

Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR).

Ana-Maria Orbai, Alexis Ogdie, Laure Gossec, William Tillett, Ying Ying Leung, Jingjing Gao, Mona Trivedi, Chantal Tasset, Luc Meuleners, Robin Besuyen and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03101670 (A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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.

NCT03101670 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2017 to 2018Enrolled131ConditionsPsoriatic ArthritisArmsfilgotinib, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. JAK Inhibitors in Psoriatic Disease.Clinical, cosmetic and investigational dermatology · 2023
    Review
  10. Review
  11. The JAK/STAT signaling pathway: from bench to clinic.Signal transduction and targeted therapy · 2021
    Review
  12. Review
  13. Measuring Outcomes in Psoriatic Arthritis.Arthritis care & research · 2020
    Review
  14. Efficacy of JAK inhibitors in Crohn's Disease.Journal of Crohn's & colitis · 2020
    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

12 authors at 10 institutions in 6 countries.

Ana-Maria OrbaiDivision of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MA.
Alexis OgdieDivision of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Laure GossecInstitut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université.
William TillettRheumatology, Royal National Hospital for Rheumatic Diseases.
Ying Ying LeungDepartment of Rheumatology & Immunology, Singapore General Hospital, Duke-NUS Medical School, Singapore, Singapore.
Jingjing GaoBiostatistics.
Mona TrivediClinical Research, Gilead Sciences, Inc, Foster City, CA, USA.
Chantal TassetClinical Development.
Luc MeulenersBiostatistics, Galapagos NV, Mechelen, Belgium.
Robin BesuyenClinical Development.
Thijs HendrikxMedical Affairs, Galapagos BV, Leiden, Netherlands.
Laura C CoatesDepartment of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Cancer Research And Biostatistics · USGalapagos (Belgium) · BEGalapagos (Netherlands) · NLGilead Sciences (United States) · USJohns Hopkins University · USRoyal National Hospital for Rheumatic Diseases · GBSingapore General Hospital · SGSorbonne Université · FRUniversity of Oxford · GBUniversity of Pennsylvania · US

Funding

Sample Processing and Immunoassay Research CoreP30AR070254 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI CLIFTON O BINGHAM, Antony Rosen · 2016 to 2026
$8.9M
NIAMS NIH HHS P30 AR070254
6 · The paper itself

Abstract

objectiveTo examine the effects of filgotinib, an oral, selective Janus kinase 1 inhibitor, on health-related quality of life (HRQoL) using the Psoriatic Arthritis Impact of Disease (PsAID)9 questionnaire in active PsA.

methodsPatients were randomized 1 : 1 to filgotinib 200 mg or placebo once daily for 16 weeks in EQUATOR, a multicentre, double-blind, phase 2 randomized controlled trial. HRQoL was assessed with PsAID9 at Weeks 4 and 16. Change from baseline in total and individual domain scores, plus the proportions of patients achieving minimal clinically important improvement (MCII; ⩾3 points) and patient-accepted symptom status (PASS; score <4), were evaluated. Correlation with the 36-item short-form health survey (SF-36) was investigated.

resultsOne hundred and thirty-one patients were randomized to filgotinib or placebo. Filgotinib effects on PsAID9 were observed from Week 4. At Week 16, mean (s.d.) change from baseline in PsAID9 was -2.3 (1.8) and -0.8 (2.2) for filgotinib and placebo, respectively (least-squares mean of group difference -1.48 [95% CI -2.12, -0.84], P < 0.0001), with significant improvements in all domains vs placebo. Significantly more patients on filgotinib achieved MCII (group difference 25.4% [95% CI 8.92, 39.99], P = 0.0022) and PASS (group difference 29.6% [95% CI 10.65, 45.60], P = 0.0018) at Week 16 vs placebo. Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.

conclusionFilgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9. To our knowledge, EQUATOR is the first randomized controlled trial to evaluate PsAID9.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov/ct2/show, NCT03101670.

Indexed as

Quality of LifeAdaptation, PsychologicalArthritis, PsoriaticDouble-Blind MethodFatigueHumansJanus Kinase InhibitorsLeast-Squares AnalysisMinimal Clinically Important DifferencePainPhysical Functional PerformancePsoriasisPyridinesSleep Wake DisordersSocial BehaviorTreatment OutcomeGLPG0634Janus Kinase InhibitorsPyridinesTriazolesclinical trials and methodsDMARDsoutcome measurespsoriatic arthritisquality of life

Identifiers

PMID31624837
PMCPMC7310097
OpenAlexW2968219004

What OpenQuestion holds

Textmetadata
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.