Evidence map›Paper›PMID 33822898›Full record

Trial reportRheumatology (Oxford, England)2021

Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies.

Dennis McGonagle, Iain B McInnes, Atul Deodhar, Georg Schett, May Shawi, Shelly Kafka, Chetan S Karyekar, Alexa P Kollmeier, Elizabeth C Hsia, Xie L Xu and 6 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2021. 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 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 5% 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.

NCT03158285 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2020Enrolled741ConditionsArthritis, PsoriaticArmsGuselkumab, Placebo
NCT03162796 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2019Enrolled383ConditionsArthritis, PsoriaticArmsGuselkumab, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  6. Article
  7. Observational
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  12. Enthesitis in IBD Patients.Journal of clinical medicine · 2024
    Review
  13. Article
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  17. Article
  18. Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023
    Article
  19. Targeted Therapies in Psoriatic Arthritis-An Update.International journal of molecular sciences · 2023
    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

16 authors at 9 institutions in 6 countries.

Dennis McGonagleDepartment of Rheumatology, Leeds Biomedical Research Centre, University of Leeds, Leeds.ORCID 0000-0001-7715-8226
Iain B McInnesDepartment of Rheumatology, University of Glasgow, Glasgow, UK.
Atul DeodharDepartment of Rheumatology, Oregon Health & Science University, Portland, OR, USA.
Georg SchettInternal Medicine 3, FAU Erlangen-Nuremburg and Universitatsklinikum, Erlangen, Germany.
May ShawiDepartment of Immunology, Janssen Global Services.
Shelly KafkaDepartment of Immunology, Janssen Scientific Affairs, LLC, Horsham, PA.
Chetan S KaryekarDepartment of Immunology, Janssen Global Services.
Alexa P KollmeierDepartment of Immunology, Janssen Research & Development, LLC, San Diego, CA.
Elizabeth C HsiaDepartment of Immunology, Janssen Research & Development, LLC, Spring House.
Xie L XuDepartment of Immunology, Janssen Research & Development, LLC, San Diego, CA.
Shihong ShengDepartment of Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA.
Prasheen AgarwalDepartment of Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA.
Bei ZhouDepartment of Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA.
Christopher T RitchlinAllergy/Immunology and Rheumatology, University of Rochester Medical Center, Rochester, NY, USA.
Proton RahmanDepartment of Rheumatology, Memorial University of Newfoundland, St Johns, NL, Canada.
Philip J MeaseDepartment of Rheumatology, Swedish Medical Center/Providence, St Joseph Health and University of Washington, Seattle, WA, USA.ORCID 0000-0002-6620-0457
Janssen (United States) · USJanssen (Switzerland) · CHMemorial University of Newfoundland · CAOregon Health & Science University · USProvidence College · USUniversitätsklinikum Erlangen · DEUniversity of Glasgow · GBUniversity of Leeds · GBUniversity of Rochester Medical Center · US

Funding

Janssen Research & Development
6 · The paper itself

Abstract

objectiveTo further characterize the effect of guselkumab, a selective IL-23p19-subunit inhibitor approved for PsA, on enthesitis and assess relationships between enthesitis resolution and patient status/outcomes.

methodsAdults with active PsA despite standard therapies in the phase 3 DISCOVER-1 and DISCOVER-2 studies were randomized 1:1:1 to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, Q8W; or placebo through week 20 followed by guselkumab 100 mg Q4W. Independent assessors evaluated enthesitis using the Leeds Enthesitis Index (LEI; total score 0-6). Enthesitis findings through week 24 were pre-specified to be pooled across studies; post hoc and week 52 analyses also employed pooled data.

resultsAmong 1118 randomized, treated patients in DISCOVER-1 and 2 who had ≥1 LEI site evaluated, 65% had enthesitis at baseline. These patients exhibited numerically more swollen and tender joints, systemic inflammation and impaired physical function than patients without enthesitis. Guselkumab Q4W and Q8W were superior to placebo in resolving pre-existing enthesitis at week 24 (45 and 50% vs 29%; both adjusted P = 0.0301). Enthesitis resolution rates continued to rise; 58% of guselkumab-randomized patients achieved resolution at week 52, including patients with mild (LEI = 1; 70-75%), moderate (LEI = 2; 69-73%) or severe (LEI = 3-6; 42-44%) enthesitis at baseline. Among guselkumab-randomized patients with resolved enthesitis at week 24, 42% achieved minimal disease activity at week 52, vs 17% of patients with unresolved enthesitis.

conclusionGuselkumab resulted in higher proportions of PsA patients with resolved enthesitis by week 24, with maintenance of resolution rates through 1 year. As enthesitis confers greater disease burden, sustained resolution could portend better patient outcomes. CLINICAL

trial registrationDISCOVER 1 (NCT03162796) and DISCOVER 2 (NCT03158285).

Indexed as

AdultAntibodies, Monoclonal, HumanizedArthritis, PsoriaticEnthesopathyFemaleHumansInterleukin-23 Subunit p19MaleMiddle AgedAntibodies, Monoclonal, HumanizedguselkumabInterleukin-23 Subunit p19biologicenthesesinterleukin-23p19 proteinpsoriatic arthritisspondyloarthritis

Identifiers

PMID33822898
PMCPMC8566200
OpenAlexW3145673326

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.