Evidence map›Paper›PMID 38472528›Full record

ArticleClinical rheumatology2024

Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis.

Proton Rahman, Iain B McInnes, Atul Deodhar, Georg Schett, Phillip J Mease, May Shawi, Daniel J Cua, Jonathan P Sherlock, Alexa P Kollmeier, Xie L Xu and 3 more

Registry-linked trialOpen access · hybridAbstract readEvaluation Study
In one paragraph

Article in Clinical rheumatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03158285 (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), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% 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
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. 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 9 institutions in 4 countries.

Proton RahmanMemorial University of Newfoundland, St. Johns, NF, Canada.ORCID http://orcid.org/0000-0002-4521-2029
Iain B McInnesUniversity of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-6462-4280
Atul DeodharOregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0002-2130-1246
Georg SchettFAU Erlangen-Nürnberg and Universitätsklinikum, Erlangen, Germany.ORCID http://orcid.org/0000-0001-8740-9615
Phillip J MeaseRheumatology Research, Providence Swedish Medical Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-6620-0457
May ShawiJanssen Research & Development, LLC, Titusville, NJ, USA.ORCID http://orcid.org/0000-0001-6005-3938
Daniel J CuaJanssen Research & Development, LLC, Spring House, PA, USA.
Jonathan P SherlockJanssen Research & Development, LLC, Spring House, PA, USA.ORCID http://orcid.org/0000-0003-2596-2209
Alexa P KollmeierJanssen Research & Development, LLC, San Diego, CA, USA.ORCID http://orcid.org/0000-0002-2059-7866
Xie L XuJanssen Research & Development, LLC, San Diego, CA, USA.
Shihong ShengJanssen Research & Development, LLC, Spring House, PA, USA.
Christopher T RitchlinUniversity of Rochester Medical Center, Rochester, NY, USA.ORCID http://orcid.org/0000-0002-2602-1219
Dennis McGonagleLeeds Biomedical Research Centre, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA, UK. D.G.McGonagle@leeds.ac.uk.ORCID http://orcid.org/0000-0001-7715-8226
Janssen (United States) · USMemorial University of Newfoundland · CAOregon Health & Science University · USProvidence College · USUniversitätsklinikum Erlangen · DEUniversity of Glasgow · GBUniversity of Leeds · GBUniversity of Oxford · GBUniversity of Rochester Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the association between enthesitis resolution (ER) and dactylitis resolution (DR) and meaningful improvements in patient-reported outcomes (PROs) among biologic-naïve patients with PsA receiving guselkumab in the DISCOVER-2 study.

methodsEnthesitis and dactylitis, characteristic lesions of PsA, were evaluated by independent assessors using the Leeds Enthesitis Index (range, 0-6) and Dactylitis Severity Score (range, 0-60). Proportions of patients with ER or DR (score = 0) among those with score > 0 at baseline were determined at weeks 24, 52, and 100. PROs included: fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]), pain (0-100 visual analog scale), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and health-related quality of life (36-item Short-Form Health Survey physical/mental component summary [SF-36 PCS/MCS]). Meaningful responses were defined as: improvements of ≥ 4 for FACIT-Fatigue, ≥ 0.35 for HAQ-DI, and ≥ 5 for SF-36 PCS/MCS and absolute scores of ≤ 15 for minimal pain and ≤ 0.5 for normalized HAQ-DI. Associations between ER/DR status and PRO response status were tested using a Chi-square test.

resultsGuselkumab-treated patients with ER were more likely than those without ER to achieve minimal pain (p < 0.001), normalized HAQ-DI (p < 0.001), and PCS response (p < 0.05) at weeks 24, 52, and 100. Patients with DR were more likely than those without DR to achieve FACIT-Fatigue response at week 24 and week 52 (both p ≤ 0.01) and minimal pain at week 24 and normalized HAQ-DI at week 52 (both p ≤ 0.03).

conclusionIn biologic-naïve patients with active PsA treated with guselkumab, achieving ER or DR was associated with durable improvements in selected PROs, including those of high importance to patients.

trial registrationClinicalTrials.gov ( https://clinicaltrials.gov ) NCT03158285; Registered: May 16, 2017. Key Points • At week 100, 65% and 76% of guselkumab-treated patients achieved enthesitis and dactylitis resolution (ER/DR). • Achieving ER was associated with achieving DR and vice versa through the end of study. • Achieving ER or DR was associated with durable and meaningful improvements in selected patient-reported outcomes.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticBiological ProductsEnthesopathyHumansPainPatient Reported Outcome MeasuresQuality of LifeTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiological ProductsguselkumabBiologicDactylitisEnthesitisGuselkumabPsoriatic arthritis

Identifiers

PMID38472528
PMCPMC11018666
OpenAlexW4394765285

What OpenQuestion holds

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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.