Evidence map›Paper›PMID 38531621›Full record

Trial reportRMD open2024

Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study.

Laura C Coates, Laure Gossec, Miriam Zimmermann, May Shawi, Emmanouil Rampakakis, Natalie J Shiff, Alexa P Kollmeier, Xie L Xu, Peter Nash, Philip J Mease and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in RMD open, 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

9 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Uveitis in Psoriatic Arthritis: A Comprehensive Review.European journal of rheumatology · 2025
    Article
  7. Article
  8. Review
  9. Article
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

11 authors at 9 institutions in 6 countries.

Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK laura.coates@ndorms.ox.ac.uk.ORCID 0000-0002-4756-663X
Laure GossecINSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Universite, Paris, France.ORCID 0000-0002-4528-310X
Miriam ZimmermannImmunology, Janssen Medical Affairs, LLC, Zug, Switzerland.ORCID 0000-0001-6063-3000
May ShawiImmunology, Janssen Research & Development LLC, Titusville, New Jersey, USA.
Emmanouil RampakakisScientific Affairs, JSS Medical Research Inc, Montreal, Quebec, Canada.ORCID 0000-0002-7427-8246
Natalie J ShiffDepartment of Community Health & Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Alexa P KollmeierJanssen Research & Development LLC, San Diego, California, USA.
Xie L XuJanssen Research & Development LLC, San Diego, California, USA.
Peter NashGriffith University, Nathan, Queensland, Australia.ORCID 0000-0002-2571-788X
Philip J MeaseRheumatology Research, Providence Swedish Medical Center, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Philip S HelliwellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-4155-9105
Janssen (United States) · USGriffith University · AUInserm · FRJanssen (Switzerland) · CHMcGill University · CANuffield Orthopaedic Centre · GBProvidence College · USUniversity of Leeds · GBUniversity of Saskatchewan · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEvaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).

methodsPost hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data.

results442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported.

conclusionIn biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets.

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticBiological ProductsEnthesopathyInflammatory Bowel DiseasesJoint DiseasesPsoriasisUveitisDouble-Blind MethodHumansAntibodies, Monoclonal, HumanizedBiological ProductsguselkumabBiological TherapyPsoriatic ArthritisSeverity of Illness Index

Identifiers

PMID38531621
PMCPMC10966800
OpenAlexW4393204527

What Socratic 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 Socratic graph.