Evidence map›Paper›PMID 39672591›Full record

Trial reportRMD open2024

Sustained response to guselkumab regardless of baseline characteristics in patients with active psoriatic arthritis and inadequate response to TNF inhibitors: results from the phase 3b COSMOS clinical trial.

Iain B McInnes, Philipp Sewerin, Mohamed Sharaf, Michela Efficace, Frédéric Lavie, Miriam Zimmermann, Laura C Coates

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Psoriatic Arthritis: Developments in 2025.Mediterranean journal of rheumatology · 2026
    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

7 authors.

Iain B McInnesCollege of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK Iain.McInnes@glasgow.ac.uk.ORCID 0000-0002-6462-4280
Philipp SewerinRheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Herne, Germany.ORCID 0000-0001-8465-6207
Mohamed SharafJohnson & Johnson, Middle East FZ LLC, Dubai, UAE.ORCID 0009-0003-9847-2996
Michela EfficaceJanssen-Cilag SpA, Imperia, Italy.
Frédéric LavieThe Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France.ORCID 0000-0002-5213-257X
Miriam ZimmermannJanssen EMEA Medical Affairs, LLC, Zug, Switzerland.ORCID 0000-0001-6063-3000
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-4756-663X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo prospectively evaluate the effect of guselkumab through 48 weeks across various clinical outcomes in subgroups of patients with psoriatic arthritis (PsA) and inadequate response to tumour necrosis factor inhibitors (TNFi-IR) from the phase 3b COSMOS trial. Subgroups were defined by baseline demographics, disease characteristics and prior/ongoing therapies.

methodsPatients with active PsA (tender joint count (TJC) and swollen joint count (SJC) both ≥3) and TNFi-IR were randomised 2:1 to receive guselkumab 100 mg at week 0, week 4, then every 8 weeks through week 44 or to placebo with cross-over to guselkumab 100 mg at week 16 (early escape) or week 24 (planned). Guselkumab effect on joints (American College of Rheumatology (ACR) 20/50/70, enthesitis, dactylitis), skin (Psoriasis Area and Severity Index 90/100, Investigator's Global Assessment 0/1), patient-reported outcomes (PROs) (Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index) and composite outcome measures (PsA Disease Activity Score low disease activity, minimal disease activity) were evaluated by baseline patient age, sex, body mass index, SJC, TJC, PsA duration, %body surface area, C reactive protein, pain Visual Analogue Scale, number of prior TNFi and discontinuation reason, and conventional synthetic disease-modifying antirheumatic drug status. Results are descriptive only.

resultsBaseline characteristics were similar between guselkumab (n=189) and placebo (n=96) groups. The benefit of guselkumab over placebo in achieving ACR 20 (primary endpoint; 50% vs 28%) and ACR 50 (23% vs 8%) response at week 24 was observed within all subgroups. Furthermore, response rates in the guselkumab group increased between week 24 and week 48 within almost all subgroups. Similar response patterns at week 24 and through week 48 were observed across various clinical outcomes.

conclusionsGuselkumab every 8 weeks led to consistent improvements through week 24 in joint, skin, PRO and composite outcomes versus placebo across diverse baseline-defined subgroups of TNFi-IR patients with PsA. Response rates increased or were durable through week 48 within most subgroups.

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticAdultAntirheumatic AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresProspective StudiesSeverity of Illness IndexTreatment OutcomeTumor Necrosis Factor InhibitorsAntibodies, Monoclonal, HumanizedAntirheumatic AgentsguselkumabTumor Necrosis Factor Inhibitorsarthritis, psoriaticfatiguepatient reported outcome measures

Identifiers

PMID39672591
PMCPMC11647317

What OpenQuestion holds

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Registered trials

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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.