Evidence map›Paper›PMID 39261446›Full record

ArticleRheumatology and therapy2024

Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials.

Jeffrey R Curtis, Atul Deodhar, Enrique R Soriano, Emmanouil Rampakakis, May Shawi, Natalie J Shiff, Chenglong Han, William Tillett, Dafna D Gladman

2 registry-linked trialsAbstract read
In one paragraph

Article in Rheumatology and therapy, 2024. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Article
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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

9 authors.

Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA. jrcurtis@uabmc.edu.ORCID http://orcid.org/0000-0002-8907-8976
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.
Enrique R SorianoRheumatology Section, Internal Medicine Service, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.ORCID http://orcid.org/0000-0003-3143-1084
Emmanouil RampakakisDepartment of Pediatrics, McGill University, Montreal, Canada.
May ShawiJanssen Research & Development, LLC, Immunology, Titusville, NJ, USA.
Natalie J ShiffJanssen Scientific Affairs, LLC, a Johnson & Johnson Company, Immunology, Horsham, PA, USA.
Chenglong HanJanssen Global Services, LLC, Immunology, Malvern, PA, USA.
William TillettDepartment of Pharmacy and Pharmacology, Centre for Therapeutic Innovation, Royal National Hospital For Rheumatic Diseases, Combe Park, Bath, UK.ORCID http://orcid.org/0000-0001-7531-4125
Dafna D GladmanDepartment of Medicine, Center for Prognosis Studies in Rheumatic Diseases, Schroeder Arthritis Institute, Krembil Research Institute, University of Toronto, Toronto, Canada.

Funding

Methods and Health Informatics CoreP30AR072583 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI JEFFREY R. CURTIS · 2020 to 2026
$5.7M
NIAMS NIH HHS P30 AR072583
6 · The paper itself

Abstract

introductionPatterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA).

methodsPost hoc analyses evaluated 1120 patients with PsA receiving guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo from DISCOVER-1 (31% tumor necrosis factor inhibitor-experienced) and DISCOVER-2 (biologic-naïve). Achievement of MCII in clinical Disease Activity Index for PsA (cDAPSA), patient global assessment (PtGA) of arthritis, PtGA of psoriasis, patient-reported pain, Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index, 36-item Short-Form Health Survey Physical Component Summary score, PtGA Arthritis + Psoriasis, and PsA Disease Activity Score (PASDAS) was compared between the guselkumab and placebo groups using Cox regression. Logistic regression adjusting for baseline factors evaluated associations between early (W4/W8) MCII achievement and stringent response (≥%50/%70 improvement in American College of Rheumatology response criteria, cDAPSA low disease activity [LDA], PASDAS LDA, and minimal disease activity) at W24/W52 among guselkumab-randomized patients.

resultsAmong patients with highly active PsA (baseline cDAPSA = 44.1-45.0, PASDAS = 6.4-6.5), times to MCII were significantly faster for guselkumab vs. placebo (hazard ratios 1.3-2.5; P < 0.05). Across measures, at first timepoint assessed, MCII rates were significantly higher with guselkumab (Q4W/Q8W 28-68%/29-65%) vs. placebo (19-47%; both P < 0.05). Early (W4/W8) MCII with guselkumab associated with higher odds of achieving stringent responses at W24/W52 (odds ratios 1.4-17.2/1.4-5.4).

conclusionsIn a mixed PsA population, significant proportions of patients treated with guselkumab achieved early (W4/W8) MCII across clinical and PRO measures, which associated with a higher likelihood of attaining clinically relevant improvements and low levels of disease activity at W24/W52.

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

Indexed as

Disease activityFatigueGuselkumabJoint diseaseMinimal clinically meaningful improvementPainPatient-reported outcomePhysical functionPsoriatic arthritisSkin psoriasis

Identifiers

PMID39261446
PMCPMC11557817

What Socratic 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 Socratic graph.