Evidence map›Paper›PMID 35296534›Full record

ArticleRMD open2022

Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies.

Christopher T Ritchlin, Philip J Mease, Wolf-Henning Boehncke, John Tesser, Elena Schiopu, Soumya D Chakravarty, Alexa P Kollmeier, Xie L Xu, May Shawi, Yusang Jiang and 6 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in RMD open, 2022. 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 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
4.1field-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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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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

16 authors at 10 institutions in 3 countries.

Christopher T RitchlinDepartment of Medicine - Allergy/Immunology and Rheumatology, University of Rochester Medical Center, Rochester, New York, USA christopher_ritchlin@urmc.rochester.edu.ORCID 0000-0002-2602-1219
Philip J MeaseRheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Wolf-Henning BoehnckeDivision of Dermatology and Venereology, Geneva University Hospitals, Geneva, Switzerland.
John TesserArizona Arthritis & Rheumatology Associates, Phoenix, Arizona, USA.
Elena SchiopuDepartment of Rheumatology & Internal Medicine, Michigan Medicine Rheumatology Clinic, Ann Arbor, Michigan, USA.ORCID 0000-0002-1831-5292
Soumya D ChakravartyImmunology, Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.ORCID 0000-0001-7957-838X
Alexa P KollmeierImmunology, Janssen Research and Development LLC, San Diego, California, USA.
Xie L XuImmunology, Janssen Research and Development LLC, San Diego, California, USA.
May ShawiImmunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Horsham, Pennsylvania, USA.
Yusang JiangBiostatistics, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.
Shihong ShengBiostatistics, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.
Yanli WangBiostatistics, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.
Stephen XuBiostatistics, Janssen Research and Development LLC, Spring House, Pennsylvania, USA.
Joseph F MerolaDermatology and Medicine, Division of Rheumatology and Immunology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Iain B McInnesInstitute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK.ORCID 0000-0003-4449-8501
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
Janssen (United States) · USArthritis and Rheumatism Associates · USBrigham and Women's Hospital · USJohnson & Johnson (United States) · USMichigan Medicine · USOregon Health & Science University · USUniversity Hospital of Geneva · CHUniversity of Glasgow · GBUniversity of Rochester Medical Center · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy through 52 weeks of guselkumab, an interleukin 23-p19 subunit inhibitor, in subgroups of pooled psoriatic arthritis (PsA) patients from the DISCOVER-1 and DISCOVER-2 trials defined by baseline patient characteristics.

methodsAdults with active PsA despite standard therapies were enrolled in DISCOVER-1 (≥3 swollen and ≥3 tender joints, C reactive protein (CRP) level ≥0.3 mg/dL) and DISCOVER-2 (≥5 swollen and ≥5 tender joints, CRP ≥0.6 mg/dL, biological-naïve). Randomised patients received 100 mg guselkumab at weeks 0, 4, and then every 4 or 8 weeks (Q4W/Q8W) or placebo. Guselkumab effects on joint (ACR20/50/70), skin (IGA 0/1, IGA 0), patient-reported outcome (Health Assessment Questionnaire Disability Index/Functional Assessment of Chronic Illness Therapy-Fatigue) and disease severity (minimal disease activity/PsA Disease Activity Score low disease activity) endpoints were evaluated by patient sex, body mass index, PsA duration, swollen/tender joint counts, CRP level, percent body surface area with psoriasis, Psoriasis Area and Severity Index score, and conventional synthetic disease-modifying antirheumatic drug use at baseline.

resultsBaseline patients characteristics in DISCOVER-1 (N=381) and DISCOVER-2 (N=739) were well balanced across randomised groups. At week 24, 62% (232/373) and 60% (225/375), respectively, of guselkumab Q4W-treated and Q8W-treated patients pooled across DISCOVER-1 and DISCOVER-2 achieved the primary endpoint of ACR20 response versus 29% (109/372) of placebo-treated patients. Guselkumab treatment effect at week 24 was observed across patient subgroups. Within each patient subgroup, response rates across all disease domains were sustained or increased at week 52 with both guselkumab regimens.

conclusionsGuselkumab Q4W and Q8W resulted in robust and sustained improvements in PsA signs and symptoms consistently in subgroups of patients defined by diverse baseline characteristics. TRIAL REGISTRATION NUMBERS: NCT03162796, NCT03158285.

Indexed as

Arthritis, PsoriaticAdultAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicDemographyHumansRandomized Controlled Trials as TopicTreatment OutcomeAntibodies, Monoclonal, Humanizedguselkumabarthritis, psoriaticbiological therapytherapeutics

Identifiers

PMID35296534
PMCPMC8928386
OpenAlexW4220885824

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.