Evidence map›Paper›PMID 33568556›Full record

Trial reportRMD open2021

Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced.

Christopher T Ritchlin, Philip S Helliwell, Wolf-Henning Boehncke, Enrique R Soriano, Elizabeth C Hsia, Alexa P Kollmeier, Soumya D Chakravarty, Federico Zazzetti, Ramanand A Subramanian, Xie L Xu and 9 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
12.1field-weighted citation impact, top 1% 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.

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

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 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

19 authors at 8 institutions in 6 countries.

Christopher T RitchlinRheumatology, University of Rochester Medical Center, Rochester, New York, USA Christopher_Ritchlin@URMC.Rochester.edu.ORCID 0000-0002-2602-1219
Philip S HelliwellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, West Yorkshire, UK.ORCID 0000-0002-4155-9105
Wolf-Henning BoehnckeDermatology, University of Geneva Hospitals, Geneva, Switzerland.
Enrique R SorianoRheumatology Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Federal District, Argentina.ORCID 0000-0003-3143-1084
Elizabeth C HsiaImmunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Alexa P KollmeierImmunology, Janssen Research & Development LLC, San Diego, California, USA.
Soumya D ChakravartyRheumatology, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA.ORCID 0000-0001-7957-838X
Federico ZazzettiImmunology Medical Affairs, Janssen Latin America LLC, Buenos Aires, Argentina.
Ramanand A SubramanianImmunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Xie L XuImmunology, Janssen Research & Development LLC, San Diego, California, USA.
Qing C ZurawImmunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Shihong ShengBiostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Yusang JiangBiostatistics, Cytel Inc on behalf of Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Prasheen AgarwalBiostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Bei ZhouBiostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Yanli ZhuangBiologics Clinical Pharmacology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
May ShawiImmunology Medical Affairs, Janssen Global Services LLC, Horsham, PA, USA.
Chetan S KaryekarImmunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA.
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
Janssen (Belgium) · BECancer Research And Biostatistics · USHospital Italiano de Buenos Aires · ARJanssen (Switzerland) · CHOregon Health & Science University · USUniversity of Geneva · CHUniversity of Leeds · GBUniversity of Rochester Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEvaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year.

methodsAdults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated.

resultsOf 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease.

conclusionGuselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticBiological ProductsAdultAntibodies, Monoclonal, HumanizedHumansInterleukin-23 Subunit p19Quality of LifeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiological ProductsguselkumabInterleukin-23 Subunit p19arthritisbiological therapycytokinespsoriatictumor necrosis factor inhibitors

Identifiers

PMID33568556
PMCPMC7880108
OpenAlexW3126609786

What OpenQuestion holds

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LicenceCC BY-NC
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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.