Evidence map›Paper›PMID 36880890›Full record

ArticleACR open rheumatology2023

Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies.

Dennis McGonagle, Iain B McInnes, Atul Deodhar, Georg Schett, May Shawi, Soumya D Chakravarty, Alexa P Kollmeier, Xie L Xu, Shihong Sheng, Stephen Xu and 3 more

Open access · goldAbstract read
In one paragraph

Article in ACR open rheumatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. 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

13 authors at 11 institutions in 5 countries.

Dennis McGonagleLeeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds; National Institute for Health Research (NIHR) Biomedical Research Centre, Leeds, UK.
Iain B McInnesInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.ORCID https://orcid.org/0000-0002-6462-4280
Atul DeodharOregon Health and Science University, Portland.ORCID https://orcid.org/0000-0002-2130-1246
Georg SchettFriedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.ORCID https://orcid.org/0000-0001-8740-9615
May ShawiImmunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania.
Soumya D ChakravartyJanssen Scientific Affairs, LLC, Horsham, and Drexel University College of Medicine, Philadelphia, Pennsylvania.ORCID https://orcid.org/0000-0001-7957-838X
Alexa P KollmeierJanssen Research & Development, LLC, San Diego, California.
Xie L XuJanssen Research & Development, LLC, San Diego, California.
Shihong ShengImmunology Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania.
Stephen XuImmunology Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania.
Christopher T RitchlinUniversity of Rochester Medical Center, Rochester, New York.ORCID https://orcid.org/0000-0002-2602-1219
Proton RahmanCraig L. Dobbin Genetics Research Centre, Memorial University of Newfoundland, St John's, Newfoundland, Canada.
Phillip J MeaseSwedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington.ORCID https://orcid.org/0000-0002-6620-0457
Janssen (Belgium) · BESpringhouse · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DEInstitute of Infection and Immunity · CAJanssen (United States) · USJohnson & Johnson (United States) · USMemorial University of Newfoundland · CAOregon Health & Science University · USProvidence College · USUniversity of Leeds · GBUniversity of Rochester Medical Center · US

Funding

Janssen Research and Development
6 · The paper itself

Abstract

objectivePrevious analyses of pooled DISCOVER-1 and DISCOVER-2 data through Week 24 showed significantly higher rates of dactylitis resolution in patients treated with guselkumab compared with placebo. Here, we investigate associations between dactylitis resolution and other outcomes through 1 year.

methodsPatients were randomized 1:1:1 to receive subcutaneous injections of guselkumab 100 mg at Week 0, Week 4, and then every 4 or 8 weeks, or placebo with crossover to guselkumab at Week 24. Independent assessors determined dactylitis severity score (DSS; 0-3/digit; total = 0-60). Dactylitis resolution (DSS = 0) (prespecified) and at least 20%, at least 50%, and at least 70% DSS improvement from baseline (post hoc) were determined through Week 52 (nonresponder imputation for treatment failure through Week 24 and for missing data through Week 52). ACR50, tender/swollen joints, low disease activity (LDA) as assessed by composite indices, and radiographic progression (DISCOVER-2 only) were assessed in patients with dactylitis versus without dactylitis resolution at Week 24 and Week 52.

resultsPatients with dactylitis at baseline (473 of 1118) had more severe joint and skin disease than those without dactylitis (645 of 1118). At Week 52, approximately 75% of guselkumab-randomized patients with dactylitis at baseline had complete resolution; approximately 80% had at least 70% DSS improvement. Through Week 52, new-onset dactylitis (DSS ≥1) was uncommon among patients with a DSS of 0 at baseline. Guselkumab-randomized patients with dactylitis resolution were more likely to achieve ACR50, at least 50% reduction in tender and swollen joints, and LDA at Week 24 and Week 52 than those without resolution. At Week 52, patients with dactylitis resolution had numerically less radiographic progression from baseline (DISCOVER-2).

conclusionThrough 1 year, approximately 75% of guselkumab-randomized patients had complete resolution of dactylitis; patients exhibiting resolution were more likely to achieve other important clinical outcomes. Given the high burden of dactylitis, resolution may be associated with better long-term patient outcomes.

Identifiers

PMID36880890
PMCPMC10100698
OpenAlexW4323348387

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.