Evidence map›Paper›PMID 35352313›Full record

ArticleRheumatology and therapy2022

Collagen Turnover Biomarkers Associate with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase 3 Clinical Trial (DISCOVER-2).

Georg Schett, Matthew J Loza, Arumugam Palanichamy, Oliver FitzGerald, Christopher Ritchlin, Anne-Christine Bay-Jensen, Signe Holm Nielsen, Sheng Gao, Elizabeth C Hsia, Alexa P Kollmeier and 3 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Rheumatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03158285 (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), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Georg SchettDepartment of Internal Medicine 3, Friedrich Alexander University Erlangen-Nuremberg and Universitätsklinikum Erlangen, Erlangen, Germany. georg.schett@uk-erlangen.de.ORCID http://orcid.org/0000-0001-8740-9615
Matthew J LozaJanssen Research & Development LLC, Spring House, PA, USA.
Arumugam PalanichamyJanssen Research & Development LLC, Spring House, PA, USA.
Oliver FitzGeraldSchool of Medicine, Conway Institute for Biomolecular Research, University College Dublin, Dublin 4, Ireland.
Christopher RitchlinMedical Center, University of Rochester, Rochester, NY, USA.
Anne-Christine Bay-JensenNordic Bioscience, Herlev, Denmark.
Signe Holm NielsenNordic Bioscience, Herlev, Denmark.
Sheng GaoJanssen Research & Development LLC, Spring House, PA, USA.
Elizabeth C HsiaJanssen Research & Development LLC, Spring House, PA, USA.
Alexa P KollmeierJanssen Research & Development, LLC, San Diego, CA, USA.
Xie L XuJanssen Research & Development, LLC, San Diego, CA, USA.
Frédéric BaribaudJanssen Research & Development LLC, Spring House, PA, USA.
Kristen SweetJanssen Research & Development LLC, Spring House, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGuselkumab, a novel interleukin-23p19 subunit monoclonal antibody, has been shown to effectively improve the diverse manifestations of active psoriatic arthritis (PsA) in two phase 3 trials (DISCOVER-1, DISCOVER-2). Serum concentrations of extracellular matrix (ECM) biomarkers at baseline and following treatment with guselkumab were evaluated in patients with active PsA, and the relationship of these biomarkers with baseline PsA characteristics and clinical response to guselkumab treatment was explored.

methodsSerum samples were collected at weeks 0, 4, 24, and 52 from a selected subset (N = 260) of the 739 biologic-naïve patients with PsA treated with guselkumab 100 mg every 4 or 8 weeks or placebo in DISCOVER-2. Demographically matched healthy controls (N = 76) were used for comparison. The samples were analyzed for ECM biomarkers associated with collagen degradation (C1M, C2M, C3M, C4M, C6M, C10C) and collagen formation (PRO-C1, PRO-C2, PRO-C3, PRO-C4, PRO-C6).

resultsBaseline concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M and collagen formation biomarkers PRO-C3 and PRO-C6 were significantly higher (i.e., ≥ 1.25-fold and false discovery rate adjusted p < 0.05) in PsA patients than in healthy controls. Serum C1M, C3M, C4M, and C6M levels declined from baseline in guselkumab-treated patients in both dosing regimens. In addition, guselkumab-treated ACR20 responders (≥ 20% improvement in American College of Rhematology response criteria) had significantly lower C1M levels than ACR20 nonresponders.

conclusionThese data demonstrate that serum collagen biomarkers are elevated in patients with PsA compared with healthy controls and that treatment with guselkumab decreases levels of C1M, C3M, C4M, and C6M. Importantly, C1M serves as a biomarker that associates with improvement of joint signs and symptoms.

trial registrationClinicalTrials.gov identifier: NCT03158285.

Indexed as

BiomarkersCollagen turnoverExtracellular matrixGuselkumabPsoriatic arthritis

Identifiers

PMID35352313
PMCPMC9314487

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.