Evidence map›Paper›PMID 34165604›Full record

Trial reportRheumatology international2021

Revisiting the JOQUER trial: stratification of primary Sjögren's syndrome and the clinical and interferon response to hydroxychloroquine.

Alexis Collins, Dennis Lendrem, James Wason, Jessica Tarn, Nadia Howard-Tripp, Iris Bodewes, Marjan A Versnel, Jacques-Eric Gottenberg, Raphaele Seror, Xavier Mariette and 1 more

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

Trial report in Rheumatology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 11% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Observational
  12. Long Non-Coding RNAs in Sjögren's Disease.International journal of molecular sciences · 2024
    Review
  13. Article
  14. What can patients tell us in Sjögren's syndrome?Rheumatology and immunology research · 2024
    Review
  15. Manifestations and management of Sjögren's disease.Arthritis research & therapy · 2024
    Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

Alexis CollinsMusculoskeletal Research Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-9902-2407
Dennis LendremMusculoskeletal Research Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0001-6268-5509
James WasonFaculty of Medical Sciences, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-4691-126X
Jessica TarnMusculoskeletal Research Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0003-0083-8543
Nadia Howard-TrippMusculoskeletal Research Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-2043-862X
Iris BodewesDepartment of Immunology, Erasmus University Medical Centre, Rotterdam, The Netherlands.ORCID http://orcid.org/0000-0001-5206-4231
Marjan A VersnelDepartment of Immunology, Erasmus University Medical Centre, Rotterdam, The Netherlands.ORCID http://orcid.org/0000-0003-0245-5386
Jacques-Eric GottenbergDepartment of Rheumatology, National Reference Centre for Rare Systemic Autoimmune Diseases, Strasbourg University Hospital, CNRS, IBMC, Université de Strasbourg, UPR 3572, Strasbourg, France.ORCID http://orcid.org/0000-0002-9469-946X
Raphaele SerorCentre for Immunology of Viral Infections and Autoimmune Diseases, INSERM, UMR 1184, Université Paris- Saclay, Paris, France.ORCID http://orcid.org/0000-0002-5523-1856
Xavier MarietteCentre for Immunology of Viral Infections and Autoimmune Diseases, INSERM, UMR 1184, Université Paris- Saclay, Paris, France.ORCID http://orcid.org/0000-0002-4244-5417
Wan-Fai NgMusculoskeletal Research Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. wan-fai.ng@newcastle.ac.uk.ORCID http://orcid.org/0000-0002-5539-388X
Newcastle University · GBInserm · FRNIHR Newcastle Biomedical Research Centre · GBCentre National de la Recherche Scientifique · FR

Funding

Dutch Arthritis Society 14-3-404French Ministry of Research P070125NECESSITY 806975
6 · The paper itself

Abstract

To re-analyse the clinical outcomes and interferon (IFN) activity data from the JOQUER trial, a phase III trial investigating hydroxychloroquine (HCQ) in patients with primary Sjögren's syndrome (pSS), after stratifying patients into putative pathobiological subgroups utilizing the Newcastle Sjögren's Stratification Tool (NSST) based on patient-reported symptoms of dryness, pain, fatigue, anxiety and depression. 107 patients were assigned to one of four subgroups using NSST at baseline-the high symptom burden (HSB), pain dominant with fatigue (PDF), dryness dominant with fatigue (DDF) and low symptom burden (LSB). Endpoints were re-analysed after stratification, testing for treatment differences within subgroups and adjusting for baseline differences using a repeated measures covariate model. The HSB subgroup (n = 32) showed a relative improvement in ESSPRI of 1.49 points (95% CI 0.54-2.43; p = 0.002) within 12 weeks in patients taking HCQ compared to placebo, with no further changes after 24 weeks. For the LSB subgroup (n = 14), the ESSPRI worsened in the placebo but not the HCQ arm after 12 weeks (mean difference 1.44, 95% CI 0.05-2.83, p = 0.042). Neither the HSB nor the LSB patients showed significant changes in IFN activity at 24 weeks. There were no significant differences in ESSPRI in the PDF (n = 39) and DDF (n = 22) patients taking HCQ. However, significant reductions in overall IFN score at 24 weeks were seen in both PDF (difference at 24 weeks; 6.41, 95% CI, 2.48-10.34, p = 0.002) and DDF (difference at 24 weeks; 7.23, 95% CI, 1.85-12.6, p = 0.009) without improvement in ESSPRI. Although the JOQUER trial reported no overall benefit from HCQ in pSS patients, stratification suggests that both HSB and LSB subgroups may respond to HCQ. However, these patients may benefit through mechanisms other than the reduction of IFN activities.

Indexed as

Antirheumatic AgentsFemaleFollow-Up StudiesHumansHydroxychloroquineInterferonsMaleSjogren's SyndromeAntirheumatic AgentsHydroxychloroquineInterferonsHydroxychloroquineInterferonSjögren’s syndrome

Identifiers

PMID34165604
PMCPMC8316226
OpenAlexW3176852801

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.