Evidence map›Paper›PMID 40986255›Full record

ArticleRheumatology and therapy2025

Real-World Assessment of Systemic Disease Activity in Seropositive and Seronegative Patients with Sjögren's Disease and Association with Patient-Reported Outcomes.

Jacques-Eric Gottenberg, Raphaele Seror, Nicola Massey, Megan Hughes, Victoria Barton, Sarah Weatherby, Federico Zazzetti, Andras Borsi, Wim Noel, Harman Dhatt and 3 more

Abstract read
In one paragraph

Article in Rheumatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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.

Jacques-Eric GottenbergDepartment of Rheumatology, National Reference Centre for Rare Systemic Autoimmune Diseases, IBMC UPR3572, CNRS, Strasbourg University Hospital, Strasbourg, France.
Raphaele SerorRheumatology, Hôpitaux Universitaires Paris- Sud, Assistance Publique Hopitaux de Paris (APHP), National Reference Centre for Rare Auto-Immune Diseases, Le Kremlin Bicêtre, France.
Nicola MasseyAdelphi Real World, Bollington, UK.
Megan HughesAdelphi Real World, Bollington, UK.
Victoria BartonAdelphi Real World, Bollington, UK. vicky.barton@adelphigroup.com.ORCID http://orcid.org/0009-0005-2636-0703
Sarah WeatherbyAdelphi Real World, Bollington, UK.
Federico ZazzettiJohnson & Johnson Innovative Medicine, Spring House, PA, USA.
Andras BorsiJohnson & Johnson Innovative Medicine, Beerse, Belgium.
Wim NoelJohnson & Johnson Innovative Medicine, Titusville, NJ, USA.
Harman DhattJanssen Global Services, LLC, A Johnson & Johnson Company, Raritan, NJ, USA.
Angelina Villasis-KeeverJohnson & Johnson Innovative Medicine, Spring House, PA, USA.
Anna SheahanJohnson & Johnson Innovative Medicine, Spring House, PA, USA.
Urbano SbarigiaJohnson & Johnson Innovative Medicine, Beerse, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSjögren's disease (SjD) is often characterized by the presence of anti-SSA/Ro and anti-SSB/La autoantibodies. The Clinical European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ClinESSDAI) and Patient-Reported Index (ESSPRI) assess disease activity and patient-reported symptomatology; however, their association with patient-reported outcome measures (PROMs) remains unclear. We aimed to describe systemic disease activity in seropositive and seronegative SjD patients and evaluate the association between proxy ClinESSDAI and ESSPRI scores with PROMs.

methodsData were drawn from the Adelphi Real World SjD Disease Specific Programme™, a cross-sectional survey conducted in France, Germany, Italy, Spain and the United States between June and October 2018. Physicians reported patient demographics and clinical characteristics. Patients completed the EQ-5D-3L and Visual Analogue Scale (EQ-VAS), and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Proxy ClinESSDAI and ESSPRI scores were calculated using physician-reported organ activity and averaged patient ratings of dryness, pain, and fatigue, respectively. Associations between ClinESSDAI, ESSPRI, physician-reported disease severity, and PROMs were determined using linear and logistic regression modeling. Statistical significance was p < 0.05 for all tests.

resultsOverall, 319 rheumatologists provided data on 1879 patients with SjD. Mean (standard deviation) patient age was 53.2 (12.2) years, 89% were female, and 89% were White. Of patients who received serum antibody testing for both anti-SSA/Ro and anti-SSB/La antibodies (n = 1344), 69% were double seropositive and 6% were double seronegative. The most common symptoms experienced by double seropositive and double seronegative SjD patients, respectively, included dry eyes (94% and 74%), and physical fatigue (82% and 60%). ClinESSDAI and ESSPRI were significantly associated with EQ-5D-3L, EQ-VAS, and FACIT-F (all p < 0.001).

conclusionsSystemic disease activity and patient-reported symptomatology were significantly associated with health-related quality of life measures, highlighting the need for disease management that considers both clinical outcomes and the patient experience.

Indexed as

Anti-SSA/RoAnti-SSB/LaAutoantibodiesClinESSDAIESSPRIPROMsRWESjögren’s disease

Identifiers

PMID40986255
PMCPMC12638550

What Socratic holds

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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 Socratic graph.