EULAR recommendations for a core dataset to support clinical care and translational and observational research in systemic lupus erythematosus

Johanna Mucke¹, George Bertsias², Martin Aringer³, Laurent Arnaud⁴, Carina Boström⁵, Ricard Cervera⁶, Gamal Chehab⁷, László Czirják⁸, Lene Wohlfahrt Dreyer⁹, Luís Inês¹⁰, Søren Jacobsen¹¹, Charite Kjaerside Nielsen¹², Emiliano Marasco¹³, Marta Mosca¹⁴, Kirsi Myllys¹², Cristina Pamfil¹⁵, Jose M Pego-Reigosa¹⁶, Jutta G Richter¹⁷, Savino Sciascia¹⁸, Farah Tamirou¹⁹, Michel Tsang-A-Sjoe²⁰, Edward M Vital²¹, Ronald Van Vollenhoven²⁰, Chris Wincup²², Matthias Schneider¹⁷; Taskforce for development of EULAR recommendations for a core dataset to support clinical care and translational and observational research in systemic lupus erythematosus

Affiliations

¹ Ruhr-Universität Bochum, Germany; Rheumazentrum Ruhrgebiet, Herne, Germany; Department of Rheumatology, Heinrich-Heine University, Duesseldorf, Germany. Electronic address: johanna.mucke@med.uni-duesseldorf.de.
² Department of Rheumatology, Clinical Immunology and Allergy, University of Crete, Medical School, Heraklion, Greece.
³ Division of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany; Interdisciplinary University Center for Autoimmune and Rheumatic Entities (UCARE), University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany.
⁴ Department of Rheumatology & National Reference Center for Autoimmune Diseases (CRMR RESO), Hôpital de Hautepierre, Strasbourg, France.
⁵ Department of Neurobiology, Karolinska Institute, Care Sciences and Society, Stockholm, Sweden.
⁶ Department of Autoimmune Diseases, University of Barcelona, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; IRIDIS (Investigation in Rheumatology and Immune-Mediated Diseases)-VIGO Group, Galicia Sur Health Research Institute, Vigo, Spain.
⁷ Department of Rheumatology, Heinrich-Heine University, Duesseldorf, Germany; Department of Rheumatology and Clinical Immunology, Evangelisches Krankenhaus Kliniken Essen-Mitte, Essen, Germany.
⁸ Department of Rheumatology and Immunology, University of Pecs, Medical School, Pecs, Hungary.
⁹ Department of Rheumatology, Center of Rheumatic Research Aalborg (CERRA), Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
¹⁰ Rheumatology Department, Centro Hospitalar Universitário de Coimbra, Coimbra, Portugal.
¹¹ Copenhagen Research Center for Autoimmune Connective Tissue Diseases (COPEACT), Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
¹² Lupus Europe, Rue d'Egmont 11, 1000 Bruxelles, Belgium.
¹³ Division of Rheumatology, Bambino Gesù Children's Hospital, Rome, Italy.
¹⁴ Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
¹⁵ Department of Rheumatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
¹⁶ Rheumatology Department, University Hospital of Vigo, Vigo, Spain.
¹⁷ Department of Rheumatology, Heinrich-Heine University, Duesseldorf, Germany; Hiller Research Center for Rheumatology, Heinrich-Heine University, Duesseldorf, Germany.
¹⁸ Department of Clinical and Biological Sciences, University Center of Excellence on Nephrology, Rheumatology and Rare Diseases, ASL Città Di Torino and University of Turin, Turin, Italy.
¹⁹ Department of Rheumatology, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium.
²⁰ Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands.
²¹ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
²² Department of Clinical and Academic Rheumatology, King's College Hospital, London, UK.

PMID: 40841299
DOI: 10.1016/j.ard.2025.07.001

Free article

EULAR recommendations for a core dataset to support clinical care and translational and observational research in systemic lupus erythematosus

Johanna Mucke et al. Ann Rheum Dis. 2025 Oct.

Free article

. 2025 Oct;84(10):1621-1631.

doi: 10.1016/j.ard.2025.07.001. Epub 2025 Aug 21.

Authors

Affiliations

¹ Ruhr-Universität Bochum, Germany; Rheumazentrum Ruhrgebiet, Herne, Germany; Department of Rheumatology, Heinrich-Heine University, Duesseldorf, Germany. Electronic address: johanna.mucke@med.uni-duesseldorf.de.
² Department of Rheumatology, Clinical Immunology and Allergy, University of Crete, Medical School, Heraklion, Greece.
³ Division of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany; Interdisciplinary University Center for Autoimmune and Rheumatic Entities (UCARE), University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany.
⁴ Department of Rheumatology & National Reference Center for Autoimmune Diseases (CRMR RESO), Hôpital de Hautepierre, Strasbourg, France.
⁵ Department of Neurobiology, Karolinska Institute, Care Sciences and Society, Stockholm, Sweden.
⁶ Department of Autoimmune Diseases, University of Barcelona, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; IRIDIS (Investigation in Rheumatology and Immune-Mediated Diseases)-VIGO Group, Galicia Sur Health Research Institute, Vigo, Spain.
⁷ Department of Rheumatology, Heinrich-Heine University, Duesseldorf, Germany; Department of Rheumatology and Clinical Immunology, Evangelisches Krankenhaus Kliniken Essen-Mitte, Essen, Germany.
⁸ Department of Rheumatology and Immunology, University of Pecs, Medical School, Pecs, Hungary.
⁹ Department of Rheumatology, Center of Rheumatic Research Aalborg (CERRA), Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
¹⁰ Rheumatology Department, Centro Hospitalar Universitário de Coimbra, Coimbra, Portugal.
¹¹ Copenhagen Research Center for Autoimmune Connective Tissue Diseases (COPEACT), Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
¹² Lupus Europe, Rue d'Egmont 11, 1000 Bruxelles, Belgium.
¹³ Division of Rheumatology, Bambino Gesù Children's Hospital, Rome, Italy.
¹⁴ Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
¹⁵ Department of Rheumatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
¹⁶ Rheumatology Department, University Hospital of Vigo, Vigo, Spain.
¹⁷ Department of Rheumatology, Heinrich-Heine University, Duesseldorf, Germany; Hiller Research Center for Rheumatology, Heinrich-Heine University, Duesseldorf, Germany.
¹⁸ Department of Clinical and Biological Sciences, University Center of Excellence on Nephrology, Rheumatology and Rare Diseases, ASL Città Di Torino and University of Turin, Turin, Italy.
¹⁹ Department of Rheumatology, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium.
²⁰ Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands.
²¹ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
²² Department of Clinical and Academic Rheumatology, King's College Hospital, London, UK.

PMID: 40841299
DOI: 10.1016/j.ard.2025.07.001

Abstract

Objectives: To enhance clinical and multicentre research outcomes in systemic lupus erythematosus (SLE), standardised documentation of patient- and disease-related features is important. The aim of this European Alliance of Associations for Rheumatology (EULAR) taskforce was to define a core set of essential items for the comprehensive care of SLE patients in clinical practice, with an extension for vital elements required for translational and observational research.

Methods: A multidisciplinary EULAR task force group engaged in a multistep approach including a 4-round Delphi survey and a face-to-face meeting.

Results: Twenty-five stakeholders from 14 different countries participated. During the process, the initial list of 99 items was reduced to 73 items for inclusion in the clinical core dataset and 8 additional items for research extension. The items were grouped in the domains 'general', 'disease activity', 'disease history', 'disease damage', 'comorbidities', 'patient reported outcomes', 'laboratory markers', 'outcomes', and 'treatment', with suggested frequencies of assessment.

Conclusions: The presented clinical core dataset and its research extension are designed to improve SLE patient care and facilitate collaborative research by ensuring the comparability of datasets and cohort descriptions. This initiative lays the foundation for the establishment of a global SLE data space and has the potential to expedite the implementation of personalised medicine in SLE care.

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Conflict of interest statement

Competing interests Johanna Mucke reports financial support, administrative support, and travel were provided by EULAR. Johanna Mucke reports a relationship with AbbVie Inc, AstraZeneca, BMS, GSK, Janssen-Cilag, Lilly, Novartis that includes: consulting or advisory and speaking and lecture fees. Chris Wincup reports a relationship with AbbVie, AstraZeneca, Bristol Myers Squibb, Kyverna, Otsuka, UCB that includes: speaking and lecture fees. Chris Wincup reports a relationship with Biogen Inc that includes: board membership. Edward M Vital reports a relationship with Roche, GSK, AstraZeneca, UCB, Otsuka, BMS, Pfizer, AbbVie, Pfizer, Alpine, Alumis, Merck, BMS, Aurinia Pharmaceuticals that includes: consulting or advisory. Edward M Vital reports a relationship with AstraZeneca, Sandoz that includes: funding grants. George Bertsias reports a relationship with AbbVie, Pfizer, GSK, AstraZeneca, Lilly, Otsuka, Novartis that includes: funding grants and speaking and lecture fees. Gamal Chehab reports a relationship with GSK, AstraZeneca, Otsuka, Alexion that includes: consulting or advisory and speaking and lecture fees. Jose M Pego-Reigosa reports a relationship with GSK, Pfizer that includes: funding grants. Jose M Pego-Reigosa reports a relationship with GSK, AstraZeneca, Lilly that includes: speaking and lecture fees. Jose M Pego-Reigosa reports a relationship with GSK, AstraZeneca that includes: travel reimbursement. Jose M Pego-Reigosa reports a relationship with GSK, Otsuka, Gebro, AstraZeneca, Boehringer Ingelheim, MSD that includes: consulting or advisory. Laurent Arnaud reports a relationship with Alexion, Amgen, AstraZeneca, AbbVie, Alpine, Biogen, BMS, Boehringer Ingelheim, Chugaï, GSK, Grifols, Janssen-Cilag, Kezar, LFB, Lilly, Medac, Novartis, Pfizer, Roche, UCB that includes: consulting or advisory, funding grants, and speaking and lecture fees. László Czirjak reports a relationship with AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Pfizer that includes: consulting or advisory and speaking and lecture fees. Luís Ines reports a relationship with GSK, AstraZeneca that includes: consulting or advisory. Lene Wohlfahrt Dreyer reports a relationship with BMS, AbbVie that includes: funding grants. Martin Aringer reports a relationship with AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Lilly, Novartis, Otsuka Pharma, Pfizer, Roche, UCB that includes: consulting or advisory and funding grants. Marta Mosca reports a relationship with AstraZeneca, GSK, AbbVie, UCB, Jansse, BMS, Otsuka, Alpine, Pfizer, Novartis that includes: consulting or advisory and speaking and lecture fees. Matthias Schneider reports a relationship with GSK, AstraZeneca, Otsuka that includes: consulting or advisory and speaking and lecture fees. Matthias Schneider reports a relationship with GSK, AstraZeneca that includes: funding grants. Michel W P Tsang-A-Sjoe reports a relationship with AstraZeneca, GSK that includes: consulting or advisory and speaking and lecture fees. Ricard Cervera reports a relationship with GSK, AstraZeneca, Celgene, Janssen, Eli Lilly, Pfizer, UCB, Rubió, Werfen, ThermoFisher that includes: consulting or advisory. Ronald Van Vollenhoven reports a relationship with BMS, Alfasigma, AstraZeneca, Galapagos, MSD, Novartis, Pfizer, Roche, Sanofi, UCB that includes: funding grants. Ronald Van Vollenhoven reports a relationship with AbbVie, AstraZeneca, Biogen, BMS, Galapagos, GSK, Janssen, Pfizer, RemeGen, UCB that includes: consulting or advisory and speaking and lecture fees. The other authors declare they have no competing interests.

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EULAR recommendations for a core dataset to support clinical care and translational and observational research in systemic lupus erythematosus

Affiliations

EULAR recommendations for a core dataset to support clinical care and translational and observational research in systemic lupus erythematosus

Authors

Affiliations

Abstract

Conflict of interest statement

MeSH terms

LinkOut - more resources

Full Text Sources

Medical