Assessment of 2023 ACR/EULAR antiphospholipid syndrome classification criteria in a Spanish cohort
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Rodrigo Cantera Estefanía
,
Rafael Gálvez Sánchez
Abstract
Objectives
The 2023 ACR/EULAR criteria aim to improve the classification of antiphospholipid syndrome (APS). This study aims to validate these criteria and compare clinical and laboratory domains between classified and non-classified patients.
Methods
A retrospective cohort study was conducted at the Hospital Universitario Marqués de Valdecilla, a tertiary referral center in Cantabria, Spain. Data were retrieved from the laboratory information system, identifying patients with at least one positive determination of lupus anticoagulant (LA), anticardiolipin (aCL), or anti-β2 glycoprotein I (anti-β2GPI) between January 2018 and March 2024. Patients were classified according to the 2006 Sydney and 2023 ACR/EULAR criteria.
Results
Among 375 patients meeting the Sydney criteria, 152 (40.6 %) fulfilled the 2023 ACR/EULAR criteria. The sensitivity and specificity of the 2023 ACR/EULAR criteria were 30.2 and 97.7 % respectively, with a positive predictive value of 0.84, and a negative predictive value of 0.77. Area under the ROC curve was 0.639 (95 % CI: 0.605–0.673). The exclusion of thrombosis with high-risk thrombotic profiles and recurrent pregnancy loss or fetal death as individual events on obstetric APS accounted for most declassified patients. Additionally, patients meeting the 2023 ACR/EULAR criteria had a higher prevalence of arterial thrombosis without cardiovascular risk factors. In laboratory domains, isolated IgM aPL positivity was a major exclusion factor due to its lower weight in the new criteria.
Conclusions
The 2023 ACR/EULAR criteria enhance specificity but significantly reduce sensitivity, excluding many APS patients, particularly those with obstetric APS or IgM aPL. This raises concerns about clinical trial eligibility and applicability in diverse populations.
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Research ethics: This study was approved by Cantabria Ethics Committee for Research with Medicines and Healthcare Products (CEIm2024.111).
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Informed consent: No informed consent was obtained. Exemption for use of informed consent was obtained from Cantabria Ethics Committee for Research with Medicines and Healthcare Products.
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Author contributions: RCE and VMMT contributed to the design of the study, lead the statistical analysis, writing, and critical revision of the final manuscript. RCE lead the data collection. RGS, MAC, JAFG, RGR, IGA, HCB, MOM, MHL, LGGR, AGA and SDBL contributed to data collection. JLHH, LYSS and JJDG contributed to statistical analysis. All authors contributed to a literature review on the topic and a critical revision of the manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Data is electronically stored and available for sharing upon reasonable request.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0508).
© 2025 Walter de Gruyter GmbH, Berlin/Boston
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- Advancing diagnostic stewardship through claims-based utilization analysis: toward a system-wide vision of diagnostic excellence
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- Biomarkers in body fluids and their detection techniques for human intestinal permeability assessment
- Mini Review
- Challenges of using natriuretic peptides to screen for the risk of developing heart failure in patients with diabetes: a report from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Clinical Applications of Cardiac Bio-Markers (C-CB)
- Opinion Papers
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- Overview of laboratory diagnostics for immediate management of patients presenting to the emergency department with acute bleeding
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