Validation of the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus in an academic tertiary care centre
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Published on: October 13, 2023
Irene Schmidtmann1, Daniel Kraus2, Arndt Weinmann2
1Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
Insights
The 2019 EULAR/ACR systemic lupus erythematosus (SLE) criteria are sensitive and specific for outpatients. They showed good agreement with 1997 ACR criteria, confirming their utility in clinical practice.
Area of Science:
- Rheumatology
- Immunology
- Clinical Diagnostics
Background:
- Systemic lupus erythematosus (SLE) classification requires accurate diagnostic criteria.
- Previous criteria, such as the 1997 ACR and 2012 SLICC, have been instrumental but may require updates.
- Evaluating new criteria in diverse patient cohorts is crucial for clinical application.
Purpose of the Study:
- To evaluate the sensitivity and specificity of the 2019 EULAR/ACR classification criteria for SLE.
- To compare the performance of the 2019 criteria against the 1997 ACR and 2012 SLICC criteria.
- To assess the utility of the 2019 criteria in an outpatient academic tertiary care setting.
Main Methods:
- A prospective and retrospective observational cohort study design was employed.
- 3377 patients were analyzed, including those with SLE, non-SLE autoimmune-mediated rheumatic diseases (ARD), and non-ARD conditions.
- Statistical analysis focused on sensitivity, specificity, and Youden Indexes for comparing classification criteria.
Main Results:
- The 2019 EULAR/ACR criteria demonstrated higher sensitivity (87.0%) than the 1997 ACR criteria (81.8%).
- Specificity was slightly lower for the 2019 criteria (98.1%) compared to the 1997 criteria (99.5%).
- Key sensitive indicators included ANA positivity and anti-dsDNA antibodies, while specific indicators included lupus nephritis classes and low complement levels.
Conclusions:
- The 2019 EULAR/ACR SLE classification criteria were confirmed as sensitive and specific in this independent academic medical center cohort.
- The 2019 criteria showed very good overall agreement with the 1997 ACR criteria.
- These findings support the clinical utility of the 2019 criteria for classifying SLE in outpatients.
Objectives:
To assess the sensitivity and specificity of the 2019 EULAR/American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE) in outpatients at an academic tertiary care centre and to compare them to the 1997 ACR and the 2012 Systemic Lupus International Collaborating Clinics criteria.
Methods:
Prospective and retrospective observational cohort study.
Results:
3377 patients were included: 606 with SLE, 1015 with non-SLE autoimmune-mediated rheumatic diseases (ARD) and 1756 with non-ARD diseases (hepatocellular carcinoma, primary biliary cirrhosis, autoimmune hepatitis). The 2019 criteria were more sensitive than the 1997 criteria (87.0% vs 81.8%), but less specific (98.1% vs 99.5% in the entire cohort and 96.5% vs 98.8% in patients with non-SLE ARD), resulting in Youden Indexes for patients with SLE/non-SLE ARD of 0.835 and 0.806, respectively. The most sensitive items were history of antinuclear antibody (ANA) positivity and detection of anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies. These were also the least specific items. The most specific items were class III/IV lupus nephritis and the combination of low C3 and low C4 complement levels, followed by class II/V lupus nephritis, either low C3 or low C4 complement levels, delirium and psychosis, when these were not attributable to non-SLE causes.
Conclusions:
In this cohort from an independent academic medical centre, the sensitivity and specificity of the 2019 lupus classification criteria were confirmed. Overall agreement of the 1997 and the 2019 criteria was very good.
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