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Performance of the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease in a Large Chinese Cohort
Zhuo-Yu An1, Jiang-Nan Fu1, Qiao-Zhu Zeng1
1From the Department of Rheumatology and Immunology, Peking University People's Hospital.
Insights
The 2019 EULAR/ACR criteria effectively classify IgG4-related disease (IgG4-RD) in Chinese patients. These criteria show high specificity and moderate sensitivity in real-world clinical settings.
Area of Science:
- Rheumatology
- Immunology
- Clinical Diagnostics
Background:
- Immunoglobulin G4-related disease (IgG4-RD) is a complex fibroinflammatory condition.
- Accurate classification is crucial for timely and effective treatment.
- The 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) criteria were developed to aid in IgG4-RD diagnosis.
Purpose of the Study:
- To evaluate the real-world effectiveness of the 2019 EULAR/ACR classification criteria for IgG4-related disease (IgG4-RD).
- To assess the diagnostic performance of these criteria in a large Chinese cohort.
Main Methods:
- Retrospective analysis of digital health records from 605 confirmed IgG4-RD patients and 760 individuals with mimicking conditions.
- Diagnosis of IgG4-RD was established by expert rheumatologists.
- Performance metrics (sensitivity and specificity) of the 2019 EULAR/ACR criteria were calculated.
Main Results:
- The 2019 EULAR/ACR criteria demonstrated a sensitivity of 69.1% and a specificity of 90.9% in the Chinese cohort.
- IgG4-RD patients were more likely to be male, older at diagnosis, and exhibit greater pancreatic, salivary gland, and multi-organ involvement compared to mimickers.
- Significant differences (p < 0.001) were observed in demographic and clinical characteristics between IgG4-RD patients and controls.
Conclusions:
- The 2019 EULAR/ACR classification criteria are effective for diagnosing IgG4-RD in the Chinese population.
- The criteria exhibit high specificity, indicating strong ability to correctly identify non-IgG4-RD cases.
- Moderate sensitivity suggests potential for missed diagnoses, highlighting the need for continued clinical vigilance.
Objective:
The purpose of this research was to ascertain the effectiveness of the newly established criteria for classifying IgG4-related disease (IgG4-RD), as applied to a large Chinese cohort in real-world clinical settings.
Methods:
Patient data were procured from the digital health records of 4 prominent academic hospitals. The criterion standard for identifying IgG4-RD patients was from a seasoned rheumatologist. The control group consisted of individuals with other ailments such as cancer, other forms of pancreatitis, infectious diseases, and illnesses that mimic IgG4-RD.
Results:
A total of 605 IgG4-RD patients and 760 mimickers were available for analysis. The 2019 EULAR/ACR criteria have a sensitivity of 69.1% and a specificity of 90.9% in this large Chinese cohort. IgG4-RD had a greater proportion of males (55.89% vs 36.25%, p < 0.001), an older average age at diagnosis (54.91 ± 13.44 vs 48.91 ± 15.71, p < 0.001), more pancreatic (29.59% vs 6.12%, p < 0.001) and salivary gland (63.30% vs 27.50%, p < 0.001) involvement, and a larger number of organ involvement (3.431 ± 2.054 vs 2.062 ± 1.748, p < 0.001) compared with mimickers.
Conclusions:
The 2019 EULAR/ACR criteria are effective in classifying IgG4-RD in Chinese patients, demonstrating high specificity and moderate sensitivity.
