Evaluation of a Practical Approach to Diagnosis of Sjögren's Disease in Clinical Practice.

OBJECTIVE The 2016 ACR-EULAR Classification Criteria (AECC) borrow from oral pathology, ophthalmology, pathology and serology to define Sjogren's disease (SD). The objective of this study is to analyze the utility of incorporating the 2016 AECC tools into clinical practice. METHODS A cross-sectional database with 374 patients evaluated on protocol between 1993 and 2019 at the University Health Network Multidisciplinary Sjögren's Clinic was used for the purpose of this data analysis. All patients used for this analysis had a complete evaluation including serology, ocular surface staining and minor salivary gland (MSG) biopsy. RESULTS Of the 374 patients, 263 (70.3%) were diagnosed with SD in clinic on the basis of Schirmer's Test (ST), Unstimulated Salivary Flow (USSF) and serology results alone (Group A). An additional 14% were diagnosed after further assessment with ocular surface staining (Ophthalmology) and minor salivary gland biopsy (ENT) (Group B). Group C patients did not have SD. Groups B and C together were frequently seronegative (for ANA and/or anti-Ro) or AMA positive. Seronegative patients with abnormal ST and USSF had a positive MSG biopsy in 70% of cases. CONCLUSION SD could be diagnosed according to 2016 AECC in most patients on the basis of ST, USSF and serology results where there is concern for the disease on clinical evaluation. Patients that required further testing for diagnosis had some distinctive features. This analysis provides the practicing physician with some guidelines for establishing a diagnosis of SD in clinic.