Objective: This study aimed to reassess the diagnostic contribution of minor salivary gland biopsy (MSGB) in patients with clinically suspected Sjögren's disease (csSjD) and to assess its association with serological status, clinical features, and fulfillment of classification criteria.
Methods: We retrospectively analyzed 313 patients who underwent MSGB for evaluation of csSjD between 2021 and 2024. All patients were evaluated according to 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria at the end of the diagnostic workup. The MSGB was defined as positive if the focus score was ≥ 1/4 mm2. Subgroup analyses were performed according to anti-Ro/SSA antibody status. Predictors of MSGB positivity were examined using logistic regression, and diagnostic performance was evaluated by receiver operating characteristic (ROC) analysis.
Results: The overall MSGB positivity rate was 24.6%. Rates were comparable between anti-Ro-positive (27.8%) and negative (24.2%) patients (p = 0.655). In seronegative patients, older age and longer symptom duration independently predicted biopsy positivity (p < 0.05), although the diagnostic discrimination was limited (AUC: 0.511). Notably, MSGB enabled fulfillment of classification criteria in 22.3% of seronegative cases. No clinical or laboratory variables predicted biopsy outcome in seropositive patients. Across the entire cohort, only CRP showed a weak correlation with histological severity (p = 0.05); MSGB positivity was not associated with systemic manifestations.
Conclusion: Minor salivary gland biopsy provides substantial diagnostic value in seronegative csSjD, where clinical and serological data are insufficient. In contrast, its additional contribution in seropositive patients is limited. While biopsy does not reliably predict systemic disease activity, it remains a cornerstone diagnostic tool, especially in seronegative patients with objective sicca symptoms. Integration of MSGB with salivary ultrasonography and molecular biomarkers may further optimize future diagnostic pathways.
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