Establishing guidelines for the role of minor salivary gland biopsy in clinical practice for Sjögren's syndrome.

OBJECTIVE: To evaluate the predictive value of clinical variables for the finding of a positive minor salivary gland biopsy (focus score > or = 2) in patients investigated for Sjögren's syndrome (SS).

METHODS: One hundred twenty-one patients with sicca symptoms were referred to a multidisciplinary SS clinic in a tertiary hospital. Each patient was evaluated on protocol and labial salivary gland (LSG) biopsy was obtained. Using the San Diego criteria as a model, patient data were subjected to a cross sectional analysis on an algorithm to determine when the LSG biopsy would be most useful for determining the diagnosis of SS in clinical practice.

RESULTS: Eighty-four patients had sufficient data to be included in the study. Forty patients had LSG biopsy with focus score < 2 and 44 had focus score > or = 2. Twenty-three patients had objective evidence of sicca and positive serology according to criteria standards. Eighteen of these had a positive biopsy (78%). The remaining 5 patients had many extraglandular features suggestive of SS, and the biopsies appeared to add little practical information. Patients with incomplete criteria for sicca could be diagnosed as possible SS (3 of 4 criteria) with a positive biopsy in 14 of 18 cases. The finding of anti-Ro or anti-La positivity in patients with incomplete criteria for sicca predicted a positive LSG biopsy in 85.7% of such cases. Patients with incomplete sicca and negative anti-Ro and anti-La had a negative LSG biopsy in 82% of cases.

CONCLUSION: The LSG biopsy is most necessary in patients who have partial San Diego criteria for sicca and positive anti-Ro or anti-La antibody. Where SS is not reasonably suspected, or where the diagnosis is clinically obvious, the LSG biopsy adds little useful clinical information.