Background/Purpose: Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. This is commonly observed in patients with rheumatic diseases, particularly among patients with Sjögren’s Syndrome (SS). SS is an autoimmune disease that mainly affects exocrine glands such as the salivary and lacrimal glands, causing chronic dryness of the ocular surface resulting in inflammatory reaction and gradual destruction of conjunctival epithelium. According to the 2016 ACR/EULAR classification criteria, a positive minor salivary gland (MSG) biopsy is considered the criterion with the highest weight, along with positive serology. However, the relationship between MSG involvement and dry eye disease (DED) is poorly understood. We aimed to determine the DED severity among patients with SS with a positive or negative MSG biopsy.

Methods: We performed a cross-sectional study, including patients of 18 years or older, with DED symptoms and primary SS (according to 2016 ACR/EULAR criteria), between 2015-2024. MSG biopsy, Unstimulated Whole Salivary Flow rate (UWSF), tear film osmolarity, tear matrix metalloproteinase 9 (MMP-9), Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), SICCA ocular surface staining (SICCA OSS), and Schirmer tear test with and without anesthesia (STT) were evaluated. Only the worst eye was included, which was selected based on the SICCA OSS score. We used descriptive statistics (frequencies [%], mean ± SD, median [IQR]) to present the results and compared the patients with positive or negative biopsies with Chi2, Mann-Whitney U, or Student’s tests as appropriate. A p-value < 0.05 was considered statistically significant. This study was approved by the institutional review board and all participants provided written informed consent.

Results: We included 142 patients, the mean age was 52.93 ± 12.62 years, and 97.2% (n=138) of patients were women. One hundred twenty-one (85.2%) had a positive MSG biopsy, and 21 patients were biopsy negative. Patients with positive biopsy had similar OSDI scores (39.6 [IQR: 0-100]) than those with negative biopsies (47.91 [IQR: 4-79.2]; p=0.505; Table 1). Similarly, biopsy-positive patients had similar SICCA OSS (7.0 [IQR: 0-15] vs. 6.0 [IQR: 1.0-12]; p=0.443) and tear film osmolarity (307 [IQR: 277-397] vs 307 [IQR: 284-345]; p=0.392) than biopsy-negative patients. Positivity to tear MMP-9 (29, 24.0% vs 4, 19.0%; p=0.440), STT with anesthesia (5, 1-35 vs 7.0, 1-25; p=0.399) or without anesthesia (5, 0-35 vs 7, 1-35; p=0.290), and the TBUT (4, 1-15 vs 4, 2-10; p=0.289) were no different between patients with positive or negative MSG biopsy.

Conclusion: Positive minor salivary gland biopsy was not associated with worse dry eye disease in patients with primary SS.

Table 1. Dry eye disease among patients with SS and positive or negative minor salivary gland (MSG) biopsy.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/dry-eye-disease-severity-and-salivary-gland-biopsy-in-patients-with-primary-sjogrens-syndrome/