Introduction:

Sjögren's disease is a common autoimmune disorder characterized by chronic lymphocytic infiltration of exocrine glands and various extraglandular systemic manifestations. While most patients are seropositive (with anti-Ro/SSA and anti-La/SSB antibodies), there is a significant seronegative subgroup that lacks these markers. In this group, minor salivary gland biopsy becomes an essential diagnostic tool.

Objectives:

To evaluate the usefulness of minor salivary gland biopsy (MSBG) in the diagnosis of Sjögren's disease in patients with a high clinical suspicion but negative autoantibodies, and to characterize its clinical manifestations, complete serological profile, and disease activity level using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).

Materials and methods:

A retrospective, cross-sectional, analytical, observational study was conducted, including patients over 18 years of age with suspected Sjögren's disease and negative autoantibodies referred for minor salivary gland biopsy (MSBG) between January 2023 and January 2025. Data collection was based on electronic medical records, pathology reports, and serological profiles (ANA, Anti-Ro/SSA, Anti-La/SSB). The main objective was to evaluate the usefulness of minor salivary gland biopsy (MSGB) (using the focus score ) and to characterize disease activity using the ESSDAI score. Statistical analysis of the data was performed using IBM SPSS software version 30.0.0.

Results:

Seven female patients were included, with a mean age of 44.71 years (SD ± 13.21). Clinically, 100% reported xerophthalmia and 71.4% xerostomia, although objective functional tests (Schirmer test) were negative in all cases. Minor salivary gland biopsy (MSGB) was positive (focus score ≥ 1) in 6 of 7 patients (85.7%), with a mean focus score of 2.14 (SD ± 1.574). Despite the initial remission, serological analysis reclassified 4 patients (57.1%) as seropositive (anti-Ro/SSA and/or anti-La/SSB positive), leaving 3 patients (42.9%) as true seronegatives. The overall disease activity, as measured by the ESSDAI, was 7.14 (SD ± 7.081), with the glandular domain being the most prevalent and exhibiting the highest activity burden (mean 2.29).

Conclusion:

Minor salivary gland biopsy is a valuable diagnostic tool in the seronegative patient group. Disease activity, as measured by the ESSDAI, was predominantly concentrated in the glandular domain.

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