Background/Purpose: The presence of lymphocytic infiltrate with ≥ 1 focus score/4mm² in minor salivary gland is a useful tool for the diagnosis of Sjögren’s syndrome (SS) and was included in the American–European Consensus Criteria (AECC) (2002) and the criteria proposed by the American College of Rheumatology (ACR) in 2012. The purpose of this study is to evaluate the sensitivity and specificity of the histological analysis of minor salivary gland and the clinical profile of patients undergoing labial salivary biopsy for investigation of glandular SS.

Methods: Retrospective chart review was performed of all patients underwent labial salivary biopsy in Rheumatology Outpatient Clinic of Hospital Universitário Cassiano Antônio de Moraes/Universidade Federal do Espírito Santo (UFES) from March 2008 to March 2011. Biopsy indication, dryness symptons (AECC), unstimulated salivary flow (USF), Schirmer test (ST), presence of autoantibodies, number of foci score were obtained. The sensitivity and specificity of biopsy were calculated considering the expert opinion as the gold standard.

Results: Two-hundred forty-three patients underwent to labial salivary biopsies, 95.9% (233) were female, mean of age was 48.49 ±12.4, 95.88% (233) had dryness symptoms and 4.11% (10) systemic manifestation without dryness (parotid hypertrophy (3), pancytopenia (1), lymphopenia (1), arthritis and positive ANA (4), anemia + arthralgia and positive ANA (1)). The frequency of  ≥ 1 focus score/4mm²was 35.8% (87), USF ≤ 1.5ml/15min was positive in 56.8% (138) and ST in 45.7% (111). For analysis of sensitivity and specificity, patients were excluded due to insufficient clinical data (N = 40), presence of another autoimmune rheumatic disease (N = 19), hepatitis C (N = 1), diagnosis by the rheumatologist expert opinion that was not described (N = 31).Of the 183 patients analyzed, 32.78% (60 patients) were classified as primary SS by AECC. In these, the frequency of positive biopsy SS, oral and ocular subjective criteria were 88.7% (53), 91.7% (55) and 93.3% (56) respectively. Only 1 patient with SS (with objective criteria, biopsy and anti-Ro positives) showed no dry mouth and eye, 81.7% (49) showed USF ≤ 1.5, 66.7% (40) ST ≤5mm/5min and 33.33% (20) positive anti-SSA and /or anti-SSB antibodies, 66.7% (40) positive ANA, 25% (15) positive rheumatoid factor. Among the systemic manifestations presented there were 1.65% (1) increase of the parotid glands, 1.65% (1) lymphoma, 20% (12) peripheral arthritis, 8.3% (5) cutaneous involvement, 6.7% (4) respiratory involvement, 6.7% (4) renal involvement, 13.3% (8) peripheral neuropathy. For 65% (39) biopsy was necessary to confirm the diagnosis of SS. Of patients with fibromyalgia and dry syndrome (87), 58.3% (35) were diagnosed with SS. The sensitivity and specificity of the biopsy found were 86.57% and 98.23% respectively.

Conclusion: The frequency of Sjögren’s syndrome in suspected patients referred to be biopsy submission was 32.78%. The sensitivity and specificity of the salivary biopsy presented high values consistent with other data from the literature. The frequency of SS confirmed by biopsy in patients with fibromyalgia syndrome is high and SS should be investigated in patients with dryness.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/diagnostic-value-of-labial-minor-salivary-gland-biopsy-for-primary-sjogrens-syndrome/