SICCA: Labial Salivary Gland Biopsy – Diagnostic Association Analyses
D.P. COX1, T.E. DANIELS2, J.S. GREENSPAN3, R.C.K. JORDAN2, A.M. CHIRIFE4, D. DU5, P. IBSEN6, A. KESZLER4, M. KUROSE7, T. NOJIMA7, S. SHIBOSKI2, and J. XIAO5, 1University of California San Francisco, USA, 2University of California, San Francisco, USA, 3University of California - San Francisco, USA, 4University of Buenos Aires, Argentina, 5Peking Union Medical College Hospital, Beijing, China, 6Copenhagen Country University Hospital, Denmark, 7Kanazawa Medical University, Japan

Objectives: Labial salivary gland (LSG) biopsy is generally considered the most disease-specific means of diagnosing the salivary component of Sjögren's syndrome (SS), but is insufficient alone for diagnosing SS. The Sjögren's International Collaborative Clinical Alliance (SICCA) is a multi-site, observational longitudinal 5-year registry funded in 2003 by the NIH. It includes recording many variables and collecting nine types of biospecimens, including LSGs, from participants suspected of having SS. We used SICCA data to assess the validity of LSG diagnosis and scoring, to represent the salivary component of SS by analyzing LSG associations to other diagnostic tests. Methods: LSG biopsy is performed on each SICCA participant according to specific protocols. Morphological diagnosis is made by two oral pathologists at the SICCA Coordinating Center in UCSF followed by focus score (FS) measurement of specimens exhibiting focal lymphocytic sialadenitis (FLS) and observation of germinal centers and/or ductal epithelial hyperplasia. Bivariate, cohort-wide analyses compared LSG diagnosis and FS to salivary flow rates, anti-SS-A/B serologic and ocular findings. Results: Currently, 564 LSG biopsies are available for analysis, 364 of which exhibit FLS, with or without areas of focal sclerosis, and mean FS of 1.9 (ranging 0.1 to 12). Other biopsies are classified as: within normal limits, non-specific chronic inflammation, sclerosing chronic sialadenitis, or granulomatous inflammation. The 247 LSG specimens with FLS and FS >1 are associated with: the presence of serum anti-SS-A/B (p<.0001); ocular staining > 4 (p<.0001); unstimulated salivary flow rate < 0.1 ml /m (p<.0001); and lower parotid flow rate (p=0.005), compared with LSG specimens having FS <= or other diagnoses. Conclusion: LSG biopsy, when performed and diagnosed appropriately, is currently essential in diagnosing the salivary component of SS. We have defined a specific method of classification that is easily applied and reproducible and will aid in better defining the SS phenotype. NO1-DE-32636

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