Impression Cytology and Confocal Microscopy of Lip Mucosa Compared With Labial Gland Biopsy and Classification Criteria In Patients With Clinically Suspected Primary Sjögren's Syndrome.

PURPOSE

The study assessed the validity of impression cytology (IC) and confocal microscopy (IVCM) of lip mucosa compared with labial gland biopsy, anti-Sjögren's syndrome A (SSA)/Ro antibody status, and classification criteria in suspected primary Sjögren's syndrome (pSS) patients.

METHODS

Clinically suspected pSS patients (n = 201) were enrolled consecutively and were divided into pSS (n = 56) and control (n = 145, only with dryness) groups according to the American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) criteria. All patients underwent lip mucosa IC (inflammatory cell density) and IVCM (epithelium/intrinsic layer thickness and labial gland density/diameter) analyses. The associations between IC/IVCM parameters and clinical/laboratory results were analyzed.

RESULTS

The absolute agreement between positive lip mucosal IC (≥50 cells/4 mm) and the ACR-EULAR criteria (94.5%)/labial gland biopsy (95.5%) was good, with sensitivities of 82.1 and 85.2%, respectively, and a specificity of 99.3%. Compared with controls, IVCM revealed significant lip mucosal atrophy and glandular decreases in the pSS group (all = 0.000). The sensitivities for diagnosing pSS corresponding to a lamina propria thickness ≤128 μm and a gland diameter ≤114 μm were 85.7 and 89.3%; the specificities were 90.3 and 95.9%, respectively. A combination of positive IC/IVCM and anti-SSA/Ro antibody results showed a high predictive value for diagnosing pSS.

CONCLUSIONS

IC and IVCM could detect distinctive cellular and morphological changes in the lip mucosa of patients with pSS. These noninvasive and easy-to-perform examinations may be an alternative to labial gland biopsy for diagnosing pSS.