LAUSR

Objectives The pathological diagnostic criteria for primary Sjögren’s syndrome (SjS) have certain limitations. We first explored the key pathogenic pathways of SjS through a bioinformatics approach, and then evaluated the diagnostic value of the important biomarker in SjS. Methods Transcriptome data from non-SjS controls and patients with SjS were analysed using integrated bioinformatics methods. In a case–control study, phosphorylated signal transducer and activator of transcription proteins 1 (p-STAT1), a key biomarker for the activation of interferon (IFN) pathway, was selected to evaluate its diagnostic value by immunohistochemical analyses in salivary gland (SG) tissues. Results The IFN-related pathways were aberrantly activated in patients with SjS. Positive staining of p-STAT1 was detected in the SjS group, but not in non-SjS control group. There was a significant difference in the integrated optical density values of p-STAT1 expressions between the controls and the SjS groups, as well as between the controls and the SjS lymphatic foci-negative groups (p<0.05). The area under the curve of the receiver operating characteristic curve for p-STAT1 was 0.990 (95% CI 0.969 to 1.000). There was a significant difference in both accuracy and sensitivity of p-STAT1 compared with the Focus Score (p<0.05). The Jorden index for p-STAT1 was 0.968 (95% CI 0.586 to 0.999). Conclusions The IFN pathway is the key pathogenic pathway in SjS. p-STAT1 may serve as an important biomarker, in addition to lymphocytic infiltration, to diagnose SjS. Particularly in SG samples with negative lymphatic foci, p-STAT1 confers pathological diagnostic value.