Ultra-High Frequency Ultrasonography in Sjögren's Syndrome

Primary Sjögren's syndrome is a complex autoimmune disease involving the exocrine salivary and lachrymal glands, with a progressive functional impairment caused by lymphocytic infiltration in the glandular tissue. The diagnosis is currently performed according to the criteria established in 2016 by the American College of Rheumatologists/European League Against Rheumatism (ACR/EULAR) and relies on 5 items, namely i) histologic Focus Score (FS) ≥1, ii) positivity to Anti-SSA (Ro) antibodies, iii) Ocular staining score ≥ 5 (or van Bijsterfeld score ≥ 4) on at least one eye, iv) Schirmer test ≤ 5 mm/5min on at least one eye and v) Unstimulated Salivary Flow Rate (USFR) ≤ 0.1 ml/min. Focus Score and positivity to antibodies are items with a weight of 3 points each, while the other items are assigned score 1. Diagnosis is performed with a total score ≥ 4 when summing the weights. While the improvement in the sensitivity of ACR/EULAR classification criteria by 5-10% has been previously reported for ultrasonography of major salivary glands, at present no evidence is available for minor salivary glands. Minor salivary glands ultrasonography with the use of ultra-high frequencies up to 70 MHz has been recently introduced in the diagnostic work-up of Sjögren's syndrome, and involves the assessment of glandular ultrasonographic structural alterations through the application of the Outcome Measures in Rheumatology (OMERACT) scoring system, which is routinely used for major salivary glands. The present study therefore aims to assess the correlation between minor salivary glands ultrasonography and ACR/EULAR items, in order to evaluate whether this technique may integrate the current evaluation of Sjögren's syndrome patients.

Inclusion criteria

• adults ≥ 18 years of age
• clinical suspect of Sjogren's syndrome
• acceptance to undergo complete Sjogren's Syndrome diagnostic work-up
• acceptance to be included in the study.

Exclusion criteria

• pregnancy or breastfeeding
• any acute or chronic condition that would limit the ability of the patient to participate in the study
• refusal to give informed consent