Background/Purpose: Recently published ACR classification criteria for primary Sjögren’s syndrome (pSS) include only 3 objective tests: 1) a serological item: anti-SSA/SSB antibodies or [antinuclear antibody (ANA) titer ≥1:320 and rheumatoid factor (RF) positivity], 2) an Ocular Staining Score (OSS) ≥3, and 3) focus score ≥1 on salivary gland biopsy (SGB). None of these tests explore the function or the morphology of the salivary glands. In a recent study, we have shown that salivary gland ultrasonography (SGUS) has good diagnostic properties for SS.Our objective was to evaluate if SGUS could improve the diagnostic properties of ACR 2012 criteria.

Methods: The pSS Brittany cohort includes patients with suspected pSS (sicca symptoms, parotidomegaly or extraglandular manifestations suggestive of pSS). All patients had a standardized clinical and biological evaluation and a SGB. Ophtalmologic evaluation used fluorescein and lissamine green to assess the presence of keratoconjunctivitis sicca, allowing the subsequent calculation of the OSS. SGUS was performed on bilateral parotid and submandibular glands. Their echostructure was quoted on a scale between 0 and 4, as previously published. A SGUS score ≥2 was considered pathologic. The gold standard for the analysis was a clinical diagnosis of pSS performed by a group of experts, unaware of the of the SGUS score.

Results: 101 patients were included in this study (mean age 57.4±13.0 years, symptoms duration 6.7±6.1 years, 94.1% females). The diagnosis of pSS was made in 45 patients, and 34 patients fulfilled ACR criteria. Sensitivity (Se) and specificity (Sp) of the different items for the diagnosis of pSS were respectively: 60.0% and 96.4% for the serological item of ACR criteria; 82.2% and 82.1% for the focus score ≥1; 55.6% and 58.9% for the OSS ≥3; 60.0% and 87.5% for SGUS. ACR criteria displayed 64.4% Se and 91.1% Sp. We created a new criteria set including the 3 items of ACR criteria and SGUS; these criteria were considered positive for all patients fulfilling almost 2 of these 4 items. The adjunction of SGUS to ACR criteria increased their Se to 84.4%, for a similar 89.3% Sp. This improvement of ACR criteria diagnostic performance was also found when we restricted the analyses to patients with disease duration of less than 5 years.

Conclusion: The diagnosis properties of ACR classification criteria for pSS are notably improved by the addition of the SGUS score. SGUS should be included in future consensual classification criteria for pSS.

---

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/salivary-gland-ultrasonography-improves-the-diagnostic-performance-of-acr-2012-classification-criteria-for-sjogrens-syndrome-even-in-the-early-stages-of-the-disease/