Background 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) a focus score ≥1 on salivary gland biopsy (SGB). According to these criteria, a patient can be classified as pSS if almost 2 of these 3 items are present. 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 pSS.1
Objectives 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.1 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 SGUS score.
Results Eighty-eight patients were included in this study (mean age 57.0±13.0 years, symptoms duration 6.9±6.7 years, 94.3% females). The diagnosis of pSS was made in 40 patients, and 33 patients fulfilled ACR criteria. Sensitivity (Se) and specificity (Sp) of the different items for the diagnosis of pSS were respectively: 62.5% and 95.8% for the serological item of ACR criteria; 85.0% and 81.3% for the focus score ≥1; 60.0% and 60.0% for the OSS ≥3; 60.0% and 87.5% for SGUS. ACR criteria displayed 72.5% Se and 91.7% 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 90.0%, for a similar 89.6% Sp.
Conclusions 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.
Cornec D, Jousse-Joulin S, Pers J-O, Marhadour T, Cochener B, Boisramé-Gastrin S, et al. Contribution of salivary gland ultrasonography to the diagnosis of Sjögren’s syndrome: Toward new diagnostic criteria? Arthritis Rheum 2013;65:216-225.
Disclosure of Interest None Declared
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