New model identifies stages of salivary gland secretion function in Sjögren disease patients

A novel ultrasonographic scoring model integrating precise definitions for each stage of salivary gland (SG) hypofunction addresses the clinical heterogeneity seen in patients with Sjögren disease (SjD) and demonstrates accuracy in reflecting three distinct stages of SG secretion function, reveals a study.

“By using the official Outcome Measures in Rheumatology (OMERACT) score and the simplified gland score, we have established an SG ultrasonography-based stratification approach for patients with SjD,” the investigators said.

“This approach provides clear definitions for stratification, facilitating their classification into three distinct stages of SG hypofunction and indicating potential variations in autoimmunity severity,” they added.

In this study, the investigators measured whole salivary flows to assess SG secretory hypofunction and performed B-mode ultrasonography bilaterally on the parotid and submandibular glands to evaluate the gland score and OMERACT score. They then analysed the correlation between these scores and SG secretion function in SjD patients, leading to the development of the model for staging SG hypofunction.

A total of 164 patients with SjD were included in a single-centre derivation cohort and 107 in a double-centre validation cohort. Both ultrasonographic scores displayed excellent discriminatory ability between patients with SjD hypofunction and those with normal function (area under the curve >0.8 for both; p<0.001). [J Rheumatol 2026;53:43-53]

Based on the novel ultrasonographic scoring model, low total OMERACT scores (<5) suggested initial-stage SG hypofunction, while high scores (>9) indicated end-stage hypofunction. In contrast, patients with moderate total OMERACT scores (5‒9) required further stratification using total gland scores.

Hypofunction

Of the 271 patients with SjD, 18 percent were found to be in the initial stage of SG hypofunction, 58 percent in the progressive stage, and 100 percent in the end stage (p<0.01). Moreover, the incidence of lacrimal gland involvement and hyperglobulinemia (IgG >16 IU/mL) was significantly lower in patients in the initial stage and those at other stages (p<0.01 for all).

“[W]e identified hypoechoic presence as the ultrasonographic feature most associated with SG secretory function during B-mode ultrasonography examination, which is considered to reflect a combination of damage and inflammation,” the investigators said. [Clin Exp Rheumatol 2018;112:215-221]

Previous studies preferred either the OMERACT or the gland score for assessment purposes, but the current study combined both into a single ultrasonographic scoring model to quantitatively and complementarily characterize hypoechoic features.

“This integration expands the application of these two scoring systems in clinical practice,” the investigators said.

“For instance, if a patient diagnosed with SjD undergoes B-mode ultrasonography examination on four major SGs to obtain a total gland score and a total OMERACT score, our proposed ultrasonographic scoring model will assist their primary physician in determining the stage of SG secretory hypofunction,” they added.

Implications

Overall, these findings provide new avenues for further exploration of SG secretory function in this disease and may contribute to personalized management strategies, according to the investigators.

“Moreover, our ultrasonographic scoring model allows for easy stratification and clinical management planning without the need for complicated stimulated whole salivary flow tests or laborious ultrasonographic scoring systems,” the investigators said.

“Lastly, our proposed stratification tool may greatly affect clinical trial design by facilitating patient stratification and defining relevant study endpoints, thereby enhancing efficiency and reducing drug development costs—particularly in trials aiming to restore SG secretory function,” they added.