The identification of objective, non-invasive biomarkers for primary Sjögren's disease (pSS) remains a clinical challenge, particularly for assessing local glandular involvement and immune activity. A recent observational cross-sectional study found elevated salivary galectin-9 levels in pSS patients compared to healthy controls, yet these levels did not correlate with established disease activity scores or patient-reported symptoms.1

Primary Sjögren's disease is a systemic autoimmune condition characterized by chronic inflammation of exocrine glands and diverse clinical manifestations.1 The need for objective, non-invasive biomarkers that reflect local glandular involvement and disease-related immune activity persists.1

Study Design and Findings

An observational cross-sectional case-control study included 34 patients fulfilling the 2016 ACR/EULAR classification criteria for primary Sjögren's disease and 34 healthy controls.1 The study was conducted between December 2024 and February 2025.1 Unstimulated whole-saliva samples were collected in the morning using the passive drool method.1 Salivary galectin-9 concentrations were measured via enzyme-linked immunosorbent assay.1 Disease activity and symptom burden were assessed using validated indices.1 Receiver operating characteristic analysis was performed to evaluate discriminatory performance.1

Salivary galectin-9 levels were significantly higher in patients with primary Sjögren's disease compared with healthy controls.1 However, the study observed no significant associations between salivary galectin-9 levels and disease activity scores after correction for multiple comparisons.1 Furthermore, no significant associations were found with patient-reported symptoms, autoantibody profiles, Schirmer test results, or minor salivary gland biopsy findings.1 Salivary galectin-9 demonstrated limited discriminative ability between patients and controls.1

Limitations and Next Steps

The study's cross-sectional design limits the ability to infer causality or track changes over time. The sample size of 34 patients and 34 controls is relatively small. While salivary galectin-9 levels were elevated, their lack of correlation with established disease activity markers and patient-reported outcomes suggests limited utility as a standalone biomarker for monitoring disease progression or treatment response. The authors concluded that salivary galectin-9 levels were elevated in primary Sjögren's disease and may be associated with local glandular immune processes.1 They recommend further prospective studies to determine the clinical relevance of these findings.1

Clinical Implications

The persistent search for reliable, non-invasive biomarkers in primary Sjögren's disease highlights a critical gap in current diagnostic and monitoring strategies. While the elevation of salivary galectin-9 in pSS patients is an interesting biological observation, its failure to correlate with established disease activity scores or patient-reported symptoms means it offers no immediate practical benefit for clinicians. This study reinforces that a biomarker's presence does not automatically equate to clinical utility; correlation with disease progression or treatment response is paramount for adoption into practice.

For patients, the promise of a simple saliva test to monitor their condition remains elusive. The current reliance on subjective symptom assessment, autoantibody profiles, and invasive biopsies underscores the need for more objective measures. Pharmaceutical companies developing treatments for pSS should note that novel biomarkers must demonstrate clear associations with clinically meaningful endpoints to gain traction, both for trial stratification and post-market monitoring. Without such correlations, even statistically significant differences in biomarker levels are unlikely to influence prescribing patterns or guideline recommendations.

This research, while methodologically sound within its scope, serves as a reminder that the path from biological discovery to clinical application is often long and fraught with null results. Future research should focus on longitudinal studies with larger cohorts, exploring galectin-9's role in specific disease subsets or its potential as part of a multi-biomarker panel, rather than as a solitary indicator.

Key Takeaways
  • The Pivot Salivary galectin-9 is elevated in pSS, suggesting a role in local glandular immune processes.
  • The Data Salivary galectin-9 levels were significantly higher in pSS patients (N=34) compared to healthy controls (N=34), but showed no significant associations with disease activity scores after correction for multiple comparisons.1
  • The Action Salectin-9 is not currently a useful biomarker for assessing pSS disease activity or symptom burden in clinical practice.

ART-2026-207

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Team TLSFE. Salivary galectin-9 elevated in primary sjögren's, lacks disease activity correlation. The Life Science Feed. Published June 4, 2026. Updated June 4, 2026. Accessed June 4, 2026. https://thelifesciencefeed.com/rheumatology/spondylarthropathies/insights/salivary-galectin-9-elevated-in-primary-sjgrens-lacks-disease-activity-correlation.

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References

1. İnanç E, Yolbaş S, Zontul S. Salivary Galectin-9 Levels in Primary Sjögren's Disease: An Observational Cross-Sectional Case-Control Study. J Clin Med 2026;15(1):234. doi:10.3390/jcm15010234