ABSTRACT Objective To identify key clinical and therapeutic predictors of malignancy in a well‐characterized, multicenter Spanish cohort of patients with Sjögren's disease (SjD). Methods A retrospective, cross‐sectional study was conducted using data from the SjögrenSER‐TRANS registry, a national cohort of 437 SjD patients from 33 Spanish hospitals who fulfilled the 2002 AECG classification criteria. Clinical, serological, and treatment‐related variables were systematically collected. Descriptive statistics were used to summarize demographic and clinical characteristics. Bivariate analysis (chi‐squared for categorical variables and t ‐tests for continuous variables) was performed to identify associations with malignancy ( p < 0.05), followed by multivariate logistic regression to determine independent predictors. Results Malignancy was identified in 30 patients (6.86%), with gynecological cancers (30%) and lymphomas (23.3%) being the most common types. Independent predictors of malignancy included older age (OR 1.042, 95% CI 1.007–1.079), glandular inflammation (OR 2.888, 95% CI 1.281–6.512), and rituximab use (OR 3.959, 95% CI 1.461–10.730). Conclusion This study underscores the role of older age, glandular inflammation, and rituximab use as key risk factors for malignancy in SjD. However, the association with rituximab should be interpreted with caution, as indication bias cannot be ruled out. These findings emphasize the need for improved risk stratification and targeted surveillance strategies to facilitate early detection and enhance malignancy management in clinical practice. Prospective studies are warranted to refine monitoring protocols and optimize patient outcomes.
Rusinovich‐Lovgach et al. (2026) studied this question.