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Serum CA125 is independently associated with adverse outcomes in primary Sjögren’s syndrome-associated interstitial lung disease: a prospective multicenter cohort study

Year: 2026

Type: article

Abstract: BACKGROUND: Primary Sjögren's syndrome-associated interstitial lung disease (pSS-ILD) shows heterogeneous patterns and variable prognosis. We previously observed elevated serum CA125 in pSS-ILD. This study investigated whether CA125 predicts adverse outcomes in pSS-ILD. METHODS: Data were derived from the ILD-China cohort (ClinicalTrials.gov: NCT04370158). Among enrolled pSS-ILD patients, a total of 395 with follow-up data were included. The adverse outcomes were death or lung transplantation (LTx). Associations were evaluated using Cox proportional hazards models, with restricted cubic splines to assess nonlinearity. RESULTS: Among 395 patients, 87 experienced adverse outcomes (83 deaths and 4 LTx). CA125 levels were higher in patients with adverse outcomes and were associated with indices of disease severity. In ROC analysis, CA125 showed the highest discrimination among the evaluated biomarkers (AUC 0.764), with a higher AUC than KL-6 (0.580). In multivariable Cox models, higher CA125 modeled as a continuous biomarker was independently associated with adverse outcomes (adjusted HR 1.005 per 1 U/mL increase, 95% CI 1.002-1.007; P < 0.001), corresponding to an approximately 5% higher hazard per 10 U/mL increase. Spline analysis supported a nonlinear relationship between CA125 and hazard. CONCLUSIONS: Higher serum CA125 is independently associated with adverse outcomes in pSS-ILD, with evidence of a nonlinear exposure-hazard relationship. CA125 may aid prognostic assessment in pSS-ILD. TRIAL REGISTRATION: Clinical trials.govs: NCT04370158, Registration date: 30 April 2020.

Source: Respiratory Research

DOI: 10.1186/s12931-026-03573-x

Authors: Wenyan Meng, Jing Geng, Xueying Chen, Huaping Dai