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Background <p>Progressive pulmonary fibrosis (PPF) represents a challenging phenotype of interstitial lung disease (ILD), characterised by functional deterioration and radiological progression despite treatment. The identification of reliable biomarkers to predict PPF remains a critical unmet need in clinical practice. This study aimed to investigate the predictive value of serum cytokeratin 19 fragment (CYFRA21-1) for PPF in patients with non-idiopathic pulmonary fibrosis (non-IPF) ILD.</p> Methods <p>A retrospective cohort of 203 patients with non-IPF ILD were enrolled between January 2020 and December 2021 and followed for a median of 19 months. Baseline serum CYFRA21-1 levels were measured, and progression to PPF was defined according to the 2022 ATS clinical guideline. Associations between CYFRA21-1 levels and PPF risk were analysed using Cox proportional hazards models, and the optimal cut-off value was determined by receiver operating characteristic curve analysis.</p> Results <p>During follow-up, 48 patients (23.6%) developed PPF. Baseline CYFRA21-1 levels were significantly higher in the PPF group than in the non-PPF group (5.54 [4.36, 8.44] vs. 3.73 [2.63, 5.21] ng/mL, <i>P</i> &lt; 0.001). Following variable selection via Least Absolute Shrinkage and Selection Operator (LASSO) regression, CYFRA21-1 was identified as an independent predictor of PPF in the multivariate Cox model (hazard ratio [HR] = 1.085, 95% confidence interval: 1.018–1.156, <i>P</i> = 0.013). The optimal cut-off value for CYFRA21-1 was determined to be 5.12 ng/mL (area under the curve = 0.712). Patients stratified by this cut-off (high vs. low CYFRA21-1) demonstrated significant differences in baseline lung function and computed tomography severity scores. Moreover, the high CYFRA21-1 group was associated with a substantially increased risk of PPF progression (HR = 3.803, <i>P</i> &lt; 0.001).</p> Conclusions <p>Elevated serum CYFRA21-1 levels independently predict the development of PPF in patients with non-IPF ILD. It is correlated with impaired pulmonary function and radiographic severity. CYFRA21-1 may serve as a valuable biomarker for early risk stratification, supporting the need for validation in prospective multicentre studies.</p>

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Serum CYFRA21-1 as a novel biomarker for predicting progressive pulmonary fibrosis in non-IPF interstitial lung disease, a cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月27日

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  • Guoxin Zhang,
  • Ming Sun,
  • Hao Cao,
  • Xi Chen,
  • Hui Ma,
  • Wei Jia

摘要

Background

Progressive pulmonary fibrosis (PPF) represents a challenging phenotype of interstitial lung disease (ILD), characterised by functional deterioration and radiological progression despite treatment. The identification of reliable biomarkers to predict PPF remains a critical unmet need in clinical practice. This study aimed to investigate the predictive value of serum cytokeratin 19 fragment (CYFRA21-1) for PPF in patients with non-idiopathic pulmonary fibrosis (non-IPF) ILD.

Methods

A retrospective cohort of 203 patients with non-IPF ILD were enrolled between January 2020 and December 2021 and followed for a median of 19 months. Baseline serum CYFRA21-1 levels were measured, and progression to PPF was defined according to the 2022 ATS clinical guideline. Associations between CYFRA21-1 levels and PPF risk were analysed using Cox proportional hazards models, and the optimal cut-off value was determined by receiver operating characteristic curve analysis.

Results

During follow-up, 48 patients (23.6%) developed PPF. Baseline CYFRA21-1 levels were significantly higher in the PPF group than in the non-PPF group (5.54 [4.36, 8.44] vs. 3.73 [2.63, 5.21] ng/mL, P < 0.001). Following variable selection via Least Absolute Shrinkage and Selection Operator (LASSO) regression, CYFRA21-1 was identified as an independent predictor of PPF in the multivariate Cox model (hazard ratio [HR] = 1.085, 95% confidence interval: 1.018–1.156, P = 0.013). The optimal cut-off value for CYFRA21-1 was determined to be 5.12 ng/mL (area under the curve = 0.712). Patients stratified by this cut-off (high vs. low CYFRA21-1) demonstrated significant differences in baseline lung function and computed tomography severity scores. Moreover, the high CYFRA21-1 group was associated with a substantially increased risk of PPF progression (HR = 3.803, P < 0.001).

Conclusions

Elevated serum CYFRA21-1 levels independently predict the development of PPF in patients with non-IPF ILD. It is correlated with impaired pulmonary function and radiographic severity. CYFRA21-1 may serve as a valuable biomarker for early risk stratification, supporting the need for validation in prospective multicentre studies.