CYFRA 21-1 Predicts Progression in Idiopathic Pulmonary Fibrosis: A Prospective Longitudinal Analysis of the PROFILE Cohort

• DOI: 10.1164/rccm.202107-1769oc
• Publication Date: 2022-04-01T17:57:55Z
• Authors: Philip L. Molyneaux; William A. Fahy; Adam J. Byrne; Rebecca Braybrooke; Peter Saunders; Richard Toshner; Gesa Albers; Felix Chua; Elisabetta A. Ren...; Athol U. Wells; Yakshitha Karkera; Eunice Oballa; Gauri Saini; Andrew G. Nicholson; R. Gisli Jenkins; Toby M. Maher
• Keywords: Keratin-19; 0301 basic medicine; 03 medical and health sciences; Antigens, Neoplasm; Disease Progression; Humans; Prospective Studies; Biomarkers; Idiopathic Pulmonary Fibrosis

Rationale: Idiopathic pulmonary fibrosis (IPF) is a progressive and inevitably fatal condition for which there are lack of effective biomarkers to guide therapeutic decision making. Objectives: To determine the relationship between serum concentrations cytokeratin fragment CYFRA 21-1 disease progression mortality in individuals with IPF enrolled Prospective Observation Fibrosis Lung Clinical Endpoints (PROFILE) study. Methods: was identified by immunohistochemistry samples human lung obtained at surgery. Concentrations were measured using an ELISA-based assay collected baseline, 1 month, 3 months from 491 incident diagnosis who PROFILE study 100 control subjects baseline. Study followed minimum years after their first blood draw. Measurements Main Results: localizes hyperplastic epithelium tissue. Peripheral significantly higher than healthy both discovery (n = 132) (control: 0.96 ± 0.81 ng/ml; vs. IPF: 2.34 2.15 P < 0.0001) validation 359) 2.21 1.54 4.13 2.77 cohorts. Baseline able distinguish risk 12-month (C-statistic, 0.70; 95% confidence interval, 0.61–0.79; predictive overall (hazard ratio, 1.12 [95% 1.06–1.19] per ng/ml increase 21-1; 0.0001). Furthermore, 3-month change separately predicted survival Conclusions: 21-1, marker epithelial damage turnover, has potential be important prognostic biomarker IPF.