Prognostic Significance of Bile Duct Loss in Early‐Stage Primary Biliary Cholangitis: A Long‐Term Observational Study

Background & Aims Primary biliary cholangitis (PBC) is a chronic, slowly progressive, and autoimmune liver disease. This study aimed to establish the clinicopathological features that accurately predict long‐term prognosis in patients with early‐stage PBC. Methods The present long‐term (8.8 years), multicenter, and retrospective investigation enrolled 274 treatment‐naïve PBC patients who had undergone liver biopsy. Among them, 207 patients with albumin–bilirubin (ALBI) grade 1 were categorized as clinical early‐stage, and 230 patients with Nakanuma stage 1/2 were classified as pathological early‐stage. The prognostic factors related to the time to liver‐related events (LRE) were statistically evaluated. Results Cox regression analysis identified Nakanuma bile duct loss score of ≥ 1 as a significant independent factor associated with LRE development in clinical early‐stage PBC patients (hazard ratio [HR] 12.89, 95% confidence interval [95% CI] 1.60–103.96, P = 0.016). Kaplan–Meier testing revealed that the cumulative incidence of LRE was significantly higher in patients with bile duct loss score of ≥ 1 than in those with bile duct loss score 0 (log‐rank test; P < 0.001). Similarly, bile duct loss score could predict LRE in pathological early‐stage PBC patients, as confirmed by both multivariable Cox regression (HR 6.60, 95% CI 1.37–31.86, P = 0.019) and Kaplan–Meier (log‐rank test; P < 0.001) analyses. Conclusions Nakanuma bile duct loss score may be a valuable prognostic indicator in the early clinical and pathological stages of PBC.