ArticleJournal of clinical and translational hepatology2026
A Dual Time Window-driven Strategy to Optimize Primary Biliary Cholangitis Treatment via Alkaline Phosphatase Normalization.
Article in Journal of clinical and translational hepatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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18 authors.
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Abstract
Background and Aims: The current criterion of biochemical response to ursodeoxycholic acid in primary biliary cholangitis is an alkaline phosphatase (ALP) level of ≤1.67 × the upper limit of normal (ULN) after 12 months of treatment. However, a proportion of patients who meet this parameter may still progress to liver decompensation. This study aimed to optimize the clinical management of primary biliary cholangitis by (1) establishing ALP normalization as a core treatment target, (2) identifying early intervention windows, and (3) developing risk stratification criteria. Methods: This multicenter retrospective study included an internal cohort and an external validation cohort. We assessed the prognostic impact of ALP normalization with Kaplan-Meier and Cox regression. Sankey diagrams and segmented Poisson regression analysis mapped dynamic risk transitions to identify critical intervention windows. Predictive performance (sensitivity/specificity/positive predictive value/negative predictive value [NPV]) of Mayo, Paris II, and Toronto criteria for 12-month ALP normalization was compared. Results: Patients achieving ALP normalization showed significantly higher complication-free survival versus those with ALP 1.0-1.67 × ULN (89.8% vs. 79.8%; Conclusions: ALP normalization significantly improves clinical outcomes. Two subgroups demonstrate low normalization probability and warrant early intervention: (1) patients with ALP ≥ 1.67 × ULN after 3 months and (2) those not meeting Paris II criteria by month 6.
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