GLOBE Score and UK-PBC Risk Score Predict Long-Term Clinical Outcomes of Patients With Primary Biliary Cholangitis and Receiving Ursodeoxycholic Acid and Fenofibrate

Objectives

Fenofibrate is widely used as add-on therapy for patients with primary biliary cholangitis (PBC) who have a suboptimal response to ursodeoxycholic acid (UDCA). We aimed to evaluate whether the UDCA biochemical response criteria, especially the GLOBE and UK-PBC risk scoring systems, could predict the long-term prognosis of PBC patients who received fenofibrate add-on therapy.

Methods

PBC patients receiving fenofibrate add-on therapy were included in this retrospective–prospective study. We compared the utility of nine biochemical response criteria and two scoring systems to predict clinical outcomes by Kaplan–Meier plots and the receiver operating characteristic (ROC) curve analysis.

Results

Sixty-three patients were included in this study, of whom 11 had a poor outcome (hepatic decompensation, liver-related death, or liver transplantation) and 52 had a good outcome. After a median follow-up of 45 months, fenofibrate add-on therapy steadily decreased the serum levels of alkaline phosphatase, γ-glutamyl transferase, and alanine aminotransferase in both groups. The patients with poor outcomes had a higher GLOBE score and UK-PBC risk score than those with good outcomes after 12 months of treatment. More importantly, both scores had better predictive performance for hepatic decompensation- and transplant-free survival than the other criteria. The areas under the ROC curve of the GLOBE and UK-PBC risk scores at 12 months were 0.878 (95% confidence interval [CI] 0.751–0.955) and 0.919 (95% CI 0.803–0.978), respectively.

Conclusion

The GLOBE and UK-PBC risk scores outperformed the other biochemical response criteria in predicting the clinical outcomes of PBC patients with suboptimal response to UDCA and receiving fenofibrate add-on therapy.