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.