Minerva Medica 2021 May 05

DOI: 10.23736/S0026-4806.21.07316-X

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Fenofibrate improves GLOBE and UK-PBC scores and histological features in primary biliary cholangitis

Lu WANG ^{1, 2}, Keshuai SUN ¹, Ai TIAN ³, Yansheng LIU ¹, Miao ZHANG ¹, Xinmin ZHOU ¹, Ying HAN ¹ ✉

¹ Institute of Digestive Diseases, Xijing Hospital, Air Force Medical University, Xi'an, China; ² State Key Laboratory of Cancer Biology, Department of Biochemistry and Molecular Biology, Air Force Medical University, Xi'an, China; ³ Department of Hepatology, the 9th Hospital of Nan chang, Nan chang, China

BACKGROUND: Fenofibrate (FF) has been suggested as a second-line therapy for primary biliary cholangitis (PBC) with suboptimal response to ursodeoxycholic acid (UDCA). But its long-term effect is unclear.
METHODS: From a retrospective cohort (n=838), we enrolled 106 UDCA-refractory PBC patients, among them 62 received UDCA monotherapy (UDCA group) and 44 received FF combined with UDCA (UDCA+FF group). Changes of liver biochemistries and prognosis after treatment were determined. In addition, sequential liver biopsies were used to assess the effect of FF on histological parameters.
RESULTS: We found adding FF could significantly reduce serum levels of ALP, but for patients with pre-treatment ALP≥1.67 upper limit of normal (ULN), the significant decline of serum ALP was only observed in the UDCA+FF group after 1 year of therapy. The mean GLOBE score and the liver transplant-free survival predicted by GLOBE score were both improved significantly in patients receiving UDCA+FF after 1 year of therapy. The liver-related death or liver transplant calculated using UK-PBC risk score was significantly reduced in patients receiving UDCA+FF after 1 year of therapy. Although there was no marked difference in the final histological analysis after 3 years of therapy, patients receiving UDCA+FF had improvements or stabilization in fibrosis (85.7%), and bile duct loss (78.6%) were more than that of patients receiving UDCA (70.6% and 76.5%, respectively).
CONCLUSIONS: Adding FF improves GLOBE and UK-PBC scores, and is also associated with the improvements or stabilization of disease features, including fibrosis and ductular injury.

KEY WORDS: Fenofibrate; Primary biliary cholangitis; Liver disease; Hepatic