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Bezafibrate Improves GLOBE and UK‐PBC Scores and Long‐Term Outcomes in Patients With Primary Biliary Cholangitis
Author(s) -
Honda Akira,
Tanaka Atsushi,
Kaneko Tetsuji,
Komori Atsumasa,
Abe Masanori,
Inao Mie,
Namisaki Tadashi,
Hashimoto Naoaki,
Kawata Kazuhito,
Takahashi Atsushi,
Ninomiya Masashi,
Kang JongHon,
Arakawa Mie,
Yamagiwa Satoshi,
Joshita Satoru,
Umemura Takeji,
Sato Ken,
Kaneko Akira,
Kikuchi Kentaro,
Itakura Jun,
Nomura Takako,
Kakisaka Keisuke,
Fujii Hideki,
Kawada Norifumi,
Takikawa Yasuhiro,
Masaki Tsutomu,
Ohira Hiromasa,
Mochida Satoshi,
Yoshiji Hitoshi,
Iimuro Satoshi,
Matsuzaki Yasushi,
Takikawa Hajime
Publication year - 2019
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.30552
Subject(s) - medicine , ursodeoxycholic acid , hazard ratio , gastroenterology , combination therapy , propensity score matching , liver transplantation , bezafibrate , proportional hazards model , cohort , survival analysis , transplantation , confidence interval
In Japan, bezafibrate (BF) is a second‐line agent for primary biliary cholangitis (PBC) that is refractory to ursodeoxycholic acid (UDCA) treatment. From a retrospective cohort (n = 873) from the Japan PBC Study Group, we enrolled 118 patients who had received UDCA monotherapy for at least 1 year followed by combination therapy with UDCA+BF for at least 1 year. GLOBE and UK‐PBC scores after UDCA monotherapy (i.e., immediately before UDCA+BF combination therapy) were compared with those after 1 year of UDCA+BF combination therapy. The real outcomes of enrolled patients estimated by Kaplan–Meier analysis were compared with the predicted outcomes calculated using GLOBE and UK‐PBC scores. In addition, the hazard ratio of BF treatment was calculated using propensity score analysis. The mean GLOBE score before the combination therapy was 0.504 ± 0.080, which improved significantly to 0.115 ± 0.085 ( P < 0.0001) after 1 year of combination therapy. The real liver transplant‐free survival of enrolled patients was significantly better than that predicted by GLOBE score before introducing BF. Combination therapy did not significantly improve the real rates of liver transplantation or liver‐related death compared with those predicted by UK‐PBC risk score before introducing BF, but the predicted risk was significantly reduced by the addition of BF ( P < 0.0001). Cox regression analysis with inverse probability of treatment weighting showed that the addition of BF significantly reduced the hazard of liver transplant or liver‐related death in patients who, after 1 year of UDCA monotherapy, had normal serum bilirubin (adjusted hazard ratio 0.09, 95% confidence interval 0.01‐0.60, P = 0.013). Conclusion: Addition of BF to UDCA monotherapy improves not only GLOBE and UK‐PBC scores but also the long‐term prognosis of PBC patients, especially those with early‐stage PBC.