TY - JOUR
T1 - Bezafibrate Improves GLOBE and UK-PBC Scores and Long-Term Outcomes in Patients With Primary Biliary Cholangitis
AU - Japan PBC Study Group
AU - Honda, Akira
AU - Tanaka, Atsushi
AU - Kaneko, Tetsuji
AU - Komori, Atsumasa
AU - Abe, Masanori
AU - Inao, Mie
AU - Namisaki, Tadashi
AU - Hashimoto, Naoaki
AU - Kawata, Kazuhito
AU - Takahashi, Atsushi
AU - Ninomiya, Masashi
AU - Kang, Jong Hon
AU - Arakawa, Mie
AU - Yamagiwa, Satoshi
AU - Joshita, Satoru
AU - Umemura, Takeji
AU - Sato, Ken
AU - Kaneko, Akira
AU - Kikuchi, Kentaro
AU - Itakura, Jun
AU - Nomura, Takako
AU - Kakisaka, Keisuke
AU - Fujii, Hideki
AU - Kawada, Norifumi
AU - Takikawa, Yasuhiro
AU - Masaki, Tsutomu
AU - Ohira, Hiromasa
AU - Mochida, Satoshi
AU - Yoshiji, Hitoshi
AU - Iimuro, Satoshi
AU - Matsuzaki, Yasushi
AU - Takikawa, Hajime
N1 - Publisher Copyright:
© 2019 by the American Association for the Study of Liver Diseases.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - 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.
AB - 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.
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U2 - 10.1002/hep.30552
DO - 10.1002/hep.30552
M3 - Article
C2 - 30737815
AN - SCOPUS:85064514976
VL - 70
SP - 2035
EP - 2046
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 6
ER -