Are the Globe and UK-PBC scores also effective for predicting risk in patients treated with bezafibrate in addition to ursodeoxycholic acid?: A validation study in Japan

Tanaka, Akihito; Komori, Atsumasa; M, Abe; Inao, Mie; Namisaki, Tadashi; Hashimoto, Nobuyuki; Kawata, Kouichi; Takahashi, Akira; Ninomiya, Motoki; Honda, Arata; Jong-Hon, K.; Arakawa, Masaaki; Yamagiwa, Saburo; Joshita, Satoru; Sato, Ken; Kaneko, Atsushi; Kikuchi, K; Itakura, Jun; Nomura, Taisuke; Kakisaka, Keisuke; Takao, Masaki; Matsuzaki, Youichirou; Ohira, Hiromasa; Mochida, Satoshi; Yoshiji, Hitoshi; Takikawa, Hajime

doi:10.1016/s0168-8278(18)30227-7

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“…A). Because the real outcome was much better than that predicted by the GLOBE score before and after combination therapy, the score appears to overestimate the risk of BF‐treated patients, as was recently reported . However, high AUROC suggests that the score is able to discriminate high‐risk patients with high sensitivity and specificity.…”

Section: Discussionmentioning

confidence: 71%

“…Because the real outcome was much better than that predicted by the GLOBE score before and after combination therapy, the score appears to overestimate the risk of BF-treated patients, as was recently reported. (38) However, high AUROC suggests that the score is able to discriminate high-risk patients with high sensitivity and specificity. In contrast, although UDCA+BF combination therapy improved the UK-PBC risk scores, a significant reduction of the risk of a liver transplant or liver-related death was not detected because of a wide 95% CI (Fig.…”

Section: Discussionmentioning

confidence: 99%

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Bezafibrate Improves GLOBE and UK‐PBC Scores and Long‐Term Outcomes in Patients With Primary Biliary Cholangitis

et al. 2019

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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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Section: Discussionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 99%