A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis

Minami Yagi, Kosuke Matsumoto, Atsumasa Komori, Masanori Abe, Naoaki Hashimoto, Mie Inao, Tadashi Namisaki, Kazuhito Kawata, Masashi Ninomiya, Hideki Fujii, Atsushi Takahashi, Jong Hon Kang, Masaaki Takamura, Mie Arakawa, Satoru Joshita, Ken Sato, Jun Itakura, Takako Nomura, Keisuke Kakisaka, Akira KanekoYamato Tamura, Ryo Miura, Mitsuhiko Aiso, Toshihiko Arizumi, Yoshinari Asaoka, Kentaro Kikuchi, Yasuhiro Takikawa, Tsutomu Masaki, Takeji Umemura, Akira Honda, Hiromasa Ohira, Norifumi Kawada, Hitoshi Yoshiji, Satoshi Mochida, Hajime Takikawa, Atsushi Tanaka

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Background/Purpose: Although ursodeoxycholic acid (UDCA) is a first-line treatment for primary biliary cholangitis (PBC), 20%-30% of patients with PBC exhibit an incomplete response to UDCA. Recently, the UDCA Response Score was proposed for predicting response to UDCA using pretreatment parameters in patients with PBC. We aimed to validate the UDCA Response Score in Japanese patients with PBC. Methods: Registry data of Japanese patients (n = 873) were collected. Patients with data on all clinical parameters required for calculating the UDCA Response Score were selected. The endpoint was UDCA response, defined as alkaline phosphatase <1.67 times the upper limit of the normal value after 12 months of UDCA treatment. Results: All parameters were available in 804 patients (male/female = 120/684, age 58.9 [interquartile range 51.1-66.9] years). Bezafibrate was commenced within 12 months of UDCA in 78 patients (9.7%) because of the lack of an early response. We found that the endpoint was not reached in these 78 patients, and the area under the receiver operating characteristic curve (AUROC) of the score was 0.74 (95% confidence interval [CI] 0.70-0.79). The AUROC was 0.77 (95% CI 0.70-0.83) in patients undergoing UDCA monotherapy (n = 726). Finally, the AUROC of the modified UDCA Response Score using only data from the treatment start date was 0.80 (95% CI 0.70-0.90) in patients receiving a combination therapy of UDCA and bezafibrate (n = 160). Conclusion: The validity of the UDCA Response Score was acceptable in Japanese patients; this score will be informative in patients treated with a combination therapy of UDCA and bezafibrate.

Original languageEnglish
Pages (from-to)1926-1933
Number of pages8
JournalLiver International
Volume40
Issue number8
DOIs
Publication statusPublished - 2020 Aug 1

Keywords

  • alkaline phosphatase
  • bezafibrate
  • cohort study
  • endpoint
  • treatment response
  • validation

ASJC Scopus subject areas

  • Hepatology

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