A validation study of the Ursodeoxycholic Acid Response Score in Japanese patients with primary biliary cholangitis.
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Yagi Minami, Matsumoto Kosuke, Komori Atsumasa, Abe Masanori, Hashimoto Naoaki, Inao Mie, Namisaki Tadashi, Kawata Kazuhito, Ninomiya Masashi, Fujii Hideki, Takahashi Atsushi, Kang Jong-Hon, Takamura Masaaki, Arakawa Mie, Joshita Satoru, Sato Ken, Itakura Jun, Nomura Takako, Kakisaka Keisuke, Kaneko Akira, Tamura Yamato, Miura Ryo, Aiso Mitsuhiko, Arizumi Toshihiko, Asaoka Yoshinari, Kikuchi Kentaro, Takikawa Yasuhiro, Masaki Tsutomu, Umemura Takeji, Honda Akira, Ohira Hiromasa, Kawada Norifumi, Yoshiji Hitoshi, Mochida Satoshi, Takikawa Hajime, Tanaka Atsushi, Japan PBC Study Group (JPBCSG)
Аннотация
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.