Pemafibrate improves liver biochemistry and GLOBE scores in patients with primary biliary cholangitis: Nationwide, multicenter study by the Japanese Red Cross Liver Study Group
Keiji Tsuji
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorNobuharu Tamaki
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Search for more papers by this authorCorresponding Author
Masayuki Kurosaki
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Correspondence
Masayuki Kurosaki, Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo 180-8610, Japan.
Email: [email protected]
Search for more papers by this authorNami Mori
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorShintaro Takaki
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorKazuki Ohya
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorToshie Mashiba
Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Japan
Search for more papers by this authorHironori Ochi
Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Japan
Search for more papers by this authorHaruhiko Kobashi
Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Japan
Search for more papers by this authorChikara Ogawa
Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Kagawa, Japan
Search for more papers by this authorMichiko Nonogi
Department of Gastroenterology, Tokushima Red Cross Hospital, Tokushima, Japan
Search for more papers by this authorHideo Yoshida
Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan
Search for more papers by this authorTakehiro Akahane
Department of Gastroenterology, Ishinomaki Red Cross Hospital, Ishinomaki, Japan
Search for more papers by this authorMasahiko Kondo
Department of Gastroenterology, Otsu Red Cross Hospital, Otsu, Japan
Search for more papers by this authorToyotaka Kasai
Department of Gastroenterology, Fukaya Red Cross Hospital, Saitama, Japan
Search for more papers by this authorHideki Fujii
Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Search for more papers by this authorYasushi Uchida
Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Japan
Search for more papers by this authorHirotaka Arai
Department of Gastroenterology, Maebashi Red Cross Hospital, Maebashi, Japan
Search for more papers by this authorKaoru Tsuchiya
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Search for more papers by this authorNamiki Izumi
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Search for more papers by this authorKeiji Tsuji
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorNobuharu Tamaki
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Search for more papers by this authorCorresponding Author
Masayuki Kurosaki
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Correspondence
Masayuki Kurosaki, Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo 180-8610, Japan.
Email: [email protected]
Search for more papers by this authorNami Mori
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorShintaro Takaki
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorKazuki Ohya
Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
Search for more papers by this authorToshie Mashiba
Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Japan
Search for more papers by this authorHironori Ochi
Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Japan
Search for more papers by this authorHaruhiko Kobashi
Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Japan
Search for more papers by this authorChikara Ogawa
Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Kagawa, Japan
Search for more papers by this authorMichiko Nonogi
Department of Gastroenterology, Tokushima Red Cross Hospital, Tokushima, Japan
Search for more papers by this authorHideo Yoshida
Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan
Search for more papers by this authorTakehiro Akahane
Department of Gastroenterology, Ishinomaki Red Cross Hospital, Ishinomaki, Japan
Search for more papers by this authorMasahiko Kondo
Department of Gastroenterology, Otsu Red Cross Hospital, Otsu, Japan
Search for more papers by this authorToyotaka Kasai
Department of Gastroenterology, Fukaya Red Cross Hospital, Saitama, Japan
Search for more papers by this authorHideki Fujii
Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Search for more papers by this authorYasushi Uchida
Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Japan
Search for more papers by this authorHirotaka Arai
Department of Gastroenterology, Maebashi Red Cross Hospital, Maebashi, Japan
Search for more papers by this authorKaoru Tsuchiya
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Search for more papers by this authorNamiki Izumi
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
Search for more papers by this authorAbstract
Aim
We aimed to evaluate the effect of pemafibrate, a selective peroxisome proliferator-activated receptor-α modulator, on patients with primary biliary cholangitis (PBC) complicated by dyslipidemia.
Methods
In total, 61 patients with PBC (Add-on group: 33 patients on ursodeoxycholic acid [UDCA] + pemafibrate combination therapy; Switch group: 28 patients who switched from UDCA + other fibrates to UDCA + pemafibrate combination therapy) were included in the study. Changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), and GLOBE scores were retrospectively analyzed from 6 months before to 12 months after treatment. The POISE criteria were also used to evaluate the treatment efficacy after 12 months.
Results
After 12 months of UDCA + pemafibrate combination therapy, AST significantly decreased from 45 ± 3 to 28 ± 3 U/L (p < 0.05), ALT from 49 ± 5 to 32 ± 5 U/L (p < 0.005), GGT from 155 ± 223 to 91 ± 182 U/L (p < 0.005), and ALP from 1.4 ± 0.9 to 0.9 ± 0.8 × upper limit of normal (p < 0.0005) in all patients. ALT, GGT, and ALP levels were significantly lower after 12 months of UDCA + pemafibrate combination therapy in both the Add-on and Switch groups. After 12 months of combination therapy, the mean GLOBE score of all patients significantly decreased from 0.37 to 0.01 (p < 0.05) and the percentage of patients with a GLOBE score of 0.3 or higher decreased.
Conclusions
In patients with PBC who showed an inadequate response to prior therapy, pemafibrate add-on or switch therapy improved liver biochemistry and GLOBE scores. Pemafibrate may be useful as a second-line drug when UDCA alone is inadequate, or as an alternative after combination therapy with other fibrates.
CONFLICT OF INTEREST STATEMENT
Masayuki Kurosaki is the Editor-in-Chief of Hepatology Research. Kaoru Tsuchiya is the editorial board member of Hepatology Research. The other authors declare no conflict of interest.
Open Research
DATA AVAILABILITY STATEMENT
Research data are not shared.
Supporting Information
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| hepr14172-sup-0001-suppl-data.pptx1.1 MB | Supporting Information S1 |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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