Clinical and Molecular Hepatology (Apr 2024)

Prognosis of biopsy-confirmed metabolic dysfunction-associated steatotic liver disease: A sub-analysis of the CLIONE study

  • Michihiro Iwaki,
  • Hideki Fujii,
  • Hideki Hayashi,
  • Hidenori Toyoda,
  • Satoshi Oeda,
  • Hideyuki Hyogo,
  • Miwa Kawanaka,
  • Asahiro Morishita,
  • Kensuke Munekage,
  • Kazuhito Kawata,
  • Tsubasa Tsutsumi,
  • Koji Sawada,
  • Tatsuji Maeshiro,
  • Hiroshi Tobita,
  • Yuichi Yoshida,
  • Masafumi Naito,
  • Asuka Araki,
  • Shingo Arakaki,
  • Takumi Kawaguchi,
  • Hidenao Noritake,
  • Masafumi Ono,
  • Tsutomu Masaki,
  • Satoshi Yasuda,
  • Eiichi Tomita,
  • Masato Yoneda,
  • Akihiro Tokushige,
  • Yoshihiro Kamada,
  • Hirokazu Takahashi,
  • Shinichiro Ueda,
  • Shinichi Aishima,
  • Yoshio Sumida,
  • Atsushi Nakajima,
  • Takeshi Okanoue,

DOI
https://doi.org/10.3350/cmh.2023.0515
Journal volume & issue
Vol. 30, no. 2
pp. 225 – 234

Abstract

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Background/Aims Metabolic dysfunction-associated steatotic liver disease (MASLD) was recently proposed as an alternative disease concept to nonalcoholic fatty liver disease (NAFLD). We aimed to investigate the prognosis of patients with biopsy-confirmed MASLD using data from a multicenter study. Methods This was a sub-analysis of the Clinical Outcome Nonalcoholic Fatty Liver Disease (CLIONE) study that included 1,398 patients with NAFLD. Liver biopsy specimens were pathologically diagnosed and histologically scored using the NASH Clinical Research Network system, the FLIP algorithm, and the SAF score. Patients who met at least one cardiometabolic criterion were diagnosed with MASLD. Results Approximately 99% of cases (n=1,381) were classified as MASLD. Patients with no cardiometabolic risk (n=17) had a significantly lower BMI than patients with MASLD (20.9 kg/m2 vs. 28.0 kg/m2, P<0.001), in addition to significantly lower levels of inflammation, ballooning, NAFLD activity score, and fibrosis stage based on liver histology. These 17 patients had a median follow-up of 5.9 years, equivalent to 115 person-years, with no deaths, liver-related events, cardiovascular events, or extrahepatic cancers. The results showed that the prognosis for pure MASLD was similar to that for the original CLIONE cohort, with 47 deaths and one patient who underwent orthotopic liver transplantation. The leading cause of death was extrahepatic cancer (n=10), while the leading causes of liver-related death were liver failure (n=9), hepatocellular carcinoma (n=8), and cholangiocarcinoma (n=4). Conclusions Approximately 99% of NAFLD cases were considered MASLD based on the 2023 liver disease nomenclature. The NAFLD-only group, which is not encompassed by MASLD, had a relatively mild histopathologic severity and a favorable prognosis. Consequently, the prognosis of MASLD is similar to that previously reported for NAFLD.

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