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Multicenter Study
. 2024 Apr;30(2):225-234.
doi: 10.3350/cmh.2023.0515. Epub 2024 Jan 24.

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

Michihiro Iwaki  1 , Hideki Fujii  2 , Hideki Hayashi  3 , Hidenori Toyoda  4 , Satoshi Oeda  5 , Hideyuki Hyogo  6 , Miwa Kawanaka  7 , Asahiro Morishita  8 , Kensuke Munekage  8   9 , Kazuhito Kawata  10 , Tsubasa Tsutsumi  11 , Koji Sawada  12 , Tatsuji Maeshiro  13 , Hiroshi Tobita  14 , Yuichi Yoshida  15 , Masafumi Naito  15 , Asuka Araki  16 , Shingo Arakaki  13 , Takumi Kawaguchi  11 , Hidenao Noritake  10 , Masafumi Ono  17 , Tsutomu Masaki  8 , Satoshi Yasuda  4 , Eiichi Tomita  3 , Masato Yoneda  1 , Akihiro Tokushige  18 , Yoshihiro Kamada  19 , Hirokazu Takahashi  20 , Shinichiro Ueda  18 , Shinichi Aishima  21 , Yoshio Sumida  22 , Atsushi Nakajima  1 , Takeshi Okanoue  23
Affiliations
Multicenter Study

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

Michihiro Iwaki et al. Clin Mol Hepatol. 2024 Apr.

Abstract

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).

Conclusion: 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.

Keywords: Liver biopsy; Prognosis; Steatotic liver disease.

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Conflict of interest statement

Conflicts of Interest

The authors have no conflicts to disclose.

Figures

Figure 1.
Figure 1.
Overall mortality and liver-related events stratified according to cardiometabolic criteria in patients with NAFLD (n=1,398). (A) Overall mortality and (B) liver-related events according to the presence of cardiometabolic criteria. NAFLD, nonalcoholic fatty liver disease.
Figure 2.
Figure 2.
Overall mortality and liver-related events stratified according to histological characteristics in patients with pure MASLD (n=1,381). (A) Overall mortality and (B) liver-related events according to fibrosis stage. (C) Overall mortality and d, liver-related events according to the presence or absence of MASH. MASH, metabolic dysfunction-associated steatohepatitis; MASLD, metabolic dysfunction-associated steatotic liver disease.
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References

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