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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Lackner, C; Gouw, ASH; Alves, V; Arola, J; Bedossa, P; Behling, C; Brunt, EM; Burt, A; Clouston, A; Cummings, O; Goodman, ZD; Guido, M; Guy, C; Hubscher, SG; Hytiroglou, P; Kleiner, D; Pai, R; Paradis, V; Park, YN; Rastogi, A; Schirmacher, P; Wee, A; Yano, H; Yeh, M; Avian, A; Tiniakos, DG.
Consensus position statements for the standardized application of histological grading and staging systems in MASH clinical trials.
J Hepatol. 2025;
Doi: 10.1016/j.jhep.2025.09.019
PubMed
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- Autor*innen der Med Uni Graz:
- Avian Alexander
- Lackner Karoline
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- Abstract:
- BACKGROUND & AIMS: Assessment of histologic disease activity (grading) and fibrosis (staging) is a prerequisite for patient selection and evaluation of treatment response in clinical trials of metabolic dysfunction-associated steatohepatitis (MASH). The lack of universally accepted definitions of histological components required for metabolic dysfunction-associated disease (MASLD) grading and staging, inconsistent histologic interpretations, and absence of guidelines for the application of currently used scoring systems contribute to high inter-observer variation and also influence supervised machine learning algorithms. METHODS: The International MASLD Pathology Group (IMPG) of 25 expert liver pathologists and a statistician was established to develop guidance for the histological assessment of liver biopsies in MASH for clinical trials and to define standards for processing of liver biopsies as well as to further refine criteria for histological MASLD grading and staging. Statements were generated by three IMPG working subgroups (WG) and were evaluated in a Delphi procedure. RESULTS: The IMPG WGs issued a total of 278 primary statements which were evaluated in a first Delphi round (DR) yielding 162 statements with 80% or higher agreement. Remaining 116 statements were discussed and revised or not further considered. The resulting 33 revised statements were evaluated in a second DR yielding 192 final statements with 80% or higher agreement. CONCLUSION: The IMPG statements provide for the first time guidelines to promote consensus among liver pathologists for the histopathological evaluation and scoring of liver biopsies for MASH clinical trials. Furthermore, they may be used to inform supervised machine learning algorithms for quantitative MASLD histology assessments. IMPACT AND IMPLICATIONS: Inter- (and intra-) observer variations in the histological interpretation of key morphological features of MASH limit the precision of histological grading and staging as well as the diagnosis of the histological MASLD types, MASL and MASH. This is thought to account in clinical trials, at least in part, for screening failure as well as variable placebo response rates, potentially obscuring treatment effects. The International MASLD Pathology Group, consisting of 25 expert liver pathologists, generated consensus statements for histopathological procedures, technical aspects and histological criteria for the diagnosis of MASH, for grading disease activity and staging fibrosis. These may provide a basis for standardized histologic interpretation and the development of AI-based grading and staging algorithms for clinical trials of MASH.