Prospective validation of imaging and serum diagnostic biomarkers of steatohepatitis and fibrosis in MASLD: the LITMUS Imaging Study.

Authors

Michael Pavlides, Yasaman Vali, Ferenc E Mózes, Kristy Wonders, Salma Akhtar, Paul D Hockings, Elizabeth Shumbayawonda, Kay Pepin, Isabel Fernandez-Lizaranzu, Diana Julie Leeming, Jeremy F Cobbold, Michael E D Allison, Guruprasad P Aithal, Manuel Romero-Gomez, Rocio Aller, Juan M Pericàs, Jérôme Boursier, Salvatore Petta, Jörn M Schattenberg, Mattias Ekstedt, Annalisa Berzigotti, Hannele Yki-Järvinen, Miljen Martic, Theresa Tuthill, Clifford A Brass, Michael Kalutkiewicz, Rajarshi Banerjee, Richard L Ehman, Moritz J Schneider, Dina Tiniakos, Morten Karsdal, Jeremy Magnanensi, Céline Fournier-Poizat, Vlad Ratziu, Carla Yunis, Elisabetta Bugianesi, Stephen A Harrison, LITMUS Consortium Investigators, Patrick M Bossuyt, Quentin M Anstee

Published in

Nature medicine. Jul 24, 2026. Epub Jul 24, 2026.

Abstract

There is a need for robust evaluations of noninvasive biomarkers for metabolic dysfunction-associated steatotic liver disease. This prospective multicenter study assessed the diagnostic accuracy of imaging (including liver stiffness measurement (LSM) using magnetic resonance elastography (MRE) and FibroScan (vibration-controlled transient elastography (VCTE)), serum biomarkers (including NIS2+) and composite scores (including Agile 3+ and Agile 4) for centrally read steatohepatitis and fibrosis. For cirrhosis, several biomarkers exceeded the minimum acceptable performance criterion (MAC), including MRE (area under the receiver operating curve (AUC) 0.91; P < 0.01), VCTE-LSM (AUC 0.87; P < 0.01), Agile 3+ (AUC 0.89; P < 0.01) and Agile 4 (AUC 0.88; P < 0.01). Among 357 participants, fibrosis stages F0-F4 were present in 12%, 16%, 25%, 32% and 15%, respectively. NIS2+ had the highest diagnostic accuracy among serum biomarkers for metabolic dysfunction-associated steatohepatitis (MASH; AUC 0.83) and at-risk MASH (MASH with at least stage 2 fibrosis; AUC 0.82), although neither significantly exceeded the MAC (P = 0.15 and P = 0.19). Among imaging biomarkers, MRE showed the highest performance for MASH (AUC 0.71) and at-risk MASH (AUC 0.75), but these remained below the MAC. For fibrosis staging, performance was stronger: MRE met the MAC for advanced fibrosis (AUC 0.91; P < 0.01), as did Agile 3+ (AUC 0.84; P = 0.03). For cirrhosis, several biomarkers exceeded the MAC, including MRE (AUC 0.91; P < 0.01), VCTE-LSM (AUC 0.87; P < 0.01), Agile 3+ (AUC 0.89; P < 0.01) and Agile 4 (AUC 0.88; P < 0.01). Serum biomarkers tended to outperform imaging for identifying at-risk MASH, whereas elastography and composite scores showed excellent accuracy for staging advanced fibrosis and cirrhosis.

PMID:
42498741
Bibliographic data and abstract were imported from PubMed on 25 Jul 2026.

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