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

@article{pavlides2026prospective,
  title = {{Prospective validation of imaging and serum diagnostic biomarkers of steatohepatitis and fibrosis in MASLD: the LITMUS Imaging Study}},
  author = {Michael Pavlides and Yasaman Vali and Ferenc Emil Mózes and Kristy Wonders and Salma Akhtar and Paul D. Hockings and Elizabeth Shumbayawonda and Kay Pepin and Isabel Fernández-Lizaranzu and Diana Julie Leeming and Jeremy F. Cobbold and Michael E.D. Allison and Guruprasad Padur Aithal and Manuel Romero‐Gómez and Rocio Aller and Juan Manuel Pericàs and Jérôme Boursier and Salvatore Petta and Jörn Markus Schattenberg and Mattias Ekstedt and Annalisa Berzigotti and Hannele Yki‐Järvinen and Miljen Martić and Theresa A. Tuthill and Clifford A. Brass and Michael J. Kalutkiewicz and Rajarshi Banerjee and Richard L. Ehman and Moritz J. Schneider and DINA G. TINIAKOS and Morten Karsdal and Jérémy Magnanensi and Céline Fournier and Vlad Ratziu and Carla Yunis and Elisabetta Bugianesi and Stephen A. Harrison and Quentin M. Anstee and Ann Daly and Fiona Oakley and Simon Cockell and DINA G. TINIAKOS and Pierre Bédossa and Heather Jane Cordell and Christopher Paul Day and Kristy Wonders and Olivier Govaere and Paolo Missier B and Matthew McTeer and Luke Vale and Yemi Oliboyede and Matthew Breckons and Patrick M. Bossuyt and Yasaman Vali and Jenny Lee and Max Nieuwdorp and Yaïr I. Z. Acherman and Arnold van de Laar and Athanasios Angelakis and Adriaan Georgius Holleboom},
  journal = {Nature Medicine},
  year = {2026},
  month = jul,
  doi = {10.1038/s41591-026-04496-2},
  url = {https://hal.science/hal-05840940v1},
  note = {CC BY},
}

TY  - JOUR
TI  - Prospective validation of imaging and serum diagnostic biomarkers of steatohepatitis and fibrosis in MASLD: the LITMUS Imaging Study
AU  - Michael Pavlides
AU  - Yasaman Vali
AU  - Ferenc Emil Mózes
AU  - Kristy Wonders
AU  - Salma Akhtar
AU  - Paul D. Hockings
AU  - Elizabeth Shumbayawonda
AU  - Kay Pepin
AU  - Isabel Fernández-Lizaranzu
AU  - Diana Julie Leeming
AU  - Jeremy F. Cobbold
AU  - Michael E.D. Allison
AU  - Guruprasad Padur Aithal
AU  - Manuel Romero‐Gómez
AU  - Rocio Aller
AU  - Juan Manuel Pericàs
AU  - Jérôme Boursier
AU  - Salvatore Petta
AU  - Jörn Markus Schattenberg
AU  - Mattias Ekstedt
AU  - Annalisa Berzigotti
AU  - Hannele Yki‐Järvinen
AU  - Miljen Martić
AU  - Theresa A. Tuthill
AU  - Clifford A. Brass
AU  - Michael J. Kalutkiewicz
AU  - Rajarshi Banerjee
AU  - Richard L. Ehman
AU  - Moritz J. Schneider
AU  - DINA G. TINIAKOS
AU  - Morten Karsdal
AU  - Jérémy Magnanensi
AU  - Céline Fournier
AU  - Vlad Ratziu
AU  - Carla Yunis
AU  - Elisabetta Bugianesi
AU  - Stephen A. Harrison
AU  - Quentin M. Anstee
AU  - Ann Daly
AU  - Fiona Oakley
AU  - Simon Cockell
AU  - DINA G. TINIAKOS
AU  - Pierre Bédossa
AU  - Heather Jane Cordell
AU  - Christopher Paul Day
AU  - Kristy Wonders
AU  - Olivier Govaere
AU  - Paolo Missier B
AU  - Matthew McTeer
AU  - Luke Vale
AU  - Yemi Oliboyede
AU  - Matthew Breckons
AU  - Patrick M. Bossuyt
AU  - Yasaman Vali
AU  - Jenny Lee
AU  - Max Nieuwdorp
AU  - Yaïr I. Z. Acherman
AU  - Arnold van de Laar
AU  - Athanasios Angelakis
AU  - Adriaan Georgius Holleboom
PY  - 2026
DA  - 2026/07/24
JO  - Nature Medicine
DO  - 10.1038/s41591-026-04496-2
UR  - https://hal.science/hal-05840940v1
AB  - 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.
SN  - 1078-8956
SN  - 1744-7933
SN  - 1546-170X
ER  -