Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials : Expert consensus from the Liver Forum
© 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd..
BACKGROUND: Causality assessment of suspected drug-induced liver injury (DILI) during metabolic dysfunction-associated steatohepatitis (MASH) clinical trials can be challenging, and liver biopsies are not routinely performed as part of this evaluation. While the field is moving away from liver biopsy as a diagnostic and prognostic tool, information not identified by non-invasive testing may be provided on histology.
AIM: To address the appropriate utilisation of liver biopsy as part of DILI causality assessment in this setting.
METHODS: From 2020 to 2022, the Liver Forum convened a series of webinars on issues pertaining to liver biopsy during MASH trials. The Histology Working Group was formed to generate a series of consensus documents addressing these challenges. This manuscript focuses on liver biopsy as part of DILI causality assessment.
RESULTS: Expert opinion, guidance and recommendations on the role of liver biopsy as part of causality assessment of suspected DILI occurring during clinical trials for a drug(s) being developed for MASH are provided. Lessons learned from prior MASH programs are reviewed and gaps identified.
CONCLUSIONS: Although there are no pathognomonic features, histologic evaluation of suspected DILI during MASH clinical trials may alter patient management, define the pattern and severity of injury, detect findings that favour a diagnosis of DILI versus MASH progression, identify prognostic features, characterise the clinicopathological phenotype of DILI, and/or define lesions that influence decisions about trial discontinuation and further development of the drug.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:59 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 59(2024), 2 vom: 25. Jan., Seite 201-216 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Palmer, Melissa [VerfasserIn] |
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| Links: |
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| Themen: |
DILI |
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| Anmerkungen: |
Date Completed 29.12.2023 Date Revised 29.12.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/apt.17762 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM363699872 |
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| 100 | 1 | |a Palmer, Melissa |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials |b Expert consensus from the Liver Forum |
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| 500 | |a Date Completed 29.12.2023 | ||
| 500 | |a Date Revised 29.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Causality assessment of suspected drug-induced liver injury (DILI) during metabolic dysfunction-associated steatohepatitis (MASH) clinical trials can be challenging, and liver biopsies are not routinely performed as part of this evaluation. While the field is moving away from liver biopsy as a diagnostic and prognostic tool, information not identified by non-invasive testing may be provided on histology | ||
| 520 | |a AIM: To address the appropriate utilisation of liver biopsy as part of DILI causality assessment in this setting | ||
| 520 | |a METHODS: From 2020 to 2022, the Liver Forum convened a series of webinars on issues pertaining to liver biopsy during MASH trials. The Histology Working Group was formed to generate a series of consensus documents addressing these challenges. This manuscript focuses on liver biopsy as part of DILI causality assessment | ||
| 520 | |a RESULTS: Expert opinion, guidance and recommendations on the role of liver biopsy as part of causality assessment of suspected DILI occurring during clinical trials for a drug(s) being developed for MASH are provided. Lessons learned from prior MASH programs are reviewed and gaps identified | ||
| 520 | |a CONCLUSIONS: Although there are no pathognomonic features, histologic evaluation of suspected DILI during MASH clinical trials may alter patient management, define the pattern and severity of injury, detect findings that favour a diagnosis of DILI versus MASH progression, identify prognostic features, characterise the clinicopathological phenotype of DILI, and/or define lesions that influence decisions about trial discontinuation and further development of the drug | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a MASH | |
| 650 | 4 | |a MASLD | |
| 650 | 4 | |a NAFLD | |
| 650 | 4 | |a NASH | |
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| 650 | 4 | |a liver biopsy | |
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| 700 | 1 | |a Kleiner, David E |e verfasserin |4 aut | |
| 700 | 1 | |a Goodman, Zachary |e verfasserin |4 aut | |
| 700 | 1 | |a Brunt, Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Avigan, Mark I |e verfasserin |4 aut | |
| 700 | 1 | |a Regev, Arie |e verfasserin |4 aut | |
| 700 | 1 | |a Hayashi, Paul H |e verfasserin |4 aut | |
| 700 | 1 | |a Lewis, James H |e verfasserin |4 aut | |
| 700 | 1 | |a Mehta, Ruby |e verfasserin |4 aut | |
| 700 | 1 | |a Harrison, Stephen A |e verfasserin |4 aut | |
| 700 | 1 | |a Siciliano, Massimo |e verfasserin |4 aut | |
| 700 | 1 | |a McWherter, Charles A |e verfasserin |4 aut | |
| 700 | 1 | |a Vuppalanchi, Raj |e verfasserin |4 aut | |
| 700 | 1 | |a Behling, Cynthia |e verfasserin |4 aut | |
| 700 | 1 | |a Miller, Veronica |e verfasserin |4 aut | |
| 700 | 1 | |a Chalasani, Naga |e verfasserin |4 aut | |
| 700 | 1 | |a Sanyal, Arun J |e verfasserin |4 aut | |
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