Biomarkers for staging fibrosis and non-alcoholic steatohepatitis in non-alcoholic fatty liver disease (the LITMUS project): a comparative diagnostic accuracy study

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Biomarkers for staging fibrosis and non-alcoholic steatohepatitis in non-alcoholic fatty liver disease (the LITMUS project) : a comparative diagnostic accuracy study

Vali, Yasaman (författare): Univ Amsterdam, Netherlands

Lee, Jenny (författare): Univ Amsterdam, Netherlands

Boursier, Jerome (författare): Univ Angers, France; Univ Hosp Angers, France

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Petta, Salvatore (författare): Univ Palermo, Italy

Wonders, Kristy (författare): Newcastle Univ, England

Tiniakos, Dina (författare): Newcastle Univ, England; Natl & Kapodistrian Univ Athens, Greece

Bedossa, Pierre (författare): Newcastle Univ, England

Geier, Andreas (författare): Wurzburg Univ Hosp, Germany

Francque, Sven (författare): Univ Antwerp, Belgium

Allison, Mike (författare): Cambridge Univ Natl Hlth Serv Fdn Trust, England

Papatheodoridis, Georgios (författare): Natl & Kapodistrian Univ Athens, Greece

Cortez-Pinto, Helena (författare): Univ Lisbon, Portugal

Pais, Raluca (författare): Sorbonne Univ, France

Dufour, Jean-Francois (författare): Univ Bern, Switzerland

Leeming, Diana Julie (författare): Nordic Biosci, Denmark

Harrison, Stephen A (författare): Univ Oxford, England

Chen, Yu (författare): Eli Lilly, IN USA

Cobbold, Jeremy F (författare): Oxford Univ Hosp, England

Pavlides, Michael (författare): Univ Oxford, England

Holleboom, Adriaan G (författare): Univ Amsterdam, Netherlands

Yki-Jarvinen, Hannele (författare): Univ Helsinki, Finland; Minerva Fdn, Finland

Crespo, Javier (författare): Marques de Valdecilla Univ Hosp, Spain

Karsdal, Morten (författare): Nordic Biosci, Denmark

Ostroff, Rachel (författare): SomaLogic, CO USA

Zafarmand, Mohammad Hadi (författare): Univ Amsterdam, Netherlands

Torstenson, Richard (författare): AstraZeneca, Sweden

Duffin, Kevin (författare): Eli Lilly, IN USA

Yunis, Carla (författare): Pfizer, FL USA

Brass, Clifford (författare): Novartis Pharmaceut, NJ USA

Ekstedt, Mattias, 1976- (författare): Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken

Aithal, Guruprasad P (författare): Univ Nottingham, England

Schattenberg, Jörn M (författare): Univ Med Ctr Mainz, Germany

Bugianesi, Elisabetta (författare): Univ Turin, Italy

Romero-Gomez, Manuel (författare): Univ Seville, Spain

Ratziu, Vlad (författare): Sorbonne Univ, France

Anstee, Quentin M (författare): Newcastle Univ, England; Newcastle Upon Tyne Hosp Natl Hlth Serv Trust, England

Bossuyt, Patrick M (författare): Univ Amsterdam, Netherlands

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Elsevier Ltd, 2023
2023
Engelska.
Ingår i: The Lancet Gastroenterology & Hepatology. - : Elsevier Ltd. - 2468-1253. ; 8:8, s. 714-725

Relaterad länk:: https://urn.kb.se/re...; visa fler...; https://doi.org/10.1...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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Background: The reference standard for detecting non-alcoholic steatohepatitis (NASH) and staging fibrosis—liver biopsy—is invasive and resource intensive. Non-invasive biomarkers are urgently needed, but few studies have compared these biomarkers in a single cohort. As part of the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) project, we aimed to evaluate the diagnostic accuracy of 17 biomarkers and multimarker scores in detecting NASH and clinically significant fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) and identify their optimal cutoffs as screening tests in clinical trial recruitment. Methods: This was a comparative diagnostic accuracy study in people with biopsy-confirmed NAFLD from 13 countries across Europe, recruited between Jan 6, 2010, and Dec 29, 2017, from the LITMUS metacohort of the prospective European NAFLD Registry. Adults (aged ≥18 years) with paired liver biopsy and serum samples were eligible; those with excessive alcohol consumption or evidence of other chronic liver diseases were excluded. The diagnostic accuracy of the biomarkers was expressed as the area under the receiver operating characteristic curve (AUC) with liver histology as the reference standard and compared with the Fibrosis-4 index for liver fibrosis (FIB-4) in the same subgroup. Target conditions were the presence of NASH with clinically significant fibrosis (ie, at-risk NASH; NAFLD Activity Score ≥4 and F≥2) or the presence of advanced fibrosis (F≥3), analysed in all participants with complete data. We identified thres holds for each biomarker for reducing the number of biopsy-based screen failures when recruiting people with both NASH and clinically significant fibrosis for future trials. Findings: Of 1430 participants with NAFLD in the LITMUS metacohort with serum samples, 966 (403 women and 563 men) were included after all exclusion criteria had been applied. 335 (35%) of 966 participants had biopsy-confirmed NASH and clinically significant fibrosis and 271 (28%) had advanced fibrosis. For people with NASH and clinically significant fibrosis, no single biomarker or multimarker score significantly reached the predefined AUC 0·80 acceptability threshold (AUCs ranging from 0·61 [95% CI 0·54–0·67] for FibroScan controlled attenuation parameter to 0·81 [0·75–0·86] for SomaSignal), with accuracy mostly similar to FIB-4. Regarding detection of advanced fibrosis, SomaSignal (AUC 0·90 [95% CI 0·86–0·94]), ADAPT (0·85 [0·81–0·89]), and FibroScan liver stiffness measurement (0·83 [0·80–0·86]) reached acceptable accuracy. With 11 of 17 markers, histological screen failure rates could be reduced to 33% in trials if only people who were marker positive had a biopsy for evaluating eligibility. The best screening performance for NASH and clinically significant fibrosis was observed for SomaSignal (number needed to test [NNT] to find one true positive was four [95% CI 4–5]), then ADAPT (six [5–7]), MACK-3 (seven [6–8]), and PRO-C3 (nine [7–11]). Interpretation: None of the single markers or multimarker scores achieved the predefined acceptable AUC for replacing biopsy in detecting people with both NASH and clinically significant fibrosis. However, several biomarkers could be applied in a prescreening strategy in clinical trial recruitment. The performance of promising markers will be further evaluated in the ongoing prospective LITMUS study cohort. Funding: The Innovative Medicines Initiative 2 Joint Undertaking. © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)

Nyckelord

Adolescent; Adult; Biomarkers; Female; Fibrosis; Humans; Liver Cirrhosis; Male; Non-alcoholic Fatty Liver Disease; Prospective Studies; alanine aminotransferase; biological marker; triacylglycerol; biological marker; adult; alcohol consumption; area under the curve; Article; blood analysis; clinical assessment; clinical trial; cohort analysis; controlled study; diabetes mellitus; diagnostic accuracy; diagnostic test accuracy study; diastolic blood pressure; disease registry; dyslipidemia; enzyme linked immunosorbent assay; Europe; female; Fibrosis-4 Index; histology; human; human tissue; hypertension; liver biopsy; liver fibrosis; liver stiffness; major clinical study; male; medical ethics; nonalcoholic fatty liver; Nonalcoholic Fatty Liver Disease Activity Score; nonalcoholic steatohepatitis; platelet count; predictive value; prospective study; screening test; sensitivity and specificity; systolic blood pressure; adolescent; complication; fibrosis; liver cirrhosis; nonalcoholic fatty liver

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