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  • Vali, YasamanUniv Amsterdam, Netherlands (author)

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

  • Article/chapterEnglish2023

Publisher, publication year, extent ...

  • Elsevier Ltd,2023
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:liu-200772
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-200772URI
  • https://doi.org/10.1016/S2468-1253(23)00017-1DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding: Innovative Medicines Initiative 2 Joint Undertaking
  • 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

Subject headings and genre

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

Added entries (persons, corporate bodies, meetings, titles ...)

  • Lee, JennyUniv Amsterdam, Netherlands (author)
  • Boursier, JeromeUniv Angers, France; Univ Hosp Angers, France (author)
  • Petta, SalvatoreUniv Palermo, Italy (author)
  • Wonders, KristyNewcastle Univ, England (author)
  • Tiniakos, DinaNewcastle Univ, England; Natl & Kapodistrian Univ Athens, Greece (author)
  • Bedossa, PierreNewcastle Univ, England (author)
  • Geier, AndreasWurzburg Univ Hosp, Germany (author)
  • Francque, SvenUniv Antwerp, Belgium (author)
  • Allison, MikeCambridge Univ Natl Hlth Serv Fdn Trust, England (author)
  • Papatheodoridis, GeorgiosNatl & Kapodistrian Univ Athens, Greece (author)
  • Cortez-Pinto, HelenaUniv Lisbon, Portugal (author)
  • Pais, RalucaSorbonne Univ, France (author)
  • Dufour, Jean-FrancoisUniv Bern, Switzerland (author)
  • Leeming, Diana JulieNordic Biosci, Denmark (author)
  • Harrison, Stephen AUniv Oxford, England (author)
  • Chen, YuEli Lilly, IN USA (author)
  • Cobbold, Jeremy FOxford Univ Hosp, England (author)
  • Pavlides, MichaelUniv Oxford, England (author)
  • Holleboom, Adriaan GUniv Amsterdam, Netherlands (author)
  • Yki-Jarvinen, HanneleUniv Helsinki, Finland; Minerva Fdn, Finland (author)
  • Crespo, JavierMarques de Valdecilla Univ Hosp, Spain (author)
  • Karsdal, MortenNordic Biosci, Denmark (author)
  • Ostroff, RachelSomaLogic, CO USA (author)
  • Zafarmand, Mohammad HadiUniv Amsterdam, Netherlands (author)
  • Torstenson, RichardAstraZeneca, Sweden (author)
  • Duffin, KevinEli Lilly, IN USA (author)
  • Yunis, CarlaPfizer, FL USA (author)
  • Brass, CliffordNovartis Pharmaceut, NJ USA (author)
  • Ekstedt, Mattias,1976-Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken(Swepub:liu)matek92 (author)
  • Aithal, Guruprasad PUniv Nottingham, England (author)
  • Schattenberg, Jörn MUniv Med Ctr Mainz, Germany (author)
  • Bugianesi, ElisabettaUniv Turin, Italy (author)
  • Romero-Gomez, ManuelUniv Seville, Spain (author)
  • Ratziu, VladSorbonne Univ, France (author)
  • Anstee, Quentin MNewcastle Univ, England; Newcastle Upon Tyne Hosp Natl Hlth Serv Trust, England (author)
  • Bossuyt, Patrick MUniv Amsterdam, Netherlands (author)
  • Univ Amsterdam, NetherlandsUniv Angers, France; Univ Hosp Angers, France (creator_code:org_t)

Related titles

  • In:The Lancet Gastroenterology & Hepatology: Elsevier Ltd8:8, s. 714-7252468-1253

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