FibroScan-based score to identify patients with non-alcoholic steatohepatitis: development in a multi-centric British cohort and validation in a large American cohort

Sasso, M.; Harrison, S.A.; Eddowes, Peter; Anstee, Quentin M.; Guha, IN; Sherridan, D.; Tsochatzis, E.; Cobbold, J; Allison, Mike; Fournier, C.; Miette, Véronique; Roberts, K.; Paredes, Angelo H.; Cebe, Katherine; Paradis, Valérie; Bedossa, P.; Lédinghen, Victor de; Newsome, Philip N.

doi:10.1016/s0168-8278(17)30395-1

Cited by 1 publication

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“…27 In addition, a previous report demonstrated that increasing the AST, LSM and CAP inclusion criteria would reduce the screen failure rate at the expense of an increase in the missed cases rate. 29 The FAST score was first published in February 2020 after the SYNERGY-NASH trial had been initiated. In this report, we describe the original design of the SYNERGY-NASH trial and how the protocol was modified in November 2020 in an attempt to reduce screen failures.…”

Section: Introductionmentioning

confidence: 99%

“…A FAST score ≤0.35 has a high negative predictive value (NPV), and a score ≥0.67 has a high positive predictive value (PPV) for at‐risk MASH 27 . In addition, a previous report demonstrated that increasing the AST, LSM and CAP inclusion criteria would reduce the screen failure rate at the expense of an increase in the missed cases rate 29 …”

Section: Introductionmentioning

confidence: 99%

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Randomised clinical trial: Design of the SYNERGY‐NASH phase 2b trial to evaluate tirzepatide as a treatment for metabolic dysfunction‐associated steatohepatitis and modification of screening strategy to reduce screen failures

Vuppalanchi,

Loomba,

Sanyal

et al. 2024

Aliment Pharmacol Ther

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SummaryBackgroundThe use of histological inclusion criteria for clinical trials of at‐risk metabolic dysfunction‐associated steatohepatitis (MASH) is often associated with high screen failure rates.AimsTo describe the design of a trial investigating tirzepatide treatment of MASH and to examine the effect of new inclusion criteria incorporating the use of the FibroScan‐AST (FAST) score on the proportion of patients meeting histological criteria.MethodsSYNERGY‐NASH is a Phase 2b, multicentre, randomised, double‐blinded, placebo‐controlled trial in patients with biopsy‐confirmed MASH, F2–F3 fibrosis and NAFLD Activity Score ≥4. New inclusion criteria (FAST score >0.35 and an increase in AST inclusion criterion from >20 to >23 U/L) were adopted during the trial, allowing us to examine its impact on the qualification rate.Results1583 participants were screened, 651 participants proceeded to liver biopsy and 190 participants were randomised with an overall screen fail rate of 87%. Following the protocol amendment, the overall qualification rate for per‐protocol biopsies was minimally changed from 27.5% to 28.9% with considerable variation among different investigator medical speciality types: endocrinology: from 37.5% to 39.3%; gastroenterology/hepatology: from 26.0% to 23.3%; other specialities: from 21.3% to 29.7%. At 29 sites that performed per‐protocol biopsies before and after the amendment, qualification rates changed as follows: all: 26.1% to 29.1%; endocrinology: from 35.0% to 40.9%; gastroenterology/hepatology: 25.6% to 20.0%; other specialities: from 16.1% to 27.8%.ConclusionsFor at‐risk MASH trials based on liver histology, the implementation of inclusion criteria with the proposed FAST score and AST cut‐offs in this trial was most effective at non‐specialist sites.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%