Aramchol improves hepatic fibrosis in metabolic dysfunction–associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology

纤维化 医学 内科学 脂肪性肝炎 胃肠病学 肝病学 病理 脂肪肝 疾病
作者
Vlad Ratziu,Yusuf Yılmaz,Don Lazas,Scott L. Friedman,C. Lackner,Cynthia Behling,Oscar W. Cummings,Li Chen,Mathieu Petitjean,Yossi Gilgun‐Sherki,Tali Gorfine,Shaul Kadosh,Eli Eyal,Arun J. Sanyal
出处
期刊:Hepatology [Lippincott Williams & Wilkins]
被引量:5
标识
DOI:10.1097/hep.0000000000000980
摘要

Background and Aims: Antifibrotic trials rely on conventional pathology despite recognized limitations. We compared single-fiber digital image analysis with conventional pathology to quantify the antifibrotic effect of Aramchol, a stearoyl-CoA desaturase 1 inhibitor in development for metabolic dysfunction–associated steatohepatitis. Approach and Results: Fifty-one patients with metabolic dysfunction–associated steatohepatitis enrolled in the open-label part of the ARMOR trial received Aramchol 300 mg BID and had paired pre-post treatment liver biopsies scored by consensus among 3 hepatopathologists, and separately assessed by a digital image analysis platform (PharmaNest) that generates a continuous phenotypic Fibrosis Composite Severity (Ph-FCS) score. Fibrosis improvement was defined as: ≥1 NASH Clinical Research Network (NASH-CRN) stage reduction; “improved” by ranked pair assessment; reduction in Ph-FCS (“any” for ≥0.3 absolute reduction and “substantial” for ≥25% relative reduction). Fibrosis improved in 31% of patients (NASH-CRN), 51% (ranked pair assessment), 74.5% (any Ph-FCS reduction), and 41% (substantial Ph-FCS reduction). Most patients with stable fibrosis by NASH-CRN or ranked pair assessment had a Ph-FCS reduction (a third with substantial reduction). Fibrosis improvement increased with treatment duration: 25% for <48 weeks versus 39% for ≥48 weeks by NASH-CRN; 43% versus 61% by ranked pair assessment, mean Ph-FCS reduction −0.54 (SD: 1.22) versus −1.72 (SD: 1.02); Ph-FCS reduction (any in 54% vs. 100%, substantial in 21% vs. 65%). The antifibrotic effect of Aramchol was corroborated by reductions in liver stiffness, Pro-C3, and enhanced liver fibrosis. Changes in Ph-FCS were positively correlated with changes in liver stiffness. Conclusions: Continuous fibrosis scores generated in antifibrotic trials by digital image analysis quantify antifibrotic effects with greater sensitivity and a larger dynamic range than conventional pathology.
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