The Association Of Histologic And Non-Invasive Tests With Adverse Clinical And Patient-Reported Outc

This study was undertaken to investigate the relationship between histologic and non-invasive (NITs) fibrosis tests with clinical and patient-reported outcomes (PROs) in advanced NASH. Researchers included individuals with advanced NASH (NASH CRN stage F3 or F4) in four multinational clinical trials of simtuzumab and selonsertib. They prospectively obtained liver biopsies, NITs, and PROs (SF-36, CLDQ-NASH, EQ-5D, WPAI). They included 2,154 patients with advanced NASH: 52.5% F4, 40% male, 72% type 2 diabetes, baseline liver stiffness 24.1±14.2 kPa in F4, 14.6 ± 8.0 kPa in F3, baseline mean enhanced liver fibrosis score 11.4±1.2 in F4, 10.3±1.0 in F3; median follow-up16 months. This study’s findings revealed that in patients with advanced NASH, baseline NIT scores, and their variations over time are predictors of adverse clinical and PROs.

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