S2904 Safety and Efficacy of Efruxifermin in Patients With Non-Alcoholic Steatohepatitis: A Meta-Analysis of Randomized Controlled Trials

Introduction: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease, closely linked with metabolic syndromes. Despite its prevalence, effective treatments are limited. This meta-analysis aimed to assess efruxifermin's efficacy and safety in NASH patients. Methods: We conducted an extensive search in PubMed, Scopus, Cochrane, and Web of Science until 30 October 2023, focusing on randomized clinical trials comparing efruxifermin to placebo in NASH patients. Dichotomous data were analyzed as risk ratio (RR) and 95% confidence interval (CI) using R software for data analysis. Results: Three randomized controlled trials (RCTs) were included. Efruxifermin compared to placebo showed a significant improvement in liver fibrosis (≥1 stages) and no worsening of NASH at doses of 28 mg (RR = 22.5; 95% CI: 3.19, 158.72) and 50 mg (RR = 18.22; 95% CI: 3.44, 96.56). Improvement in liver fibrosis (≥1 stage) and resolution of NASH were observed at 28 mg (RR = 6.39; 95% CI: 1.78, 23.01) and 50 mg (RR = 7.49; 95% CI: 2.29, 24.57). The 70 mg dosage showed no significant benefits. No significant increase in serious adverse events was noted across all dosages. Conclusion: Our analysis indicated efruxifermin, especially at doses of 28 mg and 50 mg, as a promising therapeutic agent for NASH with significant improvements in liver fibrosis and NASH markers with a manageable safety profile. These findings highlight efruxifermin's potential as a key intervention in the treatment of NASH, warranting further investigation and clinical application.