SYSTEMATIC REVIEW article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1594091
A systematic review and meta-analysis of efruxifermin's efficacy in improving liver fibrosis in patients with NASH/MASH
Provisionally accepted
- 1Department of Anesthesiology，The First People's Hospital of Chenzhou，The ChenZhou Affiliated Hosipital，HengYang Medical School，University of South China，Chenzhou，Hunan，423000，China, Chenzhou, Hunan Province, China
- 2Department of Anesthesiology, Xiangya Hospital of Central South University, Changsha, Hunan Province, China
- 3Department of Critical Care Medicine, The First People's Hospital, the Affiliated Chenzhou Hospital, Hengyang Medical School, University of South China, Chenzhou 423000, Hunan, China
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Background & Aims：Efruxifermin is a potential treatment for non-alcoholic steatohepatitis (NASH, now termed metabolic dysfunction-associated steatohepatitis, MASH). This study aimed to analyze the effectiveness of efruxifermin in improving liver fibrosis in patients with MASH.Methods： Systematic searches of PubMed, Cochrane Library, and Embase databases were conducted. Randomized controlled trials evaluating the efficacy of efruxifermin compared with placebo in patients with MASH were included. The primary outcome was the proportion of patients with improvement in liver fibrosis by 1 or more stages without worsening of MASH. The secondary outcomes were non-invasive biomarkers of fibrosis and treatment-emergent adverse events (TEAEs).Results：This meta-analysis included 4 studies with a total of 325 patients with biopsy-proven MASH and stage F1–F4 fibrosis. All studies reported histological outcomes. Compared to placebo, efruxifermin demonstrated a higher relative risk (RR) of 1.97 (95% CI 1.21 to 3.19, I²= 0%, P = 0.006) for achieving improvement in fibrosis by ≥1 stage without worsening of MASH. Furthermore, efruxifermin improved fibrosis-related non-invasive biomarkers (enhanced liver fibrosis [ELF]score, N-terminal type-III collagen pro-peptide [ProC3], and liver stiffness by FibroScan). However, efruxifermin was associated with an increased risk of adverse events compared to placebo, but this finding was not robust in sensitivity analysis.Conclusion：Efruxifermin may be a potential therapeutic for MASH-related fibrosis, with the available data indicating seemingly favorable tolerability.Impact and implications:To our knowledge, this is the first systematic review and meta-analysis specifically focusing on efruxifermin, and the included studies were multicenter, randomized, double-blind, placebo-controlled trials, yielding high generalizability. We found that efruxifermin may be a potential therapeutic for MASH-related fibrosis, with the available data indicating a seemingly favorable tolerability. Our study may provide some scientific support for drug selection in patients with non-alcoholic steatohepatitis.
Keywords: Efruxifermin, FGF21, Non-alcoholic, steatohepatitis, Fibrosis
Received: 15 Mar 2025; Accepted: 14 May 2025.
Copyright: © 2025 Li, Zou, Zhou, Li, Liao, Li and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Tao Li, Department of Critical Care Medicine, The First People's Hospital, the Affiliated Chenzhou Hospital, Hengyang Medical School, University of South China, Chenzhou 423000, Hunan, China
Zhiming Zhang, Department of Anesthesiology，The First People's Hospital of Chenzhou，The ChenZhou Affiliated Hosipital，HengYang Medical School，University of South China，Chenzhou，Hunan，423000，China, Chenzhou, Hunan Province, China
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