Efruxifermin improves fibrosis in patients with metabolic dysfunction-associated steatohepatitis

1. Efruxifermin 50 mg once-weekly significantly improved fibrosis at 96 weeks versus placebo.

2. MASH resolution without worsened fibrosis was greater in the efruxifermin group.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Efruxifermin is a fibroblast growth factor analogue used for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Patients with MASH and advanced fibrosis have limited therapeutic options. As such, effective long-term therapies are needed. This randomized controlled trial aimed to evaluate the safety and efficacy of efruxifermin over 96 weeks in adults with biopsy-confirmed MASH and stage F2–F3 fibrosis. The primary outcome of this study was improvement in liver fibrosis without worsening of MASH, while key secondary outcome was resolution of MASH. According to study results, efruxifermin 50 mg led to significantly greater improvements in fibrosis compared with placebo, with acceptable safety and tolerability. Although this study was well done, it was limited by a small sample size and short follow-up period.

Click to read the study in The Lancet

Relevant Reading: Efruxifermin in Compensated Liver Cirrhosis Caused by MASH

In-depth [randomized controlled trial]: Between Mar 22, 2021, and Feb 7, 2022, 747 patients were assessed for eligibility across 41 centers in the USA. Included were patients aged ≥ 18 years with biopsy-confirmed MASH, a non-alcoholic fatty liver disease (NAFLD) activity score ≥ 4, and stage F2 or F3 fibrosis. Altogether, 115 patients (42 in placebo, 37 in efruxifermin 28 mg, and 36 in efruxifermin 50 mg) were included in the final analysis. The primary outcome of improved fibrosis without worsening of MASH was significantly greater in with 50 mg compared to placebo (49% vs. 19%, p=0.0030). Patient in efruxifermin 28 mg also had improved fibrosis without statistical significance (30% vs. 19%, p=0.19). The secondary outcome of MASH resolution without fibrosis worsening was more frequent among efruxifermin-treated patients versus placebo (75% in 50 mg vs. 24% in placebo, p<0.0001). Findings from this study suggest that efruxifermin shows promise as an effective therapy for improving fibrosis and MASH outcomes in patients with advanced disease.

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