Summary

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• Rezdiffra (Resmetirom) is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• NASH resolution with no worsening of fibrosis was achieved in 25.9% of patients in the 80-mg resmetirom group and 29.9% in the 100-mg resmetirom group, compared to 9.7% in the placebo group (P<0.001 for both comparisons with placebo).
• Improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score was observed in 24.2% of patients in the 80-mg resmetirom group and 25.9% in the 100-mg resmetirom group, compared to 14.2% in the placebo group (P<0.001 for both comparisons with placebo).
• The change in LDL cholesterol levels from baseline to week 24 was -13.6% in the 80-mg resmetirom group and -16.3% in the 100-mg resmetirom group, compared to 0.1% in the placebo group (P<0.001 for both comparisons with placebo).
• Treatment-emergent adverse events (TEAEs) occurred in 88.4% of patients in the 80-mg resmetirom group, 86.1% in the 100-mg resmetirom group, 86.5% in the open-label 100-mg group, and 81.8% in the placebo group.
• The incidence of serious adverse events was 10.9% in the 80-mg resmetirom group, 12.7% in the 100-mg resmetirom group, and 11.5% in the placebo group.
• There is no population type or subgroup information available in the reviewed studies.