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Resmetirom Therapy for the Management of Patients With MASLD: Updates to the AASLD Practice Guidance
TAKE-HOME MESSAGE
- Resmetirom received accelerated FDA approval in March 2024 for the management of MASH with moderate to advanced liver fibrosis (stages F2–F3) based on the MAESTRO-NASH and MAESTRO-NAFLD-1 trials. In the MAESTRO-NASH trial, resmetirom demonstrated significant efficacy compared with placebo, resulting in the resolution of steatohepatitis without worsening fibrosis (26%–30% vs 10%) and improvement in fibrosis without worsening steatohepatitis (24%–26% vs 14%) at 52 weeks. This 2023 AASLD practice guidance update integrates data from non-invasive liver disease assessments, clinical trials, expert opinions, and FDA documents to provide practical recommendations for resmetirom use in clinical practice.
- As additional clinical and real-world data emerge, these recommendations may be revised to reflect updated evidence.
abstract
This abstract is available on the publisher's site.
Access this abstract nowResmetirom received accelerated approval from the United States Food and Drug Administration (FDA) in March 2024 for the treatment of metabolic dysfunction-associated steatohepatitis (MASH; formerly known as nonalcoholic steatohepatitis or NASH) with moderate to advanced liver fibrosis consistent with stages F2 to F3 fibrosis (F2-F3). The approval was based on findings from the MAESTRO-NASH clinical trial combined with safety data from the MAESTRO-NAFLD-1 trial. In the MAESTRO-NASH trial, treatment with resmetirom achieved the 2 primary endpoints of resolution of steatohepatitis without worsening of fibrosis (26%-30% compared with 10% for resmetirom and placebo, respectively) and improvement in fibrosis without worsening of steatohepatitis at 52 weeks (24%-26% compared with 14% for resmetirom and placebo, respectively).
Additional Info
Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance
Hepatology 2025 Jan 01;81(1)312-320, VL Chen, TR Morgan, Y Rotman, HM Patton, K Cusi, F Kanwal, WR KimFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.