Expert Panel Recommendations: Practical Clinical Applications for Initiating and Monitoring Resmetirom in Patients...

Area of Science:

• Hepatology
• Pharmacology
• Gastroenterology

Background:

• Metabolic dysfunction-associated steatotic liver disease (MASLD) affects 25% of people in the US and Western Europe.
• Metabolic dysfunction-associated steatohepatitis (MASH), a progressive form of MASLD, can lead to cirrhosis and hepatocellular carcinoma.
• Currently, no specific pharmacotherapies exist for MASH.

Purpose of the Study:

• To review the literature on identifying patients with MASH and fibrosis stages 2-3 for resmetirom treatment.
• To propose criteria for discontinuing resmetirom therapy in eligible patients.

Main Methods:

• Literature review of studies on MASH diagnosis and fibrosis staging.
• Analysis of resmetirom's conditional FDA approval criteria.
• Discussion of noninvasive methods for fibrosis assessment.

Main Results:

• Resmetirom is conditionally approved for moderate to advanced MASH with fibrosis stages 2-3.
• Challenges include noninvasively identifying fibrosis stages and excluding patients with advanced disease.
• Literature review informs patient selection and treatment cessation criteria.

Conclusions:

• Resmetirom offers a new therapeutic option for specific MASH patients.
• Accurate patient selection and monitoring are crucial for effective and safe MASH treatment.
• Further research is needed to refine treatment guidelines and long-term outcomes.