Clinical insights on resmetirom: clinical indications, patient selection, and monitoring response to therapy

Abstract

The recent conditional approval by the Food and Drug Administration of resmetirom for treating metabolic dysfunction-associated steatohepatitis (MASH) with significant or advanced fibrosis represents a pivotal milestone in the history of metabolic dysfunction-associated steatotic liver disease (MASLD) treatment. As the first liver-directed pharmacological therapy option for MASLD, resmetirom offers a novel approach that specifically targets liver pathology, marking a transformative step forward in managing this widespread and challenging condition. For initiating therapy with resmetirom, a liver biopsy is not required. Consequently, accurately excluding patients with less severe liver histology or cirrhosis using noninvasive tests (NITs) is essential. In addition, monitoring the therapy response should be conducted using NITs. Given the recent approval, our current clinical understanding of resmetirom is primarily informed by phase 3 clinical trials. The long-term effects of the drug should be evaluated in further studies by encouraging the use of the drug in eligible patients. This review highlights key aspects of clinical resmetirom use, including identifying the target population, monitoring therapeutic response, determining appropriate discontinuation criteria, and strategies to prevent unnecessary treatment interruptions.