{"title":"雷司替罗的临床观察:临床适应症、患者选择和监测治疗反应。","authors":"Eda Kaya, Yusuf Yilmaz, Naim Alkhouri","doi":"10.1097/MCG.0000000000002150","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":"59 5","pages":"412-419"},"PeriodicalIF":2.8000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Insights on Resmetirom: Clinical Indications, Patient Selection, and Monitoring Response to Therapy.\",\"authors\":\"Eda Kaya, Yusuf Yilmaz, Naim Alkhouri\",\"doi\":\"10.1097/MCG.0000000000002150\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":15457,\"journal\":{\"name\":\"Journal of clinical gastroenterology\",\"volume\":\"59 5\",\"pages\":\"412-419\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of clinical gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MCG.0000000000002150\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/13 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MCG.0000000000002150","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/13 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Clinical Insights on Resmetirom: Clinical Indications, Patient Selection, and Monitoring Response to Therapy.
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.
期刊介绍:
Journal of Clinical Gastroenterology gathers the world''s latest, most relevant clinical studies and reviews, case reports, and technical expertise in a single source. Regular features include cutting-edge, peer-reviewed articles and clinical reviews that put the latest research and development into the context of your practice. Also included are biographies, focused organ reviews, practice management, and therapeutic recommendations.