Study: Majority of TARGET-NASH Patients Meet Revised MASLD Criteria

Analytics firm Target RWE has released a groundbreaking study indicating that 99% of participants in the TARGET-NASH registry meet the newly established criteria for metabolic dysfunction-associated steatotic liver disease (MASLD). TARGET-NASH is a comprehensive research registry involving patients diagnosed with nonalcoholic fatty liver (NAFL) or nonalcoholic steatohepatitis (NASH) from both academic and community-based medical practices.

In June 2023, MASLD replaced the previously used term NAFLD (non-alcoholic fatty liver disease). This change is part of a concerted effort spearheaded by the American Association of Liver Diseases and other stakeholders in the Nomenclature Development Initiative. The goal is to create a more globally consistent terminology that improves the direction of research and allocation of funding, ultimately aiming to save lives.

Metabolic-associated steatohepatitis (MASH) is another term that has been updated, replacing NASH since last year. MASH is characterized by inflammation and liver cell damage due to fat accumulation in the liver. Unlike simple fatty liver disease, MASH can escalate to more severe conditions, such as cirrhosis and liver cancer.

The American Journal of Gastroenterology recently published an analysis based on data from 5,745 adult patients participating in the TARGET-NASH study. These patients were drawn from 47 academic centers and 18 community practice centers across the United States. The study's findings have significant implications for the medical community.

"Our findings validate the accuracy and relevance of the TARGET-NASH cohort definitions," stated A. Sidney Barritt IV, a professor of medicine and the director of hepatology at the University of North Carolina School of Medicine, Chapel Hill. He emphasized that the adoption of the MASLD nomenclature would not interfere with ongoing research. This assurance is crucial for studies focusing on disease natural history, biomarker development, and therapeutic interventions for patients previously classified under older terms such as NAFLD, NASH, and related conditions.

In a related development, pharmaceutical companies Boehringer Ingelheim and Zealand Pharma have recently shared promising results from a Phase II trial (NCT04771273) involving their GLP-1/glucagon receptor dual agonist, survodutide. The sub-analysis of this trial demonstrated that survodutide significantly improved liver fibrosis in patients suffering from MASH. This breakthrough offers a glimmer of hope for those affected by this severe liver condition.

The transition to using terms like MASLD and MASH aims to eliminate confusion and streamline research efforts to improve patient outcomes. By adopting a more specific nomenclature, healthcare providers and researchers can better target their efforts, potentially leading to more effective treatments and interventions.

In summary, the study by Target RWE and the successful Phase II trial results for survodutide indicate significant strides in the understanding and treatment of liver diseases previously categorized under NAFLD and NASH. The adoption of the new terminology, MASLD and MASH, backed by robust research, promises to enhance the clarity and direction of future medical and therapeutic endeavors.