How Approval of Resmetirom Impacts Management, Screening for NASH - Episode 4

Real-World MASH Populations Compared to MAESTRO-NASH

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In part 4 of our 5-part video series, Arab and Banerjee discuss how the study population of MAESTRO-NASH compares to MASH populations in real-world settings.

In this portion of the discussion, Arab and Banerjee address how the population and inclusion criteria for MAESTRO-NASH compare to that of real-world populations with MASH, with a specific focus on fibrosis levels. To begin the discussion, Arab notes a substantial proportion of patients in the MAESTRO study had advanced fibrosis (F3 or higher), which may influence the perspectives of clinicians entering the field. Banerjee emphasizes that the distribution of fibrosis severity can vary depending on the clinical setting, with primary care offices likely seeing more patients with early-stage fibrosis (F1 or F2) and liver transplant centers dealing with more advanced cases.

Regarding treatment targets, Banerjee suggests focusing on patients with higher fibrosis scores (F2 or F3) as they are at greater risk of adverse outcomes and may derive the most benefit from treatment. Arab concurs with this sentiment, suggesting an approach targeting this population could help prevent disease progression and associated complications, such as cirrhosis.

When discussing thresholds for initiating treatment, Banerjee mentions the use of transient elastography (Fibroscan) to assess fibrosis levels. He suggests using thresholds such as less than 8 for non-significant fibrosis (F0-F1) and greater than 12 for significant fibrosis (F2-F3), with patients falling between 8 and 12 potentially deriving the greatest magnitude of benefit from treatment.

Editor’s Note: This conversation was recorded on March 14, 2024 prior to the FDA’s approval of resmetirom.

Arab has no relevant disclosures to report. Banerjee’s disclosures include Perspectum Ltd.