Published On: 12/11/2024

New Patient-Reported Outcome Insights from Target RWE: NASH-CHECK Reveals Stability Over Time and Worse Scores Among Those with Decompensated Cirrhosis of Patients with MASLD

DURHAM, N.C., Dec. 11, 2024 /PRNewswire/ -- Target RWE, real-world evidence leader, shared two studies at The Liver Meeting 2024 that revealed insights on the NASH-CHECK¹ patient-reported outcome measure (PROM) tailored for patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

The previously developed MASLD-specific NASH-CHECK PROM provides a robust and validated tool for assessing patient-reported outcomes over time in drug development settings. Recent findings utilizing the NASH-CHECK PROM in a real-world setting of patients with MASLD in the U.S. include:

Stability of the NASH-CHECK patient-reported outcome measure over time in patients with metabolic dysfunction-associated steatotic liver disease and stable clinical status

• This study evaluated the stability of NASH-CHECK PROM scores at two time points in patients with MASLD whose clinical status remained unchanged between the first and second administration of the NASH-CHECK PROM.
• NASH-CHECK was administered to 272 patients with MASLD and with a mean duration of 10.1 months between NASH-CHECK assessments.
• The findings indicate that NASH-CHECK scores remained stable in patients with varying MASLD severity without change in clinical status, supporting the reliability and consistency of NASH-CHECK as a PROM tool to support MASLD drug development and patient management.

A prospective assessment of the impact of decompensation of cirrhosis on patient-reported outcomes in metabolic dysfunction-associated steatotic liver disease

• The second study from Target RWE addressed the impact of decompensated cirrhosis on MASLD-specific patient-reported outcome measures by comparing patients with MASH and compensated or decompensated cirrhosis in a real-world setting.
• 281 patients with MASH and cirrhosis who completed the NASH-CHECK PROM had median age of 64 years, were 62% female, 85% non-Hispanic White, and 82% with type 2 diabetes.
• Worse scores on the NASH-CHECK PROM were observed for decompensated cirrhosis compared to compensated cirrhosis across all domains.

"The findings from these analyses not only demonstrate the stability of the NASH-CHECK measure but also highlight the nuanced ways in which disease progression impacts patients. This knowledge will help shape patient-centered approaches in managing MASLD and MASH, supporting regulatory efforts to ensure that treatments meet patient needs," said Arun J. Sanyal, MBBS, MD, Director of Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Interim Chair of Division of Gastroenterology, Hepatology, and Nutrition, Z. Reno Vlahcevic Professor of Medicine, Physiology, and Molecular Pathology, Virginia Commonwealth University School of Medicine. Dr. Sanyal is also co-chair of the TARGET-NASH steering committee and co-author of both studies.

To learn more about Target RWE real-world registries and access a full list of all publications, visit targetrwe.com/research/publications/.

¹Doward, Lynda C., et al. (2021). Development of a patient-reported outcome measure for non-alcoholic steatohepatitis (NASH-CHECK): results of a qualitative study. The Patient-Patient-Centered Outcomes Research, 14, 533-543