Published On: 11/13/2020

Target RWE Data Presented at AASLD Virtual Meeting Provides Important Updates for NASH and PBC Communities

DURHAM, N.C., Nov. 13, 2020 /PRNewswire/ -- Target RWE announced today that five studies will be presented at The Liver Meeting Digital Experience™ hosted by the American Association for the Study of Liver Diseases, November 13-16, 2020. The analyses are derived from TARGET-NASH, which includes more than 5,000 participants with non-alcoholic fatty liver disease (NAFLD) and/or non-alcoholic steatohepatitis (NASH), and TARGET-PBC which includes more than 660 participants with primary biliary cholangitis (PBC).

A Pragmatic Clinical Prognostic Classification Suitable for Universal Application Stratifies Patients with NAFLD by Risk of Mortality and Both Hepatic and Extrahepatic Outcomes evaluated an approach to risk stratify patients with NAFLD based on previously described profiles (Nature Reviews, 2016; 13:196-205) and using widely available measures to predict outcomes. This pragmatic prognostic classification of NAFLD is associated with increasing severity of clinical outcomes and is practical for clinical settings.

"There is a clear need to establish a practical and accurate prognostic classification system in the NAFLD population. Our NAFLD classification is suitable for use across virtually all clinical settings, can be used to support clinical decisions, and provides a framework for the design of outcome trials," said Arun Sanyal, M.D., Professor, Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, and lead author.

Heterogeneous Documentation and Poor Concordance of NASH Pathology May Limit its Clinical Utility in Real-World Practice found there is substantial heterogeneity in the histological reporting of NASH in the real world with a large proportion of reports missing important descriptors of NASH disease activity and discordance between the interpretation by site and central pathologists. This lack of reliability in reporting and interpretation may negatively affect patient assessment and use of new NASH therapies.

"Reporting of liver biopsy results in real-world settings, outside of clinical trials, is not standardized and may be of limited value to clinicians. We hope this information will encourage further discussion among all stakeholders, which will be increasingly important when NASH therapeutics become routinely available," said Michael W. Fried, M.D., FAASLD, chief medical officer, Target RWE and co-author.

Fibrosis Assessed by Non-Invasive Tests (NIT) is Similar to Liver Biopsy for Predicting Clinical Outcomes: A TARGET-NASH Study compared compensated cirrhosis diagnosed clinically or by NITs to liver biopsy for predicting clinical outcomes and death and found that a diagnosis of advanced fibrosis/cirrhosis made by FIB-4 predicted clinical outcomes as well as biopsy.

TARGET-PBC research was also presented: The Pervasive Impact of Pruritus on Quality of Life in Patients with Primary Biliary Cholangitis (PBC): Real World Experience in TARGET-PBC and Pruritus in Primary Biliary Cholangitis is Under-Treated in Clinical Practice: Results from TARGET-PBC.

"Data presented shed light on the significant impact that PBC has on many aspects of quality of life, including fatigue, social, emotional and cognitive symptoms," said Dr. Fried.

The research also found pruritus in PBC is under-treated in clinical practice and many patients with significant itch never receive treatment.

Visit www.targetrwe.com for more information.