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Published On: 11/3/2021

Peer-Reviewed Target RWE Study Finds Wide Variance in Nonalcoholic Steatohepatitis (NASH) Pathology Reporting

DURHAM, N.C., Nov. 3, 2021 /PRNewswire/ -- Target RWE, a leading real-world evidence (RWE) solutions company for the healthcare industry, shared results from a recent TARGET-NASH study that revealed documentation of NASH related pathology reports in clinical practice is often inconsistent and incomplete. Published in the journal Alimentary Pharmacology and Therapeutics, the study titled Liver Biopsy in the Real World – Reporting, Expert Concordance, and Correlation with a Pragmatic Clinical Diagnosis (doi.org/10.1111/apt.16674) also validated the company's clinical definition of NASH.

"The findings support the notion that there is substantial variability in reporting and grading NASH and fibrosis staging in clinical practice," said Hannah P. Kim, MD, former Gastroenterology Fellow at the University of North Carolina at Chapel Hill, and current Assistant Professor of Medicine at Vanderbilt University. "The current lack of consistency is concerning in terms of patient assessment and translation of practice guidelines for this growing population. The TARGET-NASH clinical definition can help more accurately identify NASH patients in clinical practice."

The study analyzed 222 liver pathology reports from TARGET-NASH patients from 38 sites, including re-examination by a blinded central expert pathologist. Key results included:

• Documentation was missing from reports of steatosis (21%), lobular inflammation (35%), portal inflammation (46%) and ballooning (40%).
• Slight-to-fair concordance between site and central pathologists for inflammatory features and moderate concordance for fibrosis staging.
• 75-91% concordance between expert central pathologist diagnosis and TARGET-NASH clinical definition for NASH.

"As non-alcoholic fatty liver disease (NAFLD) becomes more common, the ability to diagnose and assess disease severity in patients with non-alcoholic steatohepatitis is critically important," said A. Sidney Barritt IV, MD, MSCR, Associate Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill. "While liver biopsy is the referent standard, it is limited by its invasive nature, inconsistent reporting, and inter-observer variability. There is a significant unmet need for a reliable, pragmatic clinical definition of NASH that can better guide treatment decisions."

Target RWE's pragmatic clinical diagnosis of NASH was created by a panel of NASH experts and is based on elevated alanine aminotransferase (ALT) levels, hepatic steatosis on biopsy or imaging, and one or more of the following: BMI equal to or greater than 30kg/m2, type 2 diabetes mellitus, and/or dyslipidemia.

The Target RWE NASH baseline manuscript, Patient Determinants for Histologic Diagnosis of NAFLD in the Real World: A TARGET–NASH Study (doi.org/10.1002/hep4.1689), initially featured it's clinical definition of NASH and was published in February 2021 in Hepatology Communications.

TARGET-NASH (NCT02815891) is a longitudinal study of adult and pediatric participants with NAFLD and/or NASH in usual clinical practice. Target RWE's network of NASH sites includes 60 active community and academic centers in the U.S. and Europe, enrolling over 6,000 participants to date. Three years of retrospective data is obtained at enrollment and patients are then followed prospectively for a minimum of five years, including the collection of patient-reported outcome measures and biospecimen samples.