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Published On: 6/24/2022

Nonalcoholic Fatty Liver Disease (NAFLD) Research from Target RWE's Real-World Study Presented at International Liver Congress 2022

DURHAM, N.C., June 24, 2022 /PRNewswire/ -- New TARGET-NASH data shows longitudinal trajectories of alanine aminotransferase (ALT) remained comparatively stable among patients with nonalcoholic fatty liver disease (NAFLD) in the latest real-world study by Target RWE. Selected as part of the Poster Tours at the International Liver Congress™ (ILC) 2022 in London, the analysis aimed to evaluate longitudinal variability in ALT and estimated the probability of a patient transitioning from their baseline level.

"Researchers have not been able to keep pace with the rapidly growing disease burden of NAFLD that is increasing concern from a public health standpoint. As a common biomarker used to monitor liver injuries, very little is known about ALT fluctuations over periods of time and, further, the influence of patient characteristics on ALT trajectories in patients with NAFLD. It's important to continue to generate valuable real-world data, as presented today at ILC 2022, to battle the rising global prevalence of NAFLD," said Arun J. Sanyal, M.B.B.S., M.D., 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 is a co-author of the study.

The TARGET-NASH abstract, Longitudinal ALT trajectories are generally stable among patients with non-alcoholic fatty liver disease (NAFLD): An investigation using artificial recurrent neural networks (Poster #3710/FRI103), analyzed over 3,600 adult patients with NAFLD in the U.S. with three or more ALT measures. ALT categories were defined as: normal (≤30U/L), slightly high (1-2X normal), high (2-3X normal), and very high (>3X normal).

Patients were followed over a median of 38.2 months with 3.9 months between ALT measures. The median age of patients was 59 with a history of hypertension (74%), type 2 diabetes (54%), cardiovascular disease (22%), and statin use (46%). Patients in higher ALT categories at baseline were younger with a higher proportion of Hispanic or Latino participants in comparison to lower ALT categories.

"Understanding the course of ALT fluctuations is important for helping to differentiate natural variation from potential hepatotoxic or beneficial effects of therapeutics. Our study found that longitudinal ALT trajectories remained relatively stable for many participants with NAFLD over time," said Michael W. Fried, M.D., FAASLD, Co-Founder and Chief Medical Officer, Target RWE, and first author. "Further research and analyses are needed to explore ALT trends associated with probability of clinical outcomes."

Sponsored by Target RWE, TARGET-NASH is a longitudinal, observational cohort of adult and pediatric participants with NAFLD and/or NASH receiving usual care from academic and community centers in the U.S. and Europe, enrolling over 7,000 participants to date. Real world data is collected from consented participants, who may also provide patient-reported outcome measures and biospecimens. Learn about TARGET-NASH publications here.

About Target RWE

Target RWE is a leading health evidence solutions company that generates innovative real-world evidence (RWE) and provides scientific intelligence tools and solutions for pharmaceutical, biotechnology, and other healthcare partners. Specifically designed to address the complexities of the natural history of disease, the drug development process and treatments in real-world settings, Target RWE builds regulatory-grade clinical data sets and applies state of the science epidemiologic methods to produce RWE about patients with specific conditions, symptoms, and therapies used in usual clinical practice.

Target RWE's regulatory-grade data sets and evidence, modern epidemiological methods, and sound scientific principles rendered as software can be utilized to better health outcomes, inform patient health guidelines, and improve overall quality of care. For more information, visit www.targetrwe.com.

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