Published On: 9/13/2021

Update from Paris NASH 2021: New Target RWE Nonalcoholic Steatohepatitis (NASH) Data Presented at This Year’s Meeting

Chief Scientific Officer Also Spoke About Clinical Trial Innovation

In September 2021, Target RWE participated in the annual Paris NASH conference and presented findings from a recent TARGET-NASH abstract poster, “Determination of Optimal Thresholds for Significant Fibrosis in NAFLD Using Non-Invasive Tests from TARGET-NASH Study.” The real-world data findings were virtually presented by 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.

“Paris NASH is an international think tank that brings together leading public health, biology, research and regulatory experts from around the world. NASH is a growing public health concern, with few treatment options. It is essential that we continue to connect and collaborate to discuss not only the latest research, but the best ways to go about conducting that research,” said Arun Sanyal, MD, Professor, Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, and co-author on the TARGET-NASH poster.

The TARGET-NASH research analysis focused on determining optimal thresholds for identifying significant fibrosis using non-invasive tests (NITs). The analysis found that FIB-4 at a threshold of ≥2.43 and APRI ≥1.07 can be used to potentially identify significant fibrosis among real-world NASH patients with an acceptable level of accuracy. Area under receiver operating characteristic (AUROC) curves were used to determine optimal NIT thresholds, and both a high and low threshold were selected to maximize classification accuracy (optimized for specificity >=90% and optimized for sensitivity >=90%, respectively).

“Liver biopsy is considered the standard for fibrosis staging; however, use of this invasive procedure is limited in clinical real-world practice,” said Dr. Barritt, the lead author. “The TARGET-NASH study findings presented at Paris NASH provide more evidence to help support the ability of NITs to discriminate significant liver fibrosis in a real-world registry.”

Target RWE’s Chief Scientific Officer Alan Brookhart, PhD, additionally gave a talk at this year’s hybrid conference focused on estimating causal effects of treatments in real-world data.

“While there have been tremendous advancements in clinical trial study design and statistical methodology in the past two decades, real-world data quality and availability has also increased significantly as well,” said Dr. Brookhart. “The use of causal inference methods applied to real-world data can repair aspects of the trial design that tend to be commonly broken, such as lack of randomization or confounding, missing data, or censoring.”

Dr. Sanyal is a key organizer of the Paris NASH Meeting Congress. Both Dr. Barritt and Dr. Sanyal are TARGET-NASH steering committee members.

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