New Target RWE Research Validates Updated Liver Disease Terminology in Children

One of the first studies demonstrating high concordance between legacy
NAFLD and new MASLD terminology in children and adolescents

DURHAM, N.C., Nov. 25, 2024 /PRNewswire/ -- Target RWE, a leading real-world evidence solutions company, today announced the results of an innovative research study validating the new nomenclature for fatty liver disease in pediatric patients. The research published in Hepatology Communications was conducted using data from the TARGET-NASH real-world longitudinal pediatric cohort and demonstrates a remarkably high concordance between the legacy non-alcoholic fatty liver disease (NAFLD) terminology and the new metabolic dysfunction-associated steatotic liver disease (MASLD) nomenclature among pediatric patients.

Additionally, the TARGET-NASH pediatric pragmatic clinical criteria used to identify patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly NASH, were highly concordant with MASH confirmed by an expert pathologist who reviewed digitized slides from patients who had a prior liver biopsy.

Key findings from the study include:

• 99% of pediatric patients in the TARGET-NASH cohort met the new MASLD diagnostic criteria
  
  
• 100% of patients with NAFLD cirrhosis met the new criteria
  
  
• 89% concordance between Target RWE's clinical MASH criteria and histologically confirmed NASH

"This study is the first to investigate the correlation between old and new nomenclature in pediatric patients with metabolic dysfunction-associated steatohepatitis, formerly known as fatty liver disease," said Miriam B. Vos, MD, MSPH, Director, Pediatric Program Georgia Center for Clinical and Translational Science Alliance, Emory University. Dr. Vos is a TARGET-NASH advisory committee member and co-author of the study. "Our findings provide crucial validation for the applicability of the new MASLD/MASH terminology in children and adolescents, ensuring the continued relevance of prior research conducted under the legacy NAFLD framework. This analysis also supports the use of readily available non-invasive clinical data to diagnose pediatric patients with MASH."

The research utilized data from 828 pediatric patients enrolled in the Target RWE MASLD cohort across the United States. The study also evaluated the effectiveness of clinical criteria to diagnose MASH compared to histological diagnosis by a central pathologist, offering a non-invasive approach for clinical evaluation of MASLD in pediatric patients.

"The strong concordance between clinical and histological MASH diagnoses presents a valuable opportunity for clinicians to further study MASH in pediatric patients," added Michael W. Fried, MD, FAASLD, Chief Medical Officer at Target RWE. "Our findings support the recent consensus recommendations that established the new nomenclature for steatotic liver diseases that better reflects the underlying pathophysiology of the disease."

Target RWE published a manuscript in the American Journal of Gastroenterology earlier this year regarding high concordance of the new MASLD terminology in adult patients enrolled in the TARGET-NASH registry.

For more information about Target RWE and its publications, please visit targetrwe.com/research/publications/.

About Target RWE

Target RWE generates real-world evidence (RWE) that informs strategic decisions across the drug development lifecycle. Our unique combination of clinical, analytical and technical expertise enables comprehensive insight generation from complete retrospective and prospective longitudinal patient journeys, with unparalleled scale and accuracy.

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SOURCE Target RWE