2022 - Time for Change in NASH: How Non-Invasive Biomarkers are Driving a Paradigm Shift in Clinical Trials and Clinical Care

Diagnosing and assessing the progression of nonalcoholic steatohepatitis (NASH) continue to be some of the most challenging aspects of its management. Most patients would opt out of the diagnostic or follow-up liver biopsy. In addition, liver biopsies would not be a front-line test offered by primary care physicians, endocrinologists and diabetologists where a large proportion of undiagnosed patients exist. In addition, recent clinical trial data has shown considerable variability in histopathology readings, making it unreliable for use in clinical trials.
A better approach is needed. Over the last 10 years, there has been increasing interest in the development and validation of non-invasive tests (NITs) that can diagnose NASH, stratify risk, predict clinical outcomes and/or monitor the progression or regression of the disease. These NITs would have greater acceptance amongst patients, broader applicability across physician specialties and offer the potential of improved management of NASH patients. NITs may also help to identify NASH sub-phenotypes with potential distinct natural history and prognosis and eventually, facilitate personalized treatment and better response rate. Finally, available data suggest that NITs can predict clinical outcomes and help accelerate clinical development and bring a safe and efficacious therapy to NASH patients with high unmet need.
Currently, many different imaging and blood-based NITs are being explored in clinical trials. In some trials, pre-biopsy enrichment strategies with NITs are becoming increasingly popular to reduce the number of liver biopsy-related screen failures. These NITs include genetic susceptibility alleles, specific protein biomarkers and multi-analyte algorithms. Sorting through these NITs, their use individually and in combination, admittedly requires some navigational assistance.
While the identification of patients at high risk of progressive NASH remains an on-going challenge, there is a wealth of emerging data from clinical trials which will directly influence future NIT use in NASH clinical care.
Register to learn how non-invasive biomarkers are driving a paradigm shift in NASH clinical trials and clinical care.