Tuesday, November 3, 2020
Researchers find change in liver fat measured by MRI scan may be able to be used in liu of invasive liver biopsy to monitor response to treatment in patient with NASH
Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease worldwide affecting 30% of the global population. Nonalcoholic steatohepatitis (NASH) is the progressive form of NAFLD. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) offers promise as a non-invasive biomarker of treatment response in early-phase nonalcoholic steatohepatitis (NASH) trials. A 30% reduction or more in MRI-PDFF was associated with histologic response in previous individual controlled clinical trials.
A collaborative systematic review and meta-analysis from researchers at Penn State, University of California San Diego, University of Chicago and University of Virginia quantified the association between a ≥ 30% reduction in MRI-PDFF and histologic response in NASH across multiple clinical trials.
Seven studies were analyzed and contributed data to this analysis. In aggregate, there were 109 MRI-PDFF responders, 237 MRI-PDFF non-responders, 89 histologic responders, and 257 histologic non-responders. The pooled histologic response rate among MRI-PDFF responders versus MRI-PDFF non-responders was 51% and 14%, (p-value <0.001), respectively. Meta-analysis demonstrated that MRI-PDFF responders had higher odds of histologic response (pooled OR 6.98, 95% CI 2.38-20.43, p<0.001) when compared to MRI-PDFF non-responders.
The researchers concluded that MRI-PDFF offers an accurate and reliable biomarker for assessment of treatment response in early phase NASH trials. Further research is needed to define the role of MRI-PDFF in clinical trials of drugs with different mechanisms of action, including antifibrotics, and to clarify the role of MRI-PDFF in late-phase clinical trials and clinical care.
See the article in full here: Change in MRI-PDFF and Histologic Response in Patients with Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis