Magnetic resonance elastography bests other diagnostic tests for identifying at-risk NASH
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WASHINGTON — Magnetic resonance elastography was among the most accurate screening test to identify patients with at-risk nonalcoholic steatohepatitis, according to study results presented at The Liver Meeting.
“This study is setting the stage for how these tests can be used to identify who needs to be treated without needing a liver biopsy,” Rohit Loomba, MD, MHSc, director of hepatology and the NAFLD Research Center at UC San Diego School of Medicine, told Healio. “For each test we provide its diagnostic test characteristics in the patient population of this trial. Elastography based tests will be needed for risk stratification and among them [magnetic resonance elastography (MRE)] is most accurate, but you can use a combination like MEFIB — where we combine FIB-4 with MRE — to increase positive predictive value.”
Loomba and colleagues applied FIB-4 cutoff values of 1.3 and 1 to 2,000 patients who were screened for the MAESTRO-NASH study, a 52-week phase 3, double-blind, placebo-controlled NASH clinical trial evaluating the impact of resmetirom in patients with NASH and significant liver fibrosis. Patients were screened using FibroScan, MRE, MRI Proton Density Fat Fraction (MRI-PDFF), labs and liver biopsy.
Researchers evaluated correlations between screening FIB-4 of at least 1 and 1.3 and imaging tests with liver biopsy NAFLD activity score and fibrosis stage.
According to results, 56.9% of F2, 40.3% of F3 and 24.4% of F4 biopsy-confirmed patients had a FIB-4 less than 1.3. Further, 46.4% of patients with active NASH fibrosis F2/F3 had FIB-4 less than 1.3 and 32.6% of F2 and 18% of F3 patients had FIB-4 less than 1. Among those with active NASH, 41.7% of F2 and 17.3% of F3 patients had FIB-4 less than 1.
The mean age of F2/F3 patients with FIB-4 of at least 1.3 was 61.1 years, whereas those patients with FIB-4 less than 1.3 had a mean age of 52.2 years (P < 0.001). Additionally, patients with FIB-4 of at least 1 had a mean age of 59.9 years and patients with a FIB-4 less than 1 had a mean age of 47.6 years (P < 0.001).
According to Loomba and colleagues, there were more low risk NAFLD patients with a FIB-4 less than 1.3 compared with a FIB-4 less than 1 (84.3% vs. 58.1%, respectively).
The area under the receiver operating characteristic for MRE, magnetic resonance imaging-aspartate aminotransferase (MAST) and FibroScan-aspartate aminotransferase (FAST) scores for fibrosis stage, and NASH exceeded 0.7, while MEFIB had high specificity and low sensitivity. The AUROC for FIB-4 was 0.68.
“One of the key findings of this study is the clinical validation in the setting of a clinical trial that MRE provides the highest accuracy and positive predictive value for detecting patients with NASH and stage 2 or 3 fibrosis who need pharmacologic therapy,” Loomba said.