Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis

EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis – 2021 update

“…In 200 adults with NASH, a > − 17 IU/L decrease of ALT at week 24 was the strongest predictor (odd ratio >10) of histological response as defined by a > − 2-point improvement in NAS without worsening of fibrosis. 177 In a recent meta-analysis (n = 7 studies; 346 patients), 178 MRI-PDFF responders (defined as relative decline in liver fat > − 30%) were more likely to have NASH resolution (41% vs. 7%, p <0.001; odds ratio 5.45, 95% CI 1.53-19.46, p = 0.009) compared to MRI-PDFF nonresponders. Such association between histological response and steatosis decrease was however not reproduced in another large study (n = 121 patients).…”

MRI‐Proton Density Fat Fraction Treatment Response Criteria in Nonalcoholic Steatohepatitis

“…Compared with nonresponders, MRI‐PDFF responders had significantly higher odds of ≥2‐point improvement in NAS as well as NASH resolution. ( 9 ) Table 1 summarizes the MRI‐PDFF response criteria that may be used for assessment of treatment response in early‐phase clinical trials. A secondary analysis of the Resmetirom Trial that was presented at the Digital International Liver Meetings held in August 2020 showed that NASH resolution rate was dose‐dependently higher in super‐responders (MRI‐PDFF ≥ 50% decline) versus responders (MRI‐PDFF ≥ 30% decline) versus nonresponders (MRI‐PDFF < 30% decline).…”

“…( 8 ) Subsequently, a recent meta‐analysis has been published that provides pooled estimates on the association between MRI‐PDFF responders, defined as ≥30% reduction in MRI‐PDFF relative to baseline and histologic response. ( 9 ) Seven studies were examined in this meta‐analysis, including 346 subjects. The rate of histologic response as defined as ≥2‐point improvement in NAS in MRI‐PDFF responders versus nonresponders was 51% versus 14% ( P value < 0.01), respectively, and the rate of NASH resolution as defined as 0 ballooning and 0‐1 in lobular inflammation in MRI‐PDFF responders versus nonresponders was 41% versus 7% ( P value < 0.01), respectively.…”

“…The rate of histologic response as defined as ≥2‐point improvement in NAS in MRI‐PDFF responders versus nonresponders was 51% versus 14% ( P value < 0.01), respectively, and the rate of NASH resolution as defined as 0 ballooning and 0‐1 in lobular inflammation in MRI‐PDFF responders versus nonresponders was 41% versus 7% ( P value < 0.01), respectively. ( 9 )…”

Sodium-Glucose Cotransporter-2 Inhibitors for Treatment of Nonalcoholic Fatty Liver Disease: A Meta-Analysis of Randomized Controlled Trials

“…Fourthly, RCTs with liver histological endpoints as a primary outcome were not available in the literature. Although MRI-PDFF or MRS can provide non-invasive, accurate measures of liver fat content, their efficacy for detecting relevant histological features of NAFLD (i.e., NASH and fibrosis) is somewhat limited [ 39 , 40 ]. In addition, magnetic resonance-based techniques may not be as useful to assess treatment response in patients with NAFLD as previously believed, given that some evidence suggests that improvements in liver fat content measured by MRI do not necessarily translate in improvements in liver histology features (lobular inflammation, hepatocyte ballooning, or fibrosis) in patients with NASH [ 41 ].…”