Table 1.
Characteristics of Included Studies
| First author (year) and country | Study design, time period | Population diagnosis | Population demographics | NASH severity |
|---|---|---|---|---|
| Argo et al. (2015), USA |
RCT, 2007 to 2010 |
34 subjects (biopsy proven NASH, NAS > or = 4) 28 subjects with biopsy and MRI-PDFF |
Median Age: 47 years Male: 38% (n=13) DM:32% (n=11) HTN:50% (n=17) HLD:15% (n=5) BMI, median 33kg/m2 |
Mean liver fat (MRI-PDFF): 18.4 % (fish oil and 11.3 % (placebo) Mean NAS: 5.4 (fish oil) and 4.9 (placebo) Mean Fibrosis: 2.1 (fish oil) and 1.6 (placebo) |
| Jayakumar et al.
(2018), USA and Canada |
RCT, June 2015 to March 2016 |
72 subjects (liver biopsy within 3 months of screening consistent with a diagnosis of NASH and stage 2/3 fibrosis according to the NASH CRN histologic scoring. All patients with NAS ≥5 and at least 3 of the metabolic syndromes 65 subjects with biopsy and MRI-PDFF |
Median Age: 56 years Male: 29% (n=19) DM: 63% (n=45) HTN: n/a HLD: n/a BMI, median 33kg/m2 |
NAS:
7–8: 12 (19%) Fibrosis: F2: 21 (32%) F3: 44 (68%) |
| Le et al. (2012), USA | RCT, September 2009 to January 2011 |
50 subjects (Hepatic steatosis of >5% by MRI-PDFF and liver biopsy with evidence of NASH, defined by the presence of all of the following features including steatosis, ballooning degeneration and lobular inflammation with or without fibrosis or suspicious for NASH defined as NAS ≥4) |
Mean Age: 48 years Male: 46% (n=23) DM: 36% (n=18) HTN: n/a HLD: n/a BMI, mean: 31kg/m2 |
Mean liver fat (MRI-PDFF): 14.2% (colesevelam) and 17.9% (placebo) Mean NAS: 4.7 (colesevelam) and 4.6 (placebo) Mean Fibrosis: 1.2 (colesevelam) and 1.1 (placebo) |
| Loomba et al. (2020), USA |
Secondary analysis of RCT, March 2011 to Dec 2012 |
78 subjects (Biopsy-proven NASH and NAS ≥4) | Mean Age: 53 years Male: 37% (n=29) DM: 51% (n=40) HTN: 53% (n=41) HLD: 53% (n=41) BMI, mean: 34kg/m2 |
Mean liver fat (MRI-PDFF): 18.0% (obeticholic acid) and 20.0% (placebo) Mean NAS: 5.1 (obeticholic acid) and 5.4 (placebo) Mean fibrosis stage: 1.9 (obeticholic acid) and 1.7 (placebo) |
| Loomba R et al. (2020), USA | Secondary analysis of RCT, October 2016 to July 2017 |
125 subjects (Biopsy confirmed NASH defined as F1–3 and NAS ≥4 and hepatic fat fraction of ≥10% by MRI-PDFF) 107 subjects with biopsy and MRI-PDFF |
Mean Age: 50 years Male: 50% (n=62) DM: 39% (n=49) HTN: 50% (n=63) HLD: n/a BMI, mean: 35kg/m2 |
Mean liver fat (MRI-PDFF): 20.2 (resmetirom) and 19.6 (placebo) NAS: Mean 4.9 (resmetirom) and 4.8 (placebo) NAS ≥5: 47 (resmetirom) vs 19 (placebo) Fibrosis: Fibrosis 0: 1 vs 2 Fibrosis 1: 47 vs 19 Fibrosis 2: 18 vs 13 Fibrosis 3: 18 vs 7 |
| Patel et al. (2016), USA |
Secondary analysis of RCT, Jan 2013 to Dec 2013 |
35 subjects (Liver biopsy-confirmed NASH as defined by the NASH CRN histologic scoring system and MRI-PDFF ≥5% hepatic steatosis) |
Median Age: 61 years for histological responders and 49 years for non-responders Male: 34% (n=12) DM: mean A1c 6.1% HTN: n/a HLD: n/a BMI, median: 31kg/m2 in responders and 35 kg/m2 in non-responders |
Mean liver fat (MRI-PDFF): 13.4% (responders) vs 18.2% (non-responders) Mean NAS: 5.5 (histologic responders) vs 5 (non-responders) Mean fibrosis: 0.5 (histologic responders) vs 1 (non-responders) |
| Stine et al. (2020), USA |
Controlled trial, May 2018 to May 2019 |
3 subjects (Biopsy proven NASH defined by NASH-CRN and NAS ≥5) |
Mean age: 55 years Male: 67% (n=2) DM: 67% (n=2) HTN: 100% (n=3) HLD: 67% (n=2) BMI, mean: 34kg/m2 |
Mean liver fat (MRI-PDFF): 19.4% Mean NAS: 5.3 Mean fibrosis: 2.3 |
BMI=body mass index; CRN=Clinical Research Network; DM=diabetes; F=fibrosis; HLD=hyperlipidemia; HTN=hypertension; MRI-PDFF=magnetic resonance imaging proton density fat fraction; NAS=NASH Activity Score; NASH=nonalcoholic steatohepatitis; RCT=randomized controlled trial; USA=United States of America
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All studies had the same definition of histologic response which was an improvement in NAS by ≥2 points without worsening of fibrosis
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NASH resolution defined either by 0 ballooning and 0–1 lobular inflammation as assed by NAS