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Table 1. Clinical Characteristics of Patients with MASH.

From: Treatment Resistant Patients with Metabolic Dysfunction-associated Steatohepatitis: Long-term Follow-up Prospective Study

Characteristics Group1+2+3 Group1 Group2 Group3
(n=51） (n=35) (n=11) (n=5)
Age --- yrs 49.8±6.3 50.1±6.5 47.3±5.1 53.4±5.0
Male --- no. (%) 27 (53) 20 (57) 6 (55) 1 (20)
Body measurement
　Body mass index 31.2±4.9 31.7±4.6 30.9±5.7 29.1±4.3
　Visceral fat cm2 199.0±63.1 202.2±67.0 205.9±54.0 165.6±41.9
Diabetes Mellitus (DM%) (51%) (49%) (55%) (60%)
　HbA1c 6.7±1.3 6.7±1.4 6.7±1.1 6.4±0.5
　f-IRI 18.8±7.7 17.9±6.3 21.7±10.4 21.2±3.4
Lipid metabolism
　Triglyceride (hyperTG %) 242±257 (55%) 223±290 (45%) 292±178 (64%) 260±98 (100%)
　LDL cholesterol (hyperLDL％) 131±27 (39%) 127±28 (34%) 136±11 (55%) 149±33 (40%)
Biochemical data
　ALT (Hepatitis) 97.5±52.5 97.5±58.4 99.2±29.7 93.4±51.6
Diagnostic imaging (FibroScan)
　E value (fibrosis/hepatitis) 10.2±6.2 9.5±4.9 8.7±4.9 17.8±10.0
　CAP (Steatosis) 321.4±44.0 321.7±45.4 325.9±32.3 310±54.0
Liver fibrosis
　Type IV collagen 4s 4.9±1.7 4.6±1.3 5.1±1.8 7.3±1.8
　MASH stage (1/2/3/4) no. 33/9/9/0 24/7/4/0 8/1/2/0 0/2/3/0
　FIB4-index 1.67±0.89 1.51±0.64 1.33±0.56 3.16±1.09
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Table 2. Effectiveness Rate and Duration Time in Primary and Pemafibrate Treatment.

From: Treatment Resistant Patients with Metabolic Dysfunction-associated Steatohepatitis: Long-term Follow-up Prospective Study

Effectiveness rate (%) Duration time (years)
Primary treatment pemafibrate treatment Group 1 Group 2 Group 3
n=35 n=11 n=5
1) BW 29% 2.4ys
2) BW Vitamin E 43% 3.1ys
3) BW (Vitamin E) SGLT2i 17% 3.3ys
Low effect
4) (BW) Vitamin E SGLT2i 11% 5.0ys
　Low effect
5) (BW) Vitamin E (SGLT2i) +pemafibrate 36% 4.4ys
　Low effect Low effect
6) (BW) Vitamin E SGLT2i +pemafibrate 64% 4.1ys
　Low effect
7) (BW) (Vitamin E) (SGLT2i) (+pemafibrate) 0% 5.7ys
　Low effect Low effect low effect low effect
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Table 3. Therapeutic Effects of Primary and Pemafibrate Treatment on Representative Items; BW, Diabetes (HbA1c) and Lipid (TG).

From: Treatment Resistant Patients with Metabolic Dysfunction-associated Steatohepatitis: Long-term Follow-up Prospective Study

Body weight (kg) HbA1c (%) Triglyceride (mg/dl)
baseline after primary treatment baseline after primary treatment baseline after primary treatment
Group1 83.1±16.0 77.8±16.4 6.7±1.3 6.4±1.1 182.2±115.5 148.8±66.7
p<0.001 p<0.02 p<0.02
baseline after pemafibrate treatment baseline after pemafibrate treatment baseline after pemafibrate treatment
Group2 87.7±15.6 85.5±13.3 6.7±1.1 6.6±0.7 304.5±186.5 157.2±110.2
p=0.13 p=0.95 p<0.01
baseline after pemafibrate treatment baseline after pemafibrate treatment baseline after pemafibrate treatment
Group3 73.4±10.8 73.0±9.7 6.4±0.5 7.1±0.8 259.6±97.89 250.8±82.2
p=0.89 p=0.22 p=0.08
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Table 4. Statistical Analysis of Treatment Resistance-Related Parameters (The Summary of the Results in Figure 3).

From: Treatment Resistant Patients with Metabolic Dysfunction-associated Steatohepatitis: Long-term Follow-up Prospective Study

Clinical parameters p values (t test/chi-square test＊) Cutoff value
Group1-Group2 vs Group3
(treatment effective) (treatment resistant)
Obesity BMI 0.33
Metabolic syndrome VF(visceral fat) (CT) 0.22
CAP (fibroscan) 0.55
Diabetes Mellitus HbA1c 0.58
f IRI 0.49
Lipid metabolism Triglyceride 0.87
LDL cholesterol 0.13
Hepatitis ALT 0.86
Liver fibrosis/hepatitis E value(fibroscan) <0.01 13.7kPa
Liver fibrosis type IV collagen <0.001 5.3ng/ml
stage (fibrosis) 0.01 (Stage1+Stage2/Stage3)* Stage2
0.031(Stage1/Stage2+Stage3)*
FIB4-index <0.001 1.89
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