Biomarkers and Diagnostic Tests in MASH

Understanding the Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Spectrum

Patients With Cardiometabolic Risk Factors for Fibrosis Should Be Evaluated for MASH1

  • Obesity
  • Prediabetes or type 2 diabetes
  • Elevated triglycerides
  • Low HDL cholesterol
  • Hypertension

MASLD

Steatotic liver disease + presence of ≥1 cardiometabolic criterion, with exclusion of excessive alcohol intake and other causes of steatosis2

Excessive alcohol consumption is

>3 drinks/day (F)
>4 drinks/day (M)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Active form of the disease characterized by histologic features2

  • Hepatocellular ballooning
  • Lobular inflammation

Fibrosis Progression in MASH2,3

  1. Healthy liver Healthy
  2. Liver with no to mild fibrosis No/Mild Fibrosis (F0/F1)
  3. Liver with moderate fibrosis Moderate Fibrosis (F2)
  4. Liver with severe fibrosis Severe Fibrosis (F3)
  5. Cirrhotic liver Cirrhosis (F4)

Early identification of patients at risk for fibrosis may prevent future liver-related complications1,4

Patient Screening, Risk Stratification, and Assessment: Guidelines and Key NITs

Initial Screening and Risk Stratification

For additional information, explore the Biomarkers and Diagnostic Tests in MASH presentation

Fibrosis-4 (FIB-4)1,2,5

The FIB-4 Index is a nonproprietary score based on age, , and that estimates the likelihood of advanced liver fibrosis (≥F3)

FIB-4 is recommended by current guidelines as an initial screening and risk stratification tool

SAFE (Steatosis-Associated Fibrosis Estimator)9

The is a nonproprietary score calculated using 7 variables to estimate the likelihood of clinically significant liver fibrosis (≥F2)

  • Age
  • and (total protein minus albumin)

Patients with an elevated FIB-4 (>1.3 or >2.0 if 65 years or older) or SAFE >0 should be further assessed to stage liver fibrosis1,2,9

Patient Screening, Risk Stratification, and Assessment: Guidelines and Key NITs

Fibrosis Assessment

Elastography is recommended as second-line tools to stage fibrosis. If elastography is not available, advanced blood-based tools (eg, Enhanced Liver Fibrosis [ELF™] test) can be considered2,4

Ultrasound-based elastography

US elastography is used to noninvasively quantify liver stiffness, which estimates the degree of fibrosis. Cutoff values may be system dependent2

Cutoff values for fibrosis staging using VCTE (FibroScan®)2,4

PARAMETER DEFINITION CUTOFF, kPa
F0-F1 No to mild fibrosis <8
F2-F3 Moderate to advanced fibrosis 8 to 20
F4* Cirrhosis 20

Cutoff values for fibrosis staging using VELACUR 3D11

PARAMETER DEFINITION CUTOFF, kPa
F0-F1 No to mild fibrosis <5.7
F2-F3 Moderate to advanced fibrosis 5.7 to 8.3
F4* Cirrhosis ≥8.4

*Consider additional tests for confirming stage of liver fibrosis in patients with VCTE-LSM between 15 to <20 kPa.4

Magnetic resonance elastography (MRE)

MRE measures liver stiffness and is considered the most accurate noninvasive imaging technique for staging liver fibrosis in MASH2

Cutoff values for fibrosis staging using MRE4

PARAMETER DEFINITION CUTOFF, kPa
F0-F1 No to mild fibrosis <3.1
F2-F3 Moderate to advanced fibrosis 3.1 to 4.9
F4 Cirrhosis ≥5.0

ELF

Following a positive first-line test result (eg, FIB-4), the ELF blood test is commonly recommended as a second-line assessment if elastography is unavailable1,4

Cutoff values for fibrosis staging using ELF4

FIBROSIS STAGE DEFINITION CUTOFF
F0-F1 No to mild fibrosis <9.2
F2-F3 Moderate to advanced fibrosis 9.2 to <11.3
F4 Cirrhosis ≥11.3

For additional information, explore the Biomarkers and Diagnostic Tests in MASH presentation