TY - JOUR
T1 - Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort
AU - TARGET-NASH Investigators
AU - Sanyal, Arun J.
AU - Munoz, Breda
AU - Cusi, Kenneth
AU - Barritt, A. Sidney
AU - Muthiah, Mark
AU - Mospan, Andrea R.
AU - Reddy, K. Rajender
AU - Firpi-Morell, Roberto
AU - Thuluvath, Paul J.
AU - Bhamidimarri, Kalyan Ram
AU - Fried, Michael W.
AU - Abdelmalek, Manal
AU - Aguilar, Humberto
AU - Ahmed, Aijaz
AU - Allen, Alina
AU - Barlow, Sarah
AU - Barritt, Sid
AU - Bernstein, David
AU - Bhamidimarri, Kaylan
AU - Billings, Liana
AU - Brown, Kyle
AU - Brown, Robert
AU - Corbin, Karen
AU - deLemos, Andrew
AU - Emerick, Karan
AU - Ghali, Maged Adel
AU - Henry, Zachary
AU - Jackson, Whitney
AU - Janardhan, Sujit
AU - Kabbany, Mohammad
AU - Kemmer, Nyingi
AU - Koch, David
AU - Kupec, Justin
AU - Landis, Charles
AU - Lawrence, Mary Katherine
AU - Levy, Cynthia
AU - Lidofsky, Steven
AU - Lok, Anna
AU - Luketic, Velimir
AU - Martinez, Enrique
AU - McClain, Craig
AU - McKiernan, Patrick
AU - Mitchell, Ellen
AU - Noureddin, Mazen
AU - Palle, Sirish
AU - Pham, Yen
AU - Pound, David
AU - Reddy, Rajender
AU - Regenstein, Fredric
AU - Rinella, Mary
N1 - Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.
PY - 2023/10
Y1 - 2023/10
N2 - BACKGROUND & AIMS: There is an unmet need to validate simple and easily available methods that can be used in routine practice to identify those at risk of adverse outcomes from nonalcoholic fatty liver disease (NAFLD). A retrospective-prospective analysis of NAFLD patients enrolled in a longitudinal noninterventional study (TARGET-NASH) was performed to validate the prognostic utility of the following risk-categories: (A) Fibrosis-4 (FIB-4) <1.3 and/or liver-stiffness measurement (LSM) measured by Fibroscan <8 kp, (B) FIB-4 1.31‒2.6 and/or LSM 8.1-12.5 kp, and (C) FIB-4 >2.6 and/or LSM >12.5 kp.METHODS: Those in class A with aspartate transaminase:alanine transaminase ratio >1 or platelets <150,000/mm
3, or class B with aspartate transaminase:alanine transaminase ratio >1 or platelets <150,000/mm
3 were upstaged by one class. Fine-Gray competing risk analyses were performed for all outcomes.
RESULTS: A total of 2523 individuals (class A = 555, B = 879, C = 1089) were followed for a median duration of 3.74 years. Adverse outcomes increased from class A to C in all-cause mortality (0.07 vs 0.3 vs 2.5/100 person-years [PY], hazard ratio [HR], 3.0 and 16.3 class B and C vs A), liver-associated clinical events (0.2 vs 1 vs 8/100 PY, HR, 4.3 and 36.6 B and C vs A), major adverse cardiovascular events (0.69 vs 0.87 vs 2.02/100 PY, HR, 0.78 and 1.55 B and C vs A), hepatocellular carcinoma (0 vs 0.09 vs 0.88/100 PY, HR, 8.32 C vs B), and chronic kidney disease (1.24 vs 2.48 vs 3.51/100 PY). Those who were upstaged had outcome rates similar to the lower class defined by their FIB-4.CONCLUSIONS: These data support a FIB-4-based risk-stratification of NAFLD that can be used in routine clinical practice.CLINICALTRIALS: gov Identifier: NCT02815891.
AB - BACKGROUND & AIMS: There is an unmet need to validate simple and easily available methods that can be used in routine practice to identify those at risk of adverse outcomes from nonalcoholic fatty liver disease (NAFLD). A retrospective-prospective analysis of NAFLD patients enrolled in a longitudinal noninterventional study (TARGET-NASH) was performed to validate the prognostic utility of the following risk-categories: (A) Fibrosis-4 (FIB-4) <1.3 and/or liver-stiffness measurement (LSM) measured by Fibroscan <8 kp, (B) FIB-4 1.31‒2.6 and/or LSM 8.1-12.5 kp, and (C) FIB-4 >2.6 and/or LSM >12.5 kp.METHODS: Those in class A with aspartate transaminase:alanine transaminase ratio >1 or platelets <150,000/mm
3, or class B with aspartate transaminase:alanine transaminase ratio >1 or platelets <150,000/mm
3 were upstaged by one class. Fine-Gray competing risk analyses were performed for all outcomes.
RESULTS: A total of 2523 individuals (class A = 555, B = 879, C = 1089) were followed for a median duration of 3.74 years. Adverse outcomes increased from class A to C in all-cause mortality (0.07 vs 0.3 vs 2.5/100 person-years [PY], hazard ratio [HR], 3.0 and 16.3 class B and C vs A), liver-associated clinical events (0.2 vs 1 vs 8/100 PY, HR, 4.3 and 36.6 B and C vs A), major adverse cardiovascular events (0.69 vs 0.87 vs 2.02/100 PY, HR, 0.78 and 1.55 B and C vs A), hepatocellular carcinoma (0 vs 0.09 vs 0.88/100 PY, HR, 8.32 C vs B), and chronic kidney disease (1.24 vs 2.48 vs 3.51/100 PY). Those who were upstaged had outcome rates similar to the lower class defined by their FIB-4.CONCLUSIONS: These data support a FIB-4-based risk-stratification of NAFLD that can be used in routine clinical practice.CLINICALTRIALS: gov Identifier: NCT02815891.
KW - Cirrhosis
KW - Epidemiology
KW - NAFLD
KW - Nonalcoholic Steatohepatitis
KW - Real World
KW - Aspartate Aminotransferases
KW - Prospective Studies
KW - Alanine Transaminase
KW - Humans
KW - Biopsy/adverse effects
KW - Liver/pathology
KW - Liver Neoplasms/pathology
KW - Liver Cirrhosis/pathology
KW - Fibrosis
KW - Retrospective Studies
KW - Non-alcoholic Fatty Liver Disease/complications
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U2 - 10.1016/j.cgh.2023.02.024
DO - 10.1016/j.cgh.2023.02.024
M3 - Article
C2 - 36871772
AN - SCOPUS:85160248839
SN - 1542-3565
VL - 21
SP - 2889-2900.e10
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 11
ER -