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Abstract Details
Definite and indeterminate NASH share similar clinical features and prognosis: a longitudinal study of 1893 biopsy-proven NAFLD subjects
Javier Ampuero123, Rocío Aller4, Rocío Gallego-Durán23, Javier Crespo5, Javier Abad6, Águeda González-Rodríguez7, Judith Gómez-Camarero8, Joan Caballería39, Oreste Lo Iacono10, Luis Ibañez311, Javier García-Samaniego312, Rosa Martín-Mateos313, Rubén Francés314, Conrado Fernández-Rodríguez15, Moisés Diago16, Germán Soriano317, Raúl J Andrade318, Raquel Latorre19, Francisco Jorquera320, Rosa María Morillas321, Desamparados Escudero22, Pamela Estévez23, Manuel Hernández Guerra24, Salvador Augustín25, María Jesús Pareja-Megia26, Jesús M Banales327, Patricia Aspichueta28, Salvador Benlloch329, José Miguel Rosales30, Javier Salmerón31, Juan Turnes32, Manuel Romero Gómez123, HEPAmet Registry
Author information
1Hospital Universitario Virgen del Rocío, Universidad de Sevilla.
2SeLiver group, Instituto de Biomedicina de Sevilla.
3CIBERehd, Spain.
4Hospital Clínico Universitario de Valladolid. Centro de Investigación de Endocrinología y Nutrición. Universidad de Valladolid, Spain.
5Hospital Universitario Marqués de Valdecilla, Santander, Spain.
6Hospital Universitario Puerta de Hierro, Madrid, Spain.
7Liver Research Unit, Hospital Universitario Santa Cristina Instituto de Investigación Sanitaria Princesa Madrid, Spain.
8Hospital Universitario de Burgos, Spain.
9Liver Unit. Hospital Clínic. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBPAS), Barcelona, Spain.
10Hospital Universitario Tajo, Aranjuez, Spain.
11Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
12Hospital Universitario La Paz. IdiPAZ, Madrid, Spain.
13Hospital Universitario Ramón y Cajal, Madrid, Spain.
14Hospital General Universitario de Alicante. Universidad Miguel Hernández, Spain.
15Hospital Universitario Fundación de Alcorcón, Universidad Rey Juan Carlos, Spain.
16Hospital General Universitario de Valencia, Spain.
17Hospital de la Santa Creu i San Pau, Barcelona, Spain.
18Unidad de Gestión Clínica de Enfermedades Digestivas, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain.
19Hospital Universitari Son Llátzer, Mallorca, Spain.
20Servicio de Aparato Digestivo, Complejo Asistencial Universitario de León, IBIOMED, León, España.
21Hospital Germans Trias i Pujol, Badalona, Spain.
22Hospital Clínico Universitario de Valencia, Universitat de València, Spain.
23Complejo Hospitalario Universitario de Vigo, Spain.
24Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
25Hospital Vall d'Hebrón, Barcelona, Spain.
26Pathology Department, Hospital Universitario Virgen de Valme, Sevilla, Spain.
27Department of Liver and Gastrointestinal Diseases, Biodonostia Research Institute - Donostia University Hospital, University of the Basque Country (UPV/EHU), Ikerbasque, San Sebastian, Spain.
28Biocruces Research Institute, Barakaldo. Department of Physiology, Faculty of Medicine and Nursing, University of Basque Country UPV/EHU, Leioa, Spain.
29Hospital Universitari i Politecnic La Fe, Valencia, Spain.
30Agencia Sanitaria Costa del Sol, Marbella, Spain.
31Hospital Universitario San Cecilio, Granada, Spain.
32Complejo Hospitalario de Pontevedra, Spain.
Abstract
Background&aim: Histological score systems may not fully capture the essential NASH features, which is one of the leading causes of screening failure in clinical trials. We assessed the NASH distribution and its components across the fibrosis stages and their impact on the prognosis, and their relationship with the concept of MAFLD.
Methods: Spanish multicenter study including 1893 biopsy-proven NAFLD patients from HEPAmet registry. NASH was diagnosed by NAS score ≥4 (including steatosis, ballooning, and lobular inflammation), and fibrosis by Kleiner score. The presence of metabolic-associated fatty liver disease (MAFLD) was determined. Progression to cirrhosis, first episode of decompensated cirrhosis, and death were collected during the follow-up (4.7±3.8 years).
Results: Fibrosis was: F0 34.3% (649/1893), F1 27% (511/1893), F2 16.5% (312/1893), F3 15% (284/1893), and F4 7.2% (137/1893). NASH diagnosis 51.9% (982/1893), and its individual components (severe steatosis, ballooning and lobular inflammation), increased from F0 (33.6%) to F2 (68.6%), and decreased significantly in F4 patients (51.8%) (p=0.0001). More than 70% of non-NASH patients showed some inflammatory activity (ballooning or lobular inflammation), showing a similar MAFLD rate than NASH (96.2% (945/982) vs. 95.2% (535/562)) and significantly higher than NAFL subjects (89.1% (311/349)) (p<0.0001). Progression to cirrhosis was similar between NASH (9.5% (51/539)) and indeterminate NASH (7.9% (25/316)), and higher than steatosis (5% (14/263)) (logRank 8.417; p=0.015). Death and decompensated cirrhosis were similar between these.
Conclusions: The prevalence of steatohepatitis decreased in advanced liver disease. However, most of these patients showed some inflammatory activity histologically and had metabolic disturbances. These findings should be considered in clinical trials whose main aim is to prevent cirrhosis progression and complications, liver transplant, and death.