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Mózes, FE; Lee, JA; Vali, Y; Alzoubi, O; Staufer, K; Trauner, M; Paternostro, R; Stauber, RE; Holleboom, AG; van, Dijk, AM; Mak, AL; Boursier, J; de, Saint, Loup, M; Shima, T; Bugianesi, E; Gaia, S; Armandi, A; Shalimar; Lupșor-Platon, M; Wong, VW; Li, G; Wong, GL; Cobbold, J; Karlas, T; Wiegand, J; Sebastiani, G; Tsochatzis, E; Liguori, A; Yoneda, M; Nakajima, A; Hagström, H; Akbari, C; Hirooka, M; Chan, WK; Mahadeva, S; Rajaram, R; Zheng, MH; George, J; Eslam, M; Petta, S; Pennisi, G; Viganò, M; Ridolfo, S; Aithal, GP; Palaniyappan, N; Lee, DH; Ekstedt, M; Nasr, P; Cassinotto, C; de, Lédinghen, V; Berzigotti, A; Mendoza, YP; Noureddin, M; Truong, E; Fournier-Poizat, C; Geier, A; Martic, M; Tuthill, T; Anstee, QM; Harrison, SA; Bossuyt, PM; Pavlides, M, , LITMUS, investigators.
Performance of non-invasive tests and histology for the prediction of clinical outcomes in patients with non-alcoholic fatty liver disease: an individual participant data meta-analysis.
Lancet Gastroenterol Hepatol. 2023; 8(8):704-713 Doi: 10.1016/S2468-1253(23)00141-3
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Co-authors Med Uni Graz: Stauber Rudolf; Trauner Michael
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Abstract:: BACKGROUND: Histologically assessed liver fibrosis stage has prognostic significance in patients with non-alcoholic fatty liver disease (NAFLD) and is accepted as a surrogate endpoint in clinical trials for non-cirrhotic NAFLD. Our aim was to compare the prognostic performance of non-invasive tests with liver histology in patients with NAFLD. METHODS: This was an individual participant data meta-analysis of the prognostic performance of histologically assessed fibrosis stage (F0-4), liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE), fibrosis-4 index (FIB-4), and NAFLD fibrosis score (NFS) in patients with NAFLD. The literature was searched for a previously published systematic review on the diagnostic accuracy of imaging and simple non-invasive tests and updated to Jan 12, 2022 for this study. Studies were identified through PubMed/MEDLINE, EMBASE, and CENTRAL, and authors were contacted for individual participant data, including outcome data, with a minimum of 12 months of follow-up. The primary outcome was a composite endpoint of all-cause mortality, hepatocellular carcinoma, liver transplantation, or cirrhosis complications (ie, ascites, variceal bleeding, hepatic encephalopathy, or progression to a MELD score ≥15). We calculated aggregated survival curves for trichotomised groups and compared them using stratified log-rank tests (histology: F0-2 vs F3 vs F4; LSM: <10 vs 10 to <20 vs ≥20 kPa; FIB-4: <1·3 vs 1·3 to ≤2·67 vs >2·67; NFS: <-1·455 vs -1·455 to ≤0·676 vs >0·676), calculated areas under the time-dependent receiver operating characteristic curves (tAUC), and performed Cox proportional-hazards regression to adjust for confounding. This study was registered with PROSPERO, CRD42022312226. FINDINGS: Of 65 eligible studies, we included data on 2518 patients with biopsy-proven NAFLD from 25 studies (1126 [44·7%] were female, median age was 54 years [IQR 44-63), and 1161 [46·1%] had type 2 diabetes). After a median follow-up of 57 months [IQR 33-91], the composite endpoint was observed in 145 (5·8%) patients. Stratified log-rank tests showed significant differences between the trichotomised patient groups (p<0·0001 for all comparisons). The tAUC at 5 years were 0·72 (95% CI 0·62-0·81) for histology, 0·76 (0·70-0·83) for LSM-VCTE, 0·74 (0·64-0·82) for FIB-4, and 0·70 (0·63-0·80) for NFS. All index tests were significant predictors of the primary outcome after adjustment for confounders in the Cox regression. INTERPRETATION: Simple non-invasive tests performed as well as histologically assessed fibrosis in predicting clinical outcomes in patients with NAFLD and could be considered as alternatives to liver biopsy in some cases. FUNDING: Innovative Medicines Initiative 2.
Find related publications in this database (using NLM MeSH Indexing): Humans - administration & dosage; Female - administration & dosage; Middle Aged - administration & dosage; Male - administration & dosage; Non-alcoholic Fatty Liver Disease - complications, diagnosis, pathology; Diabetes Mellitus, Type 2 - complications; Esophageal and Gastric Varices - administration & dosage; Gastrointestinal Hemorrhage - complications; Liver Cirrhosis - etiology; Fibrosis - administration & dosage