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Enhanced liver fibrosis test predicts transplant‐free survival in primary sclerosing cholangitis, a multi‐centre study
Author(s) -
Vries Elisabeth M.G.,
Färkkilä Martti,
Milkiewicz Piotr,
Hov Johannes R.,
Eksteen Bertus,
Thorburn Douglas,
Chazouillères Olivier,
Pares Albert,
Nygård Ståle,
Gilja Odd H.,
Wunsch Ewa,
Invernizzi Pietro,
Carbone Marco,
Bernuzzi Francesca,
Boberg Kirsten M.,
Røsjø Helge,
Rosenberg William,
Beuers Ulrich H.,
Ponsioen Cyriel Y.,
Karlsen Tom H.,
Vesterhus Mette
Publication year - 2017
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13402
Subject(s) - primary sclerosing cholangitis , medicine , hazard ratio , interquartile range , liver transplantation , receiver operating characteristic , gastroenterology , clinical endpoint , proportional hazards model , retrospective cohort study , confidence interval , autoimmune hepatitis , population , transplantation , hepatitis , disease , clinical trial , environmental health
Background & Aims Biomarkers reflecting disease activity and prognosis in primary sclerosing cholangitis ( PSC ) have not been firmly established. Enhanced liver fibrosis ( ELF ) test was previously reported to predict outcome in PSC . We aimed to validate the prognostic utility of ELF test in an independent, multi‐centre, retrospective PSC study population. Methods We collected serum samples from PSC patients from seven countries. We estimated rates of transplant‐free survival by the Kaplan‐Meier method, used Cox proportional hazards regression to explore the association between ELF test and clinical outcome and determined prognostic performance of ELF test by computing the area under the receiver operating characteristic ( AUC ‐ ROC ) curve. Results The final analysis included 534 PSC patients (61% males). Features of autoimmune hepatitis or concomitant inflammatory bowel disease affected 44 (8%) and 379 (71%) patients respectively. ELF test levels were higher in patients reaching the combined endpoint liver transplantation or death (median 10.9 [Interquartile range ( IQR ): 9.8‐12.1]; n=24 deaths, 79 liver transplantations) compared to those censored (8.8 [ IQR : 8.0‐9.8]); P <.001. ELF test expressed as mild, moderate and severe fibrosis was significantly associated with the risk of reaching the endpoint ( P <.001). ELF test independently predicted clinical outcome (Hazard ratio 1.31; 95% confidence interval [1.05‐1.65]; P =.018), and enabled good discrimination between PSC patients with and without endpoint ( AUC ‐ ROC : 0.79). Conclusion Our retrospective data validates the predictive utility of ELF test for clinical outcomes in PSC . The clinical utility of biomarkers for fibrosis in patients with PSC should be assessed in prospective patient cohorts.