Biochemical criteria at 1 year are not robust indicators of response to ursodeoxycholic acid in early primary biliary cirrhosis: results from a 29-year cohort study

V Papastergiou, E Tsochatzis, M Rodriguez-Peralvarez, E Thalassinos, G Pieri, P Manousou, G Germani, C Rigamonti, V Arvaniti, S Karatapanis, A Burroughs (2013) Biochemical criteria at 1 year are not robust indicators of response to ursodeoxycholic acid in early primary biliary cirrhosis: results from a 29-year cohort study Aliment Pharmacol Ther (IF: 6.8) 38(11-12) 1354-64

Abstract

In primary biliary cirrhosis (PBC), biochemical criteria at 1 year are considered surrogates of response to ursodeoxycholic acid (UDCA). However, due to the slow natural history of PBC, evaluation at 1 year may be suboptimal to assess the therapeutic response, particularly in early disease.To determine whether evaluation of biochemical criteria at 1 year is a reliable surrogate of UDCA response in early PBC.We analysed the prospectively collected data of 215 patients (untreated = 129; UDCA-treated = 86) with early PBC (normal baseline bilirubin/albumin) and a median follow-up of 8 years (range: 1-29.1). The 1-year attainment rates of the Barcelona, Paris-I, Paris-II and Toronto definitions, and their predictive relevance for a poor outcome (death, transplantation, complications of cirrhosis), were assessed either as a result of UDCA or no treatment. Independent associations with attaining each UDCA response definition were identified by multivariate analysis.Untreated patients displayed 1-year biochemical features compatible with 'treatment response' at rates (Barcelona: 36.4%, Paris-I: 66.7%, Toronto: 59.7%, Paris-II: 40.3%) similar to those obtained under UDCA. Depending on the definition, baseline ALP≤3xULN (OR: 4.80-35.90), AST≤2xULN (OR: 5.63-9.34) and early histological stage (OR: 3.67-3.87) were the stronger predictors for attaining the criteria. UDCA treatment was associated with attaining Barcelona (OR = 2.16) and Paris-II (OR = 2.84), but not Paris-I, and not Toronto definition when excluding late histological cases. Paris-I criteria were significantly predictive of long-term outcomes (HR = 2.83) in untreated patients.In early PBC, biochemical criteria at 1 year reflect severity of the disease rather than the therapeutic response to UDCA.© 2013 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Links

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4028985
http://www.ncbi.nlm.nih.gov/pubmed/24117847
http://dx.doi.org/10.1111/apt.12522

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