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Summary   Background  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.    Aim  To determine whether evaluation of biochemical criteria at 1 year is a reliable surrogate of  UDCA  response in early  PBC .    Methods  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.    Results  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 ≤3x ULN  ( OR : 4.80–35.90),  AST ≤2x ULN  ( 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.    Conclusions  In early  PBC , biochemical criteria at 1 year reflect severity of the disease rather than the therapeutic response to  UDCA .

alimentary pharmacology and therapeutics

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