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.
Professor Burroughs and colleagues from the United Kingdom determined whether evaluation of biochemical criteria at 1 year is a reliable surrogate of UDCA response in early PBC.
The researchers analyzed the prospectively collected data of 215 patients with early PBC, and a median follow-up of 8 years.
|Paris-I criteria were predictive of long-term outcomes in untreated patients|
|Alimentary Pharmacology & Therapeutics|
The 1-year attainment rates of the Barcelona, Paris-I, Paris-II and Toronto definitions, and their predictive relevance for a poor outcome were assessed either as a result of UDCA or no treatment.
Independent associations with attaining each UDCA response definition were identified by multivariate analysis.
The team found that untreated patients displayed 1-year biochemical features compatible with ‘treatment response’ at rates similar to those obtained under UDCA.
Depending on the definition, baseline ALP≤3xULN, AST≤2xULN, and early histological stage were the stronger predictors for attaining the criteria.
UDCA treatment was associated with attaining Barcelona, and Paris-II, but not Paris-I, and not Toronto definition when excluding late histological cases.
The team observed that the Paris-I criteria were significantly predictive of long-term outcomes in untreated patients.
Professor Burroughs' team concludes, "In early PBC, biochemical criteria at 1 year reflect severity of the disease rather than the therapeutic response to UDCA."