Influence factors and a predictive scoring model for measuring the biochemical response of primary biliary cholangitis to ursodeoxycholic acid treatment

Eur J Gastroenterol Hepatol. 2018 Nov;30(11):1352-1360. doi: 10.1097/MEG.0000000000001186.

Abstract

Aims: The biochemical response after ursodeoxycholic acid (UDCA) treatment contributes toward predicting the prognosis for primary biliary cholangitis (PBC) patients. This study aimed to establish a score model that can be used for predicting the biochemical response.

Patients and methods: A total of 218 patients in the derivation group and 66 patients in the verification group were enrolled. Response endpoints were based on the Barcelona criteria combined with the Paris I criteria. We determined independent factors of the biochemical response by univariate and multivariate analyses. Then, we established a predictive score model on the basis of regression coefficients after adjusted multivariate analyses.

Results: The median follow-up duration in the derivation and the verification group was 12.9 and 12.2 months, respectively. Multivariate logistic regression analysis after adjusting for sex and age indicated that First-UDCA treatment [odds ratio (OR)=2.543, 95% confidence interval (CI): 1.234-5.240, P=0.011], baseline alanine aminotransferase level (OR=1.265, 95% CI: 1.089-1.471, P=0.002), and baseline total bilirubin level (OR=0.571, 95% CI: 0.420-0.776, P<0.001) were independent factors that influenced the biochemical response in PBC patients after 1 year of UDCA treatment. Therefore, the resulting biochemical response prediction score model represented the sum of the points corresponding to these three variables. The area under the receiver operating characteristic curve of the score model in the derivation group and the verification group was 0.763 (95% CI: 0.701-0.817, P<0.001) and 0.798 (95% CI: 0.681-0.887, P<0.001), respectively.

Conclusion: We developed and verified an easy-to-use scoring model for the first time, which showed excellent predictive value for the biochemical response in PBC patients.

Publication types

  • Observational Study
  • Validation Study

MeSH terms

  • Aged
  • Alanine Transaminase / blood
  • Bilirubin / blood
  • Biomarkers / blood
  • Cholagogues and Choleretics / adverse effects
  • Cholagogues and Choleretics / therapeutic use*
  • Clinical Decision-Making
  • Decision Support Techniques*
  • Female
  • Humans
  • Liver Cirrhosis, Biliary / blood
  • Liver Cirrhosis, Biliary / diagnosis
  • Liver Cirrhosis, Biliary / drug therapy*
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Reproducibility of Results
  • Retrospective Studies
  • Risk Factors
  • Treatment Outcome
  • Ursodeoxycholic Acid / adverse effects
  • Ursodeoxycholic Acid / therapeutic use*

Substances

  • Biomarkers
  • Cholagogues and Choleretics
  • Ursodeoxycholic Acid
  • Alanine Transaminase
  • Bilirubin