Prediction of poor response to ursodeoxycholic acid in patients with primary biliary cholangitis by non-invasive markers

Objective To screen non-invasive indicators for predicting poor response to ursodeoxycholic acid in patients with primary biliary cholangitis（PBC）and establish a logistic regression model. Methods A total of 106 patients with PBC were selected in the modeling group. Clinical data of PBC patients before and after receiving 1 year ursodeoxycholic acid therapy were retrospectively analyzed. According to ParisⅡcriteria， all patients were divided into two groups： poor response group （n = 38） and complete response group （n = 68）. The general condition， laboratory indicators and ultrasound examination results of the patients were analyzed by non-conditional logistic regression model before and after treatment. Non-invasive indicators for predicting poor response to ursodeoxycholic acid were screened， and the regression model was established. To validate this model， 47 patients with PBC who visited Ditan Hospital for the first time were selected in the validation group， and were treated with ursodeoxycholic acid for 1 year. Results Univariate analysis showed that in the modeling group， there were significant differences in cholinesterase， alkaline phosphatase， direct bilirubin， γ-glutamyltranspeptidase， globulin， total triglyceride， total cholesterol， low-density lipoprotein cholesterol， erythrocyte sedimentation rate， CD4+T cell count and CD8+T cell count between the poor response and complete response groups before treatment （all P < 0.05）. Multivariate unconditional logistic analysis showed that cholinesterase， alkaline phosphatase and direct bilirubin before treatment were effective predictors of poor response. The regression model was： Y = 0.000339× cholinesterase （U/L） +2.227292× （whether the ALP is lower than 2 times of normalupper limit； 1= yes， 2= no） +0.024151×DBIL （μmol/L）. The sensitivity and specificity of the model for predicting poor response were 88.6% and 84.8%， respectively. In this validation cohort， the area under the receiver operating characteristic curve was 0.81（95% CI 0.69-0.94）. Conclusion Cholinesterase， alkaline phosphatase and direct bilirubin before treatment can predict poor response to ursodeoxycholic acid in PBC patients.