Efficacy of ursodeoxycholic acid combined with prednisolone and immunosuppressant triple therapy in the treatment of refractory primary biliary cholangitis

Abstract Background and Aim To explore the efficacy treatment regimen in refractory PBC. Methods Triple treatment including ursodeoxycholic acid, prednisolone and immunosuppressant was prescribed to 47 refractory patients. Biochemistries, immune parameters, non-invasive liver fibrosis assessments were measured during follow-up. Results Triple therapy resulted in significant decrease in ALP, GGT, ALT, AST, TBIL, ALB, IgG, IgM, APRI, FIB-4 and S-INDEX. The biochemical cumulative normalization rates of ALP and other biochemical parameters were higher in long-term follow-up. Poor outcome was observed in patients with lower ALB, higher TBIL, PT, sp100 positivity and advanced liver pathology at baseline. Osteoporosis and bone fracture were observed in 15% patients. Conclusions Triple therapy is associated with marked decrease and normalization of ALP and other parameters. ALB, TBIL, PT, sp100 and pathology were related with poor outcome. Osteoporosis should be closely monitored.