Systematic Review and Meta-analysis: Immunosuppressive Agents for the Treatment of Primary Biliary Cholangitis

Background and aim: There are still no clinically satisfactory therapy for PBC. This study was performed to assess the safety and efficacy of IAs for the therapy of PBC. Methods: Relevant studies were identified and selected by searching PubMed, Web of Science and Cochrane Library databases. The primary outcome was defined as the need for mortality or liver transplantation. Adverse effects and liver biochemical variables were a secondary outcome. Results: Nine randomized controlled trials, involving six different treatment regimens with a total of 996 patients, were included in the analysis. On meta-analysis, IAs was not associated with a reduction in risk of mortality or liver transplantation (risk ratio [RR]: 0.92, 95% confidence interval [CI]: 0.69-1.22, P = 0.57, I2 = 0%), and have resulted in more adverse effects (RR: 1.44, 95% CI: 1.08-1.92, P = 0.01, I2 = 19%). Subgroup analysis showed that IAs monotherapy caused adverse effects such as diarrhea, abdominal pain, and renal insufficiency (RR: 1.36, 95% CI: 1.01-1.82, P = 0.04, I2 = 48%). IAs therapy did not prominently improve markers of liver function except for alkaline phosphatases (weighted mean difference [WMD]: -0.38, 95% CI: -0.62 to -0.14, P = 0.002). Conclusions: IAs cannot reduce the risk of mortality or liver transplantation, whether in IAs monotherapy or combination therapy, and even be associated with more adverse effects.