Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis: Interim Analysis Report of a Randomized Controlled Trial

BACKGROUND: Corticosteroids are used to induce remission in auto-immune hepatitis. They are not universally effective; therefore, alternative treatments are needed. In this study Cysclosporine-A has been compared with prednisolone as an alternative treatment in a randomized controlled trial. This paper is an interim analysis of an ongoing clinical trial. METHODS: Sixteen years and older consenting patients were enrolled. Group-A received prednisolone and group-B cyclosporine-A according to a preset protocol and followed at regular intervals for 48 weeks. Final assessment was done at week 48. Primary outcome was response rate as defined below. “Complete response” was defined as achieving AST and ALT in the normal range and absence of any clinical signs of deterioration, and partial response was defined as a decrease in AST and ALT by less than half of their original values but not to within normal limit. Non-responding ones at week eight were switched to the other arm. RESULTS: Thirty-nine patients were enrolled (24 group-A, 9 male). Mean AST and ALT at baseline were higher in group-B, but other variables were comparable. At week 12, 34.8% and 64.3% of group-A and B had achieved AST and ALT in the normal range (less than 40 IU/L) respectively ( p=0.081). Corresponding figures at week 48 were 50.0% and 47.6% ( p=0.62 & 0.48 respectively). At week 12, 86.9% and 85.7% of patients had AST and ALT levels less than twice upper normal limit in groups-A and B respectively ( p=0.54 & 0.42).Corresponding figures at week 48 were 90.0% for both groups. There was one treatment failure in group-B which did not respond to prednisolone either. Serious adverse events (death and liver transplantation) occurred in group-A only. Serum creatinine did not change during the study period in either group. CONCLUSION: According to our data, Cyclosporine-A is as effective as prednisolone for induction of remission in AIH. Adverse events and serious adverse events were more common with prednisolone.