Cyclosporine-A versus prednisolone for induction of remission in auto- immune hepatitis: Interim analysis report of a randomized controlled trial

Abstract

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.