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 alternativetreatment in a randomized controlled trial. This paper is an interimanalysis of an ongoing clinical trial.


METHODS
Sixteen years and older consenting patients were enrolled. Group-A receivedprednisolone and group-B cyclosporine-A according to a preset protocoland followed at regular intervals for 48 weeks. Final assessment was doneat week 48. Primary outcome was response rate as defined below. "Completeresponse" was defined as achieving AST and ALT in the normal range andabsence of any clinical signs of deterioration, and partial response was definedas a decrease in AST and ALT by less than half of their original values but notto within normal limit. Non-responding ones at week eight were switched tothe other arm.


RESULTS
Thirty-nine patients were enrolled (24 group-A, 9 male). Mean AST andALT 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 ALTin the normal range (less than 40 IU/L) respectively (p=0.081). Correspondingfigures 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 thantwice 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 onetreatment failure in group-B which did not respond to prednisolone either.Serious adverse events (death and liver transplantation) occurred in group-Aonly. Serum creatinine did not change during the study period in either group.


CONCLUSIONS
According to our data, Cyclosporine-A is as effective as prednisolone forinduction of remission in AIH. Adverse events and serious adverse events weremore common with prednisolone.
Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Siavosh
S
Nasseri-Moghaddam
Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Sepideh
S
Nikfam
Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Saied
S
Karimian
Endocrinology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Patricia
P
Khashayar
Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Reza
R
Malekzadeh
Adverse effect; Auto-immune hepatitis; Cyclosporine-A; Prednisolone; Randomized controlled trial; Remission