Comparison of prednisolone alone and in combination with azathioprine regimens in treatment of autoimmune hepatitis: a Prospective study

ABSTRACT

Side effects of steroid therapy of autoimmune hepatitis are seen more frequently with prednisolone only regimen. However, the question of efficacy restrains the broad use of prednisolone in combination with azathioprine. To compare biochemical responses to the two standard immunosuppressive drug regimens [prednisolone alone and prednisolone in combination with azathioprine] in children with autoimmune hepatitis. The study was performed on 42 children with autoimmune hepatitis. Patients were attributed to two groups, with group A receiving prednisolone alone and group B receiving prednisolone in combination with azathioprine, using simple random attribution unless there was a contraindication to azathioprine. The patients were evaluated for treatment response on three occasions short term [one month after starting therapy], intermediate term [four to six month after starting therapy], and long term [one year after starting therapy]. Chemical response was defined as decrease in aminotransferases to a level below two times the normal values and gamma globulin to lower than 2.8 g/dL. Clinical response was defined as improvement in the initial clinical signs and symptoms [jaundice, hepatomegaly, splenomegaly, fever, and edema/ascites]. There were no differences in chemical and clinical response rates between the two groups. Both clinical and chemical response rates in intermediate term were significantly higher than short term. However, clinical and chemical response rates in long term did not significantly differ from intermediate term. The study shows that some patients need time to respond to therapy. Nonetheless, it seems that whenever there is no improvement after six months of therapy, it is prudent to change the treatment regimen rather than waiting for response. With the same efficacy and less side effects, the combination regimen must be preferred as the standard regimen, unless there is a contraindication to azathioprine