Randomised controlled trial of azathioprine withdrawal in autoimmune chronic active hepatitis.

To assess the value of azathioprine in the maintenance therapy of autoimmune chronic active hepatitis a controlled trial of azathioprine withdrawal was carried out in 50 patients who had been maintained in remission on a combination of azathioprine and prednisolone. The patients were randomly allocated to remain on combination therapy (23) or to discontinue azathioprine (27). These 2 groups were comparable at the start of the study. Over a follow-up period of up to 3 years, biochemical and histological relapse occurred in 8 patients in the azathioprine-withdrawal group but in only 1 patient in the combination-therapy group. Cumulative probability of relapse was 32% among the patients in the withdrawal group, compared with 6.0% for those in the combination group.