Introduction Standard treatment of autoimmune hepatitis (AIH) consists of corticosteroids and azathioprine (AZA) and is effective in 80% of patients. There have been very few studies using tacrolimus as a novel second line treatment in patients with either steroid refractory or intolerant disease.
Methods The authors performed a retrospective analysis of all patients with severe AIH who were treated with tacrolimus. Steroid refractory disease was defined as persistent abnormal ALT (2×ULN) despite 3 months steroids with AZA or mycophenolate mofetil (MMF). Response to treatment was defined as: CR Complete response – sustained normalisation of ALT; PR – Partial response – improvement of ALT by >50%; NR – non-response – <50% improvement in ALT; RP – Relapse – Initial CR or PR followed by worsening of ALT.
Results Six patients (4 women, 2 men; mean age at diagnosis 30 years) had received treatment with Tacrolimus. The reasons for starting tacrolimus were as follows: steroid refractory (5 pts), intolerance of AZA (2 pts), non-responder to AZA (1 pt) and non-responder to MMF (1 pt). The mean dose of tacrolimus was 3.3 mg, mean duration of treatment was 15.5 months, and the mean duration of follow-up was 14.8 months. 3 patients had complete response CR and 3 patients had partial response PR following tacrolimus therapy. The median fall in ALT and Bilirubin is recorded on the following table 1.
None of the patients had any significant adverse effect with tacrolimus. Tremors were noted in one patient associated with a high tacrolimus level which improved on dose reduction.
Conclusion Tacrolimus is effective and well tolerated in patients with steroid refractory AIH. The use of low dose tacrolimus resulted in successful biochemical remission without significant adverse effect on renal function. This study adds to the limited data available currently on the use of tacrolimus in steroid refractory AIH.
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Competing interests None.
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