Introduction Prednisolone (PRED) in combination with azathioprine (AZA) is commonly used to induce remission in autoimmune hepatitis (AIH). Up to 20% of patients are intolerant of AZA and mycophenolate mofetil (MMF) is often used as an alternative. However there are few data on its ability to induce histological remission and prevent relapse. Therefore, we aimed to evaluate the efficacy of MMF, compared to AZA, in inducing and maintaining remission.
Methods 58 patients with AIH presenting since 2003 were retrospectively studied. All initially received PRED+AZA. Those who developed intolerance to AZA (n=13, after 1–6 weeks) were switched to MMF (1 (1–2) g/day). Follow-up liver biopsy, obtained after median 25 (12–41) months was assessed in 11 of these patients (MMF group) and 44 patients in whom AZA was continued (AZA group).
Results The two groups were similar with regards to (a) serum ALT at 0, 3, 6, 12, 24 and 36 months, and (b) Ishak necroinflammatory grade at baseline (11 vs 10 in AZA and MMF group respectively, p=0.6) and follow-up (4 vs 3, p=0.9) biopsy. 48% of the AZA group and 64% of the MMF group achieved histological remission (p=0.3). Fibrosis regressed in both groups but regression was greater in the MMF group (Ishak stage 3.2 to 1.7, p=0.002) compared to the AZA group (3.3 to 2.8, p=0.02). When attempted, PRED was successfully withdrawn in 7/10 patients in the MMF group, and in 32/37 patients in the AZA group (p=0.3). After PRED withdrawal, 4/7 patients in the MMF group and 11/32 patients in the AZA group relapsed (p=0.4). Up to the end of follow-up (71 months for AZA vs 65 months for MMF, p=0.6) PRED requirement (median 0 vs 2.5 mg, p=0.8) and relapse rate (median 0 vs 0, p=0.5) were similar in the two groups.
Conclusion MMF is as effective as AZA, at inducing and maintaining biochemical and histological remission in AIH. It may lead to more regression of fibrosis but this requires further evaluation.
Competing interests None declared.