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Mycophenolate for the treatment of autoimmune hepatitis: Prospective assessment of its efficacy and safety for induction and maintenance of remission in a large cohort of treatment-naïve patients

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Author
Zachou, K.; Gatselis, N.; Papadamou, G.; Rigopoulou, E. I.; Dalekos, G. N.
Date
2011
DOI
10.1016/j.jhep.2010.12.032
Keyword
Autoimmune hepatitis
Cirrhosis
Liver autoimmunity
Mycophenolate mofetil
aminotransferase
corticosteroid
immunoglobulin
mycophenolic acid
prednisolone
steroid
adult
aged
article
biochemistry
cohort analysis
drug dose increase
drug dose reduction
drug efficacy
drug safety
drug tolerability
drug withdrawal
female
gastrointestinal symptom
hematologic disease
human
human tissue
major clinical study
male
patient compliance
prediction
priority journal
prospective study
relapse
remission
septicemia
treatment duration
treatment outcome
Anti-Inflammatory Agents
Drug Therapy, Combination
gamma-Glutamyltransferase
Hepatitis, Autoimmune
Humans
Immunosuppressive Agents
Middle Aged
Prospective Studies
Recurrence
Remission Induction
Time Factors
Metadata display
Abstract
Background & Aims: Standard therapy for autoimmune hepatitis (AIH) is corticosteroids with or without azathioprine. However, 20% of patients do not respond or are intolerant to conventional treatment. Therefore, we evaluated prospectively the efficacy and safety of mycophenolate mofetil (MMF) in inducing and/or maintaining remission in treatment-naïve AIH patients. Methods: Fifty-nine treatment-naïve patients with well defined AIH were treated with prednisolone plus 1.5-2 g/d of MMF. Patients were candidates for MMF withdrawal after at least 4 years. Treatment outcomes were defined according to the International Autoimmune Hepatitis Group report. Results: Treatment duration with MMF was 26 months (range 3-92). Eighty-eight percent (52/59) of patients responded initially clinically and biochemically (normalization of transaminases and γ-globulins) most of them within 3 months. The remaining 7 patients (12%) had partial response. In total, 59.3% (35/59) of patients had complete response (CR) with 37% (22/59) of them having achieved CR off prednisolone, while 28.8% (17/59) had initial CR with relapses. No patient was non-responder. Prednisolone withdrew in 57.6% (34/59) of patients in 8 months. The only independent predictor of treatment outcome, was γ-GT (baseline γ-GT, p = 0.008 and γ-GT on month 24, p <0.05). Severe side effects leading to MMF discontinuation occurred in only 3.4% (2/59) of patients. Six patients (2 according to protocol and 4 for personal reasons), stopped treatment with MMF, but 3 relapsed. Conclusions: MMF seems safe and effective as first-line therapy in inducing and maintaining remission in treatment-naive patients with AIH, having a significant and rapid steroid sparing effect as attested by the fact that so far, 37% (22/59) of AIH patients achieved CR off prednisolone. © 2011 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
URI
http://hdl.handle.net/11615/34779
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