Abstract

Introduction Mycophenolate mofetil (MMF) is an alternative steroid-sparing agent in patients with AIH who either respond inadequately to, or are intolerant of azathioprine (AZA). Short-term Results seem better in AZA intolerant than in AZA sub-responsive patients (Hennes 2008 Am. J Gastro. 103:3063, Sharzehi 2010 Can. J. Gastro. 24: 588). There are few data regarding histological response and longer-term outcome in patients switched to MMF. Methods Study of consecutively recruited patients with AIH (1999 International Group Criteria) managed 1987–2016. Patients also received prednisolone and were followed for >6 months from diagnosis. Results in AZA intolerant patients who switched to MMF within 6 months (23) were compared to those who continued AZA (196), including those who switched to alternative immunosuppression (including MMF) due to AZA unresponsiveness but not intolerance. Compared to those continuing AZA, patients switching to MMF due to AZA intolerance had a trend towards lower all cause death/transplant (p=0.11) and liver death/transplant (p=0.18) rates. Cox regression analysis (including age, cirrhosis and decompensation at presentation as covariates) showed similar outcomes in both groups. Seventeen of the 23 patients continued MMF to end of follow-up and 6 discontinued MMF (lack of efficacy 4, successfully restarting of AZA 1 and cause unknown 1). Conclusions Patients switching to MMF because of AZA intolerance do not differ from those continuing AZA in regard to: (a) normalisation of serum ALT (b) necro-inflammatory and fibrosis scores on follow-up biopsy and (c) 5- and 10 year mortality. This supports use of MMF as a steroid sparing agent in AZA intolerant patients.

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