Mycophenolate mofetil appears safe and effective for the treatment of autoimmune hepatitis (AIH), according to the results of a study published in Alimentary Pharmacology & Therapeutics

Dr. George Dalekos, University of Thessaly, Greece, and colleagues conducted a real-world prospective study to investigate the long-term outcomes in a large population of consecutive treatment-naive AIH patients. A total of 158 patients were recruited between 2000–2014 with only 131 eligible for treatment. Researchers studied the long-term data on outcome following drug withdrawal. Patients discontinued treatment after achieving complete response (normal transaminases and IgG) for at least the past 2 years.

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Nearly 94% of patients (n=102/109) responded initially to mycophenolate mofetil within 2 months. Complete response was seen in 78 of 109 patients (71.6%) and 78.2% maintained remission off prednisolone. Patients treated with mycophenolate mofetil had higher probability of achieving complete response vs. patients receiving azathioprine (P=0.03). Having lower ALT at 6 months and acute presentation were independent predictors of complete response. 

Currently, 75% of patients are still in remission after 24 months. Remission maintenance was tied to longer treatment with mycophenolate mofetil (P=0.005), higher baseline ALT (P<0.02), lower IgG on 6 months (P=0.004) and histological improvement.

Overall, mycophenolate mofetil demonstrated efficacy as first-line therapy for AIH, having the highest rates of remission maintenance off treatment that has ever been published. Study authors noted that the risk of potential bias and overestimation of intervention benefits from mycophenolate mofetil “cannot be completely excluded as this is a real world and not a randomized controlled trial.” 

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