Mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis

Review by Prof. Ahad Eshraghian (Iran)

Study Summary 

The current standard regimen for induction of remission in patients with autoimmune hepatitis (AIH) is a combination of prednisolone and azathioprine. Recently, a multi-center, open-label, randomized trial, compared the efficacy of either mycophenolate mofetil (MMF) or azathioprine in combination with prednisolone in the induction of remission in 70 patients with treatment-naive autoimmune hepatitis. The primary endpoint was biochemical remission defined as normalization of serum levels of alanine aminotransferase and IgG after 24 weeks of treatment. Secondary endpoints were safety and tolerability of the drug. Biochemical remission was occurred in 56. % of patients who received MMF versus 29% in patients who received azathioprine (difference, 27.4 percentage points; 95% CI 4.0 to 46.7; p = 0.022). More serious adverse events (p = 0.034) and drug cessations (p = 0.018) occurred in the azathioprine group compared to the MMF group.

Commentary 

In this study, MMF was superior to azathioprine for induction of remission in treatment-naive autoimmune hepatitis. Patients who were treated with MMF had more favorable outcomes in terms of biochemical remission and fewer adverse events. MMF might be considered as standard treatment in patients with treatment-naive autoimmune hepatitis.

Citation

Snijders RJALM, et al; Dutch Autoimmune Hepatitis Working Group. An open-label randomised-controlled trial of azathioprine vs. mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis. J Hepatol. 2024 Apr;80(4):576-585

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