Mycophenolate mofetil induces remission in nearly 60% with autoimmune hepatitis
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Mycophenolate mofetil was superior to azathioprine in achieving biochemical remission in treatment-naive patients with autoimmune hepatitis who were also treated with prednisolone, according to data presented at EASL Congress.
“First line treatment [of autoimmune hepatitis] consists of the combination of azathioprine with prednisolone, and these recommendations are based on clinical trials executed in the ’60s and ’70s,” Romée JALM Snijders, MD, a PhD candidate in the department of gastroenterology and hepatology at Radboud University Medical Center in the Netherlands, said. “Mycophenolate mofetil (MMF) has emerged as an alternative option to azathioprine. ... MMF has shown particularly favorable outcomes in patients intolerant to azathioprine and prospective studies have shown good results and promising results regarding the efficacy and safety of MMF.”
Snijders continued: “However, there’s no data comparing MMF with azathioprine in patients with autoimmune hepatitis in a randomized clinical trial.”
The CAMARO trial is a randomized, open-label study assessing the safety and efficacy of MMF with prednisolone as induction therapy in 70 patients with treatment-naive autoimmune hepatitis. Participants were recruited from 14 Dutch and Belgian hospitals from March 2017 to November 2022.
All patients received prednisolone (40 mg or 60 mg) at study initiation, which was tapered to 5 mg per day. After 4 weeks, patients received either MMF with tapered prednisolone dosing (n = 39; mean age, 60 years; 77% women) or azathioprine with tapered prednisolone dosing (n = 31; mean age, 56 years; 68% women). At diagnosis, approximately 25% of patients had cirrhosis.
The primary outcome was the percentage of patients who achieved biochemical remission at week 24, which was defined as normalization of alanine transaminase and IgG.
Results showed 56.4% of patients in the MMF group and 29% of patients in the azathioprine group achieved biochemical remission independent of prednisolone dose (difference = 27.4; 95% CI, 4-46.7).
No patients experienced treatment-related serious adverse events in the MMF group compared with three patients in the azathioprine group. The majority of adverse events were mild to moderate and included nausea, alopecia, fatigue and infection. The incidence of nausea was higher in the azathioprine group.
Two patients in the MMF group discontinued treatment because of severe adverse events vs. eight in the azathioprine group (P = .018).
“At week 24, the proportion of patients achieving biochemical remission was significantly higher in patients assigned to MMF compared with patients assigned to azathioprine,” Snijders concluded. “In addition, cessation of treatment due to serious adverse events occurred more often with azathioprine than with MMF.”
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Snijders R, et al. Abstract LBO-06: A controlled randomized trial of azathioprine vs. mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis (CAMARO trial). Presented at: EASL Congress; June 21-24, 2023; Vienna (hybrid meeting).
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