Original articlePancreas, biliary tract, and liverEfficacy and Safety of Mycophenolate Mofetil and Tacrolimus as Second-line Therapy for Patients With Autoimmune Hepatitis
Section snippets
Study Design
We collected data from patients with an established AIH diagnosis from 19 centers across Europe, the United States, Canada, and China. AIH was diagnosed based on a combination of autoimmune serology, serum γ globulin or IgG levels, and compatible liver biopsy findings.17 Overlaps of AIH with primary biliary cholangitis and primary sclerosing cholangitis were classified according to suggested international guidelines.18 All patients who were treated with second-line agents were identified.
Characteristics of the Patient Population
The medical records of 2260 patients with AIH were evaluated. Among 302 identified AIH patients treated with second-line agents, 171 received MMF, 114 received tacrolimus, 12 received cyclosporine, 2 received everolimus, and 1 patient each received cyclophosphamide, rituximab, or methotrexate. The final study group included 201 AIH patients, 121 received MMF and 80 received tacrolimus (Figure 1). The number of cases from each participating center is presented in Supplementary Table 1.
All
Discussion
For the significant number of AIH patients who do not tolerate or have a suboptimal response to SOC therapy, the future holds a risk for cirrhosis, liver failure, liver transplantation, or death.20, 21, 22 Additional treatment options beyond standard therapy with steroids and azathioprine therefore are needed. Over the years, several second-line options have been evaluated, but reports have been limited to small case series. This study represents a large cohort of patients exposed to
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Conflicts of interest The authors disclose no conflicts.