Mycophenolate mofetil prompts remission better than azathioprine in autoimmune hepatitis

Among patients with treatment-naïve autoimmune hepatitis, more of those who receive mycophenolate mofetil achieve remission than those who receive azathioprine, as shown in the results of the CAMARO trial.

The primary endpoint of biochemical remission at 24 weeks, defined as serum levels of alanine aminotransferase and immunoglobulin G below the upper limit of normal, was met in 56.4 percent of patients assigned to mycophenolate mofetil and in 29.0 percent assigned to azathioprine (difference, 27.4 percentage points, 95 percent confidence interval [CI], 4.0–46.7; p=0.022). [EASL 2023, abstract LBO-06]

According to lead study author Dr Romée Snijders of the Radboud University Medical Center in Nijmegen, the Netherlands, the clinical benefit of mycophenolate mofetil was observed regardless of the concomitant predniso(lo)ne dose.

In terms of safety, none of the patients experienced treatment-related serious adverse events in the mycophenolate mofetil arm as opposed to three patients in the azathioprine arm (0 percent vs 9.7 percent; p=0.082). Most adverse events recorded were mild to moderate in severity, consisting of symptoms such as nausea, alopecia, fatigue, and infection.

“Cessation of treatment due to severe adverse events occurred more often with azathioprine than with mycophenolate mofetil (25.8 percent vs 5.1 percent; p=0.018),” Snijders noted.

Finally, no significant difference in the mean cumulative predniso(lo)ne dose was seen between the mycophenolate mofetil arm and the azathioprine arm (1,944 vs 1,834 mg, respectively; p=0.369).

“In patients with autoimmune hepatitis, the classical predniso(lo)ne/azathioprine regimen to induce complete remission is recommended in all present guidelines. Discontinuation of azathioprine [treatment] is, however, necessary in approximately 15 percent of patients due to side effects,” Snijders said.

“In uncontrolled studies, mycophenolate mofetil has demonstrated a potent effect in achieving complete remission in the majority of patients with autoimmune hepatitis and seems to have less adverse events,” she added.

Indeed, the overall data from CAMARO showed that mycophenolate mofetil was superior to azathioprine for induction of remission in treatment-naïve patients with autoimmune hepatitis.

CAMARO was a 24-week, open-label, multicentre superiority trial that involved 70 patients (mean age 57.9 years, 72.9 percent women) with autoimmune hepatitis.

All patients were started on predniso(lo)ne at 40 or 60 mg daily (depending on weight), which was subsequently tapered to a minimum of 5 mg daily according to a dosing scheme. After 4 weeks, the patients were randomly assigned to treatment with either mycophenolate mofetil (maximum daily dose 2,000 mg; n=39) or azathioprine (maximum daily dose 100 mg; n=31).

The final results of CAMARO were presented at EASL 2023.