Mycophenolate mofetil may be effective for autoimmune hepatitis

Last Updated: 2016-04-01

By Reuters Staff

NEW YORK (Reuters Health) - Mycophenolate mofetil (MMF) may be effective as first-line treatment of autoimmune hepatitis (AIH), researchers from Greece report.

Treatment with corticosteroids with or without azathioprine is the standard of care for AIH, with 65% to 80% of patients showing improvements, they note in a report online March 16 in Alimentary Pharmacology and Therapeutics. But relapse is almost universal when azathioprine immunosuppression is discontinued in patients in long-term remission.

Dr. George N. Dalekos and colleagues from the University of Thessaly, School of Medicine, Larissa, explored the role of MMF, which induced remission in 88% of patients in their earlier study, in a real-world observational study of treatment-naïve patients receiving MMF as first-line treatment for AIH.

One hundred and nine AIH patients received prednisolone plus MMF, and 22 patients who did not consent to the MMF protocol received conventional immunosuppression. Patients were followed for three to 168 months.

The initial complete response rates were 93.6% in the MMF group and 72.7% in the conventional treatment group (p=0.01), with 81.3% and 68.7%, respectively, achieving this result within three months.

About a quarter of MMF patients (23.5%) and 37.5% of conventional-treatment patients who achieved complete remission relapsed during prednisolone tapering or withdrawal.

Forty MMF patients had MMF withdrawn after 24 to 132 months, and 30 of these remained in remission at the time of this report. The other 10 relapsed within five to 24 months of MMF discontinuation.

Longer duration of MMF therapy was the only independent predictor of maintenance of remission after stopping treatment.

MMF was well tolerated, with only two patients discontinuing treatment and five requiring permanent dose reductions because of adverse effects.

"Most importantly, the present large cohort study not only confirmed our previous findings concerning the high efficacy and safety of MMF use as first-line treatment for AIH23 but also showed for the first time the highest rates of maintenance of complete remission off treatment (75%) ever published, although the remission criteria were strict," the researchers conclude in their paper.

They add, "As relapse after drug withdrawal is almost universal with conventional therapy (73-100% in 2 years off treatment follow-up, with almost 50-90% of the relapses occurring typically in the first 12 months after stopping treatment), MMF seems a reasonable, safe and important first-line treatment of AIH which should seriously and urgently be considered in the future, although the risk of potential bias and overestimation of intervention benefits due to the presently relative small time of follow-up off treatment (median of 24 months, so far) cannot be excluded in this real-world study."

Dr. Dalekos did not respond to a request for comments. The authors declared no conflicts of interest.

SOURCE: bit.ly/1RtF4NE

Aliment Pharmacol Ther 2016.