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Mycophenolate mofetil effective as first-line treatment for autoimmune hepatitis

In a real-world retrospective study, researchers found mycophenolate mofetil treatment to be safe and effective for the treatment of autoimmune hepatitis in treatment-naive patients, according to published findings.

“As relapse after drug withdrawal in [autoimmune hepatitis] patients is almost universal with conventional therapy, mycophenolate mofetil seems a reasonable, safe, and important alternative first-line treatment of [autoimmune hepatitis] that should seriously and urgently be considered in the future,” George N. Dalekos, MD, PhD, head of the department of medicine and research laboratory of internal medicine, University of Thessaly, Greece, said in a press release.

To study long-term outcomes of mycophenolate mofetil post-treatment, Dalekos and colleagues evaluated 131 treatment-naive patients with autoimmune hepatitis treated with either 500 mg of mycophenolate mofetil with or without prednisolone (n = 109) or azathioprine with or without prednisolone (n = 22). All patients were followed for 72 months.

Overall, 93.6% (n = 102) of patients responded to mycophenolate mofetil within 2 months. Approximately 72% (n = 78) of patients experienced a complete response on treatment and 78.2% (n = 61) maintained remission off prednisolone.

All patients treated with mycophenolate mofetil had increased probability of complete response compared with those receiving azathioprine alone (P = .03).

Lower alanine aminotransferase (ALT) serum at 6 months (P = .001) and acute presentation (P = .03) were found to be independent predictors of on-treatment complete response, according to multinomial logistic regression analysis. Remission maintenance was associated with longer mycophenolate mofetil treatment (P = .005), higher baseline ALT (P < .02), lower immunoglobulin G serum at 6 months (P = .004) and histological improvement.

Mycophenolate mofetil was generally well tolerated. Two patients discontinued mycophenolate mofetil and permanent reduction occurred in five patients.

“The present large cohort study not only confirmed our previous findings concerning the high efficacy and safety of [mycophenolate mofetil] use as first-line treatment for [autoimmune hepatitis], but also showed for the first time the highest rates of maintenance of complete remission off treatment ever published, although the remission criteria were strict,” the researchers concluded. – by Melinda Stevens

Disclosure: The researchers report no relevant financial disclosures.