Comparable Outcomes for Second-line Tac, MMF in Autoimmune Hepatitis

SAN FRANCISCO, CA—Second-line tacrolimus (TAC) or mycophenylate mofetil (MMF) therapy achieved complete or partial responses in most patients with autoimmune hepatitis (AIH) who developed intolerance or disease resistance to first-line azathioprine (AZA), according to a retrospective study reported at the The Liver Meeting® 2015. 

“MMF and TAC were generally effective and well tolerated in standard treatment-resistant or intolerant AIH patients,” reported Camali Efe, MD, of the Department of Gastroenterology, Hacettepe University, in Ankara, Turkey, and coauthors.

“There was no significant difference in outcomes between MMF and TAC treatments in AIH patients who responded to conventional therapy,” Dr. Efe concluded. “However, TAC may be superior in AIH patients who showed incomplete or non-response to standard immunosuppression.”

Eighty percent of patients respond to standard therapy, including corticosteroids alone or in combination with AZA, noted Dr. Efe. “However, this therapy is not tolerated or [is] insufficient to control disease activity in 20% of patients.”

In order to evaluate outcomes associated with second-line TAC or MMF therapy in patients diagnosed with AIH using IAIHG criteria, who demonstrated intolerance or disease-resistance to standard immunosuppression therapy, the authors undertook a multinational retrospective chart review study.

Patients had initially received corticosteroid treatment with or without AZA. They were categorized into 3 groups: complete response to standard therapy but switched due to side effects (Group I); partial response to standard therapy (Group II); or no biochemical response to standard therapy (Group III). 

A total of 180 patients (135 female) were included in the study, with an average age of 37 (age range: 9–76 years).

“Patients were treated with TAC (n=73) and MMF (n=107) [for] a median follow-up of 59 months (1–169 months) after standard immunosuppression,” Dr. Efe noted. Treatment was discontinued among 6 patients treated with TAC and 5 receiving MMF, because of adverse events. Eleven patients eventually underwent liver transplantation, Dr. Efe reported.

“MMF (93%; 54/58) and TAC (96%; 27/28) resulted in complete or partial response in nearly all of Group I patients. In Groups II and III, TAC induced complete or partial response in 78% (35/45) vs. 49% (24/49) of MMF patients (P=0.004).”

Five- and 10-year followup rates were 37% and 18.1% for MMF patients and 45.3% and 12.3% for TAC patients, the coauthors reported.