Efficacy and safety of mycophenolate mofetil and tacrolimus as second-line therapy for patients with autoimmune hepatitis

Cumali, Efe, Hannes, Hagström, Henriette, Ytting, Rahima, Bhanji, Niklas, Müller, Qixia, Wang, Tugrul, Purnak, Luigi, Muratori, Mårten, Werner, Sumita, Verma and et al, (2017) Efficacy and safety of mycophenolate mofetil and tacrolimus as second-line therapy for patients with autoimmune hepatitis. Clinical Gastroenterology and Hepatology. ISSN 1542-3565

[img] PDF - Accepted Version
Restricted to SRO admin only until 9 June 2018.

Download (393kB)

Abstract

Background: Predniso(lo)ne, alone or in combination with azathioprine, is the standard of care (SOC) therapy for autoimmune hepatitis (AIH). However, the SOC therapy is poorly tolerated or does not control disease activity in up to 20% of patients. We assessed the efficacy of mycophenolate mofetil (MMF) and tacrolimus as second-line therapy for patients with AIH.

Patients and methods: We performed a retrospective study of data (from 19 centres in Europe, the United States, Canada, and China) from 201 patients with AIH who received second-line therapy (121 received MMF and 80 received tacrolimus), for a median of 62 months (range, 6–190 months). Patients were categorized according to their response to SOC. Patients in group 1 (n=108) had a complete response to the SOC, but were switched to second line therapy due to side effects of predniso(lo)ne or azathioprine, whereas patients in group 2 (n=93) had not responded to SOC.

Results: There was no significant difference in the proportion of patients with a complete response to MMF (69.4%) vs tacrolimus (72.5%) (P=.639). In group 1, MMF and tacrolimus maintained a biochemical remission in 91.9% and 94.1% of patients, respectively (P=.682). Significantly more group 2 patients given tacrolimus compared to MMF had a complete response (56.5 % vs. 34%, P=.029) There were similar proportions of liver-related deaths or liver transplantation among patients given MMF (13.2%) vs tacrolimus (10.3%) (log-rank, P=.472). Ten patients receiving MMF (8.3%) and 10 patients receiving tacrolimus (12.5%) developed side effects that required therapy withdrawal.

Conclusions: Long-term therapy with MMF or tacrolimus was generally well tolerated by patients with AIH. The agents were equally effective in previous complete responders who did not tolerate SOC therapy. Tacrolimus led to a complete response in a greater proportion of previous non-responder patients compared to MMF.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Clinical Medicine
Research Centres and Groups: Centre for Global Health Policy
Subjects: R Medicine
R Medicine > RC Internal medicine
Depositing User: Sumita Verma
Date Deposited: 03 Jul 2017 08:53
Last Modified: 04 Jul 2017 16:19
URI: http://sro.sussex.ac.uk/id/eprint/68920

View download statistics for this item

📧 Request an update