MMF Tacrolimus CGH - R3_FINAL-non marked.pdf (384.04 kB)
Efficacy and safety of mycophenolate mofetil and tacrolimus as second-line therapy for patients with autoimmune hepatitis
journal contribution
posted on 2023-06-09, 06:58 authored by Efe Cumali, Hagström Hannes, Ytting Henriette, Bhanji Rahima, Müller Niklas, Wang Qixia, Purnak Tugrul, Muratori Luigi, Werner Mårten, Sumita VermaSumita Verma, et alBackground: 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.
History
Publication status
- Published
File Version
- Accepted version
Journal
Clinical Gastroenterology and HepatologyISSN
1542-3565Publisher
ElsevierExternal DOI
Issue
12Volume
15Page range
1950-1956Department affiliated with
- Clinical and Experimental Medicine Publications
Research groups affiliated with
- Centre for Global Health Policy Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2017-07-03First Open Access (FOA) Date
2018-06-09First Compliant Deposit (FCD) Date
2017-07-04Usage metrics
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