Efficacy and Safety of Mycophenolate Mofetil and Tacrolimus as Second-line Therapy for Patients With Autoimmune Hepatitis

Cumali Efe, Hannes Hagström, Henriette Ytting, Rahima A Bhanji, Niklas F Müller, Qixia Wang, Tugrul Purnak, Luigi Muratori, Mårten Werner, Hanns-Ulrich Marschall, Paolo Muratori, Fulya Gunşar, Daniel Klintman, Albert Parés, Alexandra Heurgué-Berlot, Thomas D Schiano, Mustafa Cengiz, Michele May-Sien Tana, Xiong Ma, Aldo J Montano-LozaThomas Berg, Sumita Verma, Fin Stolze Larsen, Ersan Ozaslan, Michael A Heneghan, Eric M Yoshida, Staffan Wahlin

    92 Citationer (Scopus)

    Abstract

    BACKGROUND & AIMS: 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.

    METHODS: We performed a retrospective study of data (from 19 centers 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 mo). 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 as a result of 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 with MMF had a complete response (56.5% vs 34%, respectively; 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 generally was 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 nonresponder patients compared with MMF.

    OriginalsprogEngelsk
    TidsskriftClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
    Vol/bind15
    Udgave nummer12
    Sider (fra-til)1950-1956.e1
    ISSN1542-3565
    DOI
    StatusUdgivet - 2017

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