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

被引：85

作者：

Efe, Cumali ^{[1
]}

Hagstrom, Hannes ^{[2
]}

Ytting, Henriette ^{[3
]}

Bhanji, Rahima A. ^{[4
,5
]}

Muller, Niklas F. ^{[6
]}

Wang, Qixia ^{[7
]}

Purnak, Tugrul ^{[1
]}

Muratori, Luigi ^{[8
]}

Werner, Marten ^{[9
]}

Marschall, Hanns-Ulrich ^{[10
]}

Muratori, Paolo ^{[8
]}

Gunsar, Fulya ^{[11
]}

Klintman, Daniel ^{[12
,13
]}

Pares, Albert ^{[14
]}

Heurgue-Berlot, Alexandra ^{[15
]}

Schiano, Thomas D. ^{[16
]}

Cengiz, Mustafa ^{[17
]}

Tana, Michele May-Sien ^{[18
]}

Ma, Xiong ^{[7
]}

Montano-Loza, Aldo J. ^{[4
,5
]}

Berg, Thomas ^{[6
]}

Verma, Sumita ^{[19
]}

Larsen, Fin Stolze ^{[3
]}

Ozaslan, Ersan ^{[20
]}

Heneghan, Michael A. ^{[21
]}

Yoshida, Eric M. ^{[13
]}

Wahlin, Staffan ^{[2
]}

机构：

[1] Hacettepe Univ, Dept Gastroenterol, TR-06100 Ankara, Turkey

[2] Karolinska Univ Hosp, Karolinska Inst, Hepatol Div, Ctr Digest Dis, Stockholm, Sweden

[3] Univ Copenhagen, Dept Hepatol, Rigshosp, Copenhagen, Denmark

[4] Univ Alberta, Div Gastroenterol, Edmonton, AB, Canada

[5] Univ Alberta, Liver Unit, Edmonton, AB, Canada

[6] Univ Klinikum Leipzig, Sekt Hepatol, Klin Gastroenterol & Rheumatol, Leipzig, Germany

[7] Shanghai Jiao Tong Univ, Div Gastroenterol & Hepatol, Renji Hosp, Sch Med,Shanghai Canc Inst,Shanghai Inst Digest D, Shanghai, Peoples R China

[8] Univ Bologna, Ctr Studio & Cura Malattie Autoimmuni Fegato & Vi, Dipartimento Sci Med & Chirurg, Alma Mater Studiorum, Bologna, Italy

[9] Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden

[10] Univ Gothenburg, Sahlgrenska Acad, Dept Mol & Clin Med, Gothenburg, Sweden

[11] Ege Univ, Dept Gastroenterol, Izmir, Turkey

[12] Skane Univ Hosp, Dept Mol & Clin Med, Lund, Sweden

[13] Univ British Columbia, Vancouver Gen Hosp, Div Gastroenterol, Vancouver, BC, Canada

[14] Univ Barcelona, Hosp Clin, Liver Unit, Barcelona, Spain

[15] CHU Reims, Dept Hepatogastroenterol, Reims, France

[16] Mt Sinai Med Ctr, Div Liver Dis, New York, NY 10029 USA

[17] Dr AY Oncol Training & Res Hosp, Dept Gastroenterol, Ankara, Turkey

[18] Univ Calif San Francisco, Ctr Liver, Div Gastroenterol, Dept Med, San Francisco, CA 94143 USA

[19] Brighton & Sussex Univ Hosp, Brighton & Sussex Med Sch, Dept Gastroenterol & Hepatol, Dept Med, Brighton, E Sussex, England

[20] Numune Res & Educ Hosp, Dept Gastroenterol, Ankara, Turkey

[21] Kings Coll Hosp Natl Hlth Serv Fdn Trust, Inst Liver Studies, London, England

来源：

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2017年 / 15卷 / 12期

关键词：

Autoimmune Liver Disease; Simplified Criteria; Liver Failure; Liver Transplantation; OVERLAP SYNDROMES; STANDARD THERAPY; MANAGEMENT; DIAGNOSIS; INTOLERANT; REMISSION; DIFFICULT; FIBROSIS;

D O I：

10.1016/j.cgh.2017.06.001

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：1950 / +

页数：8

共 25 条

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