Tacrolimus as an Effective and Durable Second-Line Treatment for Chronic Autoimmune Hepatitis: A Multicentric Study
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ORIGINAL ARTICLE
Tacrolimus as an Effective and Durable Second‑Line Treatment for Chronic Autoimmune Hepatitis: A Multicentric Study Carlos Ferre‑Aracil1 · Mar Riveiro‑Barciela2,8 · María Trapero‑Marugán1 · Manuel Rodríguez‑Perálvarez3 · Laura‑Patricia Llovet4 · Luis Téllez5 · Yolanda Sánchez‑Torrijos6 · Fernando Díaz‑Fontenla7 · Magdalena Salcedo‑Plaza7 · Patricia Álvarez‑López2 · Manuel de la Mata3 · María‑Carlota Londoño4 · Rafael Bañares‑Cañizares7 · José Luis Calleja1 Received: 17 March 2020 / Accepted: 19 August 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background Autoimmune hepatitis (AIH) is a chronic liver disease able to progress to acute liver failure, cirrhosis, and liver cancer. A significant proportion of patients fail to first-line therapy or develop severe toxicity. Aims To assess safety and effectiveness of tacrolimus as a second-line therapy in AIH patients. Methods Multicentric retrospective study of AIH patients treated with tacrolimus for at least 3 months as a second-line therapy. Effectiveness was defined as complete normalization of transaminases and IgG. Results A total of 23 AIH patients were included in the final analysis. In 13% of patients tacrolimus was initiated because of toxicity to previous first-line treatments and the rest were switched because of previous non-efficacy. Tacrolimus was effective in 18 patients (78%; 95%CI: 55.20–91.92%). The median time receiving tacrolimus was 16 months (IQR 20). There was a sustained response with a significant improvement in all liver enzymes and IgG on last follow-up. Only one patient discontinued tacrolimus at the third month because of severe neuropathy, and ototoxicity. Responders were significantly older at diagnosis of AIH (41 ± 13 vs. 27 ± 10 years old; p = 0.0496). Conclusion Tacrolimus is effective and well tolerated as a second-line therapy in patients with AIH. Keywords Autoimmune hepatitis · Tacrolimus · Therapy * Carlos Ferre‑Aracil [email protected] 1
Gastroenterology and Hepatology Unit, Hospital Universitario Puerta de Hierro Majadahonda, Joaquin Rodrigo 1, Majadahonda, 28888 Madrid, Spain
2
Hepatology ‑ Internal Medicine Unit, Hospital Universitario Vall d’Hebrón, Barcelona, Spain
3
Hepatology and Liver Transplantation Unit, Hospital Universitario Reina Sofía, IMBIC, CIBERehd, Córdoba, Spain
4
Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
5
Gastroenterology and Hepatology Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERehd, Universidad de Alcalá, Madrid, Spain
6
UGC Aparato Digestivo, Hospital Universitario Virgen del Rocío, Seville, Spain
7
Gastroenterology and Hepatology Unit, Hospital Universitario Gregorio Marañón, Madrid, Spain
8
CIBERehd, Barcelona, Spain
Abbreviations AEMPS Agencia Española de Medicamentos y Productos Sanitarios (Spanish Drug Agency) AIH Autoimmune hepatitis ALT Alanine aminotransferase AP Alkaline phosphatase AST Aspartate aminotransferase EPA - OD Estudio Postautorización
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