Carlos Ferre-Aracil1, Mar Riveiro-Barciela2,3, María Trapero-Marugán4, Manuel Rodríguez-Perálvarez5, Laura-Patricia Llovet6, Luis Téllez7, Yolanda Sánchez-Torrijos8, Fernando Díaz-Fontenla9, Magdalena Salcedo-Plaza9, Patricia Álvarez-López2, Manuel de la Mata5, María-Carlota Londoño6, Rafael Bañares-Cañizares9, José Luis Calleja4. 1. Gastroenterology and Hepatology Unit, Hospital Universitario Puerta de Hierro Majadahonda, Joaquin Rodrigo 1, Majadahonda, 28888, Madrid, Spain. c_ferre_a@hotmail.com. 2. Hepatology - Internal Medicine Unit, Hospital Universitario Vall d'Hebrón, Barcelona, Spain. 3. CIBERehd, Barcelona, Spain. 4. Gastroenterology and Hepatology Unit, Hospital Universitario Puerta de Hierro Majadahonda, Joaquin Rodrigo 1, Majadahonda, 28888, Madrid, Spain. 5. Hepatology and Liver Transplantation Unit, Hospital Universitario Reina Sofía, IMBIC, CIBERehd, Córdoba, Spain. 6. Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. 7. Gastroenterology and Hepatology Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERehd, Universidad de Alcalá, Madrid, Spain. 8. UGC Aparato Digestivo, Hospital Universitario Virgen del Rocío, Seville, Spain. 9. Gastroenterology and Hepatology Unit, Hospital Universitario Gregorio Marañón, Madrid, Spain.
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.
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 patientstacrolimus 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.
Authors: D H Van Thiel; H Wright; P Carroll; K Abu-Elmagd; H Rodriguez-Rilo; J McMichael; W Irish; T E Starzl Journal: Am J Gastroenterol Date: 1995-05 Impact factor: 10.864
Authors: Manuel Rodríguez-Perálvarez; Marta Guerrero-Misas; Douglas Thorburn; Brian R Davidson; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2017-03-31