Tacrolimus as an Effective and Durable Second-Line Treatment for Chronic Autoimmune Hepatitis: A Multicentric Study

Carlos Ferre-Aracil, Mar Riveiro-Barciela, Maria Trapero-Marugan, Manuel Rodriguez-Peralvarez, Laura-Patricia Llovet, Luis Tellez, Yolanda Sanchez-Torrijos, Fernando Diaz-Fontenla, Magdalena Salcedo-Plaza, Patricia Alvarez-Lopez, Manuel de la Mata, Maria-Carlota Londono, Rafael Banares-Canizares, Jose Luis Calleja

Research output: Contribution to journalArticleResearchpeer-review

5 Citations (Scopus)


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.
Original languageEnglish
Pages (from-to)2826-2832
Number of pages7
JournalDigestive Diseases and Sciences
Publication statusPublished - 29 Aug 2020


  • Autoimmune hepatitis
  • Tacrolimus
  • Therapy


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