Efficacy and safety profile of calcineurin inhibitor salvage therapy in autoimmune hepatitis

Stuart K. Roberts, Simone I. Strasser, Amanda J. Nicoll, William Kemp, Ammar Majeed, Joanne Mitchell, Katherine Stuart, Paul Gow, Siddharth Sood, Gerry MacQuillan, Jacob George, Jonathan Mitchell, Geoffrey W. McCaughan, on behalf of the ALA Clinical Research Network

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Background: As data is limited on the outcomes of calcineurin inhibitors (CNI) in autoimmune hepatitis (AIH), we evaluated the efficacy and safety of CNI in AIH patients who failed prior treatment(s). Methods: A retrospective study was performed of AIH patients who received cyclosporine A (CsA) and/or tacrolimus (TAC) after prior treatment(s) failure. Records were reviewed for baseline demographic and clinical characteristics, and treatment outcomes. The primary outcome was biochemical remission. Results: Thirty-three AIH patients received CNI across seven liver centers:17 received CsA, 21 TAC and 5 TAC after CsA failure/intolerance. 82% received CNI for an insufficient response to treatment(s). Overall, 48% of CNI treated patients achieved biochemical remission including 41% in prior non-responders and 83% in treatment intolerant patients. Remission rates with CNI as second-line and third-line therapy were 63% and 29% respectively. There were no baseline predictors of response to CNI on multivariate analysis. Eighteen (55%) patients developed significant side effects and 8 (24%) discontinued due to intolerance. Three patients required liver transplantation for decompensated cirrhosis and 6 patients died including one from malignancy possibly related to CNI. Conclusion: CNI salvage therapy is well tolerated and moderately effective achieving remission in around 50% of AIH who failed standard therapy.

Original languageEnglish
Pages (from-to)1309-1317
Number of pages9
JournalScandinavian Journal of Gastroenterology
Issue number11
Publication statusPublished - Nov 2020


  • autoimmune hepatitis
  • cirrhosis
  • cyclosporine
  • refractory immunosuppression
  • remission
  • response
  • Tacrolimus

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