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Multicenter Study
. 2025 Jun 1;81(6):1660-1670.
doi: 10.1097/HEP.0000000000001089. Epub 2024 Sep 6.

Efficacy and safety of infliximab in patients with autoimmune hepatitis

Cumali Efe  1 , Ellina Lytvyak  2 , Tuğçe Eşkazan  3 , Rodrigo Liberal  4   5 , Theodoros Androutsakos  6 , Dilara Turan Gökçe  7 , Benedetta Terziroli Beretta-Piccoli  8 , Maciej Janik  9 , Christine Bernsmeier  10   11 , Pinelopi Arvaniti  12 , Piotr Milkiewicz  9   13 , Ersin Batibay  1 , Osman Yüksekyayla  1 , Ilkay Ergenç  14 , Çiğdem Arikan  15 , Albert F Stättermayer  16 , Sezgin Barutçu  17 , Mustafa Cengiz  18 , Özlem Gül  19 , Alexandra Heurgue  20 , Michael A Heneghan  14 , Sumita Verma  21 , Tuğrul Purnak  22 , Murat Törüner  23 , Meral Akdogan Kayhan  24 , Ibrahim Hatemi  3 , Kalliopi Zachou  12 , Guilherme Macedo  4   5 , Joost P H Drenth  25 , Einar Björnsson  26   27 , Aldo J Montano-Loza  2 , Staffan Wahlin  28 , Fatima Higuera-de la Tijera  29
Affiliations
Multicenter Study

Efficacy and safety of infliximab in patients with autoimmune hepatitis

Cumali Efe et al. Hepatology. .

Abstract

Background and aims: A limited number of drugs are used as standard or alternative therapies in autoimmune hepatitis (AIH). No specific recommendations are available for patients failing to respond to these therapies. We analyzed the efficacy and safety of infliximab in patients with AIH.

Approach and results: We performed a retrospective study of 42 patients with AIH who received infliximab at 21 liver centers in 12 countries. Patients were categorized according to the reason for infliximab therapy. Patients in group 1 (n=20) had failed standard, second-line (mycophenolate mofetil and 6-mercaptopurine) or third-line (tacrolimus or cyclosporine) therapy. In group 2 (n=22), infliximab was given for treatment of concomitant extrahepatic autoimmune diseases. Patients received a median of 17 (range: 3-104) infliximab infusions. Complete biochemical response (CR) was achieved or maintained in 33 (78%) patients during infliximab therapy. In group 1, infliximab induced CR in 11 of 20 (55%) patients. In group 2, 16 patients with CR prior to infliximab maintained remission, and the remaining 6 patients with active AIH (5 on standard and 1 on both second-line and third-line therapy) showed CR following infliximab therapy. Infliximab led to CR in 75% (6/8) of nonresponders to second-line and in 46% (6/13) of failing third-line therapy. Overall, 65% (17/26) of the patients with active AIH achieved CR on infliximab. Infliximab was discontinued in 3 patients of group 1. One patient had a severe allergic reaction and 2 developed anti-infliximab autoantibodies.

Conclusions: Our study suggests that infliximab may be an effective and safe rescue therapy in AIH.

Keywords: Liver failure; azathioprine; budesonide; cirrhosis; liver transplantation; rituximab.

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