Systematic Reviews
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pathophysiol. Mar 22, 2025; 16(1): 101481
Published online Mar 22, 2025. doi: 10.4291/wjgp.v16.i1.101481
Evaluation of biological therapies in autoimmune hepatitis: A case-based systematic review
Haifa Eldew, Jonathan Soldera
Haifa Eldew, Consultant in Acute Internal Medicine with Specialist Interest in Hepatology, Princess Royal University Hospital, Kings College Hospital Foundation Trust, Orpington Kent BR6 8ND, United Kingdom
Jonathan Soldera, Acute Medicine and Gastroenterology, University of South Wales, Cardiff CF37 1DL, United Kingdom
Author contributions: Soldera J and Eldew H participated in the concept and design research, drafted the manuscript and contributed to data acquisition, analysis and interpretation; Soldera J contributed to study supervision; all authors contributed to critical revision of the manuscript for important intellectual content.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest pertaining to the subject matter discussed in this paper.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jonathan Soldera, MSc, PhD, Tutor, Post-Graduation in Acute Medicine and Gastroenterology, University of South Wales, Llantwit Road, Pontypridd, Cardiff CF37 1DL, United Kingdom. jonathansoldera@gmail.com
Received: September 15, 2024
Revised: February 17, 2025
Accepted: February 25, 2025
Published online: March 22, 2025
Processing time: 183 Days and 11.2 Hours
Abstract
BACKGROUND

Autoimmune hepatitis (AIH) is typically treated with immunomodulators and steroids. However, some patients are refractory to these treatments, necessitating alternative approaches. Biological therapies have recently been explored for these difficult cases.

AIM

To assess the efficacy and safety of biologics in AIH, focusing on patients unresponsive to standard treatments and evaluating outcomes such as serological markers and histological remission.

METHODS

A case-based systematic review was performed following the PRISMA protocol to evaluate the efficacy and safety of biological therapies in AIH. The primary focus was on serological improvement and histological remission. The secondary focus was on assessing therapy safety and additional outcomes. A standardized search command was applied to MEDLINE, EMBASE, and Cochrane Library databases to identify relevant studies. Inclusion criteria encompassed adult AIH patients treated with biologics. Data were analyzed based on demographics, prior treatments, and therapy-related outcomes. A narrative synthesis was employed to address biases and provide a comprehensive overview of the evidence.

RESULTS

A total of 352 studies were reviewed, with 30 selected for detailed analysis. Key findings revealed that Belimumab led to a favourable response in five out of eight AIH patients across two studies. Rituximab demonstrated high efficacy, with 41 out of 45 patients showing significant improvement across six studies. Basiliximab was assessed in a single study, where the sole patient treated experienced a beneficial outcome. Additionally, a notable number of AIH cases were induced by anti-tumor necrosis factor (TNF) medications, including 16 cases associated with infliximab and four cases with adalimumab. All these cases showed improvement upon withdrawal of the biologic agent.

CONCLUSION

Belimumab and Rituximab show promise as effective alternatives for managing refractory AIH, demonstrating significant improvements in clinical outcomes and liver function. However, the variability in patient responses to different therapies highlights the need for personalized treatment strategies. The risk of AIH induced by anti-TNF therapies underscores the need for vigilant monitoring and prompt symptom recognition. These findings support the incorporation of biologic agents into AIH treatment protocols, particularly for patients who do not respond to conventional therapies.

Keywords: Autoimmune hepatitis; Biological therapies; Belimumab; Rituximab; Basiliximab; Infliximab; Adalimumab

Core Tip: This systematic review highlights the effectiveness of biologic therapies, such as Belimumab and Rituximab, in managing refractory autoimmune hepatitis (AIH) cases. Despite standard treatments with immunomodulators and steroids, some patients remain unresponsive, necessitating alternative options. The review found that Belimumab and Rituximab significantly improved clinical outcomes and liver function in these challenging cases. Additionally, anti-tumor necrosis factor therapies were associated with AIH induction, emphasizing the need for careful monitoring and early detection. These insights advocate for the inclusion of biologics in AIH treatment protocols for patients unresponsive to conventional therapies.