Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Aug 26.
doi: 10.1111/apt.70353. Online ahead of print.

Unveiling Drug-Induced Autoimmune-Like Hepatitis in Autoimmune Hepatitis Patients: A Multicenter Retrospective Study

Pinelopi Arvaniti  1 , Ignasi Olivas  1 , Ana Pascual-Dapena  1 , Mar Riveiro-Barciela  2   3 , Paula Esteban  2   3 , Anna Aguilar  2   3 , Indhira Pérez-Medrano  4 , Diana Horta  5 , Arancha Caballero Marcos  6 , Magdalena Salcedo  6 , Isabel Conde  7   8 , Elena Gómez  9 , Inmaculada Castelló  10 , Jesús Santa Bárbara  11 , Álvaro Díaz-González  12 , Maria Del Barrio  12 , Sara Lorente  13   14 , Beatriz Mateos  15 , Ana Arencibia  16 , Miguel Jiménez  17 , Paqui Cuenca  18 , Vanesa Bernal-Monterde  19 , Eva-Maria Fernández  19 , Sergio Rodríguez-Tajes  1 , Anna Pocurull  1 , Helena Hernández-Évole  1 , Xavier Forns  1 , Raul J Andrade  11 , Maria-Carlota Londoño  1
Affiliations

Unveiling Drug-Induced Autoimmune-Like Hepatitis in Autoimmune Hepatitis Patients: A Multicenter Retrospective Study

Pinelopi Arvaniti et al. Aliment Pharmacol Ther. .

Abstract

Background and aims: Acute or chronic exposure to drugs or herbal and dietary supplements (HDS) can cause drug-induced autoimmune-like hepatitis (DI-ALH), a self-limiting condition resembling autoimmune hepatitis (AIH). We investigated the prevalence of drug exposure among AIH patients at diagnosis to recognise cases of DI-ALH and discern features predicting AIH development.

Methods: We retrospectively included 705 patients diagnosed with AIH. DI-ALH was defined using published criteria. The clinical, biochemical, serological, and histological data of DI-ALH and AIH were analysed to identify predictors of the evolution of each phenotype.

Results: Most patients were female (n = 496, 70%), with a median age of 57 years and a median follow-up of 55 months. A 59% (n = 417) reported exposure to drugs or HDS, and 8% (n = 58) fulfilled the criteria for DI-ALH. Statins and HDS were the most common culprits. Patients with DI-ALH more frequently had acute severe or fulminant hepatitis (22% vs. 12%, p = 0.013) and higher transaminase levels (ALT: 966 vs. 591, p = 0.001) at diagnosis. In total, 97% of the patients received immunosuppression. DI-ALH patients had a faster biochemical response than i-AIH patients (4 vs. 5, p = 0.031), while treatment withdrawal was attempted in only 29% (n = 17). Approximately 30% (n = 17) of DI-ALH cases presented a flare during follow-up. Neither clinical, histological, nor serological findings nor RUCAM and RECAM could predict a DI-ALH flare.

Conclusions: DI-ALH is often under-recognised in clinical practice, leading to unnecessary long-term immunosuppression. A causal relationship between drugs and AIH, along with an attempt to withdraw treatment and long-term follow-up, is essential to prevent overtreatment-associated risks.

Keywords: autoimmune hepatitis; drugs/supplements; drug‐induced autoimmune‐like hepatitis; drug‐induced liver injury; immunosuppression.

PubMed Disclaimer

References

    1. R. J. Andrade, G. P. Aithal, Y. S. de Boer, et al., “Nomenclature, Diagnosis and Management of Drug‐Induced Autoimmune‐Like Hepatitis (DI‐ALH): An Expert Opinion Meeting Report,” Journal of Hepatology 79 (2023): 853–866.
    1. E. Björnsson, J. Talwalkar, S. Treeprasertsuk, et al., “Drug‐Induced Autoimmune Hepatitis: Clinical Characteristics and Prognosis,” Hepatology 51 (2010): 2040–2048.
    1. Y. S. de Boer, A. S. Kosinski, T. J. Urban, et al., “Features of Autoimmune Hepatitis in Patients With Drug‐Induced Liver Injury,” Clinical Gastroenterology and Hepatology 15 (2017): 103–112.e2.
    1. A. Castiella, E. Zapata, M. I. Lucena, and R. J. Andrade, “Drug‐Induced Autoimmune Liver Disease: A Diagnostic Dilemma of an Increasingly Reported Disease,” World Journal of Hepatology 6 (2014): 160–168.
    1. E. S. Björnsson, I. Medina‐Caliz, R. J. Andrade, and M. I. Lucena, “Setting Up Criteria for Drug‐Induced Autoimmune‐Like Hepatitis Through a Systematic Analysis of Published Reports,” Hepatology Communications 6 (2022): 1895–1909.

LinkOut - more resources