Document Type
Article
Publication Date
6-2-2026
Abstract
BACKGROUND: We aimed to investigate and characterise DILI due to approved therapies for inflammatory bowel disease (IBD).
METHODS: Using the Drug-Induced Liver Injury Network (DILIN) prospective study, we evaluated definite, highly likely, or probable DILI attributed to IBD therapies, including use for non-IBD indications (but excluding corticosteroids). HLA allele associations were investigated.
RESULTS: Among 1806 participants, 81 (4.5%) had IBD-agent DILI: 31 biologics (27 infliximab), 35 immunomodulators (31 azathioprine/mercaptopurine), 14 aminosalicylates (11 sulfasalazine) and 1 small molecule (tofacitinib). Median age was 45 years with 75% female and 78% White. Patients with biologic-DILI were younger, had longer latency (median 124 days), predominantly hepatocellular injury (78%) and mostly mild severity (74%) with no deaths and one chronic case. Immunomodulator-DILI was mainly cholestatic or mixed, with jaundice in 57%; two were fatal, one required transplant and five became chronic. Aminosalicylate-DILI had the shortest latency (median 40 days), was hepatocellular (57%) or cholestatic (36%), often with rash (50%) or pruritus (36%), mostly mild (64%), with two chronic cases. DILI phenotype was similar with IBD and non-IBD indications. Multiple HLA alleles were associated with infliximab (HLA-DPB1*01:01, HLA-B*08:01 and HLA-DQB1*02:01) azathioprine (HLA-DR3, HLA-DRB1*03:01 and HLA-A*33:01), mercaptopurine (HLA-A*11:01 and HLA-B*37:01) and sulfasalazine (HLA-B*53:01) DILI, compared to population controls and other DILI cases.
CONCLUSIONS: Clinical features such as latency, injury pattern, jaundice and dermatologic findings help distinguish implicated agents and guide prognosis in suspected DILI from IBD therapies. HLA alleles may help identify individuals at higher DILI risk and support causality.
Recommended Citation
Gopalakrishna, Harish; Gu, Jiezhun; Li, Yi-Ju; Barnhart, Huiman; Halegoua-De Marzio, Dina; Bonkovsky, Herbert L.; Barritt, A. Sidney; Molleston, Jean P.; Chalasani, Naga P.; and Ghabril, Marwan, "Liver Injury From Medications Used for Treating Inflammatory Bowel Disease: The Drug-Induced Liver Injury Network Experience" (2026). Division of Gastroenterology and Hepatology Faculty Papers. Paper 133.
https://jdc.jefferson.edu/gastro_hepfp/133
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
42231601
Language
English
Comments
This article is the author’s final published version in Liver International, Volume 46, Issue 7, 2026, Article number e70719.
The published version is available at https://doi.org/10.1111/liv.70719. Copyright © 2026 The Author(s).
Correction published online on June 14, 2026 at https://doi.org/10.1111/liv.70749 states: "In the published version, author affiliation 1 appeared as ‘National Institute of Diabetes and Digestive and Kidney Diseases, NationalInstitutes of Health, Bethesda, Maryland, USA.’ It should have read: ‘Division of Gastroenterology and Hepatology, University ofTexas Medical Branch, Galveston, TX.’"