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Case Reports
. 2020 Dec 3;28(6):410-415.
doi: 10.1159/000511644. eCollection 2021 Nov-Dec.

Vedolizumab-Induced Liver Injury

Miguel Mascarenhas Saraiva  1 , Tiago Ribeiro  1 , Emanuel Dias  1 , Joanne Lopes Lopes  2   3 , Hélder Cardoso  1   3 , Guilherme Macedo  1   3
Affiliations
Case Reports

Vedolizumab-Induced Liver Injury

Miguel Mascarenhas Saraiva et al. GE Port J Gastroenterol. .

Abstract
in English, Portuguese

Drug-induced liver injury is an important cause of acute liver injury. Immunomodulatory therapies, such as vedolizumab (VDZ), are being increasingly used for the treatment of several diseases, most importantly inflammatory bowel disease. Several studies have demonstrated the safety of this substance. To date, only one post-marketing study has reported a case of hepatotoxicity attributable to VDZ. The authors present the case of a 41-year-old woman followed at the gastroenterology outpatient clinic for ulcerative colitis (UC) and autoimmune hepatitis (AIH). This patient was being treated with low-dose glucocorticoids for AIH (prednisolone 10 mg), with adequate disease control. Additionally, she was being treated with oral salicylates (mesalamine 3 g/day) and oral budesonide (9 mg/day) for her UC. For uncontrolled UC, she was started on VDZ. Two weeks after the first infusion of VDZ, the patient developed a clinical and analytical phenotype compatible with acute hepatitis. Diagnostic workup for causes of hepatocellular liver injury retrieved no results. A liver biopsy corroborated the diagnosis of toxic hepatitis overlapping chronic liver disease. VDZ was withdrawn and the patient experienced complete recovery of liver tests over the following weeks. In this case report, we present the first post-marketing case of hepatocellular liver injury in probable relation to VDZ.

A hepatotoxicidade induzida por fármacos é uma causa importante de lesão hepática aguda. As terapêuticas imunomoduladoras, como o vedolizumab (VDZ), são cada vez mais utilizadas para o tratamento de diversas patologias, particularmente a doença inflamatória do intestino. Vários estudos comprovaram o perfil de segurança favorável do VDZ. Até à data, apenas foi relatado um caso de hepatotoxicidade atribuída ao VDZ em estudos de farmacovigilância pós comercialização. Os autores apresentam o caso de uma mulher de 41 anos, seguida em Gastrenterologia por colite ulcerosa (CU) e hepatite autoimune (HAI). A doença hepática desta doente encontrava-se eficazmente controlada com corticoterapia em baixa dose (prednisolona 10 mg). Concomitantemente, a terapêutica dirigida à CU incluía salicilatos (messalazina 3 g/dia) e budesonido (9 mg/dia) orais. Por apresentar CU não controlada com o esquema referido, iniciou VDZ. Duas semanas após a primeira infusão de VDZ, a doente desenvolve manifestações clínicas e analíticas compatíveis com quadro de hepatite. Do estudo etiológico realizado, nenhuma causa foi identificada como responsável pela lesão hepatocelular. Foi realizada uma biópsia hepática que corroborou o diagnóstico de hepatite tóxica a sobreporse a características de doença hepática crónica. A terapêutica com VDZ foi interrompida e a doente apresentou recuperação de valores normais do perfil hepático durante as semanas que se sucederam. Com este trabalho, os autores expõem o primeiro caso pós-comercialização de lesão hepatocelular em provável relação com VDZ.

Keywords: Acute liver injury; Drug-induced liver injury; Hepatotoxicity; Inflammatory bowel disease; Vedolizumab.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
Hematoxylin-eosin stain (×100) showing portal tracts expansion with polymorphic inflammatory infiltrate constituted by lymphocytes, plasma cells and eosinophils and low-density fibrosis.
Fig. 2
Fig. 2
Hematoxylin-eosin stain (×100). Multifocal intralobular necroinflammatory lesions, with rare foci of confluent necrosis. Small aggregates of macrophages revealing previous necroinflammatory activity.
Fig. 3
Fig. 3
Hematoxylin-eosin stain (×100) showing moderate fibrosis of portal tracts, with a polymorphic inflammatory infiltrate constituted by lymphocytes, plasma cells and eosinophils.
Fig. 4
Fig. 4
Hematoxylin-eosin stain (×100) displaying parenchymal disarray, with swollen Kupffer cells and centrolobular necroinflammatory lesions. Some acidophil bodies are also seen.
Fig. 5
Fig. 5
Evolution of alanine aminotransferase (ALT), total bilirubin (TB) and alkaline phosphatase (Alk P) in relation to first VDZ infusion (t = 0 days). Days counted as negative numbers relate to a timepoint before the first infusion.
See this image and copyright information in PMC

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