Hepatotoxicity associated with vedolizumab: case report in a patient with ulcerative colitis.

Vedolizumab is a humanized antiintegrin α4β7 mAb, selective for the intestine, used in the treatment of moderate to severe inflammatory bowel disease. Safety studies show that vedolizumab has a 31% risk of serious adverse events, but reports of hepatotoxicity are rare. Previous case descriptions show that the lesion is mainly cholestatic or mixed, but hepatocellular lesion can also occur. We report a case of vedolizumab-associated hepatotoxicity in a patient with ulcerative colitis who had no previous liver disease. After starting treatment with vedolizumab, the patient presented elevated transaminases and canalicular in a cholestatic pattern, with normal liver imaging. Due to the suspicion of underlying hepatopathies such as primary sclerosing cholangitis and autoimmune hepatitis (AIH), a biopsy was performed, which showed a lymphocytic inflammatory infiltrate with lymphoid aggregates and eosinophils and plasma cells, as well as interface activity with 'spill-over' of lymphocytes to the parenchyma, which was interpreted as a lesion secondary to the drug. Discontinuation of vedolizumab led to a gradual improvement in liver tests. The case highlights the importance of monitoring liver tests in patients being treated with vedolizumab and the need to differentiate drug hepatotoxicity from other liver diseases.