Infliximab (IFX)-Biosimilar Induced Drug-Induced Liver Injury (DILI): A Case Report

Abstract

Infliximab (IFX) is a chimeric human-murine monoclonal antibody that prevents tumor necrosis factor alpha (TNF-α) activation by binding to both soluble and transmembrane forms of TNF-α. Antagonists of TNF (anti-TNF agents) can cause drug-induced liver injury (DILI). We present a non-anti-TNF naïve patient suffering from severe Crohn's disease who developed DILI with a hepatocellular pattern, without jaundice, after two infusions of an IFX biosimilar.

Inflammatory Bowel Disease Therapies and Acute Liver Injury

“…CT-P13 (Janssen Biotech, Horsham, PA, USA) is a biosimilar drug of anti-TNF alpha Infliximab and has been approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Biosimilars do not present significant differences in terms of safety and efficacy compared to the original molecules [53]. Some rare cases of DILI have also been reported for this biosimilar.…”

“…A similar event was reported by Zachau et al about a 42 year old patient suffering from Crohn's. Also in his case, the suspension of the biosimilar resulted in an improvement in the clinical picture until normal transaminase values and cholestasis indices were restored and the subsequent switch to the original Infliximab did not cause the appearance of symptoms or biohumoral alterations [53].…”

Inflammatory Bowel Disease Therapies and Acute Liver Injury

“…CT-P13 (Janssen Biotech, Horsham, PA, USA) is a biosimilar drug of anti-TNF alpha Infliximab and has been approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Biosimilars do not present significant differences in terms of safety and efficacy compared to the original molecules [ 64 ].…”

“…A similar event was reported by Zachau et al about a 42 year old patient suffering from Crohn’s. Also, in his case, the suspension of the biosimilar resulted in an improvement in the clinical picture until normal transaminase values and cholestasis indices were restored, and the subsequent switch to the original Infliximab did not cause the appearance of symptoms or biohumoral alterations [ 64 ].…”