Abstract
The most serious adverse drug reaction of adalimumab (ADR) is tuberculosis reactivation. We describe a case of a 35-year-old man, with rheumatoid arthritis (RA) and hepatitis C virus genotype 1a with a liver biopsy in 2001 with a METAVIR score pattern A1 F0; he received interferon alpha 2b for six months, but treatment was suspended because of reactivation of RA. Liver function tests after treatment were similar to previous ones showing a minimal cholestatic pattern. In 2008, methotrexate was prescribed, but the drug was withdrawn at the third month because of the appearance of pruritus and Ggt rise. Viral load at that moment was 9300000 UI/mL, log 6,9. The liver biopsy showed a Metavir Score A2 F1. Adalimumab was started in 2010, and at the third month of treatment, Ggt showed a rise of 23 times normal value (NV), alkaline phosphatase 2,5 times NV with AST and ALT with no change. A new liver biopsy showed portal inflammation with eosinophils and a METAVIR A1 F2. We think that adalimumab appears to be responsible for the liver injury, because of temporal relationship, liver biopsy findings, other clinical conditions being discarded, and the improvement of clinical symptoms and biochemical abnormalities when adalimumab was suspended.
Highlights
Adalimumab (Humira NR) is a fully humanized monoclonal antibody whose biologic target is tumor necrosis factor alpha (TNF-alpha)
We report a case of adalimumab-induced cholestasis in a patient with rheumatoid arthritis (RA) and chronic hepatitis C infection
The cholestatic pattern is the most frequent in this type of toxicity, and the withdrawal of the drug does not guarantee the solution to the problem, as sometimes the Drug-induced liver injury (DILI) persists long after the drug withdrawal, and in rare cases chronic liver injury may occur owing to a self-perpetuating injury
Summary
Adalimumab (Humira NR) is a fully humanized monoclonal antibody whose biologic target is tumor necrosis factor alpha (TNF-alpha). This pharmacodynamic mechanism diminishes inflammatory cytokines cascade. Clinical studies have demonstrated that the most frequent adverse drug reactions (ADRs) to this drug are the injection site reactions that occur in more than 10% of treated patients, and the most serious ADR is tuberculosis reactivation. Other serious systemic infections, which occur very rarely, are drug-induced systemic lupus erythematosus, lymphoma or demyelinating disease [1–4]. These same studies demonstrate that hepatotoxicity is a rare condition that occurs in less than 5% of treated patients, and asymptomatic elevation of liver enzymes is the most common manifestation of liver toxicity
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