Approval for publication Signed Date Number of amended pages returned Clin Drug Invest 2006; 26 (11): 1 CASE REPORT 1173-2563/06/0011-0001/$39.95/0  2006 Adis Data Information BV. All rights reserved. Onset of Liver Damage after a Single Administration of Infliximab in a Patient with Refractory Ulcerative Colitis Enzo Ierardi, Nicola Della Valle, Maurizio Cosimo Nacchiero, Vincenzo De Francesco, Giuseppe Stoppino and Carmine Panella Section of Gastroenterology, Department of Medical Sciences, University of Foggia, Foggia, Italy We report the case of a patient with refractory ulcerative colitis who developed Abstract cholestatic acute liver damage after a single infusion of infliximab. Unusual aspects of this case were the early onset (after the first administration) of liver damage and the absence of antinuclear antibodies, alcohol intake, hepatotoxic drugs and all known viral and metabolic causes of hepatic injury. Moreover, no serological or morphological findings of primary sclerosing cholangitis were observed. The patient’s liver damage resolved spontaneously within 6 weeks. Although a direct relationship between administration of infliximab and onset of acute liver damage could not be definitely established, our case suggests that infliximab may induce direct liver damage, the course of which is similar to acute cholestatic hepatitis and resolves following withdrawal of the drug. Introduction the appearance of antinuclear antibodies (ANAs). [3-5] Recently, there has been growing interest in the Feletar et al. observed liver toxicity in four male possibility that infliximab (anti-tumour necrosis fac- patients treated with infliximab for psoriasic arthri- tor-alpha [TNFα]) infusion induces liver damage. [1] Hepatotoxicity with anti-TNFα therapy has been tis. [6] In one of these patients, toxicity due to metho- associated with concomitant use of hepatotoxic trexate was also implicated, while another patient drugs such as methotrexate and azathioprine, relapse reported significant alcohol intake. However, the of coexistent hepatitis B and C virus (HBV and ANA levels were not reported in any of these pa- HCV) infections, or the development of malignant tients, negative viral hepatitis serology was reported diseases. [2] However, the most frequent aetiology of for only one patient, and no serological data for the infliximab-related hepatitis is autoimmune in na- other three patients were provided. ture, with a slow onset that is often accompanied by