title: Natalizumab-induced hepatic injury: A case report and review of literature.
abstract: Natalizumab is an α4-integrin monoclonal antibody used for treatment of relapsing multiple sclerosis (MS). At least and nearly 30 cases of liver failure in natalizumab-treated patients are listed in the post-marketing FDA adverse event reporting system (FAERS) and twelve patients with severe liver injury, including several after the first infusion, have been reported (Lisotti et al., 2012; Bezabeh et al., 2010; Martinez-Lapiscina et al., 2013; Michael et al., 2007; Hillen et al., 2015). Herein, we describe a case of a young woman with relapsing MS who developed acute liver injury after the second infusion of natalizumab. Liver biopsy demonstrated a mixed pattern of medication-induced injury or partially treated auto-immune hepatitis. Liver function normalized after natalizumab discontinuation and a subsequent liver biopsy showed resolution of hepatitis. The patient's MS has since been successfully treated with rituximab for over a year. We review the published cases of liver injury associated with natalizumab and those in the post-marketing FDA adverse event reporting system (FAERS).
authors.affiliation: Neuromedical Clinic of Central Louisiana, Louisiana, United States.
authors.forename: A
authors.initials: A
authors.lastname: Antezana
authors.affiliation: Division of Gastroenterology, Department of Medicine, NYU School of Medicine, New York, United States.
authors.forename: S
authors.initials: S
authors.lastname: Sigal
authors.affiliation: Multiple Sclerosis Care Center, Department of Neurology, NYU School of Medicine, New York, United States.
authors.forename: J
authors.initials: J
authors.lastname: Herbert
authors.affiliation: Multiple Sclerosis Care Center, Department of Neurology, NYU School of Medicine, New York, United States.
authors.forename: I
authors.initials: I
authors.lastname: Kister
mesh_terms: D000328:Adult; D056486:Chemical and Drug Induced Liver Injury / Q000473:pathology / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000633:toxicity*; D008099:Liver / Q000187:drug effects / Q000473:pathology; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy; D000069442:Natalizumab / Q000008:administration & dosage / Q000633:toxicity*
chemical_list: D007155:Immunologic Factors; D000069442:Natalizumab
keywords: Autoimmune hepatitis; Drug-induced liver injury; Hepatotoxicity; Natalizumab