Malignancies and ustekinumab: an analysis of the U.S. Food and Drug Administration Adverse Event Reporting System and the European Union Drug Regulating Authorities Pharmacovigilance database

Ustekinumab is a fully human monoclonal antibody that targets the common p40 subunit shared by interleukins (IL)-12 and IL-23, approved in the United States and in Europe on September 2009, for treatment of moderate to severe psoriasis and on September 2016 for moderately to severely active Crohn's disease1. Pre-marketing studies supported an acceptable risk-to-benefit profile2-4. This article is protected by copyright. All rights reserved.