Malignancies and ustekinumab: an analysis of the FDA Adverse Event Reporting System and the European Union Drug Regulating Authorities Pharmacovigilance database

Abstract

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 profile^2-4.

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