Ustekinumab for the treatment of Crohn's disease.

INTRODUCTION: Ustekinumab is a human monoclonal antibody directed against the shared p40 subunit of interleukins 12 and 23. Ustekinumab is currently approved for the treatment of psoriatic arthritis (PsA) and moderate to severe plaque psoriasis, and is being evaluated in Crohn's disease (CD). AREAS COVERED: The first evidence supporting the efficacy of ustekinumab in the treatment of moderate to severe CD was published in 2008. Results from subsequent phase II and phase III randomized controlled trials (RCTs) have shown promising data on the clinical efficacy of induction and remission of moderate to severe CD. These data and the safety profile of ustekinumab will be reviewed. Expert commentary: As a significant proportion of individuals with CD have ongoing symptoms and inflammation despite existing therapies, there is a clinical need for new agents like ustekinumab directed at different targets on the inflammatory pathway. Looking forward, more studies are needed to evaluate dosing escalation or de-escalation in addition to timing of therapy switches. In addition, further data is required to gauge the comparative effectiveness of ustekinumab to the biologic agents that are currently used in the treatment of CD.