Update on ustekinumab for the treatment of Crohn's disease.

Despite the success of antitumor necrosis factor (TNF) therapy in Crohn's disease, there remains a need for biologic therapy that targets other immune pathways of disease. Ustekinumab is a fully human monoclonal immunoglobulin antibody that targets the interleukin (IL)-12 and IL-23 shared P40 subunit. It has been studied in 2 phase 2 randomized, double-blind, placebo-controlled trials in Crohn's disease. This article reviews the clinical efficacy and safety data of ustekinumab in Crohn's disease in anticipation of the final results of the phase III development program in moderate to severe Crohn's disease.