Positioning Ustekinumab in Crohn's Disease: From Clinical Evidence to Clinical Practice.

Biological medicines have revolutionised the treatment of Crohn's disease [CD]. Yet, the management of patients not responding to tumour necrosis factor [TNF] antagonists remains a clinical challenge. Ustekinumab is a human monoclonal antibody blocking the biological activity of interleukins 12 and 23, which regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab has recently been approved for the treatment of adult patients with moderately to severely active CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF antagonist, or have medical contraindications to such therapies. Herein, we review the new biological drug's efficacy and safety data reported from randomised controlled trials and real-world observational studies conducted in populations with CD, in order to identify the patient groups most likely to benefit, and to appropriately place ustekinumab into treatment algorithms for CD.