Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study

In adults with moderate-to-severe Crohn's disease (93% previously exposed to anti-TNF), more patients were in clinical remission with risankizumab than with placebo (31% versus 15% at week 12; difference of 15.0%, 95% CI 0.1 to 30.1%; p=0.0489).

Risankizumab is a humanised monoclonal antibody targeting the p19 subunit of interleukin-23 – a pathway that is implicated in the pathogenesis of Crohn's disease. No unexpected safety signals were seen in this short-term component of a larger, long-term trial (the results of which are pending).

 

The author of a related editorial comments that inhibition of T helper 17 cell–interleukin 23 pathways in inflammatory bowel disease holds great promise. Although the results for risankizumab in this early phase II study are promising, if proven effective it would be the 8th drug approved or 15th drug nearing approval for this group of patients in the US, with several other anti-integrin and anti-cytokine agents in Phase III trials.