Risankizumab found to be noninferior, superior to ustekinumab for Crohn’s disease

For patients with moderate-to-severe Crohn’s disease, risankizumab is noninferior to ustekinumab for clinical remission at week 24 and is superior for endoscopic remission at week 48, according to a study published in the July 18 issue of the New England Journal of Medicine.

Laurent Peyrin-Biroulet, M.D., Ph.D., from the INFINY Institute in Vandoeuvre-lès-Nancy, France, and colleagues conducted an open-label randomized controlled trial involving patients with moderate-to-severe Crohn’s disease who had an inadequate response to or unacceptable side effects with anti-tumor necrosis factor therapy.

Participants were randomly assigned to receive risankizumab or ustekinumab at standard doses for 48 weeks (255 and 265 patients, respectively).

Overall, 90.2 and 72.8 percent of patients who received risankizumab and ustekinumab, respectively, completed all the assigned treatments, respectively. The researchers found that both primary end points (clinical remission at week 24 and endoscopic remission at week 48) were met.

With respect to clinical remission at week 24, risankizumab was noninferior to ustekinumab (58.6 versus 39.5 percent; adjusted difference, 18.4 percentage points; 95 percent confidence interval, 6.6 to 30.3).

With respect to clinical remission at week 48, risankizumab was superior to ustekinumab (31.8 versus 16.2 percent; adjusted difference, 15.6 percentage points; 95 percent confidence interval 8.4 to 22.9; P < 0.001). The two groups had a similar incidence of adverse events.

“The superior efficacy of risankizumab over ustekinumab that we observed aligns with findings in previous head-to-head clinical trials involving patients with moderate-to-severe plaque psoriasis,” the authors write.

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