In a head-to-head trial, risankizumab was found to be superior to ustekinumab in achieving endoscopic remission at week 48 in patients with moderate-to-severe Crohn’s disease.
In the phase IIIb, multicenter, open-label, randomized controlled trial, published in The New England Journal of Medicine, researchers compared the efficacy and safety of risankizumab vs ustekinumab in patients with moderate-to-severe Crohn’s disease who had an inadequate response to, or experienced unacceptable side effects from, anti–tumor necrosis factor (TNF) therapy. A total of 527 patients were randomly assigned to receive either risankizumab or ustekinumab over 48 weeks.
The trial met both primary endpoints. At week 24, risankizumab was noninferior to ustekinumab for clinical remission, with 58.6% of patients in the risankizumab group achieving remission compared with 39.5% in the ustekinumab group (adjusted difference = 18.4 percentage points, 95% confidence interval [CI] = 6.6–30.3). At week 48, risankizumab was superior to ustekinumab in endoscopic remission, with 31.8% of patients in the risankizumab group achieving remission compared with 16.2% in the ustekinumab group (adjusted difference = 15.6 percentage points, 95% CI = 8.4–22.9, P < .001).
Adverse events were similar between groups, with no unexpected safety concerns reported. Serious adverse events were observed in 10.3% of patients in the risankizumab group and 17.4% in the ustekinumab group, primarily related to gastrointestinal disorders, including worsening Crohn’s disease. Other reported adverse events included infections and mild hepatic enzyme elevations; however, there were no statistically significant differences between both groups.
Risankizumab was noninferior to ustekinumab in achieving clinical remission at week 24 and superior in achieving endoscopic remission at week 48 in patients with moderate-to-severe Crohn’s disease who had not responded to anti-TNF therapy. The findings indicated that risankizumab demonstrated efficacy in patients with Crohn’s disease who had not responded adequately to previous biologic therapies.
Full disclosures can be found in the published study.