Risankizumab is safe and effective in patients with Crohn's disease

A recent study found that risankizumab, an anti-interleukin-23 antibody is safe and effective in patients with moderate-to-severe Crohn’s disease. This study’s findings were published in the Journal of Gastroenterology and Hepatology.

This was a post hoc sub analysis of the global phase 3 ADVANCE, MOTIVATE, and FORTIFY studies. ADVANCE and MOTIVATE were double-blind, placebo-controlled, phase 3 induction studies that included a total of 198 patients who had previously experienced intolerance or inadequate response to biologic (MOTIVATE) or a conventional therapy (ADVANCE). The participants were randomized to receive intravenous risankizumab (600 or 1200 mg) or placebo at weeks 0, 4, and 8. The clinical responders to risankizumab entered the placebo-controlled maintenance withdrawal study (FORTIFY). Patients were re-randomized to receive subcutaneous risankizumab (180 or 360 mg) or placebo (withdrawal) every 8 weeks for 52 weeks.

Among 198 patients in the induction studies, the rates of clinical remission and endoscopic response at week 12 were achieved by 61.4% and 40.0% of patients in the risankizumab 600 mg group, 59.5% and 35.8% of patients in the risankizumab 1200 mg group, and 27.3% and 9.1% of patients in the placebo group, respectively. At week 52, among 67 patients who entered the maintenance study, clinical remission and endoscopic response rates were achieved by 57.1% and 52.4% of patients in the risankizumab 180 mg group, 75.0% and 40.0% of patients in the risankizumab 360 mg group, and 53.8% and 34.6% of patients in the placebo (withdrawal) group. Additionally, it was observed that fistula closure was observed in 28.6% (induction) and 57.1% (maintenance) of patients with risankizumab treatment.

Based on the above findings, it may be concluded that risankizumab was effective and well tolerated in patients with Crohn's disease.