Can Risankizumab Improve Remission Rates in Patients with Ulcerative Colitis?

In two phase 3 randomized clinical trials, risankizumab demonstrated significant efficacy in achieving clinical remission in patients with moderately to severely active ulcerative colitis.

Ulcerative colitis, a chronic inflammatory bowel disease, remains challenging to treat in patients who do not respond to conventional or advanced therapies. Risankizumab, a monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), had not been evaluated in ulcerative colitis, necessitating this study to assess its potential as a therapeutic option for this patient population.

In these trials, patients with moderately to severely active ulcerative colitis were enrolled. The induction trial included 977 patients across 261 clinical centers in 41 countries, while the maintenance trial enrolled 754 patients from 238 centers in 37 countries. Participants had a history of inadequate response or intolerance to conventional or advanced therapies. In the induction trial, patients received 1200 mg of risankizumab or placebo intravenously at weeks 0, 4, and 8. Those who responded to induction therapy were randomized in the maintenance trial to receive either 180 mg or 360 mg of risankizumab subcutaneously or placebo every 8 weeks for 52 weeks.

At week 12 of the induction trial, 20.3% of patients treated with 1200 mg of risankizumab achieved clinical remission compared with 6.2% in the placebo group (adjusted between-group difference, 14.0% [95% CI, 10.0%-18.0%]; P < .001). In the maintenance trial, clinical remission at week 52 was 40.2% in the 180 mg risankizumab group and 37.6% in the 360 mg group, compared with 25.1% in the placebo group. The adjusted between-group differences were 16.3% for 180 mg risankizumab versus placebo (97.5% CI, 6.1%-26.6%; P < .001) and 14.2% for 360 mg versus placebo (97.5% CI, 4.0%-24.5%; P = .002).

The study's limitations include its focus on short-term outcomes, as the follow-up was limited to 52 weeks. Long-term safety and efficacy data beyond this timeframe are needed. The study also excluded patients with prior exposure to risankizumab.

“Compared with placebo, risankizumab improved clinical remission rates in an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis,” the study authors concluded. “Further study is needed to identify benefits beyond the 52-week follow-up.”

Reference

Louis E, Schreiber S, Panaccione R, et al. Risankizumab for ulcerative colitis. JAMA. 2024;332(11):881-897. doi:10.1001/jama.2024.12414.