
Two phase 3 randomized clinical trials evaluated the efficacy and safety of risankizumab for treating moderately to severely active ulcerative colitis. Conducted at 261 and 238 clinical centers worldwide, the induction trial enrolled 977 patients, while the maintenance trial included 754 participants. Results showed that at week 12, clinical remission rates were significantly higher in the risankizumab group (20.3%) compared to placebo (6.2%). For the maintenance phase at week 52, remission rates were 40.2% for the 180 mg dosage and 37.6% for the 360 mg dosage, compared to 25.1% for placebo. No new safety risks were identified. The study concludes that risankizumab markedly improves remission rates, warranting further investigation beyond the 52-week follow-up.
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