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Risankizumab beats ustekinumab on steroid-free outcomes in Crohn's disease. A post hoc analysis of the phase 3b SEQUENCE trial found that risankizumab achieved significantly higher rates of corticosteroid discontinuation and steroid-free remission than ustekinumab in patients with moderate-to-severe Crohn's disease refractory to anti-TNF therapy. Real-world data from multiple large cohorts further confirm its effectiveness, even in heavily pretreated patients.
Risankizumab is cementing its place as a leading corticosteroid-sparing option for Crohn's disease (CD). A post hoc analysis of the phase 3b SEQUENCE trial (N=520) found that among patients using corticosteroids at baseline, 86.2% on risankizumab achieved steroid discontinuation by week 48, compared to just 57.7% on ustekinumab. The gap was visible as early as week 8. Risankizumab also led across every steroid-free outcome measured — clinical remission, endoscopic response, mucosal healing, and quality of life.
Real-world data back up the trial findings. Studies from Italy (N=520), Spain (N=857), and the Netherlands (N=151) consistently show that roughly 56–61% of patients with refractory CD achieve steroid-free clinical remission with risankizumab, even those who had failed multiple prior biologics. A phase 3 trial (AFFIRM) also confirmed strong results with subcutaneous induction, with 55% achieving clinical remission vs. 30% on placebo. Across studies, prior ustekinumab exposure and a higher number of previous biologic failures were linked to lower remission rates, suggesting earlier use may maximize benefit.
Key Takeaways:
Why it matters: For gastroenterologists managing patients with steroid-dependent or refractory CD, these findings position risankizumab as a superior corticosteroid-sparing option — and suggest earlier placement in the treatment sequence could meaningfully improve long-term outcomes.