The SEQUENCE study was a phase 3, multicenter, randomized clinical trial that compared the efficacy and safety profiles of ustekinumab and risankizumab in moderate to severe Crohn's Disease with ineffective response or significant side effects to anti-tumor necrosis factor (TNF) therapies.

A total of 520 patients were included, randomized to receive risankizumab or ustekinumab. The two primary outcomes were clinical remission at week 24 and endoscopic remission at week 48.

The clinical remission rates at week 24 were 58.6% for risankizumab and 39.5% for ustekinumab. At week 48, the endoscopic remission rates were 31.8% for risankizumab and 16.2% for ustekinumab (p<0.0001). Risankizumab was also superior to ustekinumab in all secondary outcomes (clinical remission at week 48, endoscopic response at weeks 24 and 48, and steroid-free clinical and endoscopic remission at week 48 (p<0.0001)). The rates of adverse events were comparable between the two drugs.

This study concludes that in patients with moderate to severe Crohn's Disease who failed at least one anti-TNF therapy, risankizumab demonstrated non-inferiority compared to ustekinumab in achieving early clinical remission and superiority in achieving long-term clinical and endoscopic remission.