A multicenter, open-label, controlled phase IIIb clinical trial (SEQUENCE) published in the New England Journal of Medicine, compared the efficacy and safety of risankizumab (a monoclonal antibody that targets IL-23A) versus ustekinumab (a monoclonal antibody that targets IL-12 and IL-23) in patients with moderate-to-severe Crohn's disease who previously did not respond to anti-tumour necrosis factor therapy or experienced unacceptable adverse effects.

Patients (n = 520) were randomly assigned to receive risankizumab (n = 255) or ustekinumab (n = 265; 72.8% completed all the assigned treatments). Both primary endpoints were met, that is, clinical remission at week 24 and endoscopic remission at week 48.

发表在《新英格兰医学杂志》上的一项多中心、开放标签、对照 IIIb 期临床试验 （SEQUENCE） 比较了 risankizumab（一种靶向 IL-23A 的单克隆抗体）与乌司奴单抗（一种靶向 IL-12 和 IL-23 的单克隆抗体）在既往对抗肿瘤坏死因子治疗无反应或经历过不可接受的不良反应的中度至重度克罗恩病患者中的疗效和安全性。

患者 （n = 520） 被随机分配接受 risankizumab （n = 255） 或乌司奴单抗 （n = 265;72.8% 完成了所有分配的治疗）。两个主要终点均达到，即第 24 周的临床缓解和第 48 周的内窥镜缓解。