Early clinical outcomes as predictors of achieving clinical, endoscopic, and composite endpoints following maintenance dosing. RZB 180 mg SC, N = 69; RZB 360 mg SC, N = 65. A significant odds ratio less than 1 for ΔSF and ΔAPS is reflective of the fact that as the variable decreases, the event is more likely to occur. AP remission, average daily AP score ≤1 and not worse than baseline; SF remission, average daily SF ≤2.8 and not worse than baseline; SF/APS clinical remission, average daily SF ≤2.8 and not worse than baseline and average daily AP score ≤1 and not worse than baseline; CDAI clinical remission, CDAI <150; enhanced clinical response, ≥60% decrease in average daily SF and/or ≥35% decrease in average daily AP score and both not worse than baseline, and/or clinical remission; endoscopic response, decrease in SES-CD >50% from baseline [or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline], as scored by central reviewer; endoscopic remission, SES-CD ≤4 and at least a 2-point reduction vs baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer; ulcer-free endoscopy, SES-CD ulcerated surface subscore of 0 in patients with SES-CD ulcerated surface subscore ≥1 at baseline, as scored by a central reviewer; SF/APS deep remission, SF/APS clinical remission + endoscopic remission; *p ≤0.05, **p ≤0.01. SC, subcutaneous; SF, stool frequency; APS, abdominal pain score; RZB, risankizumab; CDAI, Crohn’s Disease Activity Index; SES-CD, Simple Endoscopic Score for Crohn’s Disease.
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