APS: abdominal pain score; JAK: janus kinase; IL: interleukin; SES-CD: Simplified Endoscopic Score for Crohn’s Disease; SF: stool frequency.

Study designs: the U-EXCEL and U-EXCEED induction studies were both multicenter, double-blind, placebo-controlled clinical studies. In U-EXCEL (N=526 [287 bio-naïve, 239 biologic failures]) and U-EXCEED (N=495 biologic failures only), patients were randomized to RINVOQ 45 mg QD or placebo for 12 weeks with a 2:1 treatment allocation ratio and included in the efficacy analysis. In both studies, induction non-responders were allowed to enter an additional 12-week open-label extended treatment period. All enrolled patients had moderately to severely active CD defined as SF ≥4 and/or APS ≥2, plus an SES-CD ≥6 (≥4 for patients with isolated ileal disease) excluding the narrowing component. U-ENDURE maintenance was a multicenter, double-blind, placebo-controlled clinical study with 502 patients who achieved clinical response (≥30% decrease in average daily SF and/or in APS, neither worse than baseline) to 12 or 24 weeks of RINVOQ 45 mg QD induction treatment. Patients were rerandomized at Week 12 or Week 24 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD, or placebo.