ENDOSCOPIC ASSESSMENTS AT INDUCTION WEEK 12^1,4

APS: abdominal pain score; CDAI: Crohn’s Disease Activity Index; JAK: Janus kinase; QD: once daily; SES-CD: simple endoscopic activity score for Crohn’s disease; SF: stool frequency; STRIDE: Selecting Therapeutic Targets in Inflammatory Bowel Disease.

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-naive, 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 nonresponders 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 weeks of RINVOQ 45 mg QD induction treatment. These patients were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD, or placebo.¹

Co-primary endpoint: endoscopic response at Week 12. Secondary, multiplicity-controlled endpoints: endoscopic remission at Week 12. Additional endpoints not controlled for multiplicity: mucosal healing at Week 12 and SES-CD 0–2 at Week 12. Endoscopic response (co-primary endpoint): decrease in SES-CD >50% from baseline of the induction study (or for patients with an SES-CD of 4 at baseline of the induction study, at least a 2-point reduction from baseline of the induction study). Endoscopic remission (secondary endpoint): SES-CD ≤4 and at least a 2-point reduction vs baseline and no subscore >1 in any individual variable.