aMs: adapted Mayo score; ESS: endoscopic subscore; ITT: intention to treat; NRI-C: non-responder imputation incorporating multiple imputations to handle missing data due to coronavirus disease 2019 (COVID-19); QD: once daily; RBS: rectal bleeding score; STRIDE: Selecting Therapeutic Targets in Inflammatory Bowel Disease; UC: ulcerative colitis.

Study designs: U-ACHIEVE Induction (UC-1) and U-ACCOMPLISH (UC-2) were replicate induction studies, both of which were multicenter, double-blind, placebo-controlled clinical studies. In UC-1 and UC-2, 988 patients (473 and 515 patients, respectively) were randomized to RINVOQ 45 mg QD or placebo for 8 weeks with a 2:1 treatment allocation ratio and included in the efficacy analysis. All enrolled patients had moderately to severely active UC defined as aMs of 5 to 9 with an ESS of 2 or 3 and demonstrated prior treatment failure including inadequate response, loss of response, or intolerance to prior conventional and/or biologic treatment. U-ACHIEVE Maintenance (UC-3) was a multicenter, double-blind, placebo-controlled clinical study with 451 patients who achieved clinical response per aMs (decrease ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg QD induction treatment. Patients were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD, or placebo^.1,2

Mucosal healing (secondary, multiplicity-controlled endpoint): ESS of 0 or 1 without friability. Maintenance of mucosal healing at Maintenance Week 52 (secondary, multiplicity-controlled endpoint): ESS of 0 or 1 without friability at Maintenance Week 52 in patients who achieved mucosal healing with 8-week RINVOQ 45 mg induction treatment (n=216). Endoscopic remission: ESS=0. Histo-endo mucosal healing (secondary, multiplicity-controlled endpoint): ESS of 0 or 1 without friability and Geboes score of ≤3.1. Deep mucosal healing (secondary, multiplicity-controlled endpoint): ESS of 0 and Geboes score of <2.^1,2