Efficacy and Safety of Upadacitinib Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Final Results From the Phase 3 U-ACHIEVE Maintenance Study

ABSTRACT

Introduction: Upadacitinib(UPA), has shown superior efficacy to placebo(PBO) in patients with moderate to severe active ulcerative colitis(UC) in two Phase 3 induction studies .1,2 Patients demonstrating clinical response per Adapted Mayo score with UPA 45mg once daily(QD) after 8 weeks(wks) induction were enrolled to U-ACHIEVE Maintenance. Methods: U-ACHIEVE Maintenance efficacy data from the intent-to-treat(ITT) population, defined as UPA 45mg QD 8wk induction responders enrolled per protocol for 52wk maintenance, and safety data from the safety population, defined as patients who received ≥1 dose of study therapy(ITT plus patients receiving up to 44wksmaintenanceper prior versions of protocol amendments). Non-responder imputation incorporating multiple imputations to handle missing data due to COVID-19 was used. a Based on adjusted Cochran–Mantel–Haenszel test adjusted for strata (corticosteroid use at Week 0 (yes or no), clinical remission status at Week 0 (yes or no), biologic-IR status at baseline (biologic-IR or non-biologic-IR)). b Per Adapted Mayo score ≤2 stool frequency subscore ≤1 and not greater than induction baseline, RBS=0, and ES ≤1. c Maintenance of clinical response, defined as a decrease in Adapted Mayo score ≥2 and ≥30% from induction baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1, at Week 52 among patients who achieved clinical response at the end of the induction therapy. d ES ≤1. e Maintenance of CR at Week 52 among patients with CR at the end of the induction therapy. f CR at Week 52 and corticosteroid-free for ≥90 days prior to Week 52 among patients with CR at the end of the induction therapy. g Endoscopic improvement at Week 52 among patients with endoscopic improvement at the end of the induction therapy. h ES=0. i ES ≤1 and Geboes score ≤3.1. j ES=0 and Geboes score < 2.0.