OP04 Efficacy of upadacitinib in ulcerative colitis: A phase 3 post hoc analysis of biologic- and anti-TNF-inadequate response patients

Abstract Background Upadacitinib (UPA), an oral selective and reversible Janus kinase inhibitor, has demonstrated efficacy with a well-characterised safety profile in patients (pts) moderately to severely active ulcerative colitis (UC) Phase 3 clinical trial program.1,2 This post hoc analysis evaluated UPA pts inadequate response (IR; persistently UC despite ≥1 induction regimen of infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), loss response, intolerance biologic (bio-IR) anti-TNF agent (anti-TNF-IR) the trials. Methods Pts 45 mg once daily (QD) following 8-week (wk) therapy U-ACHIEVE U-ACCOMPLISH were subsequently randomised placebo (PBO), 15 30 QD Maintenance.1,2 Here, we after 8-wk 52-wk maintenance non-bio-IR pts, bio-IR subset anti-TNF-IR within population. Results Overall, 508 (51% overall) 464 (91% population) analysed induction, 336 (49% 306 maintenance. was significantly more efficacious than PBO across all endpoints at Wk 8 non-bio-IR, subgroups (Figure 1; Table 1). At 52 maintenance, both doses for primary endpoint remission per Adapted Mayo score 2). Adjusted rate differences vs generally similar most subgroups. had numerically better except change from baseline faecal calprotectin patients, results (Table Conclusion In UC, achieved anti-TNFIR pts. Generally observed between which consistent previously published overall population.1,2 These findings suggest that is regardless prior agents other biologics.