P179 Comparative benefit-risk profile of induction and maintenance therapy with upadacitinib versus placebo in patients with moderately to severely active ulcerative colitis

Abstract Background Upadacitinib (UPA) demonstrated efficacy and safety as induction maintenance therapy for ulcerative colitis (UC) in Phase 3 trials U-ACHIEVE (NCT02819635) U-ACCOMPLISH (NCT03653026). This post-hoc analysis aims to characterise the benefit-risk profile of UPA vs placebo (PBO) patients (pts) with moderately severely active UC based on a number needed treat/harm (NNT/NNH) analysis. Methods Efficacy data from pooled intention-to-treat population were included. Pts received 45 mg (UPA45) once daily (QD) or PBO 8 weeks (induction trials). Clinical responders (per Adapted Mayo score) at Week re-randomised receive 15 (UPA15) 30 (UPA30) QD, 52-week study. The primary endpoint was clinical remission per score. Secondary outcomes are listed Table 1 2. N, percentages, outcome differences compared by Z test reported. NNT/NNH calculated inverse difference proportions achieving efficacy/safety PBO. Positive NNT values indicate greater negative NNH imply lower risk Results A significantly proportion pts achieved (UPA45 29.9% 4.4%) (UPA15 40.4%, UPA30 53.6% 10.8%) PBO, well all secondary endpoints (all p<0.001; 1). 4.0, ranging 2.1 9.6 endpoints. At 52, 2.4; NNTs ranged 1.8 5.9 (Table 8, adverse events (AEs) worsening UPA45 PBO-treated creatine phosphokinase (CPK) elevation, acne, neutropenia, lymphopenia (p≤0.01). AEs UPA15 UC, leading discontinuation only), arthralgia (UPA30 CPK herpes zoster, hepatic disorder neutropenia only) (p≤0.05; 2). All other similar between Among different –16.1 25.6 Conclusion demonstrates generally comparable indicating favourable UC.