Efficacy and safety of upadacitinib for Crohn’s disease in patients in East Asia: a post hoc analysis of randomized phase 3 studies

Abstract

Abstract Background Upadacitinib is an oral Janus kinase inhibitor approved for the treatment of moderate-to-severe Crohn’s disease (CD). This post hoc analysis reports the efficacy and safety of upadacitinib for CD in patients in East Asia enrolled in the phase 3 clinical trials. Methods In two induction studies (U-EXCEL [NCT03345849], U-EXCEED [NCT03345836]), adults with moderately to severely active CD were randomized 2:1 to once-daily upadacitinib 45 mg or placebo for 12 weeks. In the 52-week U-ENDURE maintenance study (NCT03345823), patients with clinical response to upadacitinib induction therapy were rerandomized 1:1:1 to once-daily upadacitinib 15 mg, upadacitinib 30 mg, or placebo. Data from patients in East Asia were evaluated. Results In the induction studies, achievement of clinical and endoscopic outcomes occurred at higher rates with upadacitinib vs placebo at week 12 among the 204 patients in East Asia. Clinical remission per CD Activity Index (CDAI) and endoscopic response were achieved by 50.7% vs 20.6% and 61.8% vs 10.3% of patients in the upadacitinib 45-mg vs placebo groups, respectively. Similar trends for upadacitinib vs placebo were observed for the 117 patients in the maintenance study. Clinical remission per CDAI and endoscopic response were achieved by 41.5%, 54.8%, 8.8%, and 28.6%, 45.2%, 5.9% of patients receiving upadacitinib 15 mg, upadacitinib 30 mg, and placebo, respectively. The safety profile of upadacitinib was consistent with the global phase 3 population. Conclusions Upadacitinib was efficacious in treating moderately to severely active CD among patients in East Asia and demonstrated a favorable benefit–risk profile.