S845 Risankizumab Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomized Phase 3 INSPIRE Study

作者：Edouard J. Louis, Remo Panaccione, Gareth C. Parkes, Laurent Peyrin‐Biroulet, Marc Ferrante, Ken Takeuchi, Britta Siegmund, Phillip Levine, Jasmina Kalabic, Ezequiel Neimark, Kori L. Wallace, Su Chen, W. Rachel Duan, Alessandro Armuzzi, Luc Biedermann, Edward V. Loftus, GIL Y. MELMED, Stefan Schreiber · 发表于：The American Journal of Gastroenterology · 年份：2023 · DOI：10.14309/01.ajg.0000953020.05891.05 · 被引用次数：8 · 研究领域：Inflammatory Bowel Disease、Microscopic Colitis、Celiac Disease Research and Management

Introduction: Risankizumab (RZB), a monoclonal antibody neutralizing interleukin (IL)-23p19, was evaluated for efficacy and safety of induction therapy in patients with moderately to severely active ulcerative colitis (UC) in a large phase 3 trial, INSPIRE (NCT03398148). Methods: Eligible patients (18-80 years) with moderately to severely active UC (Adapted Mayo score of 5–9 points) and an endoscopic subscore of 2-3 (per central review) were enrolled. Patients were required to have a diagnosis of UC for at least 3 months prior to baseline, and demonstrated intolerance or inadequate response to conventional and/or advanced therapies (biologics, JAK inhibitors, and S1P receptor modulators). Patients (N=975) were randomized 2:1 to receive either RZB 1200 mg intravenously (IV) or placebo (PBO) at Weeks (Wks) 0, 4, and 8. The primary endpoint was clinical remission (per Adapted Mayo score) at Wk 12 (see Figure 1 legend for definitions). Key, ranked secondary endpoints included clinical response, endoscopic improvement, endoscopic remission, histologic-endoscopic mucosal improvement (HEMI), and histologic-endoscopic mucosal remission (HEMR), which were measured at Wk 12, unless otherwise noted. Results: Baseline characteristics were similar between treatment groups. Significantly more patients receiving RZB achieved clinical remission vs PBO (20.3% vs 6.2%, adjusted treatment difference 14.0% [95% CI, 10.0%-18.0%], P< .00001, Figure 1A). All ranked secondary endpoints were met. RZB...