Solitano Virginia, Narula Neeraj, Ma Christopher, Nanayakkara Akithma, Suarez Kenneth Ernest, Zoughlami Amine, Guizzetti Leonardo, Bessissow Talat, Jairath Vipul
Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy; Università Vita-Salute San Raffaele, Milan, Italy.
Am J Gastroenterol. 2024 Nov 14;120(7):1576-1584. doi: 10.14309/ajg.0000000000003212.
We aimed to evaluate the real-world effectiveness and safety of ustekinumab for the treatment of both bio-naive and bio-exposed ulcerative colitis patients in a real-world setting.
Retrospective, Canadian multicenter cohort study. Primary outcomes were clinical remission and endoscopic remission. Key secondary outcomes included composite clinical and endoscopic response, safety, and persistence. Univariable logistic regression was conducted to examine associations between baseline factors and 12-month clinical and endoscopic response and remission. The primary focus was on the association between these outcomes and bioexposure status.
A total of 198 patients were included, of whom 47.5% were female and 85.9% were younger than 65 years. The majority had severe endoscopic activity at baseline (47.5%, n = 87) and were bio-exposed (88.8%, n = 176; 33%, n = 66 previous failure of 3 or more biologics). Patients were followed for a median of 12.8 (interquartile range 8.2-22.1) months after induction. The overall clinical remission rates were 41.3% (69/167), 38.1% (56/147), and 43.6% (58/133) at 3, 6 and 12 months, respectively. Endoscopic remission rates (Mayo endoscopy score = 0) were 8.0% (7/88), 18.7% (23/123), and 12.5% (11/88) at 3, 6, and 12 months, respectively, and consistently higher in bio-naive patients compared with bio-exposed patients through 12 months ( P < 0.05 at all time points). Bio-naive patients were more likely to achieve endoscopic remission compared with bio-exposed (hazard ratio = 5.40, 95% confidence interval [CI]: 1.08-26.93). Adverse events were reported in 14.1% (18/198).
In a highly refractory and largely bio-exposed population, a substantial proportion of patients with ulcerative colitis treated with ustekinumab can achieve clinical and endoscopic outcomes of importance after 12 months. Previous biologic exposure is associated with lower rates of endoscopic remission.
我们旨在评估在真实世界中优特克单抗治疗初治和经生物制剂治疗的溃疡性结肠炎患者的有效性和安全性。
一项回顾性、加拿大多中心队列研究。主要结局为临床缓解和内镜缓解。关键次要结局包括综合临床和内镜反应、安全性及持续用药情况。采用单变量逻辑回归分析基线因素与12个月临床和内镜反应及缓解之间的关联。主要关注这些结局与生物制剂暴露状态之间的关联。
共纳入198例患者，其中女性占47.5%，年龄小于65岁的占85.9%。大多数患者基线时内镜活动严重（47.5%，n = 87）且曾接受生物制剂治疗（88.8%，n = 176；33%，n = 以66曾有3种或更多生物制剂治疗失败史）。诱导治疗后患者的中位随访时间为12.8个月（四分位间距8.2 - 22.1个月）。3个月、6个月和12个月时的总体临床缓解率分别为41.3%（69/167）、38.1%（56/147）和43.6%（58/133）。3个月、6个月和12个月时的内镜缓解率（梅奥内镜评分 = 0）分别为8.0%（第7/88）、18.7%（23/123）和12.5%（11/88），并且在12个月内，初治患者的内镜缓解率始终高于曾接受生物制剂治疗的患者（所有时间点P < 0.05）。与曾接受生物制剂治疗的患者相比，初治患者更有可能实现内镜缓解（风险比 = 5.40，95%置信区间[CI]：1.08 - 26.93）。14.1%（18/198）的患者报告了不良事件。
在高度难治且大多曾接受生物制剂治疗的人群中，相当一部分接受优特克单抗治疗的溃疡性结肠炎患者在12个月后可取得重要的临床和内镜治疗效果。既往生物制剂暴露与较低的内镜缓解率相关。
