Oh Kyunghwan, Hong Hee Seung, Ham Nam Seok, Lee Jungbok, Park Sang Hyoung, Yang Suk-Kyun, Yoon Hyuk, Kim You Sun, Choi Chang Hwan, Ye Byong Duk
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Intest Res. 2023 Jan;21(1):137-147. doi: 10.5217/ir.2021.00173. Epub 2022 Jul 12.
BACKGROUND/AIMS: We investigated the real-world effectiveness and safety of ustekinumab (UST) as induction treatment for Koreans with Crohn's disease (CD).
CD patients who started UST were prospectively enrolled from 4 hospitals in Korea. All enrolled patients received intravenous UST infusion at week 0 and subcutaneous UST injection at week 8. Clinical outcomes were assessed using Crohn's Disease Activity Index (CDAI) scores at weeks 8 and 20 among patients with active disease (CDAI ≥150) at baseline. Clinical remission was defined as a CDAI <150, and clinical response was defined as a reduction in CDAI ≥70 points from baseline. Safety and factors associated with clinical remission at week 20 were also analyzed.
Sixty-five patients were enrolled between January 2019 and December 2020. Among 49 patients with active disease at baseline (CDAI ≥150), clinical remission and clinical response at week 8 were achieved in 26 (53.1%) and 30 (61.2%) patients, respectively. At week 20, 27 (55.1%) and 35 (71.4%) patients achieved clinical remission and clinical response, respectively. Twenty-seven patients (41.5%) experienced adverse events, with serious adverse events in 3 patients (4.6%). One patient (1.5%) stopped UST therapy due to poor response. Underweight (body mass index <18.5 kg/m2) (odds ratio [OR], 0.085; 95% confidence interval [CI], 0.014-0.498; P=0.006) and elevated C-reactive protein at baseline (OR, 0.133; 95% CI, 0.022-0.823; P=0.030) were inversely associated with clinical remission at week 20.
UST was effective and well-tolerated as induction therapy for Korean patients with CD.
背景/目的：我们研究了乌司奴单抗（UST）作为韩国克罗恩病（CD）患者诱导治疗的真实疗效和安全性。
前瞻性纳入韩国4家医院开始使用UST的CD患者。所有纳入患者在第0周接受静脉注射UST，在第8周接受皮下注射UST。对基线时疾病活动（CDAI≥150）的患者，在第8周和第20周使用克罗恩病活动指数（CDAI）评分评估临床结局。临床缓解定义为CDAI<150，临床反应定义为CDAI较基线降低≥70分。还分析了安全性以及与第20周临床缓解相关的因素。
2019年1月至2020年12月期间纳入65例患者。在49例基线时疾病活动（CDAI≥150）的患者中，分别有26例（53.1%）和30例（61.2%）在第8周达到临床缓解和临床反应。在第20周，分别有27例（55.1%）和35例（71.4%）患者达到临床缓解和临床反应。27例患者（41.5%）发生不良事件，3例患者（4.6%）发生严重不良事件。1例患者（1.5%）因反应不佳停止UST治疗。体重过轻（体重指数<18.5kg/m2）（比值比[OR]，0.085；95%置信区间[CI]，0.014 - 0.498；P = 0.006）和基线时C反应蛋白升高（OR，0.133；95%CI，0.022 - 0.823；P = 0.030）与第20周临床缓解呈负相关。
UST作为韩国CD患者的诱导治疗有效且耐受性良好。
