皮下注射给药无反应患者静脉注射优特克单抗维持治疗的长期结果
Long-Term Outcomes of Intravenous Ustekinumab Maintenance Treatment in Patients With Loss of Response to Subcutaneous Dosing.
作者信息
Argüelles-Arias Federico, Rodriguez González F Javier, González Antuña Jaime, Castro Laria Luisa, Gutiérrez Martinez Fernando, Alcaín Martinez Guillermo, Maldonado Pérez Belén, Camargo Camero Raquel, Martos Van Dussen J Victor, Fernández Castañer Alejandra, Valdés Delgado Teresa
机构信息
Gastroenterology Department, Virgen Macarena University Hospital, Seville, Spain.
Department of Medicine, University of Seville, Seville, Spain.
出版信息
Inflamm Bowel Dis. 2025 Apr 10;31(4):1003-1009. doi: 10.1093/ibd/izae152.
BACKGROUND
Ustekinumab (UST) is commonly used to treat Crohn's disease and ulcerative colitis. However, some patients may experience diminishing response or require increased dosage. Intravenous (IV) UST maintenance is explored as a solution.
OBJECTIVES
We sought to evaluate IV UST maintenance effectiveness and safety in inflammatory bowel disease patients with partial or lost subcutaneous UST response.
METHODS
This was a multicenter retrospective study of inflammatory bowel disease patients on IV UST maintenance. Clinical response and remission at weeks 12 and 52, defined as Harvey-Bradshaw Index ≤4 for Crohn's disease or partial Mayo score ≤2 for ulcerative colitis. Objective markers reduction (fecal calprotectin, C-reactive protein), UST trough levels pre- and post-IV maintenance, and adverse events were assessed.
RESULTS
A total of 59 patients were included. Clinical remission at weeks 12 and 52 achieved by 47.5% and 64.3% respectively. 96.6% continued IV UST at follow-up. UST serum levels quadrupled. No adverse events reported.
CONCLUSIONS
IV UST maintenance effectively sustained remission in most patients at 52 weeks.
背景
乌司奴单抗（UST）常用于治疗克罗恩病和溃疡性结肠炎。然而，一些患者可能会出现疗效减退或需要增加剂量。静脉注射（IV）乌司奴单抗维持治疗被作为一种解决方案进行探索。
目的
我们试图评估静脉注射乌司奴单抗维持治疗对皮下注射乌司奴单抗反应部分丧失或完全丧失的炎症性肠病患者的有效性和安全性。
方法
这是一项对接受静脉注射乌司奴单抗维持治疗的炎症性肠病患者的多中心回顾性研究。评估第12周和第52周的临床反应和缓解情况，克罗恩病定义为哈维-布拉德肖指数≤4，溃疡性结肠炎定义为部分梅奥评分≤2。评估客观指标的降低情况（粪便钙卫蛋白、C反应蛋白）、静脉注射维持治疗前后乌司奴单抗的谷浓度以及不良事件。
结果
共纳入59例患者。第12周和第52周的临床缓解率分别为47.5%和64.3%。96.6%的患者在随访时继续接受静脉注射乌司奴单抗治疗。乌司奴单抗血清水平增至四倍。未报告不良事件。
结论
静脉注射乌司奴单抗维持治疗在52周时能有效维持大多数患者的缓解状态。
Zotero 插件