乌斯特基努马布在克罗恩病的长期安全性:使用I-CARE队列数据的观察性许可后安全性研究的描述性分析
Laurent Peyrin-Biroulet1, Maciej Nazar2, Anna Sheahan3
1Nancy University Hospital, Vandœuvre-lès-Nancy, France.
概括
这项研究发现,乌斯特基努马布对克罗恩氏病患者具有安全的长期特征,恶性瘤和严重感染率较低. 安全性调查结果与先前的临床试验和在克罗恩病中使用ustekinumab的营销后数据一致.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 临床药理学 临床药理学
背景情况:
- 关于乌斯特基努马布在克罗恩病患者的长期安全性的有限的大规模前性数据存在.
- 评估现实世界的安全性对于理解乌斯特基努马布的风险效益概况至关重要.
研究的目的:
- 评估乌斯特基努马布在克罗恩病成年患者的长期安全性.
- 在现实世界队列中确定恶性瘤,严重感染和静脉血栓栓塞的发病率.
主要方法:
- 使用I-CARE研究 (NCT02377258) 数据进行的许可后观察性安全研究 (RRA-20745).
- 预期的,观察性的,多中心的欧洲队列878个成年克罗恩病患者治疗ustekinumab.
- 随访时间平均为37.8个月,评估恶性瘤,严重感染 (包括机会性和结核病) 和住院静脉血栓栓塞.
主要成果:
- 在7名患者中报告了7种恶性瘤 (0.8%),最常见的是皮肤 (0.4%).
- 16名患者 (1.8%) 患有严重感染,主要是胃肠道 (0.8%) 和肺部 (0.3%).
- 没有报告结核病或静脉血栓栓塞的病例;发生了一种机会性细菌感染.
结论:
- 在这个克罗恩氏病队列中,乌斯特基努马布表现出了有利的长期安全性.
- 观察到的安全性概况与临床试验和现有的营销后监测数据的发现一致.
- 这项研究提供了有价值的现实世界的证据,支持乌斯特基努马布在治疗克罗恩病的长期安全性.
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