瑞桑基祖马布与古塞尔库马布的比较安全概况:基于FAERS数据库的药监测研究
Shiyi Wang1, Yongyi Xu2, Hangjuan Lin3
1Department of Gastroenterology, Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University, Ningbo, China.
两者都是IL-23抑制剂的guselkumab和risankizumab,显示出不同的现实世界的安全概况. 瑞桑基祖马布携带恶性瘤和严重系统性事件的风险,而古塞尔库马布与注射错误有关.
科学领域:
- 免疫学 免疫学 免疫学
- 药物监督 药物监督 药物监督
- 皮肤病学 皮肤病学
背景情况:
- 干白素-23 (IL-23) 抑制剂,如瑞桑基祖马布和古塞尔库马布,用于免疫介导的炎症性疾病.
- 现实世界的安全数据比较这些IL-23抑制剂是有限的.
- 了解差异性不良事件 (AE) 概况对于明智的临床决策至关重要.
研究的目的:
- 进行不成比例性分析,比较guselkumab和risankizumab的现实安全概况.
- 识别和比较每个药物的特定不良事件 (AE) 信号,使用营销后数据.
主要方法:
- 来自FDA不良事件报告系统 (FAERS) 数据库的营销后数据的不成比例分析.
- 分析的数据范围从2017年第三季度到2025年第二季度,涵盖了22,470份古塞尔库马布和48,141份里桑基祖马布AE报告.
- 对两种IL-23抑制剂的AE信号的检测和比较.
主要成果:
- 瑞桑基祖马布在皮肤癌 (尤其是65岁以上的患者),肠道阻塞,心肌梗塞和脑血管事故中表现出显著的AE信号.
- 古塞尔库马布的主要信号涉及药物管理问题 (例如,剂量遗漏,意外暴露),与疗效降低相关.
- 瓜塞尔库马布的独特AE信号包括霍奇金病,皮虫病和自身免疫性甲状腺炎;瓜塞尔库马布的中位数发病时间较短 (62天) 与瑞桑基祖马布 (168天).
结论:
- 古塞尔库马布和瑞桑基祖马布在现实世界中具有不同的安全概况,与统一的类效应相矛盾.
- 临床医生应监测Risankizumab的恶性瘤和系统性事件,特别是在老年人中.
- 患者教育对于古塞尔库马布来说至关重要,以减轻注射错误,支持个性化治疗策略.
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