儿童的阿达利穆马布不良事件概况:一个不成比例的分析
Wenting Zhang1, Ziqi Xu2, Yamin Shu1
1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
Pharmaceuticals (Basel, Switzerland)
|August 29, 2024
概括
这项研究在儿童中确定了202个阿达利木马布不良事件信号,注射部位斑块和肠是最突出的. 早期治疗监测对于儿科患者的安全至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 儿科风湿病学 儿科风湿病学
- 免疫学 免疫学 免疫学
背景情况:
- 阿达利穆马布是FDA批准的成人类类风湿性关节炎和儿童类自身免疫性疾病.
- 遗传和生理上的差异需要对儿童进行现实世界的安全评估.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 是市场后监测的关键数据来源.
研究的目的:
- 为了识别与儿科患者 (<18岁) 相关的潜在不良事件 (AE) 信号.
- 从FAERS数据库中分析现实世界的安全数据.
- 为了比较儿童与普通人口的AE发病时间.
主要方法:
- 从2017年第一季度到2022年第三季度对FAERS数据的系统审查.
- 使用的统计方法包括报告几率比率 (ROR),比例报告比率 (PRR),信息组件 (IC) 和实证贝叶斯几何平均值 (EBGM).
- 专注于儿科患者报告 (18岁以下).
主要成果:
- 在儿科患者中鉴定了202个对阿达利穆马布的显著AE信号.
- 最强烈的信号包括注射部位斑块 (ROR=261.97) 和肠道 (ROR=122.09).
- 在儿童中观察到较短的中位发病时间 (99天) 与所有年龄段 (149天) 相比,大多数AE发生在前3个月内.
结论:
- 密切监测已知和潜在的非标签AE在儿童的最初3个月的Adalimumab治疗期间是必不可少的.
- 确保儿科患者的安全需要超越药物包装说明书的警.
- 现实世界的数据分析突出显示,需要针对儿科患者群体进行量身定制的安全监测.
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