布罗达卢马布:美国六年制药监督报告
Mark G Lebwohl1, John Y Koo2, April W Armstrong3
1Icahn School of Medicine at Mount Sinai, 5 East 98th Street, 5th Floor, New York, NY, 10029, USA. lebwohl@aol.com.
Dermatology and therapy
|November 26, 2024
概括
布罗达卢马布 (互白素-17受体A抗剂) 在六年多的斑块性牛皮患者中显示出一致的长期安全性. 没有报告完成的自杀,真菌感染率仍然很低.
科学领域:
- 免疫皮肤学 免疫皮肤学
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 布罗达卢马布是介素-17受体A对抗剂,适度至严重的斑块性牛皮对其他全身疗法无反应.
- 这种药物在美国带有针对自杀想法和行为的警告盒,需要进行长期安全评估.
- 这项研究评估了六年的真实世界临床实践数据,以评估布罗达卢马布的长期安全性.
研究的目的:
- 总结药监数据并评估布罗达卢马布在斑块牛皮患者的长期安全性.
- 分析不良事件报告率,包括主要不良心血管事件,严重感染,恶性瘤和自杀行为.
主要方法:
- 计算的粗略不良事件 (AE) 报告率每100名患者的常见和特殊兴趣的AE.
- 在六年期间 (2017年8月至2023年8月) 的处方发行数据中估计的布罗达卢马布暴露.
- 使用医学监管活动词典 (MedDRA) v26.0 定义的AE首选术语和标准化查询.
主要成果:
- 来自5138名美国患者 (6900名患者年) 的数据显示,每100名患者中有13例重大心血管不良事件 (0.25/100名患者) 和2.20例严重感染.
- 自5年评估以来,报告了1例新冠状病毒感染病例和1例严重的真菌感染病例.
- 在第六年没有报告新的自杀企图,在六年期间也没有发生完成的自杀事件;在57起恶性瘤中,有4起可能与布罗达卢马布有关.
结论:
- 六年的药监数据与布罗达卢马布的已建立的临床试验安全概况一致.
- 安全性概况保持一致,没有完成自杀和观察到的真菌感染率低.
- 现实世界的数据支持布罗达卢马布在斑块性牛皮管理中的长期安全性.
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