渐进型多焦点白内障与斯芬戈-1-酸盐受体调节剂相关:一个大型病例系列
David Croteau1, Tiffany Kim1, Vicky Chan1
1Division of Pharmacovigilance I, Office of Surveillance and Epidemiology (DC, TK, VC, AB), Center for Drug Evaluation and Research, U.S. Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Multiple sclerosis and related disorders
|November 14, 2024
概括
长期使用基-1-酸盐受体 (S1PR) 调制剂 (≥18个月) 是逐渐多焦点白内障 (PML) 的重要危险因素. 这一发现导致了这些多发性硬化症治疗的更新处方信息.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药物监督 药物监督 药物监督
背景情况:
- 与基-1-酸盐受体 (S1PR) 调节器相关的渐进多焦点白血脑病 (PML) 的危险因素需要进一步表征.
- 与纳塔利祖马布相比,S1PR调节器对PML风险的现有数据不那么全面.
研究的目的:
- 描述与S1PR调节器相关的PML病例.
- 在使用S1PR调节器的患者中识别和分析PML的风险因素.
主要方法:
- 从FDA不良事件报告系统 (FAERS) 数据库中对自发不良事件报告的审查.
- 对与S1PR调节器相关的PML病例报告的医学文献进行系统审查.
主要成果:
- 在所有销售的多发性硬化症S1PR调节器中确定了57例PML病例;53例涉及fingolimod.
- 长时间的S1PR调节器暴露 (≥18个月) 成为PML的强有力的风险因素.
- 患者年龄≥50岁是潜在的风险因素,建议先前免疫抑制剂暴露进行进一步验证.
结论:
- 自发不良事件数据证实扩展S1PR调节器暴露是重要的PML风险因素.
- 美国S1PR调节器的最新处方信息反映了所识别的风险.
- 进一步验证潜在的风险因素对于分层和减轻PML风险至关重要.
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