Assessing long-term drug safety: lessons (re) learned from raptiva.
Assessing long-term drug safety: lessons (re) learned from raptiva.
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评估长期药物安全性：从 raptiva 中（重新）吸取的教训。
DOI：
10.1016/j.sder.2010.01.001
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发表时间：
2010
影响因子：
--
通讯作者：
Gelfand,JoelM
中科院分区：
文献类型：
--
作者：
Seminara,NicoleM;Gelfand,JoelM
依法利珠单抗于2003年被批准用于治疗中重度银屑病，基于对大约2,700名患者的研究，其中只有218名患者暴露于该药物超过一年。2009年，在超过46，000例患者暴露于依法利珠单抗后，在自发报告了3例确诊和1例疑似进行性多灶性白质脑病（PML）病例后，该药物退出市场。由于PML非常罕见，因此报告的4例病例极不可能是偶然事件，并且鉴于PML主要发生在免疫抑制患者中，因此可能存在因果关系。将PML确定为依法利珠单抗的一种严重但统计学上罕见的风险，证明了当前药物批准和药物警戒过程在全面衡量药物安全性方面的优势和劣势。患者和临床医生在选择治疗时需要了解药物现有安全性数据的相对完整性和局限性。
Efalizumab was approved for moderate to severe psoriasis in 2003 based on studies in approximately 2,700 patients of whom only 218 were exposed to the drug for more than one year. In 2009, after over 46,000 patients were exposed to efalizumab, the drug was withdrawn from the market after 3 confirmed and one suspected case of progressive multifocal leukoencephalopathy (PML) were spontaneously reported. As PML is very rare, it is extremely unlikely that the four reported cases were due to chance and given that PML occurs primarily in patients who are immunosuppressed, the association is likely causal. The identification of PML as a serious, but statistically rare risk of efalizumab demonstrates the strengths and weaknesses of the current drug approval and pharmacovigilance processes for fully measuring the safety of a drug. Patients and clinicians need to be aware of the relative completeness and limitations of existing safety data of a drug when selecting a treatment.