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首页> 外文期刊>Drug Target Insights >DRESS Syndrome and Daclizumab Failure—Were Potentially Dangerous Signs Missed in Clinical Trials?
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DRESS Syndrome and Daclizumab Failure—Were Potentially Dangerous Signs Missed in Clinical Trials?

机译：DRESS综合征和Daclizumab失败-在临床试验中是否遗漏了潜在危险信号？

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The US Food and Drug Administration (FDA) approved Zinbryta, an interleukin-2 receptor blocking antibody (daclizumab; Biogen and AbbVie) for the treatment of adults with relapsing forms of multiple sclerosis (MS) in May, 2016. It was also approved by the European Union in July, 2016. Zinbryta is a long-acting, self-administered monthly injection that was branded as a new MS drug for patients who needed a “new option for treatment.” It blocks interleukin-2 receptor alpha (CD25) and modulates T-cell expansion. The drug was withdrawn from the market in March, 2018 following 12 reports from Germany (9), United States (2), and Spain (1) following the development of “inflammatory encephalitis and meningoencephalitis” in patients on Zinbryta. Although cases of hepatotoxicity made news with Zinbryta earlier along this drug’s postmarketing journey in the treatment of patients with MS, the European Medicines Agency (EMA) ordered a review of the risks of hepatotoxicity with Zinbryta use June, 2017; this analysis will focus on the pharmacovigilance data concerning the central nervous system (CNS) complications. The details of the CNS complications have been elucidated by EMA. Every drug failure provides an opportunity for learning, but it is also noteworthy that no FDA-approved MS drug in modern times has met with such an untimely, sudden, and inglorious exit. This should serve as a cautionary tale for all clinicians who use “newer MS drugs” that have mushroomed in recent memory following a flurry of recent FDA approvals.
机译：美国食品药品监督管理局（FDA）于2016年5月批准了Zinbryta，一种白介素2受体阻断抗体（daclizumab; Biogen和AbbVie），用于治疗患有复发型多发性硬化症（MS）的成年人。于2016年7月在欧洲联盟（European Union）上市。Zinbryta是一种长效，自行管理的每月注射剂，被标记为需要“新治疗方案”的患者的新型MS药物。它阻断白介素2受体α（CD25）并调节T细胞扩增。在Zinbryta患者发生“炎性脑炎和脑膜脑炎”之后，德国（9），美国（2）和西班牙（1）的12项报道使该药物于2018年3月退出市场。尽管在该药物上市后的治疗MS的过程中，肝毒性病例曾在Zinbryta上引起轰动，但欧洲药品管理局（EMA）于2017年6月下令对使用Zinbryta的肝毒性风险进行评估;该分析将集中于有关中枢神经系统（CNS）并发症的药物警戒数据。 EMA已阐明了CNS并发症的详细信息。每种药物失败都会提供学习的机会，但是也值得注意的是，现代没有任何FDA批准的MS药物会遇到这样的不及时，突然和不明智的退出。对于所有使用“较新的MS药物”的临床医生来说，这应该是一个警告性的故事，在最近FDA批准之后，这些药物在最近的记忆中迅速兴起。

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