毒性和免疫抑制剂检查站:新兴重点从比例失调FDA不良事件报告系统的分析。

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Raschi E, Mazzarella Antonazzo IC, Bendinelli N, Forcesi E, Tuccori M,莫雷蒂U, Poluzzi E, F·德·庞帝

毒性和免疫抑制剂检查站:新兴重点从比例失调FDA不良事件报告系统的分析。

4月目标杂志。2019;14 (2):205 - 221。doi: 10.1007 / s11523 - 019 - 00632 - w。

PubMed ID

30927173 (在PubMed

]

文摘

背景:免疫抑制剂检查站(艾多酷),包括抗体靶向细胞毒性t淋巴球相关蛋白4 (CTLA4)和程序性细胞死亡1或其配体(PD1 / PDL1),引起不同的几种不良事件(ira),但他们的全球安全是不完全的特征。目的:本研究的目的是描述光谱,ICI-related不良事件的频率,临床特征(AEs)据报道,FDA不良事件报告系统(FAERS)。患者和方法:从FAERS AEs(2018年6月)记录艾多酷(ipilimumab、nivolumab pembrolizumab, atezolizumab, avelumab, durvalumab),怀疑是提取。通过报告综合比例失调分析优势比(ROR)和95%置信区间(95% CI),使用其他肿瘤药物作为比较。系统评价的概述(OoSRs)也进行ira认同一致的积极关联。结果:艾多酷记录47266年报告,提交主要由消费者接受单药治疗与anti-PD1 / PDL1药物。三个地区的毒性来自比例失调分析和OoSRs研究(32):内分泌(N = 2863;ROR = 6.91;95%可信区间6.60 - -7.23),肝胆的(2632;1.33; 1.28-1.39), and respiratory disorders (7240; 1.04; 1.01-1.06). Different reporting patterns emerged for anti-CTLA4 drugs (e.g., hypophysitis, adrenal insufficiency, hypopituitarism, and prescribed overdose) and anti-PD1/PDL1 agents (e.g., pneumonitis, cholangitis, vanishing bile duct syndrome, tumor pseudoprogression, and inappropriate schedule of drug administration). No increased reporting emerged when comparing combination with monotherapy regimens, but multiple hepatobiliary/endocrine/respiratory irAEs were recorded. CONCLUSIONS: This parallel approach through contemporary post-marketing analysis and OoSRs confirmed that ICIs are associated with a multitude of irAEs, with different reporting patterns between anti-CTLA4 and anti-PD1/PDL1 medications. Close clinical monitoring is warranted to early diagnose and timely manage irAEs, especially respiratory, endocrine, and hepatic toxicities, which warrant further characterization; patient- and drug-related risk factors should be assessed through analytical pharmaco-epidemiological studies and prospective multicenter registries.

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药物

Atezolizumab