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比较度普利尤单抗和常规全身治疗治疗特应性皮炎患者的安全性特征:来自美国网络的真实世界数据。

Comparison of safety profile in patients with atopic dermatitis treated with dupilumab or conventional systemic treatment: real world data from the US network.

机构信息

Institute and Comprehensive Center for Inflammation Medicine, University-Hospital Lübeck, Lübeck, Germany.

Lübeck Institute of Experimental Dermatology, University of Lübeck, Lübeck, Germany.

出版信息

J Dermatolog Treat. 2024 Dec;35(1):2421429. doi: 10.1080/09546634.2024.2421429. Epub 2024 Nov 3.

DOI:10.1080/09546634.2024.2421429
PMID:39489506
Abstract

BACKGROUND

Safety of dupilumab in atopic dermatitis (AD) was investigated in randomized controlled trials (RCT). However, head-to-head trials comparing with conventional systemic drugs are lacking and large real-world data on the long-term safety profile as compared are scarce.

OBJECTIVE

To compare long-term safety profile of dupilumab with conventional systemic drugs used in the management of moderate to severe AD.

METHODS

Data from electronic health records of AD patients treated with either dupilumab, azathioprine, Cyclosporine A, mycophenolate mofetil, methotrexate, or oral glucocorticoids were retrieved from the TriNetX . Risks of adverse events and new onset of type-2-inflammatory diseases within 5 years after treatment initiation was investigated.

RESULTS

5 propensity-matched cohorts, up to 18,708 individuals per cohort, were created. Dupilumab treatment displayed reduced risk for diseases of the circulatory, the upper respiratory, and the musculoskeletal system, infections, and type 2 diseases as compared to all other treatment options. In contrast risk for conjunctivitis was increased in dupilumab treated patients as compared to mycophenolate mofetil and methotrexate.

CONCLUSION

Here presented data indicates that treatment with dupilumab for AD has reduced risk for adverse effects of conventional systemic drugs and thus might be safer. Obtained data should be verified in prospective studies.

摘要

背景

在随机对照试验(RCT)中研究了度普利尤单抗在特应性皮炎(AD)中的安全性。然而,缺乏与传统全身药物进行头对头比较的试验,并且缺乏关于长期安全性概况的大型真实世界数据。

目的

比较度普利尤单抗与用于治疗中重度 AD 的传统全身药物的长期安全性概况。

方法

从 TriNetX 电子健康记录中检索了接受度普利尤单抗、硫唑嘌呤、环孢素 A、霉酚酸酯、甲氨蝶呤或口服糖皮质激素治疗的 AD 患者的数据。研究了治疗开始后 5 年内不良事件和 2 型炎症性疾病新发病例的风险。

结果

创建了 5 个倾向评分匹配队列,每个队列最多有 18708 人。与所有其他治疗选择相比,度普利尤单抗治疗显示出降低循环系统、上呼吸道和肌肉骨骼系统疾病、感染和 2 型疾病风险的作用。相比之下,与霉酚酸酯和甲氨蝶呤相比,度普利尤单抗治疗患者的结膜炎风险增加。

结论

目前的数据表明,AD 患者使用度普利尤单抗治疗的不良反应风险降低,因此可能更安全。应在前瞻性研究中验证获得的数据。

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