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

Henner Zirpel, Ralf J Ludwig, Henning Olbrich, Khalaf Kridin, Sascha Ständer, Diamant Thaçi
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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 US Collaborative Network. 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.

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特应性皮炎患者接受杜匹单抗治疗或传统系统治疗的安全性比较:来自美国网络的真实数据。
背景:随机对照试验(RCT)研究了杜比单抗治疗特应性皮炎(AD)的安全性。然而,目前还缺乏与传统系统性药物进行对比的头对头试验,也缺乏关于长期安全性的大型真实世界数据:比较杜必鲁单抗与用于治疗中重度AD的传统系统药物的长期安全性:方法:从TriNetX美国协作网络中检索了接受杜比鲁单抗、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患者的电子健康记录数据。调查了开始治疗后 5 年内不良事件和新发 2 型炎症性疾病的风险:结果:建立了 5 个倾向匹配队列,每个队列多达 18 708 人。与所有其他治疗方案相比,杜比单抗治疗可降低循环系统、上呼吸道和肌肉骨骼系统疾病、感染和 2 型疾病的风险。相反,与霉酚酸酯和甲氨蝶呤相比,接受杜比鲁单抗治疗的患者患结膜炎的风险增加了:本文提供的数据表明,使用杜比单抗治疗AD可降低传统全身用药的不良反应风险,因此可能更安全。获得的数据应在前瞻性研究中加以验证。
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