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

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. To compare long-term safety profile of dupilumab with conventional systemic drugs used in the management of moderate to severe AD. 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 <i>US Collaborative Network</i>. Risks of adverse events and new onset of type-2-inflammatory diseases within 5 years after treatment initiation was investigated. 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. 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. Moderate to severe atopic dermatitis can be treated by using conventional systemic treatments, monoclonal antibodies, or JAK inhibitors.Direct comparison on safety between conventional systemic treatments and monoclonal antibodies are lacking.Treatment with dupilumab reduced the risk for type 2 diseases and diseases affecting the upper respiratory and circulatory system in comparison to conventional systemic treatments.Dupilumab for the treatment of atopic dermatitis might have reduced risk for adverse effects of conventional systemic drugs and thus might be safer. Moderate to severe atopic dermatitis can be treated by using conventional systemic treatments, monoclonal antibodies, or JAK inhibitors. Direct comparison on safety between conventional systemic treatments and monoclonal antibodies are lacking. Treatment with dupilumab reduced the risk for type 2 diseases and diseases affecting the upper respiratory and circulatory system in comparison to conventional systemic treatments. Dupilumab for the treatment of atopic dermatitis might have reduced risk for adverse effects of conventional systemic drugs and thus might be safer.

本研究已通过随机对照试验（randomized controlled trials, RCT）探讨了度普利尤单抗（dupilumab）在特应性皮炎（atopic dermatitis, AD）中的安全性。然而，目前尚缺乏与传统系统性用药开展头对头比较的临床试验，且缺乏可用于对比的大规模真实世界长期安全性特征数据。本研究旨在对比度普利尤单抗与用于中重度特应性皮炎管理的传统系统性用药的长期安全性特征。研究从TriNetX <i>美国协作网络</i>中提取了接受度普利尤单抗、硫唑嘌呤、环孢素A、吗替麦考酚酯、甲氨蝶呤或口服糖皮质激素治疗的特应性皮炎患者的电子健康档案数据。本研究分析了患者在治疗起始后5年内发生不良事件及新发2型炎症性疾病的风险。研究共构建了5个倾向得分匹配队列，每个队列最多纳入18708名受试者。与其他所有治疗方案相比，度普利尤单抗治疗可降低循环系统、上呼吸道、肌肉骨骼系统疾病、感染及2型炎症性疾病的发生风险。相较吗替麦考酚酯与甲氨蝶呤，接受度普利尤单抗治疗的患者结膜炎发生风险有所升高。本研究展示的数据表明，使用度普利尤单抗治疗特应性皮炎，相较于传统系统性用药，不良事件发生风险更低，因此可能具有更优的安全性。本研究所得数据仍需在前瞻性研究中进一步验证。中重度特应性皮炎可通过传统系统性治疗、单克隆抗体或JAK抑制剂（JAK inhibitors）进行治疗，目前尚缺乏传统系统性治疗与单克隆抗体之间的安全性直接对比数据。与传统系统性用药相比，度普利尤单抗治疗可降低2型炎症性疾病及累及上呼吸道、循环系统疾病的发生风险。度普利尤单抗用于治疗特应性皮炎，相较于传统系统性用药，不良事件发生风险更低，因此可能具有更优的安全性。中重度特应性皮炎可通过传统系统性治疗、单克隆抗体或JAK抑制剂（JAK inhibitors）进行治疗，目前尚缺乏传统系统性治疗与单克隆抗体之间的安全性直接对比数据。与传统系统性用药相比，度普利尤单抗治疗可降低2型炎症性疾病及累及上呼吸道、循环系统疾病的发生风险。度普利尤单抗用于治疗特应性皮炎，相较于传统系统性用药，不良事件发生风险更低，因此可能具有更优的安全性。