Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis
Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis
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DOI：
10.1007/s40257-019-00445-7
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发表时间：
2019-06-01
影响因子：
7.3
通讯作者：
Ardeleanu, Marius
中科院分区：
文献类型：
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作者：
Eichenfield, Lawrence F.;Bieber, Thomas;Ardeleanu, Marius
中重度特应性皮炎（AD）患者感染风险增加，包括皮肤感染和全身感染。免疫调节剂（例如，抗肿瘤坏死因子、抗白细胞介素[抗IL]-23、抗IL-17、Janus激酶抑制剂）增加感染风险。Dupilumab dupilumab（一种阻断IL-4和IL-13共有受体成分的单克隆抗体）被批准用于控制不充分的中重度AD和中重度嗜酸性粒细胞或口服皮质类固醇依赖性哮喘。目的是确定dupilumab对中重度AD患者感染率的影响。在中重度AD成人中进行的安慰剂对照dupilumab试验。暴露调整分析评估了感染率。ResultsOf 2932例患者中，1091例接受安慰剂，1095例接受dupilumab 300 mg每周一次，746例接受dupilumab 300 mg每2周一次。治疗组每100患者年的总体感染率相似（安慰剂组，155; dupilumab每周一次组，150; dupilumab每2周一次组，156; dupilumab联合组，152），非皮肤感染率相似。dupilumab可降低严重/重度感染（风险比0.43; p
BackgroundPatients with moderate-to-severe atopic dermatitis (AD) have increased infection risk, including skin infections and systemic infections. Immunomodulators (e.g., anti-tumor necrosis factors, anti-interleukin [anti-IL]-23, anti-IL-17, Janus kinase inhibitors) increase risk of infections. Dupilumab (a monoclonal antibody blocking the shared receptor component for IL-4 and IL-13) is approved for inadequately controlled moderate-to-severe AD and for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma.ObjectiveThe aim was to determine the impact of dupilumab on infection rates in patients with moderate-to-severe AD.MethodsThis analysis pooled data from seven randomized, placebo-controlled dupilumab trials in adults with moderate-to-severe AD. Exposure-adjusted analyses assessed infection rates.ResultsOf 2932 patients, 1091 received placebo, 1095 dupilumab 300mg weekly, and 746 dupilumab 300mg every 2weeks. Treatment groups had similar infection rates overall per 100 patient-years (placebo, 155; dupilumab weekly, 150; dupilumab every 2weeks, 156; dupilumab combined, 152), and similar non-skin infection rates. Serious/severe infections were reduced with dupilumab (risk ratio 0.43; p