度普利尤单抗对儿童和青少年特应性皮炎疾病负担的评估：一项基于人群的队列研究。
Evaluation of dupilumab on the disease burden in children and adolescents with atopic dermatitis: A population-based cohort study.
作者信息
Tsai Serena Yun-Chen, Gaffin Jonathan M, Hawryluk Elena B, Ruran Hana B, Bartnikas Lisa M, Oyoshi Michiko K, Schneider Lynda C, Phipatanakul Wanda, Ma Kevin Sheng-Kai
机构信息
Department of Dermatology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Division of Pulmonary Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
出版信息
Allergy. 2024 Oct;79(10):2748-2758. doi: 10.1111/all.16265. Epub 2024 Aug 21.
BACKGROUND
Dupilumab is the first and only biologic agent approved for the treatment of atopic dermatitis (AD) in pediatric patients aged from 6 months to 17 years. The study aimed to evaluate the impact of dupilumab on the occurrence of comorbidities in pediatric patients with AD.
METHODS
In this population-based cohort study, we utilized electronic health records from multiple healthcare organizations across the United States. Pediatric patients (<18 years of age) with a diagnosis of AD initiating dupilumab were propensity-score matched 1:1 to those initiating other systemic agents (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, or systemic corticosteroids). The primary outcomes were new-onset comorbidities emerging during the study period measured by the risk ratio (RR) and its confidence interval (CI). Subgroup analyses were stratified by age (0-5 years, 6-11 years, and 12-17 years), sex, and race.
RESULTS
A total of 3575 pediatric patients with AD treated with dupilumab were matched to 3575 patients treated with other systemic agents. The dupilumab cohort was associated with a lowered risk of new-onset atopic comorbidities (including asthma [RR, 0.72; 95% CI, 0.59-0.89] and allergic rhinitis [RR, 0.62; 95% CI, 0.52-0.74]), infections (e.g., skin and soft tissue infection [RR, 0.70; 95% CI, 0.63-0.76] and respiratory tract infection [RR = 0.56; 95% CI, 0.51-0.61]), psychiatric disorders (e.g., mood disorder [RR, 0.52; 95% CI, 0.39-0.70] and anxiety [RR, 0.57; 95% CI, 0.46-0.70], sleep disturbance [RR, 0.60; 95% CI, 0.47-0.77]), neurologic and developmental disorders (e.g., attention deficit hyperactivity disorder [RR, 0.54; 95% CI, 0.38-0.75]). Furthermore, the positive effects are found to be more pronounced in younger children (aged 0-5 years) with AD.
CONCLUSIONS
Treatment with dupilumab compared to systemic agents resulted in reductions in AD-related comorbidities in pediatric patients.
背景
度普利尤单抗是首个且唯一被批准用于治疗6个月至17岁儿童特应性皮炎（AD）的生物制剂。本研究旨在评估度普利尤单抗对AD患儿合并症发生情况的影响。
方法
在这项基于人群的队列研究中，我们使用了来自美国多个医疗机构的电子健康记录。诊断为AD并开始使用度普利尤单抗的儿科患者（<18岁）按倾向得分1:1与开始使用其他全身药物（硫唑嘌呤、环孢素、甲氨蝶呤、霉酚酸酯或全身用糖皮质激素）的患者进行匹配。主要结局是研究期间出现的新发合并症，通过风险比（RR）及其置信区间（CI）衡量。亚组分析按年龄（0至5岁、6至11岁和12至17岁）、性别和种族进行分层。
结果
共有3575例接受度普利尤单抗治疗的AD儿科患者与3575例接受其他全身药物治疗的患者相匹配。度普利尤单抗组新发特应性合并症（包括哮喘[RR，0.72；95%CI，0.59 - 0.89]和过敏性鼻炎[RR，0.62；95%CI，0.52 - 0.74]）、感染（如皮肤和软组织感染[RR，0.70；95%CI，0.63 - 0.76]和呼吸道感染[RR = 0.56；95%CI，0.51 - 0.61]）、精神障碍（如情绪障碍[RR，0.52；95%CI，0.39 - 0.70]和焦虑[RR，0.57；95%CI，0.46 - 0.70]、睡眠障碍[RR，0.60；95%CI，0.47 - 0.77]）、神经和发育障碍（如注意力缺陷多动障碍[RR，0.54；95%CI，0.38 - 0.75]）的风险降低。此外，发现AD患儿中年龄较小（0至5岁）的儿童的积极效果更为明显。
结论
与全身药物相比，度普利尤单抗治疗可降低AD儿科患者中与AD相关的合并症发生率。
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