Infections in Children Aged 6 Months to 5 Years Treated with Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis,Pediatric Drugs

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Infections in Children Aged 6 Months to 5 Years Treated with Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis
Pediatric Drugs ( IF 3.7 ) Pub Date : 2024-01-24 , DOI: 10.1007/s40272-023-00611-9
Amy S. Paller , Elaine C. Siegfried , Michael J. Cork , Peter D. Arkwright , Lawrence F. Eichenfield , Michele Ramien , Faisal A. Khokhar , Zhen Chen , Annie Zhang , Sonya L. Cyr

Background

Patients with atopic dermatitis (AD), particularly infants and young children, are at greater risk of developing skin infections. In this study, we assessed infection rates in AD patients aged 6 months to 5 years treated with dupilumab.

Methods

In LIBERTY AD PRESCHOOL, a double-blind, placebo-controlled, phase III clinical trial, children aged 6 months to 5 years with moderate-to-severe AD were randomized 1:1 to subcutaneous dupilumab or placebo, with concomitant low-potency topical corticosteroids, every 4 weeks for 16 weeks. Exposure-adjusted infection rates were used to compare treatment groups.

Results

The analysis included 162 patients, of whom 83 received dupilumab and 79 received placebo. Total infection rates were not significantly different between the dupilumab and placebo groups (rate ratio [RR] 0.75, 95% CI 0.48–1.19; p = 0.223). Non-herpetic adjudicated skin infections and bacterial infections were significantly less frequent with dupilumab versus placebo (non-herpetic skin infections: RR 0.46, 95% CI 0.21–0.99; p = 0.047; bacterial infections: RR 0.09, 95% CI 0.01–0.67; p = 0.019), and the number of patients using systemic anti-infective medication was significantly lower in the dupilumab group (RR 0.52, 95% CI 0.30–0.89; p = 0.019). There were no significant differences in the number of herpetic infections between the dupilumab and placebo groups (RR 1.17, 95% CI 0.31–4.35; p = 0.817). The number of patients with two or more infection events was significantly higher in the placebo group (RR 0.29, 95% CI 0.12–0.68; p = 0.004), and no severe or serious infections (including eczema herpeticum) were observed among patients receiving dupilumab.

Conclusions

These data suggest that dupilumab treatment in infants and children younger than 6 years with AD does not increase overall risk of infections and is associated with a reduced risk of bacterial and non-herpetic skin infections compared with placebo, resulting in a reduced need for anti-infective medication.

Trial Registration

The trial was registered with ClinicalTrials.gov with ID number NCT03346434 on November 17, 2017.

Infographic

中文翻译：

在中度至重度特应性皮炎的安慰剂对照临床试验中，接受 Dupilumab 治疗的 6 个月至 5 岁儿童的感染情况

背景

特应性皮炎 (AD) 患者，尤其是婴儿和幼儿，发生皮肤感染的风险更大。在这项研究中，我们评估了接受 dupilumab 治疗的 6 个月至 5 岁 AD 患者的感染率。

方法

在 LIBERTY AD PRESCHOOL 中，这是一项双盲、安慰剂对照、III 期临床试验，6 个月至 5 岁的中重度 AD 儿童被随机分配至皮下注射 dupilumab 或安慰剂，同时接受低效局部用药皮质类固醇，每 4 周一次，持续 16 周。使用暴露调整感染率来比较治疗组。

结果

该分析包括 162 名患者，其中 83 名接受 dupilumab，79 名接受安慰剂。dupilumab 组和安慰剂组之间的总感染率没有显着差异（比率 [RR] 0.75，95% CI 0.48–1.19；p = 0.223）。与安慰剂相比，dupilumab 组非疱疹性皮肤感染和细菌感染的发生率显着降低（非疱疹性皮肤感染：RR 0.46，95% CI 0.21–0.99；p = 0.047；细菌感染：RR 0.09，95% CI 0.01–0.67 ；p = 0.019），dupilumab 组中使用全身抗感染药物的患者数量显着较低（RR 0.52，95% CI 0.30-0.89；p = 0.019）。dupilumab 组和安慰剂组之间的疱疹感染数量没有显着差异（RR 1.17，95% CI 0.31–4.35；p = 0.817）。安慰剂组中发生两次或两次以上感染事件的患者数量显着较高（RR 0.29，95% CI 0.12-0.68；p = 0.004），并且在接受 dupilumab 的患者中未观察到严重或严重感染（包括疱疹性湿疹）。