Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy.
Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Paediatr Drugs. 2022 Nov;24(6):671-678. doi: 10.1007/s40272-022-00531-0. Epub 2022 Aug 27.
The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6-11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable.
The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years.
Demographic and clinical data of children aged 6-11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children's Dermatology Life Quality Index (c-DLQI) score.
A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively).
Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile.
小儿特应性皮炎（AD）的管理具有挑战性，主要依赖于保湿剂和局部皮质类固醇。达必妥（dupilumab）是一种全人源单克隆抗体，最近已被批准用于治疗 6-11 岁中重度 AD 患儿，这些患儿经局部治疗未能充分控制或不适合局部治疗。
本研究旨在评估达必妥治疗 6-11 岁儿童 AD 的有效性和安全性。
回顾性收集了来自 24 个皮肤科和儿科转诊中心的 6-11 岁中重度 AD 患儿的人口统计学和临床数据，这些患儿接受了达必妥治疗。达必妥的初始剂量为 300mg，于第 1 天（D1）皮下给药，然后于 D15 和 D42 时分别给予 300mg，此后每 4 周给药一次。在达必妥治疗的第 2 周（W2）、第 4 周（W4）和第 16 周（W16），使用湿疹面积严重程度指数（EASI）、瘙痒数字评分量表（P-NRS）、睡眠 NRS（S-NRS）和儿童皮肤病生活质量指数（c-DLQI）评分评估疾病严重程度。
共纳入 55 例 AD 患儿（男 24 例[43.64%]，女 31 例[56.36%]；平均年龄 9.35±1.75 岁）。从治疗开始到第 16 周，达必妥治疗可显著改善 EASI 评分、P-NRS、S-NRS 和 c-DLQI。特别是，在第 16 周，达到 EASI75 的患者比例为 74.54%。此外，在同一时间点，P-NRS、S-NRS 和 c-DLQI 的平均百分比也显著下降（分别为 68.39%、70.22%和 79.03%）。
我们的真实数据似乎证实了达必妥在儿科患者的所有疾病方面的有效性，包括体征的严重程度和范围、症状的严重程度、睡眠和生活质量，同时具有良好的安全性。
