<br>Dupilumab 联合外用皮质类固醇治疗 6 个月至 5 岁严重特应性皮炎儿童的疗效和安全性,Advances in Therapy

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Dupilumab 联合外用皮质类固醇治疗 6 个月至 5 岁严重特应性皮炎儿童的疗效和安全性
Advances in Therapy ( IF 3.4 ) Pub Date : 2024-01-09 , DOI: 10.1007/s12325-023-02753-1
Amy S Paller _{1,

2} , Andreas Pinter ₃ , Lara Wine Lee ₄ , Roland Aschoff ₅ , Jacek Zdybski ₆ , Christina Schnopp ₇ , Amy Praestgaard ₈ , Ashish Bansal ₉ , Brad Shumel ₉ , Randy Prescilla ₈ , Mike Bastian ₁₀

Affiliation

介绍

患有严重特应性皮炎 (AD) 的 6 岁以下儿童的治疗选择有限，因为全身免疫抑制剂可能会在这个年轻年龄组中带来安全问题。 Dupilumab 是欧盟批准用于患有严重 AD 的婴幼儿的第一个全身治疗选择。本研究报告了 dupilumab 联合低效皮质类固醇治疗 6 个月至 5 岁严重 AD 儿童的疗效和安全性。

方法

这是对来自 dupilumab 随机、双盲、安慰剂对照 III 期试验的基线时患有严重 AD 的 6 个月至 5 岁患者数据进行的预先指定的亚组分析（研究者总体评估 [IGA] = 4）。患者被随机分配接受每 4 周一次皮下注射 dupilumab（200/300 mg）或匹配的安慰剂，加上低效外用皮质类固醇，持续 16 周。第 16 周的共同主要终点是 IGA ≤ 1（皮肤透明或几乎透明）的患者比例以及湿疹面积和严重程度指数 (EASI-75) 较基线改善≥ 75% 的患者比例。第 16 周的次要终点包括 EASI、瘙痒、皮肤疼痛、睡眠不足和生活质量的平均变化。

结果

该分析包括 125 名患者（63 名接受 dupilumab 治疗，62 名接受安慰剂）。第 16 周时，与安慰剂相比，接受 dupilumab 治疗的患者达到 IGA ≤ 1（14.3% vs. 1.6%； P = 0.0085）和 EASI-75（46.0% vs. 6.6%； P < 0.0001）的患者明显增多。 Dupilumab 在所有次要终点中均观察到显着改善，包括最小二乘法平均使瘙痒减少 48.9%。 dupilumab 组和安慰剂组的不良事件 (AE) 总体发生率相似（66.7% vs. 73.8%）。没有与 dupilumab 相关的严重 AE 或导致治疗停止。

结论

Dupilumab 显着改善了 6 个月至 5 岁患有严重 AD 儿童的 AD 体征、症状和生活质量，且安全性可接受。

试用注册

该试验已在 ClinicalTrials.gov 注册，ID 号为 NCT03346434，B 部分。

"点击查看英文标题和摘要"

Efficacy and Safety of Dupilumab Treatment with Concomitant Topical Corticosteroids in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis

Introduction

Treatment options for children younger than 6 years with severe atopic dermatitis (AD) are limited, as systemic immunosuppressants may present safety concerns in this young age group. Dupilumab is the first systemic treatment option approved for infants and young children with severe AD in the European Union. This study reports the efficacy and safety of dupilumab with concomitant low-potency corticosteroids in children aged 6 months to 5 years with severe AD.

Methods

This was a pre-specified subgroup analysis of data for patients aged 6 months to 5 years with severe AD at baseline (Investigator’s Global Assessment [IGA] = 4) from a randomised, double-blind, placebo-controlled, phase III trial of dupilumab. Patients were randomised to either subcutaneously administered dupilumab (200/300 mg) or matched placebo every 4 weeks, plus low-potency topical corticosteroids for 16 weeks. Co-primary endpoints at week 16 were the proportion of patients with IGA ≤ 1 (clear or almost clear skin) and the proportion of patients with ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI-75). Secondary endpoints at week 16 included mean changes in EASI, pruritus, skin pain, sleep loss and quality of life.

Results

The analysis included 125 patients (63 receiving dupilumab vs. 62 placebo). At week 16, significantly more patients receiving dupilumab vs. placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%; P = 0.0085) and EASI-75 (46.0% vs. 6.6%; P < 0.0001). Significant improvements with dupilumab were observed in all secondary endpoints, including a least squares mean 48.9% reduction in pruritus. The overall incidence of adverse events (AEs) was similar between the dupilumab and placebo groups (66.7% vs. 73.8%). No dupilumab-related AEs were serious or led to treatment discontinuation.