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度普利尤单抗改善中重度特应性皮炎患儿和青少年的临床评分:一项真实世界、单中心研究。

Dupilumab Improves Clinical Scores in Children and Adolescents With Moderate to Severe Atopic Dermatitis: A Real-World, Single-Center Study.

机构信息

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.

出版信息

J Allergy Clin Immunol Pract. 2022 Sep;10(9):2378-2385. doi: 10.1016/j.jaip.2022.06.014. Epub 2022 Jun 24.

Abstract

BACKGROUND

Dupilumab has proven safe and effective in children and adolescents with atopic dermatitis (AD) in clinical trials. However, comprehensive real-world studies in the pediatric AD population are still needed.

OBJECTIVE

To characterize the long-term treatment responses and adverse events of dupilumab-treated children and adolescents with AD during dermatology follow-up assessments.

METHODS

We reviewed electronic medical records from March 2017 to September 2021 of moderate to severe AD patients starting dupilumab at less than age 18 years. Demographics, AD scores (body surface area [BSA], Eczema Area and Severity Index [EASI], and Investigator's Global Assessment [IGA]) as well as safety data were collected.

RESULTS

A total of 89 patients, 50 females (56.2%) and 39 males (43.8%), were included. Mean ± SD treatment duration was 1.3 ± 0.9 years. Of these, 73 had score assessments at baseline and weeks 12 to 24. Mean ± SD improvements in BSA, EASI, and IGA were 63.1% ± 29.2%, 39.6% ± 29.9%, and 59.6% ± 30.7%, respectively. All patients (n = 23) who received dupilumab for 1 year or more achieved 75% improvement in EASI and IGA 0/1, and 60.8% achieved 90% improvement in EASI. Positive history of atopy was associated with greater percent improvement in BSA at weeks 12 to 24 (P < .05). Twelve patients had adverse events (13.5%), of which conjunctivitis (5.6%) and joint pain (2.2%) were most common. There were no serious adverse events.

CONCLUSIONS

Dupilumab was well-tolerated and effective in treating pediatric and adolescent AD regardless of age, sex, race, or ethnicity.

摘要

背景

在临床试验中,度普利尤单抗已被证明在儿童和青少年特应性皮炎(AD)患者中安全且有效。然而,仍需要在儿科 AD 人群中进行全面的真实世界研究。

目的

描述在皮肤科随访评估中,接受度普利尤单抗治疗的儿童和青少年 AD 患者的长期治疗反应和不良事件。

方法

我们回顾了 2017 年 3 月至 2021 年 9 月间开始接受度普利尤单抗治疗且年龄小于 18 岁的中重度 AD 患者的电子病历。收集了人口统计学数据、AD 评分(体表面积[BSA]、湿疹面积和严重程度指数[EASI]和研究者整体评估[IGA])以及安全性数据。

结果

共纳入 89 例患者,其中女性 50 例(56.2%),男性 39 例(43.8%)。平均(±SD)治疗持续时间为 1.3(±0.9)年。其中,73 例患者在基线和 12-24 周时进行了评分评估。BSA、EASI 和 IGA 的平均(±SD)改善率分别为 63.1%(±29.2%)、39.6%(±29.9%)和 59.6%(±30.7%)。所有接受度普利尤单抗治疗 1 年或以上的患者(n=23)均达到 EASI 改善 75%和 IGA 0/1,60.8%的患者达到 EASI 改善 90%。特应性疾病的阳性病史与 12-24 周时 BSA 的改善百分比更高相关(P<0.05)。12 例患者发生不良事件(13.5%),其中结膜炎(5.6%)和关节痛(2.2%)最常见。无严重不良事件发生。

结论

无论年龄、性别、种族或民族如何,度普利尤单抗治疗儿童和青少年 AD 均具有良好的耐受性和有效性。

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