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128 例 6 岁及以上特应性皮炎及相关疾病患者使用度普利尤单抗的长期真实世界不良反应经验:来自单一三级护理中心的回顾性图表分析。

Long-term real-world experience of the side effects of dupilumab in 128 patients with atopic dermatitis and related conditions aged 6 years and above: Retrospective chart analysis from a single tertiary care center.

机构信息

Department of Dermatology, Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates.

Department of Dermatology, Thumbay Hospital, Ajman, United Arab Emirates.

出版信息

Dermatol Ther. 2022 May;35(5):e15415. doi: 10.1111/dth.15415. Epub 2022 Mar 9.

Abstract

Dupilumab is a monoclonal antibody against interleukins 4 and 13 currently FDA approved for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents and severe AD in children aged 6-11 years. It is reported to be safe with the most common side effects described from clinical trials being conjunctivitis, nasopharyngitis and injection site reactions. Outside the clinical trial setting, there is insufficient data on the side effects of dupilumab in adults with AD, and much less among children and adolescents. The aim of this study was to analyze the spectrum of side effects in all patients receiving dupilumab for the treatment of AD and related conditions in a real-world setting at a single tertiary referral center, and correlate any risk factors for the development of these side effects. A retrospective review of electronic medical records was conducted for all patients who had received dupilumab for a minimum of 2 months for the treatment of AD and related conditions in the department of dermatology at Rashid hospital, Dubai from February 2018 to November 2021. We analyzed the medical records of 128 patients who received dupilumab according to standard age-related dosing. This included 78 adults (age range 18-81 years) and 50 children and adolescents (aged 6-17 years). There were 73 males and 55 females. The mean duration of dupilumab treatment was 14.9 months. The most common side effects encountered during dupilumab therapy were head and neck dermatitis in 25 (19.5%), conjunctivitis in 20 (15.6%), erythema, pruritus and peeling of skin in 14 (10.9%) and dryness of eyes in 10 (7.8%) patients, respectively. Overall, dupilumab was well-tolerated in our patient population. Most of the side effects were mild and did not require discontinuation of dupilumab. These findings would enable dermatologists understand the side effects of dupilumab better, resulting in improved treatment plan decisions in clinical practice.

摘要

度普利尤单抗是一种针对白细胞介素 4 和 13 的单克隆抗体,目前已获得美国食品药品监督管理局(FDA)批准,用于治疗成人和青少年中重度特应性皮炎(AD)和 6-11 岁重度 AD。临床试验报告显示其安全性良好,最常见的副作用为结膜炎、鼻咽炎和注射部位反应。在临床试验之外,AD 成人使用度普利尤单抗的副作用数据不足,儿童和青少年的相关数据则更少。本研究旨在分析在单一三级转诊中心的真实环境中,所有接受度普利尤单抗治疗 AD 及相关疾病的患者的副作用谱,并分析这些副作用发生的相关风险因素。回顾性分析 2018 年 2 月至 2021 年 11 月皮肤科接受度普利尤单抗治疗的至少 2 个月的 AD 及相关疾病患者的电子病历。我们根据与年龄相关的标准剂量分析了 128 名接受度普利尤单抗治疗的患者的病历。这包括 78 名成人(年龄 18-81 岁)和 50 名儿童和青少年(6-17 岁)。其中 73 名男性,55 名女性。度普利尤单抗治疗的平均持续时间为 14.9 个月。度普利尤单抗治疗期间最常见的副作用包括头颈部皮炎 25 例(19.5%)、结膜炎 20 例(15.6%)、红斑、瘙痒和皮肤剥落 14 例(10.9%)和眼睛干燥 10 例(7.8%)。总体而言,度普利尤单抗在我们的患者群体中耐受性良好。大多数副作用为轻度,无需停用度普利尤单抗。这些发现将使皮肤科医生更好地了解度普利尤单抗的副作用,从而在临床实践中做出更好的治疗计划决策。

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