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特应性皮炎成年患者中与度普利尤单抗相关的皮肤不良事件:一项回顾性研究。

Dupilumab-associated cutaneous adverse events among adult patients with atopic dermatitis: A retrospective study.

机构信息

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.

出版信息

J Dermatol. 2023 Jul;50(7):880-887. doi: 10.1111/1346-8138.16764. Epub 2023 Mar 13.

Abstract

Dupilumab, a monoclonal antibody inhibiting interleukin (IL) 4 and IL-13, is approved for the treatment of moderate to severe atopic dermatitis (AD) in children aged ≥6 years, adolescents, and adults. Both clinical trials and real-life data demonstrate its efficacy and safety. However, some cutaneous adverse events (cAEs) have been observed during real-world experiences. The authors' aim was to analyze the spectrum of cAEs in patients receiving dupilumab for the treatment of AD in a real-world setting. A retrospective review of electronic medical records was conducted for 916 patients (475 males and 541 females; mean age, 50.23 ± 19.66 years [range, 18-91 years]) who had received dupilumab for a minimum of 1 month for the treatment of AD from December 2018 to November 2022 at the Department of Dermatology of University Federico II of Naples (Italy). The mean duration of dupilumab treatment was 27.31 ± 21.26 months. A total of 148 of 916 (16.15%) (90 males; mean age, 50.91 ± 15.34 years) patients reported other cAEs apart of AD flare; namely, facial redness (82 of 916; 8.95%), psoriasis (39 of 916; 4.25%), alopecia areata (11 of 916; 1.2%), skin peeling (11 of 916; 1.2%), parapsoriasis (three of 916; 0.32%), and vitiligo (two of 916; 0.21%). Thirty-one of 916 (3.38%) patients discontinued dupilumab because of cAEs (18 of 916; 1.96%) for facial redness, 10 of 916 (1.09%) for psoriasis, and three of 916 (0.32%) for parapsoriasis. In our population, most of the cAEs were mild and did not require discontinuation of dupilumab. These findings would enable dermatologists understand the cutaneous 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抑制白细胞介素(IL)4 和 IL-13 的单克隆抗体,已获批用于治疗 6 岁及以上儿童、青少年和成人中重度特应性皮炎(AD)。临床试验和真实世界数据均证实了其疗效和安全性。然而,在真实世界的应用中观察到了一些皮肤不良反应(cAE)。作者旨在分析度普利尤单抗治疗 AD 患者的真实世界环境中 cAE 的谱。回顾性分析了 2018 年 12 月至 2022 年 11 月在那不勒斯费德里克二世大学皮肤科接受度普利尤单抗治疗 AD 的至少 1 个月的 916 例患者(475 例男性,541 例女性;平均年龄 50.23±19.66 岁[范围 18-91 岁])的电子病历。度普利尤单抗治疗的平均持续时间为 27.31±21.26 个月。916 例患者中有 148 例(16.15%)(90 例男性;平均年龄 50.91±15.34 岁)除 AD 发作外还报告了其他 cAE,包括面部发红(916 例中的 82 例[8.95%])、银屑病(916 例中的 39 例[4.25%])、斑秃(916 例中的 11 例[1.2%])、皮肤脱皮(916 例中的 11 例[1.2%])、类银屑病(916 例中的 3 例[0.32%])和白癜风(916 例中的 2 例[0.21%])。由于 cAE,31 例(3.38%)患者停止使用度普利尤单抗(18 例[1.96%]因面部发红,10 例[1.09%]因银屑病,3 例[0.32%]因类银屑病)。在我们的人群中,大多数 cAE 为轻度,不需要停止使用度普利尤单抗。这些发现将使皮肤科医生更好地了解度普利尤单抗的皮肤副作用,从而在临床实践中做出更好的治疗计划决策。

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