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度普利尤单抗治疗特应性皮炎:来自捷克共和国BIOREP注册研究的真实世界数据。

Dupilumab for the treatment of atopic dermatitis: real-world data from the Czech Republic BIOREP registry.

作者信息

Kojanova Martina, Tanczosova Milena, Strosova Daniela, Cetkovska Petra, Fialova Jorga, Dolezal Tomas, Machovcova Alena, Gkalpakiotis Spyridon

机构信息

Department of Dermatovenereology, First Faculty of Medicine, General University Hospital, Charles University, Prague, Czechia.

Department of Dermatovenereology, Third Faculty of Medicine, Charles University, Kralovske Vinohrady University Hospital, Prague, Czechia.

出版信息

J Dermatolog Treat. 2022 Aug;33(5):2578-2586. doi: 10.1080/09546634.2022.2043545. Epub 2022 Feb 21.

Abstract

BACKGROUND

Dupilumab has been approved to treat moderate-to-severe atopic dermatitis; however, the data in a real-world setting are still limited.

OBJECTIVE

To analyze the effectiveness and safety of dupilumab.

METHODS

This was a real-life Czech multicenter retrospective study from patients treated with dupilumab for severe AD.

RESULTS

A total of 360 patients were included. At 16 weeks, 66.6, 34.1, and 5.5% of patients achieved EASI75/90 and EASI100, respectively. Improvement continued with the time, and the proportion of patients with EASI75/90 and EASI100 increased to 89.5, 55.6, and 12.9% after one year of treatment and reached 95.8, 60.4, and 27.1% in the second year of therapy, respectively. A significant reduction was observed in the DLQI scores. The most common adverse events were infections in 5.8% of patients, followed by ocular complications in 2.5% of patients. Persistence rates were 98.2% at four months to 93.1% at month 24, and lack of effectiveness was the most common reason for discontinuation.

CONCLUSION

This real-life study confirmed the effectiveness and safety of dupilumab in a real-life setting during the COVID-19 pandemic. Our study revealed a higher frequency of infections and a lower conjunctivitis frequency than other real-life studies and clinical trials.

摘要

背景

度普利尤单抗已被批准用于治疗中重度特应性皮炎;然而,真实世界中的数据仍然有限。

目的

分析度普利尤单抗的有效性和安全性。

方法

这是一项来自捷克的多中心真实生活回顾性研究,纳入接受度普利尤单抗治疗的重度特应性皮炎患者。

结果

共纳入360例患者。在16周时,分别有66.6%、34.1%和5.5%的患者达到EASI75/90及EASI100。随着时间推移改善持续,治疗一年后达到EASI75/90及EASI100的患者比例分别增至89.5%、55.6%和12.9%,在治疗第二年分别达到95.8%、60.4%和27.1%。DLQI评分显著降低。最常见的不良事件是5.8%的患者发生感染,其次是2.5%的患者出现眼部并发症。持续率在4个月时为98.2%,至24个月时为93.1%,无效是最常见的停药原因。

结论

这项真实生活研究证实了度普利尤单抗在COVID-19大流行期间真实世界环境中的有效性和安全性。我们的研究显示,与其他真实生活研究和临床试验相比,感染发生率更高,结膜炎发生率更低。

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