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度普利尤单抗在日常实践中对大量治疗抵抗的特应性皮炎患者显示出长期疗效:荷兰 BioDay 登记处的 52 周结果。

Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice: 52-Week results from the Dutch BioDay registry.

机构信息

National Expertise Center for Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, the Netherlands.

National Expertise Center for Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, the Netherlands.

出版信息

J Am Acad Dermatol. 2021 Apr;84(4):1000-1009. doi: 10.1016/j.jaad.2020.08.127. Epub 2020 Sep 16.

Abstract

BACKGROUND

Real-life data on long-term effectiveness and safety of dupilumab in atopic dermatitis patients are limited.

OBJECTIVE

To study 52-week effectiveness and safety of dupilumab in a prospective multicenter cohort of adult patients with treatment-refractory atopic dermatitis.

METHODS

Patients treated with dupilumab and participating in the Dutch BioDay registry were included. Clinical effectiveness and safety were evaluated.

RESULTS

Two hundred ten atopic dermatitis patients were included. Mean percentage change in Eczema Area and Severity Index score after 16 weeks was -70.0% (standard deviation 33.2%) and further decreased to -76.6% (standard deviation 30.6%) by week 52. A greater than or equal to 75% improvement in the score was achieved by 59.9% of individuals by week 16 and by 70.3% by week 52. The most reported adverse effect was conjunctivitis (34%). Limited patients (17; 8.1%) discontinued dupilumab treatment.

LIMITATIONS

Because of the lack of a control group and observational design, factors of bias may have been induced.

CONCLUSION

Treatment with dupilumab resulted in a rapid improvement in clinical outcome measures, and effectiveness further improved during the 52-week follow-up period.

摘要

背景

特应性皮炎患者使用度普利尤单抗的长期疗效和安全性的真实世界数据有限。

目的

研究度普利尤单抗在治疗抵抗性特应性皮炎成年患者前瞻性多中心队列中的 52 周疗效和安全性。

方法

纳入接受度普利尤单抗治疗并参与荷兰生物日登记的患者。评估临床疗效和安全性。

结果

纳入 210 例特应性皮炎患者。16 周后 Eczema Area and Severity Index 评分的平均百分比变化为-70.0%(标准差 33.2%),第 52 周时进一步降至-76.6%(标准差 30.6%)。16 周时,59.9%的患者评分改善≥75%,第 52 周时,70.3%的患者评分改善≥75%。报告最多的不良反应是结膜炎(34%)。有限的患者(17 例;8.1%)停止了度普利尤单抗治疗。

局限性

由于缺乏对照组和观察性设计,可能存在偏倚因素。

结论

度普利尤单抗治疗可迅速改善临床结局指标,且在 52 周随访期间疗效进一步改善。

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