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度普利尤单抗治疗特应性皮炎患者的长期疗效和安全性:荷兰特应性皮炎治疗登记研究(TREAT NL)的结果。

Long-term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: Results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry.

机构信息

Department of Dermatology, Amsterdam Public Health, Immunity and Infections, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, the Netherlands.

Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

出版信息

J Am Acad Dermatol. 2020 Nov;83(5):1375-1384. doi: 10.1016/j.jaad.2020.05.128. Epub 2020 May 30.

DOI:10.1016/j.jaad.2020.05.128
PMID:32485210
Abstract

BACKGROUND

Evidence on long-term dupilumab treatment for atopic dermatitis in daily practice is lacking.

OBJECTIVE

To investigate patient characteristics, treatment aspects, effectiveness, and safety of up to 84 weeks of dupilumab treatment.

METHODS

An observational prospective cohort study was conducted of patients with atopic dermatitis starting dupilumab in routine clinical care.

RESULTS

Of the 221 included patients, 103 used systemic therapy at baseline. At 84 weeks, we found a change of -15.2 (SE, 1.7) for the Eczema Area and Severity Index, -16.9 (SE, 1.4) for the Patient-Oriented Eczema Measure, and -17.2 (SE, 1.6) for the Dermatology Life Quality Index. We found a trend for improvement over time for the Investigator Global Assessment and Numerical Rating Scale for pruritus. Severe (n = 79) including serious (n = 11) adverse events were observed in 69 patients. Eye complaints were most frequently reported (n = 46). Twenty-one patients adjusted the regular dosing schedule, and 14 patients discontinued treatment, mainly due to ineffectiveness (n = 7).

LIMITATIONS

Only adverse events of severe and serious nature were registered for feasibility reasons.

CONCLUSION

Daily practice dupilumab treatment of up to 84 weeks is generally well-tolerated, apart from the reporting of eye complaints. It can be considered a long-term effective treatment for atopic dermatitis in combination with topical and initial concomitant systemic treatment, showing a sustained improvement of signs, symptoms, and quality of life.

摘要

背景

缺乏关于变应性湿疹患者长期接受度普利尤单抗治疗的证据。

目的

调查度普利尤单抗治疗高达 84 周的患者特征、治疗方案、疗效和安全性。

方法

对开始接受度普利尤单抗常规临床治疗的特应性皮炎患者进行了一项观察性前瞻性队列研究。

结果

在 221 名入组患者中,103 名患者在基线时使用了全身治疗。84 周时,我们发现 Eczema Area and Severity Index 下降了-15.2(SE,1.7),Patient-Oriented Eczema Measure 下降了-16.9(SE,1.4),Dermatology Life Quality Index 下降了-17.2(SE,1.6)。我们发现研究者整体评估和瘙痒数字评分量表在时间上呈改善趋势。69 例患者中观察到 79 例(包括 11 例严重)严重(n=79)包括严重(n=11)不良事件。最常报告的是眼部投诉(n=46)。21 名患者调整了常规剂量方案,14 名患者因无效(n=7)而停止治疗。

局限性

仅为可行性原因而登记严重和严重性质的不良事件。

结论

除眼部投诉外,84 周的日常实践度普利尤单抗治疗通常耐受性良好。它可以被认为是一种有效的长期治疗特应性皮炎的方法,与局部和初始联合全身治疗相结合,可持续改善体征、症状和生活质量。

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