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度普利尤单抗治疗特应性皮炎患者:荷兰和日本的对比队列研究显示患者报告结局测量存在差异。

Dupilumab treatment in patients with atopic dermatitis: a comparative cohort study between the Netherlands and Japan shows a discrepancy in patient-reported outcome measures.

机构信息

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

Department of Dermatology, Osaka Habikino Medical Center, Habikino, Osaka, Japan.

出版信息

Br J Dermatol. 2021 Sep;185(3):555-562. doi: 10.1111/bjd.19897. Epub 2021 Jun 8.

DOI:10.1111/bjd.19897
PMID:33657668
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8453550/
Abstract

BACKGROUND

Dupilumab was equally effective among all racial subgroups in clinical trials, but a direct comparison in daily practice is lacking.

OBJECTIVES

To investigate the effectiveness of dupilumab in patients with atopic dermatitis (AD) in the Netherlands and Japan over 80 weeks of treatment.

METHODS

A longitudinal comparative cohort study was conducted in patients with AD who were treated with dupilumab in daily practice. We used linear mixed-effects models to determine changes over time.

RESULTS

We found statistically significant differences in sex, disease onset, body mass index and therapeutic history between Dutch (n = 208) and Japanese (n = 153) patients. The baseline Eczema Area and Severity Index (EASI) score was higher in Japanese patients (23·8 vs. 14·8), while baseline Patient-Reported Outcome Measures (PROMs) were higher in Dutch patients. EASI scores decreased quickly to a level indicating 'mild disease' (EASI < 7), and remained low in both countries. However, PROMs showed different trajectories with better scores in Japan.

CONCLUSIONS

Dupilumab showed significant, comparable and sustained improvement of EASI scores in Japanese and Dutch patients. However, we found striking differences in the effect on PROMs between the countries, with a better outcome in Japanese patients.

摘要

背景

度普利尤单抗在临床试验中的所有种族亚组中均具有同等疗效,但在日常实践中缺乏直接比较。

目的

在荷兰和日本,评估度普利尤单抗治疗特应性皮炎(AD)患者 80 周的疗效。

方法

对在日常实践中接受度普利尤单抗治疗的 AD 患者进行了一项纵向比较队列研究。我们使用线性混合效应模型来确定随时间的变化。

结果

我们发现荷兰(n=208)和日本(n=153)患者在性别、发病年龄、体重指数和治疗史方面存在统计学差异。日本患者的基线湿疹面积和严重程度指数(EASI)评分较高(23.8 vs. 14.8),而荷兰患者的基线患者报告结局(PROMs)评分较高。EASI 评分迅速下降至表明“轻度疾病”的水平(EASI<7),且在两个国家均保持较低水平。然而,PROMs 显示出不同的轨迹,日本患者的评分更好。

结论

度普利尤单抗在日本和荷兰患者中均显著改善 EASI 评分,且疗效持久。然而,我们发现两国在 PROMs 方面的效果存在显著差异,日本患者的结果更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57a7/8453550/fbacb5ce30ad/BJD-185-555-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57a7/8453550/fbacb5ce30ad/BJD-185-555-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57a7/8453550/fbacb5ce30ad/BJD-185-555-g001.jpg

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本文引用的文献

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2
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J Am Acad Dermatol. 2020 Nov;83(5):1375-1384. doi: 10.1016/j.jaad.2020.05.128. Epub 2020 May 30.
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Long-term Remission of Atopic Dermatitis after Discontinuation of Dupilumab.
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Acta Derm Venereol. 2022 Jun 9;102:adv00731. doi: 10.2340/actadv.v102.295.
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Impact on health-related quality of life and symptoms of anxiety and depression after 32 weeks of Dupilumab treatment for moderate-to-severe atopic dermatitis.在中重度特应性皮炎患者接受达必妥治疗 32 周后,对健康相关生活质量和焦虑及抑郁症状的影响。
Dermatol Ther. 2022 May;35(5):e15407. doi: 10.1111/dth.15407. Epub 2022 Mar 3.
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