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使用度普利尤单抗治疗的特应性皮炎患者的银屑病风险

Psoriasis Risk in Patients With Atopic Dermatitis Treated With Dupilumab.

作者信息

Lin Teng-Li, Fan Yi-Hsuan, Fan Kuo-Sheng, Juan Chao-Kuei, Chen Yi-Ju, Wu Chun-Ying

机构信息

Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.

PhD Program of Interdisciplinary Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.

出版信息

JAMA Dermatol. 2025 Jun 18. doi: 10.1001/jamadermatol.2025.1578.

Abstract

IMPORTANCE

Patients with atopic dermatitis (AD) have been reported to develop psoriasis during dupilumab treatment. Whether this represents a true association or an incidental event remains unclear.

OBJECTIVE

To compare psoriasis risk in patients with AD who are prescribed dupilumab vs other systemic agents.

DESIGN, SETTING, AND PARTICIPANTS: This population-based retrospective cohort study with 3-year follow-up, with analyses completed on October 19, 2024, included 214 430 adult patients with AD from the TriNetX Global Collaborative Network. Individuals newly prescribed dupilumab (dupilumab cohort) and those newly prescribed the other systemic agents without dupilumab exposure (control cohort) were included. Propensity score matching at a 1:1 ratio based on age, sex, race, comorbidities, laboratory measurements, and prior medications was conducted.

EXPOSURES

Dupilumab vs the other systemic agents (corticosteroids, methotrexate, cyclosporine, azathioprine, or mycophenolate mofetil).

MAIN OUTCOMES AND MEASURES

The primary outcome was incident psoriasis. Cumulative incidence was assessed using Kaplan-Meier plots and risks via Cox regression.

RESULTS

After matching, each cohort comprised 9860 patients, with 10 891 female individuals (55.2%), a mean (SD) age of 44.8 (20.3) years, 3582 African American or Black individuals (18.2%), 2004 Asian individuals (10.2%), and 9901 White individuals (50.2%). The 3-year cumulative psoriasis incidence was higher in the dupilumab cohort than the control cohort (2.86% vs 1.79%; P < .001). The number needed to harm for psoriasis was 94 for dupilumab vs the other systemic agents. The dupilumab cohort showed an increased risk for psoriasis (hazard ratio [HR], 1.58; 95% CI, 1.25-1.99), although the risk for psoriatic arthritis was not significant (HR, 1.97; 95% CI, 0.75-5.18). This increased risk was also observed in various AD subgroups, including those without atopic comorbidities (HR, 1.42; 95% CI, 1.06-1.89) or with pretreatment immunoglobulin E levels less than 0.048 mg/dL (to convert to mg/L, multiply by 10; HR, 1.59; 95% CI, 1.26-2.01). The association between dupilumab and psoriasis was further supported by validation in patients with asthma without AD (HR, 2.13; 95% CI, 1.38-3.31).

CONCLUSIONS AND RELEVANCE

The results of this cohort study suggest that patients with AD who were prescribed dupilumab exhibited a higher relative risk of developing psoriasis compared with those receiving other systemic agents. Given an estimated number needed to harm of 94, the absolute risk may have limited clinical relevance and should be weighed against dupilumab's established efficacy in treating AD.

摘要

重要性

据报道,特应性皮炎(AD)患者在使用度普利尤单抗治疗期间会出现银屑病。这是一种真正的关联还是偶然事件尚不清楚。

目的

比较接受度普利尤单抗治疗的AD患者与接受其他全身用药的患者患银屑病的风险。

设计、背景和参与者:这项基于人群的回顾性队列研究,随访3年,于2024年10月19日完成分析,纳入了来自TriNetX全球合作网络的214430例成年AD患者。纳入新使用度普利尤单抗的个体(度普利尤单抗队列)和新使用其他未接触过度普利尤单抗的全身用药的个体(对照队列)。根据年龄、性别、种族、合并症、实验室检查结果和既往用药情况进行1:1倾向得分匹配。

暴露因素

度普利尤单抗与其他全身用药(皮质类固醇、甲氨蝶呤、环孢素、硫唑嘌呤或霉酚酸酯)。

主要结局和测量指标

主要结局是银屑病的发生。使用Kaplan-Meier曲线评估累积发病率,并通过Cox回归分析风险。

结果

匹配后,每个队列包括9860例患者,其中女性10891例(55.2%),平均(标准差)年龄44.8(20.3)岁,非裔美国人或黑人3582例(18.2%),亚洲人2004例(10.2%),白人9901例(50.2%)。度普利尤单抗队列的3年银屑病累积发病率高于对照队列(2.86%对1.79%;P <.001)。度普利尤单抗与其他全身用药相比,导致银屑病发生的伤害所需人数为94。度普利尤单抗队列患银屑病的风险增加(风险比[HR],1.58;95%置信区间,1.25 - 1.99),尽管银屑病关节炎的风险不显著(HR,1.97;95%置信区间,0.75 - 5.18)。在各种AD亚组中也观察到这种风险增加,包括那些没有特应性合并症的亚组(HR,1.42;95%置信区间,1.06 - 1.89)或治疗前免疫球蛋白E水平低于0.048 mg/dL(换算为mg/L需乘以10;HR,1.59;95%置信区间,1.26 - 2.01)。在无AD的哮喘患者中进行验证进一步支持了度普利尤单抗与银屑病之间的关联(HR,2.13;95%置信区间,1.38 - 3.31)。

结论和相关性

这项队列研究的结果表明,与接受其他全身用药的患者相比,接受度普利尤单抗治疗的AD患者患银屑病的相对风险更高。鉴于估计伤害所需人数为94,绝对风险可能在临床相关性方面有限,应与度普利尤单抗在治疗AD方面已确立的疗效相权衡。

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