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度普利尤单抗在哥伦比亚中重度特应性皮炎成人患者中的有效性和安全性:真实世界经验

Effectiveness and safety of dupilumab in adults with moderate and severe atopic dermatitis in Colombia: Real-life experience.

作者信息

Londoño Julián, Perez Lucia, Moreno Sergio, Chapman Edgardo, Garcia María Beatriz, Celis Ana María, Muñoz María Angélica, Castillo David, Sánchez Jorge, Arevalo Yaicith, Lozano Ana, Alvis-Zakzuk Nelson J, Muñoz Cesar, Botero Laura, Beltran Catalina, García Elizabeth

机构信息

Allergy Research Group, UNIMEQ-ORL, Bogotá, Colombia.

School of Medicine, Universidad de Los Andes Bogotá, Colombia.

出版信息

World Allergy Organ J. 2023 Apr 5;16(4):100763. doi: 10.1016/j.waojou.2023.100763. eCollection 2023 Apr.

Abstract

BACKGROUND

Dupilumab is a treatment approved for uncontrolled moderate-to-severe atopic dermatitis (AD). Tropical and developing countries such as Colombia have characteristics that may impact the natural history of AD and access to medical treatments. In that sense, we aimed to describe the effectiveness and safety of dupilumab in adults with moderate to severe AD in a Colombian multicenter cohort.

METHODS

Multicenter descriptive study that included patients who started treatment between March 2018 and May 2020 in 6 centers. Disease severity was assessed using the following: Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), Patient Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). These measurements were collected according to availability at baseline, 3-5 months, 6-12 months, and more than 12 months. Days of sick leave, hospitalizations, and AD flares before and after dupilumab treatment were reported. Adverse events (AEs) were recorded during follow-up.

RESULTS

Ninety-three patients were included, with a median age of 32 years (IQR: 24.0; 40.0) and a disease evolution time of 21 years (IQR: 16.0; 29.5). 88.2% had at least 1 allergic disease other than AD. An improvement greater than or equal to 75% EASI was observed in 41.7% of patients at 3-5 months, in 73.7% of patients at 6-12 months, and in 75.0% of patients after 12 months. For those reporting SCORAD and POEM, the median percent change ([IQR], n) from baseline in SCORAD was -67.1 ([-79.2; -54.2], n = 16), -70.5 ([-85.8; -47.9], n = 36) and -66.7 ([-77.3; -51.0], n = 13); and POEM, -58.6 ([-66.4; -55.5], n = 4), -73.0 ([-86.5; -66.7], n = 16) and -87.3 ([-93.4; -69.6], n = 8), respectively. Before initiation of dupilumab treatment, 82 (88.2%) patients reported at least 1 flare of AD in the past 12 months. During the follow-up period, 30 (32.3%) patients reported at least 1 exacerbation or flare. Twelve patients (12.9%) presented an AE and 3 (3.2%) patients discontinued dupilumab for this cause.

CONCLUSIONS

Dupilumab was effective and safe for the treatment of moderate to severe AD in point-of-care settings, with results similar to randomized controlled and other real-life studies. These positive results are still maintained even though a high number of patients had short interruptions in the use of dupilumab due to administrative problems.

摘要

背景

度普利尤单抗是一种被批准用于治疗未控制的中度至重度特应性皮炎(AD)的药物。像哥伦比亚这样的热带和发展中国家具有一些可能影响AD自然病程及医疗治疗可及性的特征。从这个意义上讲,我们旨在描述度普利尤单抗在哥伦比亚一个多中心队列中治疗中度至重度AD成人患者的有效性和安全性。

方法

多中心描述性研究,纳入了2018年3月至2020年5月期间在6个中心开始治疗的患者。使用以下方法评估疾病严重程度:特应性皮炎评分(SCORAD)、湿疹面积和严重程度指数(EASI)、患者导向性湿疹测量(POEM)以及皮肤病生活质量指数(DLQI)。这些测量值根据基线、3 - 5个月、6 - 12个月以及12个月以上的可获得情况进行收集。报告了度普利尤单抗治疗前后的病假天数、住院次数和AD发作情况。在随访期间记录不良事件(AE)。

结果

纳入93例患者,中位年龄为32岁(四分位间距:24.0;40.0),疾病演变时间为21年(四分位间距:16.0;29.5)。88.2%的患者除AD外至少患有一种过敏性疾病。在3 - 5个月时,41.7%的患者观察到EASI改善大于或等于75%;在6 - 12个月时,73.7%的患者;在12个月后,75.0%的患者。对于报告了SCORAD和POEM的患者,SCORAD相对于基线的中位变化百分比([四分位间距],n)分别为 - 67.1([-79.2; - 54.2],n = 16)、 - 70.5([-85.8; - 47.9],n = 36)和 - 66.7([-77.3; - 51.0],n = 13);POEM分别为 - 58.6([-66.4; - 55.5],n = 4)、 - 73.0([-86.5; - 66.7],n = 16)和 - 87.3([-93.4; - 69.6],n = 8)。在开始度普利尤单抗治疗前,82(88.2%)例患者报告在过去12个月中至少有1次AD发作。在随访期间,30(32.3%)例患者报告至少有1次病情加重或发作。12例患者(12.9%)出现AE,3例患者(3.2%)因此停用度普利尤单抗。

结论

在即时医疗环境中,度普利尤单抗治疗中度至重度AD有效且安全,结果与随机对照研究及其他真实世界研究相似。即使大量患者因管理问题在使用度普利尤单抗时出现短暂中断,这些积极结果仍得以维持。

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