Real-World Effectiveness and Safety of Dupilumab, Tralokinumab, and Upadacitinib in Patients with Atopic Dermatitis: A 52-Week International, Multicenter Retrospective Cohort Study.

IF 3.5 3区 医学 Q1 DERMATOLOGY
Tiago Torres, Jensen Yeung, Vimal H Prajapati, Simone Ribero, Anna Balato, Angelo Valerio Marzano, Maria João Cruz, Maria João Paiva Lopes, Elizabeth Lazaridou, Jose-Manuel Carrascosa, José Miguel Alvarenga, Pedro Farinha, Bruno Duarte, Monica Munera-Campos, Siddhartha Sood, Brian D Rankin, Michela Ortoncelli, Stefano Caccavale, Silvia Mariel Ferrucci, Gilberto Pires Rosa, Athina Ioanna Daponte, Gianmarco Silvi, Ketty Peris, Niccolò Gori, Francesca Prignano, Antonio Kolios, Pedro Herranz, Stamatios Gregoriou, Natalia Rompoti, Spyridon Gkalpakiotis, Andrea Chiricozzi
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引用次数: 0

Abstract

Introduction: Evaluating the real-world effectiveness, safety, and tolerability of targeted biologic and non-biologic therapies in patients with atopic dermatitis (AD) treated in routine clinical practice remains crucial. In this international, multicenter, retrospective, comparative study we aimed to evaluate the 52-week effectiveness, safety, and tolerability of dupilumab, tralokinumab, and upadacitinib in patients with AD aged ≥ 12 years.

Methods: Effectiveness was assessed at weeks 16, 24, and 52 using Eczema Area and Severity Index (EASI) and itch Numerical Rating Scale (NRS) scores. Safety was measured via adverse events (AEs).

Results: A total of 1286 treatment courses were included: 62.5% received dupilumab, 24.3% received upadacitinib, and 13.1% received tralokinumab. Upadacitinib demonstrated higher effectiveness than dupilumab and tralokinumab across all time points and most evaluated outcomes both on the overall population and the biologic-/JAKi-naïve population, including stringent treatment targets such as EASI 90 response and combined EASI 90 + itch NRS 0/1 response. While upadacitinib demonstrated superior effectiveness, it was associated with a higher incidence of AEs, both leading to and not leading to treatment discontinuation, including thromboembolic events, lipid abnormalities, and hematologic abnormalities. In contrast, conjunctivitis was the most frequently observed AE among patients receiving biologics.

Conclusion: This study provides a comprehensive real-world comparison of dupilumab, tralokinumab, and upadacitinib in AD, highlighting upadacitinib's superior effectiveness in achieving stringent treatment targets, both in the short and long term, but also a higher incidence of AEs. However, the considerable heterogeneity of the study population, an inherent limitation of real-world studies, must be acknowledged when interpreting these findings.

Dupilumab、Tralokinumab和Upadacitinib治疗特应性皮炎患者的有效性和安全性:一项为期52周的国际多中心回顾性队列研究
在常规临床实践中,评估靶向生物和非生物治疗对特应性皮炎(AD)患者的实际有效性、安全性和耐受性仍然至关重要。在这项国际、多中心、回顾性、比较研究中,我们旨在评估dupilumab、tralokinumab和upadacitinib在年龄≥12岁的AD患者中的52周有效性、安全性和耐受性。方法:采用湿疹面积和严重程度指数(EASI)和瘙痒数值评定量表(NRS)评分,在第16、24和52周评估疗效。通过不良事件(ae)来衡量安全性。结果:共纳入1286个疗程:62.5%的患者接受杜匹单抗治疗,24.3%的患者接受upadacitinib治疗,13.1%的患者接受曲罗单抗治疗。Upadacitinib在所有时间点显示出比dupilumab和tralokinumab更高的有效性,并且在总体人群和生物/JAKi-naïve人群中大多数评估结果,包括严格的治疗目标,如EASI 90反应和联合EASI 90 +瘙痒NRS 0/1反应。虽然upadacitinib显示出优越的疗效,但它与较高的不良事件发生率相关,导致或不导致治疗中断,包括血栓栓塞事件、脂质异常和血液学异常。相比之下,结膜炎是接受生物制剂的患者中最常见的AE。结论:本研究对dupilumab、tralokinumab和upadacitinib治疗AD进行了全面的现实对比,强调upadacitinib在实现严格的短期和长期治疗目标方面具有优越的有效性,但也具有更高的ae发生率。然而,在解释这些发现时,必须承认研究人群的相当大的异质性,这是现实世界研究的固有局限性。
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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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