Complete/Near-Complete Itch Response Observed in Patients with Moderate-to-Severe Atopic Dermatitis Initiating Dupilumab: 3-Year, Real-World, Interim Data from the PROSE Registry.

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2025-06-01 Epub Date: 2025-04-15 DOI:10.1007/s13555-025-01395-1
Neal Bhatia, Charles W Lynde, Luz Fonacier, Liyang Shao, Andrew Korotzer, Kwinten Bosman
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引用次数: 0

Abstract

Introduction: Atopic dermatitis (AD) is a chronic, relapsing disease that can start at any age and has a significant negative impact on quality of life, including a significant itch burden. Here we report the proportion of patients in a real-world study achieving a complete/almost complete resolution of itch, as measured by the Peak Pruritus Numeric Rating Scale (PP-NRS) and improvement in overall disease severity score (ODS), in patients aged ≥ 12 years with moderate-to-severe AD up to 3 years after commencing dupilumab treatment.

Methods: PROSE is an ongoing, prospective, observational, multicenter registry in the USA and Canada, collecting real-world data from patients aged ≥ 12 years with moderate-to-severe AD who initiated dupilumab in accordance with country-specific prescribing information. Assessments include patient-reported PP-NRS (range 0-10) and clinician-measured ODS score (range 0-4).

Results: A total of 857 patients were enrolled, of whom 42% were male and 6.4% were adolescents aged ≥ 12 to < 18 years. The mean [standard deviation (SD)] age was 40.1 (17.9) years, and the duration of AD was 17.4 (16.2) years. The subsequent mean (SD) duration of dupilumab treatment was 23.1 (13.7) months. The proportion of patients achieving complete/almost complete itch resolution (PP-NRS score of 0 or 1) improved consistently over time, from 2.7% (17/622) of patients at baseline to 56.3% (58/103) at 3 years. Additionally, by year 3, 65.1% (54/83) of patients had an ODS score of no/minimal disease (score of 0 or 1), versus 2.2% (19/852) at baseline.

Conclusions: In this real-world setting of the PROSE registry, adult and adolescent patients with moderate-to-severe AD followed up for up to 3 years after the initiation of dupilumab treatment experienced sustained and substantial improvement in pruritus and ODS, using the stringent endpoints of PP-NRS 0 or 1 and ODS 0 or 1.

Trial registration: ClinicalTrials.gov identifier: NCT03428646.

在中至重度特应性皮炎患者中观察到完全/接近完全瘙痒反应:来自PROSE注册中心的3年真实世界中期数据
特应性皮炎(AD)是一种慢性、复发性疾病,可在任何年龄开始,对生活质量有显著的负面影响,包括显著的瘙痒负担。在此,我们报告了在一项现实世界研究中,在开始杜匹单抗治疗3年后,年龄≥12岁的中度至重度AD患者中,通过峰值瘙痒数值评定量表(PP-NRS)和总体疾病严重程度评分(ODS)的改善,实现瘙痒完全/几乎完全解决的患者比例。方法:PROSE是一项在美国和加拿大进行的持续、前瞻性、观察性、多中心注册研究,收集年龄≥12岁的中重度AD患者的真实数据,这些患者根据国家特定的处方信息开始使用杜匹单抗。评估包括患者报告的PP-NRS(范围0-10)和临床测量的ODS评分(范围0-4)。结果:共有857名患者入组,其中42%为男性,6.4%为年龄≥12岁的青少年。结论:在PROSE注册的现实环境中,成人和青少年中重度AD患者在开始dupilumab治疗后随访长达3年,使用PP-NRS 0或1和ODS 0或1的严格终点,瘙痒和ODS持续且显著改善。试验注册:ClinicalTrials.gov标识符:NCT03428646。
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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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