Bhatia Neal, Lynde Charles W, Fonacier Luz, Shao Liyang, Korotzer Andrew, Bosman Kwinten
Therapeutics Clinical Research, San Diego, CA, USA.
University of Toronto, Markham, ON, Canada.
Dermatol Ther (Heidelb). 2025 Jun;15(6):1523-1531. doi: 10.1007/s13555-025-01395-1. Epub 2025 Apr 15.
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.
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).
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.
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.
ClinicalTrials.gov identifier: NCT03428646.
特应性皮炎（AD）是一种慢性复发性疾病，可在任何年龄发病，对生活质量有重大负面影响，包括严重的瘙痒负担。在此，我们报告在一项真实世界研究中，年龄≥12岁的中度至重度AD患者在开始使用度普利尤单抗治疗后长达3年的时间里，通过峰值瘙痒数字评定量表（PP-NRS）测量达到瘙痒完全/几乎完全缓解的患者比例，以及总体疾病严重程度评分（ODS）的改善情况。
PROSE是美国和加拿大一项正在进行的前瞻性、观察性、多中心注册研究，收集年龄≥12岁、根据特定国家处方信息开始使用度普利尤单抗的中度至重度AD患者的真实世界数据。评估包括患者报告的PP-NRS（范围0-10）和临床医生测量的ODS评分（范围0-4）。
共纳入857例患者，其中42%为男性，6.4%为年龄≥12至<18岁的青少年。平均[标准差（SD）]年龄为40.1（17.9）岁，AD病程为17.4（16.2）年。随后度普利尤单抗治疗的平均（SD）持续时间为23.1（13.7）个月。达到瘙痒完全/几乎完全缓解（PP-NRS评分为0或1）的患者比例随时间持续改善，从基线时的2.7%（17/622）升至3年时的56.3%（58/103）。此外，到第3年时，65.1%（54/83）的患者ODS评分为无/最小疾病（评分为0或1），而基线时为2.2%（19/852）。
在PROSE注册研究的这一真实世界背景下，年龄≥12岁的中度至重度AD成年和青少年患者在开始度普利尤单抗治疗后长达3年的随访中，使用PP-NRS 0或1以及ODS
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