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.
Neal Bhatia, Charles W Lynde, Luz Fonacier, Liyang Shao, Andrew Korotzer, Kwinten Bosman
{"title":"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.","authors":"Neal Bhatia, Charles W Lynde, Luz Fonacier, Liyang Shao, Andrew Korotzer, Kwinten Bosman","doi":"10.1007/s13555-025-01395-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT03428646.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1523-1531"},"PeriodicalIF":3.5000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12092847/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01395-1","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
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.
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.