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. 2025 Jun;15(6):1523-1531.
doi: 10.1007/s13555-025-01395-1. Epub 2025 Apr 15.

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  1 , Charles W Lynde  2   3 , Luz Fonacier  4   5 , Liyang Shao  6 , Kwinten Bosman  7 , Andrew Korotzer  6
Affiliations

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 et al. Dermatol Ther (Heidelb). 2025 Jun.

Erratum in

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.

Keywords: Atopic dermatitis; Disease control; Dupilumab; Efficacy; Patient-reported outcomes; Real-world study; Safety.

Plain language summary

Atopic dermatitis (AD) is a long-term condition with rashes, inflammation and intense itching that disturbs sleep and daily activities. Dupilumab is used to treat AD when topical medications are not adequate. Our aim was to find out how many patients showed no or minimal itch and AD severity when patients use dupilumab over the long term in the real world. The PROSE real-world registry collected information on 857 adults and adolescents with AD who were prescribed dupilumab by their doctors. Patients in the registry reported their itch weekly on a scale from 0 (no itch) to 10 (worst possible itch). At the study start, and up to 36 months later, their doctor graded the severity of their AD from 0 (no disease) to 4 (severe disease). We measured how many PROSE patients had no/minimal itch and AD severity (in both cases, scores of 0 or 1) for up to 3 years after they started dupilumab treatment. At the study start, 2.7% of the patients had no or minimal itch. For those patients still being observed after 36 months (about 12% of the starting sample), 56.3% of the patients had no or almost no itch; the severity of AD improved similarly. These results show that many patients with AD receiving dupilumab can experience complete or almost complete itch and/or AD relief, although other medications could also have helped these patients improve. Our results are useful for doctors treating AD.

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Conflict of interest statement

Declarations. Conflict of interest: Neal Bhatia reports advisor or consultant funding from AbbVie, Advanced Derm Solutions, Almirall, Arcutis, Beiersdorf, Biofrontera, BMS, BI, Ferndale, Galderma, Incyte, ISDIN, J&J, La Roche-Posay, LEO, Lilly, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharma and Verrica. Charles W Lynde is an advisor, consultant and speaker for AbbVie, Altius Pharmaceuticals, Amgen, Aralez Bio, Arcutis Antiobix, Bausch Health, Bayer, BMS, BI, Cipher Pharmaceuticals, Dermavant, Fresenius Kabi, Galderma, GSK, Innovaderm, Intega, Janssen, Kyowa Kirin, La Roche-Posay, LEO Pharma, Lilly, L’Oreal, Medexus, Merck, Pediapharm, Pfizer, Procter & Gamble, Regeneron Pharmaceuticals Inc., Roche, Sanofi, Sentrex Health Solutions, Skin, Teva, Tribute Pharmaceuticals, UCB, Valeant and Viatris. Luz Fonacier reports research and educational grants (made to NYU Langone Hospital–Long Island) from AstraZeneca, Pfizer and Regeneron Pharmaceuticals Inc.; is an advisory board/consultant for AbbVie, LEO Pharma, Lilly, Pfizer and Regeneron Pharmaceuticals Inc.; was the past President (2020–2021) of American College of Allergy, Asthma & Immunology; is the Chair (2021) of American Board of Allergy and Immunology (ABAI); was the past President (2008–2010) of Long Island Allergy Society; was the past President of International Association of Filipino Allergists and Immunologists. Liyang Shao and Andrew Korotzer are employees and shareholders of Regeneron Pharmaceuticals Inc. Kwinten Bosman is an employee and a shareholder. Ethical approval: The study received approval from the Institutional Review Board/Ethics Committee. All patients provided informed consent, and patient data were anonymized in compliance with the HIPAA.

Figures

Fig. 1
Fig. 1
Assessment of PP-NRS and ODS over 36 months following initiation of dupilumab treatment. Data are presented for all patients with data at each time point. a PP-NRS score of 0/1 (complete/near-complete itch resolution) over time, b ODS of 0/1 over time. ODS Overall Disease Severity, PP-NRS Peak Pruritus Numeric Rating Scale
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