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
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 r...
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Adis, Springer Healthcare
2025-04-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-025-01395-1 |
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| author | Neal Bhatia Charles W. Lynde Luz Fonacier Liyang Shao Kwinten Bosman Andrew Korotzer |
| author_facet | Neal Bhatia Charles W. Lynde Luz Fonacier Liyang Shao Kwinten Bosman Andrew Korotzer |
| author_sort | Neal Bhatia |
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| description | 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. Graphical Abstract |
| format | Article |
| id | doaj-art-9ef8d2a84f814d0e87f280c6651c8e2d |
| institution | Kabale University |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Adis, Springer Healthcare |
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| series | Dermatology and Therapy |
| spelling | doaj-art-9ef8d2a84f814d0e87f280c6651c8e2d2025-08-20T04:01:46ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722025-04-011561523153110.1007/s13555-025-01395-1Complete/Near-Complete Itch Response Observed in Patients with Moderate-to-Severe Atopic Dermatitis Initiating Dupilumab: 3-Year, Real-World, Interim Data from the PROSE RegistryNeal Bhatia0Charles W. Lynde1Luz Fonacier2Liyang Shao3Kwinten Bosman4Andrew Korotzer5Therapeutics Clinical ResearchUniversity of TorontoNew York University Langone Hospital-Long IslandRegeneron Pharmaceuticals, Inc.SanofiRegeneron Pharmaceuticals, Inc.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. Graphical Abstracthttps://doi.org/10.1007/s13555-025-01395-1Atopic dermatitisDisease controlDupilumabEfficacyPatient-reported outcomesReal-world study |
| spellingShingle | Neal Bhatia Charles W. Lynde Luz Fonacier Liyang Shao Kwinten Bosman Andrew Korotzer 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 Dermatology and Therapy Atopic dermatitis Disease control Dupilumab Efficacy Patient-reported outcomes Real-world study |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Atopic dermatitis Disease control Dupilumab Efficacy Patient-reported outcomes Real-world study |
| url | https://doi.org/10.1007/s13555-025-01395-1 |
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