Evidence map›Paper›PMID 38175364›Full record

ArticleDermatology and therapy2024

Real-World Effectiveness of Dupilumab in Adult and Adolescent Patients with Atopic Dermatitis: 2-Year Interim Data from the PROSE Registry.

Eric L Simpson, Ben Lockshin, Lara Wine Lee, Zhen Chen, Moataz Daoud, Andrew Korotzer

Erratum issued Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03428646 (A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03428646 active not recruitingnot on this map

A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis

Typeobservational_patient_registrySponsorRegeneron PharmaceuticalsRan2018 to 2027Enrolled858ConditionsDermatitis, AtopicArmsDupilumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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  7. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Eric L SimpsonDepartment of Dermatology, Oregon Health and Science University, Portland, OR, USA. simpsone@ohsu.edu.ORCID http://orcid.org/0000-0003-0853-0252
Ben LockshinDepartment of Dermatology, Georgetown University, Washington, DC, USA.ORCID http://orcid.org/0000-0001-9256-1814
Lara Wine LeeMedical University of South Carolina, Charleston, SC, USA.ORCID http://orcid.org/0000-0001-6739-4508
Zhen ChenRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Moataz DaoudSanofi, Cambridge, MA, USA.
Andrew KorotzerRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Regeneron (United States) · USGeorgetown University · USMedical University of South Carolina · USOregon Health & Science University · USSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is a scarcity of data beyond 1 year for the use of dupilumab to treat atopic dermatitis (AD) in a real-world setting. This study aimed to evaluate the 2-year effectiveness of dupilumab among adult and pediatric patients with moderate-to-severe AD included in a real-world, longitudinal database study.

methodsPROSE is an ongoing, prospective, observational, multi-center registry in the USA and Canada, designed to collect real-world data from patients aged ≥ 12 years with moderate-to-severe AD who initiate dupilumab in accordance with country-specific prescribing information. Assessments include body surface area affected by AD (BSA), Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (P-NRS), Patient-Oriented Eczema Measure (POEM), Patient Global Assessment of Disease (PGAD) questionnaire score, and occurrence of adverse events (AEs).

resultsOf 764 patients who enrolled in PROSE, 632 (83%) remained in the study at the time of this interim analysis. Improvements were observed at the first post-baseline clinic visit (approximately 3 months) in the clinician-assessed measures (mean BSA and EASI scores); improvements were sustained throughout the 2-year period covered in the present study. Consistent and sustained improvements were also observed over the 2-year period in the patient-reported measures of P-NRS, POEM, and DLQI, and in the proportion of patients reporting "very good/excellent" in answer to the question in the PGAD questionnaire: "Considering all the ways in which your eczema affects you, indicate how well you are doing". Dupilumab treatment was well tolerated, with safety findings consistent with those previously reported in studies of dupilumab for the treatment of AD.

conclusionsIn the real-world PROSE registry, patients with moderate-to-severe AD experienced sustained improvement in disease control, symptoms, and quality of life up to 2 years after initiating dupilumab treatment. Safety data were consistent with the known safety profile of dupilumab.

trial registrationClinicalTrials.gov identifier: NCT03428646. Video abstract (MP4 20,717 kb).

Indexed as

Atopic dermatitisDisease controlDupilumabEfficacyHealth-related quality of lifePatient-reported outcomesReal-world studySafety

Identifiers

PMID38175364
PMCPMC10828305
OpenAlexW4390590043

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.