Evidence map›Paper›PMID 35984627›Full record

ArticleDermatology and therapy2022

Dupilumab Treatment of Atopic Dermatitis in Routine Clinical Care: Baseline Characteristics of Patients in the PROLEAD Prospective, Observational Study.

Diamant Thaçi, Andrea Bauer, Ralph von Kiedrowski, Florian Schenck, Konstantin Ertner, Sophie Möller, Anja Fait, Mike Bastian, Matthias Augustin

Open access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Observational
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Diamant ThaçiInstitute and Comprehensive Centre for Inflammatory Medicine, University of Luebeck, Ratzeburger Alee 160, 23538, Luebeck, Germany. Diamant.Thaci@uksh.de.ORCID http://orcid.org/0000-0001-8513-550X
Andrea BauerDepartment of Dermatology, University Allergy Center, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany.
Ralph von KiedrowskiCompany for Medical Study & Service Selters GmbH and Dermatology Practice Dr von Kiedrowski, Selters, Westerwald, Germany.
Florian SchenckHautärzte Zentrum Hannover, Hannover, Germany.
Konstantin ErtnerHautarztpraxis Dr Ertner, Nürnberg, Germany.
Sophie MöllerSanofi, Berlin, Germany.
Anja FaitSanofi, Frankfurt, Germany.
Mike BastianSanofi, Frankfurt, Germany.ORCID http://orcid.org/0000-0001-8347-7426
Matthias AugustinInstitute of Health Care Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID http://orcid.org/0000-0002-4026-8728
Sanofi (Germany) · DEUniversität Hamburg · DEUniversity Hospital Carl Gustav Carus · DEUniversity of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDupilumab is the first biologic licensed to treat patients with moderate-to-severe atopic dermatitis (AD) who require systemic therapy. PROLEAD was designed to document the real-world effectiveness and safety of dupilumab in patients with moderate-to-severe AD. The present study aims to describe the baseline characteristics of patients treated with dupilumab in Germany.

methodsPROLEAD is a national, multicentre, prospective, non-interventional study, with a 2-year observation period. Adults with moderate-to-severe AD treated with dupilumab were included. Baseline characteristics, physician assessments, and patient-reported outcomes (PROs) were collected.

resultsThe study involved 126 sites throughout Germany. Of 839 patients assessed for eligibility, 828 were included, with baseline data available for 817 patients. Mean (standard deviation, SD) age of patients was 43.4 (15.8) years, with 396 (48.5%) patients being female. Overall, 66.6% of patients received their first diagnosis of AD during childhood. In total, 423 (51.8%) patients had co-existing atopic and type 2 inflammatory diseases, including allergic conjunctivitis (36.8%) and bronchial asthma (22.5%). Overall, 61.4% of patients had received systemic therapy, most commonly oral corticosteroids (49.9%). Approximately half of patients (51.3%) had received UV/phototherapy prior to baseline. Treatment with moderate-potent (Class 2) or potent (Class 3) topical corticosteroids was the most common concomitant treatment at baseline. However, 50.4% of patients had not received concomitant AD treatment with dupilumab at baseline. The most reported reason for initiating dupilumab was "Topical therapy alone was not sufficient" (95.1%). Mean (SD) physician assessments: EASI: 22.9 (14.5); SCORAD: 63.3 (16.2); IGA: 3.3 (0.7). Mean (SD) PROs: DLQI: 13.9 (7.1); peak pruritus NRS: 7.4 (2.3).

conclusionsPatients with moderate-to-severe AD present a long medical history, impaired quality of life, and high prevalence of co-existing type 2 inflammatory diseases. Dupilumab was used as a first-line systemic treatment in 38.6% of patients.

Indexed as

Atopic dermatitisBiologicDupliumabReal-world evidence

Identifiers

PMID35984627
PMCPMC9464282
OpenAlexW4292370206

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.