Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS.
CHRONOS
LIBERTY
SOLO
adolescents
adults
atopic dermatitis
dupilumab
itch
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
21
11
2019
revised:
21
01
2020
accepted:
03
02
2020
pubmed:
7
3
2020
medline:
22
1
2021
entrez:
6
3
2020
Statut:
ppublish
Résumé
Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD). To evaluate the timing and effect of dupilumab on itch. Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428). Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all). Short duration of monotherapy trials (16 weeks). Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.
Sections du résumé
BACKGROUND
BACKGROUND
Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD).
OBJECTIVE
OBJECTIVE
To evaluate the timing and effect of dupilumab on itch.
METHODS
METHODS
Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428).
RESULTS
RESULTS
Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all).
LIMITATIONS
CONCLUSIONS
Short duration of monotherapy trials (16 weeks).
CONCLUSION
CONCLUSIONS
Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.
Identifiants
pubmed: 32135208
pii: S0190-9622(20)30305-4
doi: 10.1016/j.jaad.2020.02.060
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Dermatologic Agents
0
dupilumab
420K487FSG
Banques de données
ClinicalTrials.gov
['NCT03054428']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1328-1336Informations de copyright
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.