Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial.
J Am Acad Dermatol
; 83(5): 1282-1293, 2020 Nov.
Article
em En
| MEDLINE
| ID: mdl-32574587
ABSTRACT
BACKGROUND:
Children with severe atopic dermatitis (AD) have limited treatment options.OBJECTIVE:
We report the efficacy and safety of dupilumab + topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies.METHODS:
In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 111 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight <30 kg; 200 mg q2w, baseline weight ≥30 kg), or placebo; with concomitant medium-potency TCS.RESULTS:
Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1; 69.7%, 67.2%, and 26.8% achieved ≥75% improvement in Eczema Area and Severity Index scores; and 50.8%, 58.3%, and 12.3% achieved ≥4-point reduction in worst itch score. Response to therapy was weight-dependent optimal dupilumab doses for efficacy and safety were 300 mg q4w in children <30 kg and 200 mg q2w in children ≥30 kg. Conjunctivitis and injection-site reactions were more common with dupilumab + TCS than with placebo + TCS.LIMITATIONS:
Short-term 16-week treatment period; severe AD only.CONCLUSION:
Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Corticosteroides
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Dermatite Atópica
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Anticorpos Monoclonais Humanizados
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Child
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Female
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Humans
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Male
Idioma:
En
Revista:
J Am Acad Dermatol
Ano de publicação:
2020
Tipo de documento:
Article