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.

Administration, Topical Adrenal Cortex Hormones / administration & dosage Antibodies, Monoclonal, Humanized / administration & dosage Child Dermatitis, Atopic / drug therapy Double-Blind Method Drug Combinations Female Humans Male Prospective Studies Severity of Illness Index Treatment Outcome

atopic dermatitis children dupilumab pediatric severe

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:
Nov 2020

Historique:

received: 11 03 2020

revised: 18 05 2020

accepted: 12 06 2020

pubmed: 24 6 2020

medline: 10 4 2021

entrez: 24 6 2020

Statut: ppublish

Résumé

Children with severe atopic dermatitis (AD) have limited treatment options. 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. In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 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. 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. Short-term 16-week treatment period; severe AD only. Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.

Sections du résumé

BACKGROUND BACKGROUND

Children with severe atopic dermatitis (AD) have limited treatment options.

OBJECTIVE 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 METHODS

In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 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 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 CONCLUSIONS

Short-term 16-week treatment period; severe AD only.

CONCLUSION CONCLUSIONS

Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.

Identifiants

DOI: 10.1016/j.jaad.2020.06.054 PMID: 32574587

pubmed: 32574587

pii: S0190-9622(20)31152-X

doi: 10.1016/j.jaad.2020.06.054

pii:

doi:

Substances chimiques

Adrenal Cortex Hormones 0

Antibodies, Monoclonal, Humanized 0

Drug Combinations 0

dupilumab 420K487FSG

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

1282-1293

Commentaires et corrections

Type : ErratumIn