| Title: |
Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial |
| Authors: |
Paller, AS; Simpson, EL; Siegfried, EC; Cork, MJ; Wollenberg, A; Arkwright, PD; Soong, W; Gonzalez, ME; Schneider, LC; Sidbury, R; Lockshin, B; Meltzer, S; Wang, Z; Mannent, LP; Amin, N; Sun, Y; Laws, E; Akinlade, B; Dillon, M; Kosloski, MP; Kamal, MA; Dubost-Brama, A; Patel, N; Weinreich, DM; Yancopoulos, GD; O’Malley, JT; Bansal, A; Pepper, A; Cohen, D; Pariser, D; Leflein, J; Weinberg, J; Browning, J; Teng, J; Wine Lee, L; Sher, L; Diaz, L; Schneider, L; Rupp, N; Ong, P; Cartwright, R; Pinter, A; Schnopp, C; Korkosz, A; Bystrzanowska, D; Sygula, E; Zdybski, J; Padlewska, K |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2022 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| Description: |
Background Current systemic treatments for children younger than 6 years with moderate-to-severe atopic dermatitis that is uncontrolled with topical therapies might have suboptimal efficacy and safety. Dupilumab is approved for older children and adults with atopic dermatitis and for other type 2 inflammatory conditions. We aimed to evaluate efficacy and safety of dupilumab with concomitant low-potency topical corticosteroids in children aged 6 months to younger than 6 years with moderate-to-severe atopic dermatitis. Methods This randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial was conducted in 31 hospitals, clinics, and academic institutions in Europe and North America. Eligible patients were aged 6 months to younger than 6 years, with moderate-to-severe atopic dermatitis (Investigator's Global Assessment [IGA] score 3–4) diagnosed according to consensus criteria of the American Academy of Dermatology, and an inadequate response to topical corticosteroids. Patients were randomly assigned (1:1) to subcutaneous placebo or dupilumab (bodyweight ≥5 kg to |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
0140-6736 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/191214/10/AD_1539_part_B_Dupilumab_trial_accepted_The_Lancet.pdf; Paller, AS, Simpson, EL, Siegfried, EC et al. (55 more authors) (2022) Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, 400 (10356). pp. 908-919. ISSN: 0140-6736 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/191214/; https://eprints.whiterose.ac.uk/id/eprint/191214/10/AD_1539_part_B_Dupilumab_trial_accepted_The_Lancet.pdf |
| Rights: |
cc_by_nc_nd_4 |
| Accession Number: |
edsbas.8C3CB6CE |
| Database: |
BASE |