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Dupilumab Provides Rapid and Sustained Improvement in SCORing Atopic Dermatitis Outcomes in Paediatric Patients with
Andreas Wollenberg, Danielle Marcoux, Jonathan I Silverberg
1Sanofi, 450 Water Street, Cambridge, MA, USA. ana.rossi@sanofi.com.
Insights
Dupilumab treatment significantly improved SCORing Atopic Dermatitis (SCORAD) scores in children and adolescents. These positive outcomes, including reduced itch and improved sleep, were sustained for up to one year.
Area of Science:
- Dermatology
- Clinical Trials
- Paediatric Medicine
Background:
- Atopic dermatitis is a chronic inflammatory skin condition affecting children and adolescents.
- Current treatments aim to manage symptoms and improve quality of life.
- Evaluating long-term efficacy of novel therapies is crucial for paediatric populations.
Purpose of the Study:
- To assess the efficacy of dupilumab, with or without topical corticosteroids, on SCORing Atopic Dermatitis (SCORAD) outcomes in paediatric patients.
- To evaluate the durability of treatment effects over a 1-year period.
- To analyze improvements in specific SCORAD components and associated symptoms like pruritus and sleep disturbance.
Main Methods:
- Post hoc analysis of 471 paediatric patients (children and adolescents) with atopic dermatitis.
- Inclusion of data from two 16-week Phase 3 randomized controlled trials and a 1-year open-label extension study.
- Comparison of dupilumab (± topical corticosteroids) versus placebo (± topical corticosteroids) using SCORAD and objective SCORAD (o-SCORAD) metrics.
Main Results:
- Dupilumab treatment led to significant reductions in SCORAD, o-SCORAD, and individual SCORAD components from week 3 to 16 compared to placebo.
- These improvements were sustained and further enhanced over 1 year of continuous dupilumab therapy.
- By week 52, nearly all patients achieved SCORAD-50 (91.3-91.8%), with over 86% experiencing mild or absent pruritus and sleep loss.
Conclusions:
- Dupilumab, in combination with topical corticosteroids, demonstrates rapid and significant efficacy in improving SCORAD outcomes in paediatric patients.
- The therapeutic benefits of dupilumab are sustained for at least one year, addressing multiple facets of atopic dermatitis.
- Dupilumab offers a promising long-term treatment option for managing atopic dermatitis in children and adolescents, significantly improving skin condition and quality of life.
Abstract:
This post hoc analysis examined SCORing Atopic Dermatitis (SCORAD) outcomes in 471 paediatric patients (children age 6-<12 years, n = 304; adolescents age 12-<18 years, n = 167) with atopic dermatitis treated with dupilumab, ± topical corticosteroids, in two 16-week phase 3 randomized controlled trials and a 1-year interim data cut of a subsequent open-label extension study. Paediatric patients treated with dupilumab (± topical corticosteroids) had significantly lower SCORAD, objective SCORAD (o-SCORAD), and individual SCORAD components from week 3 to 16 compared with placebo (± topical corticosteroids) in the randomized controlled trials. The results were sustained or continuously improved over 1 year of open-label treatment with dupilumab ± topical corticosteroids. SCORAD-50 was achieved in almost all patients (91.3-91.8%) by week 52 with continued dupilumab treatment across age groups. Almost all (> 86%) patients achieved mild or absent pruritus and sleep loss at week 52. In conclusion, dupilumab ± topical corticosteroids resulted in rapid and significant improvements in all aspects of SCORAD analysed, and the results were sustained over 1 year.
