Dupilumab plus topical corticosteroids is effective in the treatment of childhood atopic dermatitis
1. At week 16, 28% of patients on dupilumab reported clear or almost clear skin (IGA 0-1) compared to 4% in the placebo group.
2. The overall incidence of treatment-related adverse events was similar between the groups. However, conjunctivitis and viral gastroenteritis were more common in the dupilumab group.
Level of evidence assessment: 1 (Excellent)
Summary of the study: Atopic dermatitis is a common inflammatory skin disease that often reduces the quality of life for patients and their caregivers. While basic treatment includes topical steroids, moderate to severe atopic dermatitis may require systemic corticosteroids. However, systemic steroids in younger age groups are not preferred given the risk of immunosuppression and other safety issues. Dupilumab is a monoclonal antibody that can be used to treat type 2 inflammatory processes, such as atopic dermatitis. This randomized controlled trial aimed to assess the safety and efficacy of dupilumab in children with moderate to severe atopic dermatitis. Patients were randomized to receive monthly injections of placebo or dupilumab for 16 weeks. The primary endpoint was an Investigator’s Global Assessment (IGA) score of 0 to 1 at week 16, while the key secondary endpoint was ≥75% improvement in area index and eczema severity (EASI-75). According to the study results, dupilumab showed significantly superior efficacy against IGA and EASI-75 scores at 16 weeks. The overall rate of treatment-related adverse events was comparable between the two groups. A limitation of this study is that both groups received topical corticosteroids at baseline, making it difficult to identify whether the improvement in IGA was due to a synergistic effect or to dupilumab alone.
Click to read the study in The Lancet
Relevant reading: Abrocitinib versus placebo or dupilumab for atopic dermatitis
In depth [randomized-controlled trial]: Between June 30, 2020 and February 12, 2021, 197 patients were screened for eligibility at 31 centers in Europe and North America. Included were those aged 6 months to 6 years with an IGA score of 3-4 and poor response to topical corticosteroids. A total of 157 patients (n=82 on dupilumab plus topical steroids; n=75 on placebo plus topical steroids) were included in the final analysis. At 16 weeks, significantly more patients in the dupilumab group had an IGA score of 0 to 1 compared to those in the placebo group (28% versus 4%, 95% confidence interval [CI] 13-34, patopic dermatitis in children under six years of age who have not had an adequate response to initial topical steroids.
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