1. By week 16, 28% of patients in dupilumab reported clear or almost clear skin (IGA 0-1) compared to 4% in placebo.
2. Overall incidence of treatment-emergent adverse events were similar between groups. However, conjunctivitis and viral gastroenteritis were more common in the dupilumab group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Atopic dermatitis is a common inflammatory skin disease that often reduces the quality-of-life of both patients and their caregivers. While mainstay therapy 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 concerns. Dupilumab is a monoclonal antibody that may 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 monthly injections of placebo or dupilumab for 16 weeks. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0-1 at week 16 while key secondary outcome was ≥75% improvement in Eczema Area and Severity Index (EASI-75). According to study results, dupilumab showed significantly greater efficacy with respect to both IGA and EASI-75 scores at 16 weeks. The overall rate of treatment-emergent adverse events was comparable between both groups. A limitation of this study is that both groups were given topical corticosteroids at baseline, making it hard to identify whether the improvement in IGA was due to synergistic effect or dupilumab alone.
Relevant Reading: Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis
In-depth [randomized-controlled trial]: Between Jun 30, 2020, and Feb 12, 2021, 197 patients were screened for eligibility across 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. Altogether, 157 patients (n=82 to dupilumab plus topical steroids; n=75 to placebo plus topical steroids) were included in the final analysis. By 16 weeks, significantly more patients in the dupilumab group had an IGA score 0-1 compared to those in the placebo group (28% vs. 4%, 95% confidence interval [CI] 13-34, p<0.0001). This was also the case for EASI-75 which was greater for dupilumab than placebo (53% vs. 11%, 95% CI 29-55, p<0.0001). Regarding treatment-emergent adverse events, the two groups were comparable (64% dupilumab vs. 74% placebo). Conjunctivitis (4% vs. 0%) and viral gastroenteritis (4% vs. 0%) were more common in the dupilumab group than placebo group, respectively. Sleep quality at week 16 among both patients and caregivers was significantly increased in the dupilumab group. Overall, findings from this study suggest that dupilumab may be used to treat atopic dermatitis in children under the age of six who did not have sufficient response to initial topical steroids.
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