Dados do Trabalho

Título

Efficacy and safety of dupilumab with topical corticosteroids in children aged 6 months to 5 years with severe atopic dermatitis

Resumo

Introduction: Atopic Dermatitis (AD) has a negative and multidimensional impact in infants and young children. The efficacy and safety of Dupilumab was assessed in LIBERTY AD PRESCHOOL in children aged 6 months to 5 years with moderate-to severe AD.

Methods: Patients aged 6 months to 5 years with moderate-to-severe AD were enrolled in the phase 3 LIBERTY AD PRESCHOOL (NCT03346434; part B) study. Patients received dupilumab 200/300 mg every 4 weeks (200 mg: weight 5 to < 15 kg; 300 mg: 15 to < 30 kg), or placebo for 16 weeks; low-potency topical corticosteroids were administered from Day −14.

Results: At week 16, dupilumab-treated patients had significantly greater percent reduction from baseline in Eczema Area and Severity Index vs placebo (LS mean [SE] −67.0 [3.5] vs −39.2 [3.6]; P < 0.0001) and Worst Scratch/Itch Numerical Rating Scale vs placebo group (LS mean [SE] −41.8 [5.4] vs 0.5 [5.4]; P < 0.0001). Dupilumab resulted in significant improvement in quality-of-life outcomes vs placebo (LS mean [SE]), reported as change from baseline to Week 16 in Children’s Dermatology Life Quality Index (−9.1 [1.1] vs −2.6 [1.2]; P < 0.0001), and Infant’s Dermatitis Quality of Life (−9.1 [1.3] vs −0.6 [1.1]; P < 0.0001). Treatment-emergent adverse events were reported in 66.7% of dupilumab-treated patients (conjunctivitis cluster: 6.4%) and 73.8% of the placebo group (conjunctivitis events: 0%). No dupilumab-related adverse events were serious or led to discontinuation.

Conclusion: Dupilumab significantly improved AD signs, symptoms, and quality of life in children aged 6 months to 5 years with severe AD. The safety profile was consistent with that seen previously in adults, adolescents, and children aged > 6 years.