Dados do Trabalho

Título

Dupilumab Treatment is Not Associated With an Increased Overall Risk of Infections in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis

Resumo

Rationale: Patients (pts) with atopic dermatitis (AD) present an increased risk of infections, including skin infections. Previous studies in children aged 6 to 11 years and adolescents showed that dupilumab is not associated with an increased risk of overall infections and is associated with lower risks of skin infections compared with placebo.

Methods: In LIBERTY AD PRESCHOOL, a double-blind, placebo (PBO)-controlled trial (NCT03346434, part B), children aged 6 months to 5 years with moderate-to-severe AD (Investigator’s Global Assessment score ≥3) were randomized 1:1 to subcutaneous dupilumab every 4 weeks (baseline weight ≥5 to <15kg: 200mg; ≥15 to <30kg: 300mg) or PBO with concomitant low-potency topical corticosteroids for 16 weeks. Exposure-adjusted rates (pts with ≥1 event per 100 pt-years [nP/100PY]) and percentage of pts with ≥1 skin infections were used to compare treatment groups.

Results: 162 pts were randomized to dupilumab (n=83) or PBO (n=79). During the 16-week treatment period, total infections rates were numerically lower with dupilumab (nP/100PY: 185.2) compared with PBO (nP/100PY: 245.7). Rates of fungal infections were not significantly different with dupilumab (nP/100PY: 0) than with PBO (nP/100PY: 4.2; P=1.0 vs PBO). Bacterial infections were significantly less frequent in dupilumab-treated (nP/100PY: 3.9) than PBO-treated pts (nP/100PY: 45.6; P<0.05 vs PBO). There was no significant difference in viral infections rates between dupilumab (nP/100PY: 64.8) and PBO (nP/100PY: 55.2; P=0.681 vs PBO). No helminthic infections were reported in either group. The percentage of pts with ≥1 skin infections was numerically lower in the dupilumab group (12.0%) than in the PBO group (24.4%). Overall safety of dupilumab was consistent with the known safety profile.

Conclusions: Dupilumab treatment is associated with lower overall infections and significantly lower bacterial infections than PBO in children aged 6 months to 5 years with moderate-to-severe AD.