Low Infection Rates With Long-Term Dupilumab Treatment in Patients Aged 6 Months to 5 Years: An Open-Label Extension Study.

Objective: To evaluate long-term infection rates in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (AD) treated with dupilumab.

Methods: This was a post hoc analysis of an ongoing open-label extension (OLE) study of dupilumab. Pediatric patients aged 6 months to 5 years with moderate-to-severe AD who had previously taken part in the LIBERTY AD PRESCHOOL phase 2 and 3 clinical trials received weight-based subcutaneous dupilumab every 2 or 4 weeks. Exposure-adjusted infection rates after a median dupilumab exposure of 52 weeks are compared with data from the earlier randomized, placebo-controlled, 16-week LIBERTY AD PRESCHOOL phase 3 trial.

Results: Infection rates were overall lower in the OLE study compared with the dupilumab and placebo groups in the earlier 16-week trial, including total infections (101.0 patients/100 patient-years [PY]), nonherpetic skin infections (22.7 patients/100PY), herpetic infections (7.3 patients/100PY), and nonskin infections (92.9 patients/100PY). The frequency of severe and serious infections was low (3.1 patients/100PY), compared with 17.1 placebo-treated patients/100PY and 0 dupilumab-treated patients in the earlier 16-week trial, and no infections leading to treatment discontinuation were observed. Systemic anti-infective medication use (58.9 patients/100PY) was lower in the OLE study compared with both the dupilumab and placebo groups in the 16-week trial.

Conclusion: Overall, reduced infection rates are observed in infants and young children with moderate-to-severe AD treated with dupilumab long-term, supporting the known safety profile of dupilumab.