1. Low Infection Rates With Long‐Term Dupilumab Treatment in Patients Aged 6 Months to 5 Years: An Open‐Label Extension Study.
- Author
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Paller, Amy S., Ramien, Michele, Cork, Michael J., Simpson, Eric L., Wine Lee, Lara, Eichenfield, Lawrence F., Khokhar, Faisal A., Coleman, Anna, Gherardi, Guy, Chen, Zhen, Zhang, Annie, and Cyr, Sonya L.
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TERMINATION of treatment , *CHILD patients , *SKIN infections , *ATOPIC dermatitis , *PEDIATRIC dermatology - Abstract
ABSTRACT Objective Methods Results Conclusion To evaluate long‐term infection rates in children aged 6 months to 5 years with moderate‐to‐severe atopic dermatitis (AD) treated with dupilumab.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.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.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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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