Positive Dupixent phase III data in children aged 6 months to 5 years with moderate to severe atopic dermatitis is published in The Lancet
Regeneron Pharmaceuticals, Inc and Sanofi announced that The Lancet has published positive results from a Phase III Dupixent (dupilumab) trial in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis
These data were the basis for the FDA approval of Dupixent in June 2022 and for a regulatory submission currently under review by the European Medicines Agency.
"The Lancet's publication of these Phase III results is a testament to the significance of the data showing dupilumab can alleviate the multidimensional burden that moderate-to-severe atopic dermatitis places on infants, toddlers and their families," said Amy S. Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, and principal investigator of the trial. "By addressing the key inflammatory pathway driving atopic dermatitis, the trial demonstrated that dupilumab not only addressed debilitating symptoms like persistent itch and skin lesions, but also meaningfully improved sleep and reduced pain – two aspects of daily life that are critical for any child's development and well-being."
Data from this trial showed that adding Dupixent to low-potency topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch compared to TCS alone (placebo) at 16 weeks. Additionally, Dupixent patients experienced significant improvement in measures of sleep quality and skin pain, as well as patient- or caregiver-reported outcomes and health-related quality of life. A substantially lower proportion of Dupixent patients needed rescue medications, compared to those on placebo.
See- "Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase III trial.";Prof Amy S Paller, MD, Prof Eric L Simpson, MD, Elaine C Siegfried, Prof Michael J Cork, MD, Prof Andreas Wollenberg, MD, Peter D Arkwright, MD et al. Published:September 17, 2022DOI:https://doi.org/10.1016/S0140-6736(22)01539-2.
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