Sanofi and Regeneron’s Dupixent combo impresses in paediatric atopic dermatitis
Sanofi and Regeneron have unveiled new Phase 3 data for their IL-4 and IL-13 inhibitor Dupixent (dupilumab), showing strong results in children aged 6-11 years with uncontrolled severe atopic dermatitis when combined with standard-of-care topical corticosteroids (TCS).
Revealed data showed that the benchmark of clear or almost clear skin was achieved by 33% of those receiving the Dupixent combo once monthly and by 30% receiving it every two weeks, nearly three times as many patients compared to those receiving TCS alone at 11%; 60% and 68% of patients from these groups respectively also saw a reduction of at least three points in itch intensity compared to 21% of TCS patients.
Furthermore, 70% of patients receiving Dupixent once monthly and 67% receiving it every two weeks saw a disease improvement of at least 75% with the combo, as measured on the Eczema Area and Severity Index (EASI), compared to just 27% of TCS patients. Average improvement on the EASI scale for the once-fortnightly group was 78% and 82% for the once monthly group, compared to 49% with TCS alone.
Dr Amy S Paller, a principal investigator on the study and Walter J Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, commented on the data: “In my practice, I see children with severe atopic dermatitis struggling with intense, persistent itching and skin lesions covering much of their body, and caregivers who are desperate for additional treatment options that can help control this disease. Data from the Phase 3 trial in children aged 6 to 11 adds to the established efficacy and safety data in adults and adolescents and provides hope to physicians and families for a potential new treatment option for children with this chronic disease.”
These findings have been submitted to regulatory bodies in the US, Canada and EU. If approval is secured, Dupixent would become the first biologic medicine available for this patient population within this indication.
It was confirmed that the full results of the trial are due to presented at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on 5 April.
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