Sanofi has unveiled more detailed late-stage data showing the benefit of biologic Dupixent (dupilumab) in a population of young patients with uncontrolled severe atopic dermatitis.
Phase III trial results show significantly improved disease signs, symptoms and health-related quality of life in children aged six-11 years with uncontrolled severe atopic dermatitis given the drug combined with standard-of-care topical corticosteroids (TCS).
At 16 weeks, nearly three times as many children achieved clear or almost clear skin when treated with Dupixent and TCS, and more than two-thirds experienced at least a 75% overall improvement of their disease compared to TCS alone.
Also, more than three times as many children experienced a significant reduction in itch with Dupixent compared to TCS alone. Improvements in itch and disease severity were observed with Dupixent as early as two weeks after the first dose and continued throughout active treatment.
On the safety side, overall rates of adverse events were 65% for Dupixent every four weeks, 67% for Dupixent every two weeks and 73% for TCS alone.
Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, which are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
The drug is being jointly developed by Regeneron.