New Agent for Atopic Dermatitis Awaits FDA Approval

Dupilumab is a human monoclonal antibody that inhibits signaling of two key cytokines that are involved in allergic disease: interleukin (IL)-4 and IL-13. In early studies, dupilumab has shown promise for managing atopic dermatitis, asthma, and chronic sinusitis with nasal polyps. Researchers now have performed two large, industry-funded, phase III trials in 671 adults with moderate-to-severe atopic dermatitis.

Patients were randomized to receive dupilumab or placebo subcutaneous injections every 1 to 2 weeks. At 16 weeks, significantly more dupilumab patients than placebo patients achieved the primary endpoint of clear or almost clear skin (37% vs. 10%). Serious adverse events occurred with similar frequency in both groups, but injection-si…