REGENERON PHARMACEUTICALS, INC. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program.
'This is the first Phase 3 trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease,' said
CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, and can also affect the throat and upper airways. CSU is typically treated with antihistamines but the disease remains uncontrolled for up to 50% of patients who have limited available treatment options. CSU is the fifth disease for which Dupixent has positive Phase 3 data including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis (EoE, investigational).
'The chronic nature of CSU, coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment,' said John Reed, M.D., Ph.D., Global Head of Research and Development at
In the trial (n=138), adding Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. Patients experienced a: 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p
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