Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease that results in the sudden onset of hives on the skin and swelling deep under the skin. People with CSU often experience symptoms including a persistent itch or burning sensation, which can significantly impact their quality of life. Swelling usually occurs on the face, hands, and feet, affecting the throat and upper airways.
CSU is typically treated with antihistamines but, in 50% of people living with CSU their disease remains uncontrolled and only a few treatment options are available. CSU is the fifth inflammatory disease for which Dupilumab has achieved positive Phase 3 data, including atopic dermatitis (eczema), asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.
In the trial, adding Dupilumab to standard antihistamines doubled the reduction in itch and urticaria activity compared to the standard-care alone at 24 weeks:
1. There was a 63% reduction in itch severity with Dupilumab vs 35% with the standard antihistamines as measured by a 0-21-point itch severity scale (10.24-point reduction with Dupilumab vs 6.01-point reduction with the standard antihistamines).
2. 65% reduction in itch and hives with Dupilumab vs 37% with the standard antihistamines, as measured by a 0-42-point urticaria activity scale, (20.53-point reduction with Dupilumab vs 12.00-point reduction with the standard antihistamines).
The most common side effects were injection site reactions.
The potential use of Dupilumab in CSU is currently under clinical development, and its safety and efficacy have not been fully approved by any regulatory authority.