USA: Adding Dupixent (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives in patients with moderate-to-severe chronic spontaneous urticaria (CSU), show results from a pivotal Phase 3 trial.
The trial evaluated dupilumab in patients with moderate-to-severe urticaria (CSU), an inflammatory skin disease. At 24 weeks, the trial met its primary endpoints and all key secondary endpoints.
"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 Sanofi. "This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in Phase 3 pivotal studies. The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population."
"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 George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "These data add to the increasing body of evidence that using Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases. By early 2022 we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well other trial results in additional dermatologic diseases."
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, but can also affect the throat and upper airways. CSU is typically treated with antihistamines but for up to 50% of people living with CSU their disease remains uncontrolled and available treatment options are few. CSU is the fifth inflammatory disease for which Dupixent has achieved positive Phase 3 data, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis (EoE, investigational).
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 at 24 weeks:
63% reduction in itch severity with Dupixent vs 35% with standard-of-care (antihistamines) as measured by a 0-21-point itch severity scale (10.24-point reduction with Dupixent vs 6.01-point reduction with standard-of-care), the primary endpoint in the US (secondary endpoint in the EU) with continuous improvement out to week 24.
65% reduction in urticaria activity (itch and hives) severity with Dupixent vs 37% with standard-of-care, as measured by a 0-42-point urticaria activity scale, (20.53-point reduction with Dupixent vs 12.00-point reduction with standard-of-care), the primary endpoint in the EU (secondary endpoint in the US) with continuous improvement out to week 24.
The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the Dupixent and placebo groups (50% of Dupixent patients and 59% of placebo patients). The most common adverse events were injection site reactions (11% Dupixent, 13% placebo).
Dupixent® (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients.
The potential use of Dupixent in CSU and EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.