Study: Dupilumab Significantly Improves Itch, Hives in Patients With Chronic Spontaneous Urticaria


Trial is the first to suggest that targeting interleukin-4 and interleukin-13 can help address symptoms such as persistent itching and hives.

New study results have found that dupilumab (Dupixent, Regeneron and Sanofi) significantly improved itch and hives in patients with chronic spontaneous urticaria (CSU), further illustrating the role of type 2 inflammation in this disease.

The phase 3 clinical trial met its primary and all key secondary endpoints at 24 weeks, according to a press release from Regeneron. The results suggest the potential of targeting interleukin-4 (IL-4) and interleukin-13 (IL-13) via an interleukin-4Ra blockade in order to improve diseases with components of type 2 inflammation, such as CSU, according to the researchers.

“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, MD, PhD, president and chief scientific officer at Regeneron, in the press release.

CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin or swelling deep under the skin. Despite standard-of-care treatment with antihistamines, patients with CSU often experience symptoms such as persistent itching or burning, which can be debilitating and can have a significant impact on quality of life.

In the trial of 138 patients, researchers found that adding dupilumab to standard-of-care treatments nearly doubled the reduction in itching and urticaria activity compared to standard-of-care treatment alone. Patients were 6 years of age or older with a CSU diagnosis, and they remained symptomatic despite antihistamine use and were not previously treated with omalizumab.

Patients experienced continuous improvement out to 24 weeks and experienced a 63% reduction in itch severity with dupilumab compared to a 35% reduction with placebo. Furthermore, patients experienced a 65% reduction in urticaria activity severity with dupilumab compared to a 37% reduction with placebo.

“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, MD, PhD, global head of research and development at Sanofi, in the press release. “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 trial also demonstrated safety results similar to the known safety profile of dupilumab in its approved indications. The occurrence of treatment emergent adverse events during the 24-week treatment period were similar between the dupilumab and placebo groups and the most common adverse reactions were injection site reactions.

Dupilumab is approved for patients 6 years of age and older with moderate-to-severe atopic dermatitis, for patients 12 years of age and older with moderate-to-severe asthma, and in adults with uncontrolled chronic rhinosinusitis with nasal polyps. Its potential use in CSU and eosinophilic esophagitis is under clinical development.

“These data add to the increasing body of evidence that Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory, and gastrointestinal diseases,” Yancopoulos said in the press release. “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 as other trial results in additional dermatologic diseases.”


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. News release. Regeneron; July 29, 2021. Accessed August 3, 2021.

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