Dupilumab for Chronic Spontaneous Urticaria
|
Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
|
Posted on July 27th, 2026
|
Chronic spontaneous urticaria is a common inflammatory skin disorder characterized by recurrent hives and angioedema that occur without an identifiable trigger. The disease is primarily driven by activation of mast cells and the subsequent release of histamine and other inflammatory mediators. Although H1 antihistamines are the first-line treatment, many patients continue to experience persistent symptoms despite high-dose therapy. A recent study evaluated the effectiveness of dupilumab as a treatment for chronic spontaneous urticaria.
Publication: Journal of the American Medical Association, Dermatology
Funding Source(s): Sanofi and Regeneron Pharmaceuticals
The phase 3 clinical trial enrolled 151 participants who had been living with chronic spontaneous urticaria for more than six months. At baseline, participants had a mean Itch Severity Score of 15.1 out of 21 and a mean Urticaria Activity Score (UAS7) of 28.3 out of 42, indicating substantial disease burden. All participants were receiving H1 antihistamines, with approximately half requiring doses higher than the standard recommended regimen to control their symptoms.
Participants were randomly assigned to receive either placebo or subcutaneous dupilumab. Patients weighing at least 60 kg received a 600 mg loading dose followed by 300 mg every two weeks. Those weighing less than 60 kg received a 400 mg loading dose followed by 200 mg every two weeks. Dupilumab is a monoclonal antibody that blocks the shared receptor for interleukin-4 (IL-4) and interleukin-13 (IL-13), thereby inhibiting key pathways involved in type 2 inflammation.
After 24 weeks of treatment, patients receiving dupilumab experienced significantly greater reductions in disease activity than those receiving placebo. Mean urticaria activity and itch severity scores decreased by 15.9 and 8.6 points, respectively. Clinical improvement became apparent as early as five weeks after treatment initiation. The researchers concluded that dupilumab offers an effective treatment option for patients with chronic spontaneous urticaria whose symptoms remain inadequately controlled with antihistamines. They also noted that future studies should include longer treatment and follow-up periods to evaluate the long-term durability of symptom control, safety profile, and the persistence of clinical benefit after discontinuation of therapy.
Publication: Journal of the American Medical Association, Dermatology
Funding Source(s): Sanofi and Regeneron Pharmaceuticals
The phase 3 clinical trial enrolled 151 participants who had been living with chronic spontaneous urticaria for more than six months. At baseline, participants had a mean Itch Severity Score of 15.1 out of 21 and a mean Urticaria Activity Score (UAS7) of 28.3 out of 42, indicating substantial disease burden. All participants were receiving H1 antihistamines, with approximately half requiring doses higher than the standard recommended regimen to control their symptoms.
Participants were randomly assigned to receive either placebo or subcutaneous dupilumab. Patients weighing at least 60 kg received a 600 mg loading dose followed by 300 mg every two weeks. Those weighing less than 60 kg received a 400 mg loading dose followed by 200 mg every two weeks. Dupilumab is a monoclonal antibody that blocks the shared receptor for interleukin-4 (IL-4) and interleukin-13 (IL-13), thereby inhibiting key pathways involved in type 2 inflammation.
After 24 weeks of treatment, patients receiving dupilumab experienced significantly greater reductions in disease activity than those receiving placebo. Mean urticaria activity and itch severity scores decreased by 15.9 and 8.6 points, respectively. Clinical improvement became apparent as early as five weeks after treatment initiation. The researchers concluded that dupilumab offers an effective treatment option for patients with chronic spontaneous urticaria whose symptoms remain inadequately controlled with antihistamines. They also noted that future studies should include longer treatment and follow-up periods to evaluate the long-term durability of symptom control, safety profile, and the persistence of clinical benefit after discontinuation of therapy.