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How effective Is Dupixent for CSU?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on June 23, 2025.

Official Answer by Drugs.com

Dupixent (dupilumab) is FDA-approved for treating chronic spontaneous urticaria (CSU) in patients aged 12 and older whose symptoms are not controlled by H1-antihistamines. Clinical trials show that Dupixent significantly reduces hives and itching, leading to improved quality of life for many patients. In this article, we will review how effective Dupixent is for CSU and when to expect results.

What Is CSU and Who Is Dupixent For?

Chronic spontaneous urticaria (CSU) is a skin disorder characterized by the sudden appearance of hives (welts) and persistent itching without a clear trigger, lasting for six weeks or longer. CSU can be highly disruptive, affecting sleep, daily activities, and overall well-being. Dupixent is intended for patients aged 12 and older who continue to have symptoms despite taking H1-antihistamines, the standard first-line treatment.

How Effective Is Dupixent?

Before starting Dupixent, many patients with CSU continue to experience frequent hives and intense itching despite standard antihistamine therapy. To determine how well Dupixent works for these individuals, researchers conducted large clinical trials comparing its effects to placebo. The following results highlight how Dupixent performed in reducing CSU symptoms and improving patient outcomes.

Key Clinical Trial Results

In pivotal Phase 3 trials (LIBERTY-CUPID Studies A and C), Dupixent as an add-on to antihistamines led to a reduction in both itch severity and urticaria (hive) activity scores compared to placebo at 24 weeks.

The benefit was especially clear in patients who had never received omalizumab (another biologic for CSU).

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When Do Results Appear?

Patients often begin to notice improvements within a few weeks of starting Dupixent. The most significant symptom relief is typically observed by 12 to 24 weeks of treatment. Some patients may continue to improve beyond this period.

How Does Dupixent Work in CSU?

Dupixent is a monoclonal antibody that blocks two key proteins involved in type 2 inflammation: interleukin-4 (IL-4) and interleukin-13 (IL-13). By inhibiting these pathways, Dupixent reduces the activation of immune cells that drive itching and hives in CSU. This mechanism addresses inflammation at its source, rather than just controlling symptoms.

Is Dupixent Well Tolerated?

Dupixent is generally well tolerated. The safety profile in CSU trials was consistent with its use in other conditions. The most common side effect reported was injection site reactions (redness, swelling, pain), occurring in 10% of patients.

Serious side effects are rare but can include allergic reactions and, less commonly, increased eosinophil counts (a type of white blood cell).

Summary

Dupixent represents a significant advance for patients with CSU who do not respond to antihistamines. It offers substantial relief from hives and itching, with about one in three patients achieving complete symptom control after 24 weeks. Its safety profile is well established, and it is now an FDA-approved option for adolescents and adults with difficult-to-treat CSU. Patients considering Dupixent should discuss the risks and benefits with their healthcare provider to determine if it is the right choice for their individual situation.

This is not all the information you need to know about Dupixent (dupilumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full patient medication guide and discuss this information and any questions you have with your doctor or other health care provider.

References
  1. Casale, T., et. al. 2024. Dupilumab significantly improves itch and hives in patients with chronic spontaneous urticaria (CUPID study C). In: Annals of Allergy, Asthma, & Immunology. DOI: https://doi.org/10.1016/j.anai.2024.10.005
  2. Dabija D, Tadi P, Danosos GN. Chronic Urticaria. [Updated 2023 Apr 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK555910/
  3. Dupixent [package insert]. Updated April 2025. sanofi-aventis U.S. LLC. Accessed on June 23, 2025 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780
  4. Maurer, M., Casale, T. B., Saini, S. S., Ben-Shoshan, M., Giménez-Arnau, A. M., Bernstein, J. A., Yagami, A., Stjepanovic, A., Radin, A., Staudinger, H. W., Patel, N., Amin, N., Akinlade, B., Fan, C., Bauer, D., Yancopoulos, G. D., Patel, K., Mannent, L. P., & Laws, E. (2024). Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. The Journal of allergy and clinical immunology, 154(1), 184–194. https://doi.org/10.1016/j.jaci.2024.01.028

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