Dupixent Phase 3 Data in Chronic Urticaria to be Presented at ACAAI

Positive late-breaking data from a Phase 3 study of Dupixent (dupilumab) will be shared at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting. This study focused on the investigational use of Dupixent in patients with chronic spontaneous urticaria (CSU) who have not previously been treated with biologics and continue to experience symptoms despite using antihistamines.

Chronic spontaneous urticaria is a persistent skin condition marked by sudden, intense itching and hives, leading to significant disruption in daily life. The results from the LIBERTY-CUPID Study C highlight Dupixent's potential to improve the quality of life for individuals affected by this condition by significantly reducing itching and hive activity compared to a placebo. The study involved 151 participants, both children and adults, who received either Dupixent or a placebo alongside their existing antihistamine treatment.

At the 24-week mark, Dupixent showed notable improvements in various measures. The itch severity score decreased by 8.64 points from baseline in the Dupixent group compared to a 6.10-point reduction in the placebo group. Additionally, the combined score for itch and hive activity showed a reduction of 15.86 points for Dupixent versus 11.21 points for the placebo. Importantly, 41% of those treated with Dupixent achieved well-controlled disease status, compared to 23% in the placebo group. Furthermore, 30% of the Dupixent group reached a complete response, versus 18% in the placebo group.

Safety results from the study were consistent with Dupixent's known safety profile in its approved dermatological uses. The rate of treatment-emergent adverse events was identical in both the Dupixent and placebo groups at 53%. Common adverse events associated with Dupixent included injection site reactions, accidental overdose, and COVID-19 infection.

Dupixent has already been approved for use in treating CSU in Japan and the United Arab Emirates and is under regulatory review in the European Union. Outside these regions, its safety and efficacy for treating CSU have not been fully established by any regulatory authority.

Chronic spontaneous urticaria is driven in part by type-2 inflammation, causing sudden hives and persistent itching. It is typically managed with H1 antihistamines, which target specific receptors on cells to control symptoms. However, many patients find their condition remains uncontrolled despite these treatments, leading to a significant impact on their quality of life. In the US alone, over 300,000 people suffer from CSU that is not adequately managed by antihistamines.

The LIBERTY-CUPID Phase 3 program for Dupixent includes three studies: Study A, Study B, and the discussed Study C. Study C focused on patients who had not been previously treated with omalizumab (a biologic treatment) and who remained symptomatic despite antihistamine use. It was a randomized, double-blind, placebo-controlled study assessing Dupixent's efficacy and safety as an add-on to standard antihistamine treatment in patients aged six years and older.

Dupixent, a fully human monoclonal antibody, works by inhibiting the signaling pathways of IL4 and IL13, which are central to type-2 inflammation involved in several chronic diseases. Approved in more than 60 countries, Dupixent is used to treat various conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease.

The development and ongoing research into Dupixent are part of a collaboration between Sanofi and Regeneron. This extensive program involves over 60 clinical studies with more than 10,000 patients, exploring Dupixent's potential in numerous conditions driven by type-2 inflammation or other allergic processes.