Dupixent® Phase 3 Data in Chronic Urticaria to Be Presented at ACAAI

A recent study has highlighted the promising potential of Dupixent® (dupilumab) for individuals suffering from chronic spontaneous urticaria (CSU) that is not well-managed by antihistamines. The Phase 3 LIBERTY-CUPID Study C, conducted by Regeneron Pharmaceuticals, Inc. and Sanofi, provided important data on the efficacy and safety of Dupixent for this condition. Presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting, the findings underscore significant improvements for patients.

Chronic spontaneous urticaria is a persistent skin condition characterized by sudden, intense itching and hives, which can severely affect daily activities. Traditional treatments often fail to control the symptoms adequately. According to Professor Thomas B. Casale from the University of South Florida, the new data reinforce previous findings, suggesting that Dupixent could offer substantial relief for patients battling this challenging disease.

The study involved 151 participants, both children and adults, who were randomly assigned to receive either Dupixent or a placebo, in addition to standard antihistamines. Over a period of 24 weeks, those treated with Dupixent experienced notable reductions in itchiness and hive activity compared to those given the placebo. Specifically, the itch severity score saw a reduction of 8.64 points versus 6.10 points with placebo, and the urticaria activity score dropped by 15.86 points compared to 11.21 points with placebo. More importantly, 41% of the patients treated with Dupixent achieved well-controlled disease status, a significant improvement over the 23% in the placebo group.

The safety profile of Dupixent in this study was consistent with its known effects in other dermatological uses. The rate of adverse events was similar between the Dupixent and placebo groups, with common side effects including injection site reactions, accidental overdoses, and COVID-19 infections.

Currently, Dupixent is approved for use in treating CSU in Japan and the United Arab Emirates, with regulatory reviews ongoing in the European Union. This medication has not yet received full evaluation for CSU outside these regions.

CSU is driven by type 2 inflammation, leading to recurrent hives and itchiness that significantly impact patients' quality of life. Despite the use of antihistamines, many sufferers experience inadequate symptom control, highlighting the need for alternative treatments like Dupixent. In the United States alone, over 300,000 people struggle with inadequately controlled CSU.

The LIBERTY-CUPID program includes several studies evaluating Dupixent for CSU, with Study C being particularly focused on those who have not previously been treated with omalizumab. Dupixent's mechanism involves inhibiting IL-4 and IL-13 pathways, which are crucial in type 2 inflammation. The drug has shown promise in reducing inflammation and improving clinical outcomes in various related conditions.

Dupixent has been approved in numerous countries for indications such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and other conditions linked to type 2 inflammation. Its development has been a collaborative effort between Regeneron and Sanofi, with extensive clinical trials involving over 10,000 patients.

Regeneron, a leading biotechnology company, continues to push the boundaries of medical science with its VelocImmune technology, which has been instrumental in developing several fully human monoclonal antibodies. This innovative approach has led to the creation of Dupixent and other significant treatments, aiming to address a wide range of serious health conditions.

In conclusion, the recent findings from the Phase 3 LIBERTY-CUPID Study C suggest that Dupixent could become a vital new treatment option for those suffering from chronic spontaneous urticaria, potentially offering significant relief and improved quality of life for many patients.