Positive results from the Phase 3 LIBERTY-CUPID Study C, evaluating Dupixent (dupilumab) for chronic spontaneous urticaria (CSU), were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting. The study demonstrated that Dupixent significantly reduced itch and urticaria activity in patients with CSU who were not adequately controlled with antihistamines.
The LIBERTY-CUPID Study C enrolled 151 adults and children who were biologic-naive, meaning they had not previously been treated with omalizumab. Participants were randomized to receive either Dupixent (n=74) or placebo (n=77) in addition to standard-of-care antihistamines. The primary endpoint was the change from baseline in itch severity score (ISS7) at 24 weeks.
Key Findings from Study C
At 24 weeks, Dupixent demonstrated statistically significant improvements compared to placebo across multiple endpoints:
- Itch Severity: Patients treated with Dupixent experienced an 8.64-point reduction in itch severity score from baseline, compared to a 6.10-point reduction in the placebo group (p=0.02).
- Urticaria Activity: The urticaria activity score, which measures both itch and hives, decreased by 15.86 points in the Dupixent group versus 11.21 points in the placebo group (p=0.02).
- Disease Control: A significantly higher proportion of patients on Dupixent achieved well-controlled disease status (urticaria activity score ≤6) compared to placebo (41% vs. 23%; p=0.005).
- Complete Response: Complete response (urticaria activity score=0) was achieved by 30% of patients in the Dupixent group compared to 18% in the placebo group (p=0.02).
Safety Profile
The safety results in Study C were consistent with the established safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment-emergent adverse events were similar in both the Dupixent and placebo groups (53%). Adverse events more commonly observed with Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).
Expert Commentary
"Chronic spontaneous urticaria is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives," said Thomas B. Casale, M.D., Professor of Internal Medicine at the Morsani College of Medicine, University of South Florida. "These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease."
Dupixent in CSU Treatment
Dupixent is currently approved for CSU in Japan and the United Arab Emirates (UAE) and is under regulatory review in the European Union. Outside of these regions, the safety and efficacy of Dupixent for CSU have not been fully evaluated by regulatory authorities.
About Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease characterized by sudden and debilitating hives and persistent itch. It is driven in part by type-2 inflammation. Many patients with CSU remain symptomatic despite treatment with H1 antihistamines, highlighting the need for alternative treatment options. More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
About Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways, key drivers of type-2 inflammation. It is not an immunosuppressant. Dupixent has received regulatory approvals in more than 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. Over 1,000,000 patients are being treated with Dupixent globally.
