Positive results from the Phase 3 LIBERTY-CUPID Study C, evaluating Dupixent (dupilumab) in biologic-naive patients with uncontrolled 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, when added to standard antihistamine therapy, significantly reduced itch and urticaria activity compared to placebo.
Key Findings from LIBERTY-CUPID Study C
The LIBERTY-CUPID Study C involved 151 children and adults who were randomized to receive either Dupixent (n=74) or placebo (n=77) in addition to standard-of-care histamine-1 (H1) antihistamines. At 24 weeks, Dupixent showed significant improvements across several key endpoints:
- Itch Severity: Dupixent led to 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, measuring 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: 41% of patients on Dupixent achieved well-controlled disease status (urticaria activity score =6), compared to only 23% in the placebo group (p=0.005).
- Complete Response: 30% of patients in the Dupixent arm achieved a complete response (urticaria activity score=0), versus 18% in the placebo arm (p=0.02).
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, Internal Medicine, Morsani College of Medicine at the University of South Florida, USA. "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."
Safety Profile
The safety profile of Dupixent in Study C was consistent with its established safety profile in approved dermatological indications. The overall rates of treatment-emergent adverse events (AEs) were similar between the Dupixent and placebo groups (53% each). 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%).
Dupixent's Mechanism of Action
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways, which are key drivers of type-2 inflammation. It is not an immunosuppressant. By blocking these pathways, Dupixent helps to reduce the inflammatory response that leads to the symptoms of CSU.
Regulatory Status and Global Impact
Dupixent has been approved for CSU in Japan and the United Arab Emirates (UAE), and is under regulatory review in the European Union. The safety and efficacy of Dupixent for CSU have not been fully evaluated by regulatory authorities outside of these regions. Over 1,000,000 patients are currently being treated with Dupixent globally across various indications.
Unmet Need in CSU
CSU is a chronic inflammatory skin disease characterized by sudden and debilitating hives and persistent itch. While H1 antihistamines are commonly used as a first-line treatment, many patients remain symptomatic despite this therapy. It is estimated that more than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines, highlighting the need for alternative treatment options like Dupixent.
