Data from 2 pivotal Phase 3 placebo-controlled trials (SINUS-24 and SINUS-52) showed that dupilumab (Dupixent; Regeneron and Sanofi) significantly reduced nasal polyp size, nasal congestion severity and the need for corticosteroids and/or surgery in patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
Specifically, in both studies, at 24 weeks, patients treated with dupilumab plus corticosteroid nasal spray experienced a 51% and 57% improvement in nasal congestion/obstruction severity vs 15% and 19% improvement with nasal spray alone. In addition, compared with placebo, treatment with dupilumab was associated with a greater reduction in nasal polyp scores (27% and 33% for dupilumab vs 4% and 7% for placebo). In a subset of patients with nasal polyps and asthma, dupilumab was found to significantly improve lung function and asthma control.
“Dupixent has now been shown to address this inflammation across the complete airway, which manifests in the upper respiratory tract as polyps and congestion, and in the lower airway as asthma,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron.
Dupixent, an interleukin-4 receptor alpha antagonist, is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Currently, the Agency is reviewing Dupixent for the treatment of asthma driven by allergic or Type 2 inflammation. The Companies are also investigating the treatment for pediatric asthma and atopic dermatitis, adolescent atopic dermatitis, eosinophilic esophagitis, grass allergy, and peanut allergy.
“For the first time, we have Phase 3 data showing that a biologic can help address the underlying Type 2 or allergic inflammation that causes chronic rhinosinusitis with nasal polyps and we look forward to working with regulatory authorities around the world to make Dupixent an option for people living with this chronic condition,” said John Reed, MD, Executive Vice President, Global Head of Research & Development at Sanofi.