With a decision from the FDA for its use in moderate-to-severe asthma expected by the end of the week, the biologic dupilumab showed positive results from a pivotal phase 3 trial for inadequately controlled chronic rhinosinusitis with nasal polyps.
With a decision from the FDA for its use in moderate-to-severe asthma expected by the end of the week, the biologic dupilumab showed positive results from a pivotal phase 3 trial for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The companies behind the drug, Regeneron Pharmaceuticals and Sanofi, said that dupilumab met all primary and secondary end points. On the coprimary end points for both trials at 24 weeks, patients treated with dupilumab added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared with a 15% and 19% improvement with nasal spray alone (placebo) (—1.25 and –1.34 change in severity for dupilumab compared with –0.38 and –0.45 for placebo, on a 0-3 scale).
Dupilumab-treated patients had a 27% and 33% reduction in their nasal polyps score compared with a 4% and 7% increase for placebo (—1.71 and –1.89 for dupilumab compared with 0.10 and 0.17 for placebo, on a 0-8 scale that measures bilateral polyps size by endoscopy).
Dupilumab also met all secondary end points in both trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery and improvements in smell and chronic rhinosinusitis symptoms.
If approved by the FDA by October 20, the drug’s Prescription Drug User Fee Act date, dupilumab would be the first drug to target the IL-4 and IL-13 pathways in type 2 asthma. Last year, the FDA approved dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis whose condition is not properly controlled with topical therapies. The monoclonal antibody is also approved for use in particular patients with atopic dermatitis in the European Union, Canada, and Japan.
Dupilumab targets address inflammation across the complete airway, the companies said, manifesting in the upper respiratory tract as polyps and congestion and in the lower airway as asthma. Patients with comorbid asthma and CRSwNP tend to have more severe disease.
In a prespecified group of patients with comorbid asthma, dupilumab significantly improved lung function and asthma control (P <.0001 for all primary and secondary end points in both trials).
In CRSwNP, type 2 or allergic inflammation causes polyps that obstruct the sinus and nasal passages, leading to severe congestion, nasal discharge, facial pain or pressure, and reduced sense of smell and taste.
Persistent symptoms of CRSwNP have a substantial adverse impact on patients' health-related quality of life. Current treatments are limited and include intranasal corticosteroids, oral corticosteroids, and surgery, with high recurrence rates after treatment. Among the patients involved in the 2 late-stage trials, more than half had previously undergone surgery for their nasal polyps and nearly three-quarters had used systemic corticosteroids within the past 2 years.
The rates of adverse events were generally similar across dupilumab and placebo, and no new or unexpected adverse events related to dupilumab were observed.