Dupilumab: Phase IIa data
Top-line data from a double-blind, international Phase IIa trial in 60 patients with moderate to severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids showed that once-weekly subcutaneous dupilumab met the primary endpoint of reducing the size of nasal polyps as measured by endoscopic nasal polyp score from baseline to week 16 vs. placebo. Dupilumab also met all secondary endpoints vs. placebo, including improving sinusitis as measured by CT scan, nasal air flow, and patient-reported symptoms of sense of smell, congestion, post-nasal drip, runny nose and sleep disturbance. The most common dupilumab-related adverse events reported were injection-site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness. Patients received intranasal mometasone furoate spray plus placebo or dupilumab at an initial loading dose of 600 mg followed by 300 mg once weekly. ...