Chronic rhinosinusitis with nasal polyps (CRSwNP) and type 2 asthma share the same inflammatory pathophysiology and are frequent comorbidities. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation.
We report the effect of dupilumab vs placebo on outcome measures of the upper and lower airways and health-related quality of life (HRQoL) in the pooled population of patients with CRSwNP and comorbid asthma from the phase III SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies.
In these randomized, double-blind, placebo-controlled trials, patients received subcutaneous dupilumab 300 mg (n = 438) or placebo (n = 286) every 2 weeks on a background of mometasone furoate nasal spray. Changes from baseline at week 24 in upper- and lower-airway outcome measures are reported.
Of 724 patients randomized, 428 (59.1%) had comorbid asthma. In patients with asthma at week 24, dupilumab vs placebo improved nasal polyp score (-2.04), patient-reported nasal congestion score (-1.04), Lund-Mackay CT scan score (-6.43), peak nasal inspiratory flow (46.15 L/minute), and 22-item Sino-Nasal Outcome Test score (-21.42; all P < .0001). Forced expiratory volume in 1 second and 6-item Asthma Control Questionnaire score were also significantly improved with dupilumab vs placebo. The most common adverse events (nasopharyngitis, headache, injectionsite erythema, worsening of nasal polyposis and asthma) were more frequent with placebo than dupilumab.
Dupilumab improved upper- and lower-airway outcome measures and HRQoL in patients with severe CRSwNP and comorbid asthma, and was well tolerated.