Dupilumab improves patient-reported outcomes in chronic sinusitis with nasal polyps patients with comorbid asthma: Results from a phase 2a trial

Abstract

Background: In a phase 2a study, dupilumab (DPL) improved endoscopic, radiographic, clinical, and patient-reported outcomes in chronic sinusitis with nasal polyps (CSwNP) patients (pts) refractory to intranasal corticosteroids with/without asthma. Injection site reaction, headache, and nasopharyngitis were most frequently reported adverse events with DPL. We now report the effect of DPL on asthma control and lung function in CSwNP pts with comorbid asthma. Methods: 60 adult CSwNP pts were randomized (1:1) to weekly subcutaneous 300mg DPL or placebo (PBO) on a background of mometasone furoate nasal spray for 16 weeks. 58% of pts (16 DPL, 19 PBO) had comorbid asthma. Asthma endpoints assessed by MMRM analysis included Asthma Control Questionnaire (ACQ-5) and forced expiratory volume in 1 second (FEV1); CSwNP disease severity and quality of life were assessed using visual analog scale (VAS) and Sino-Nasal Outcome Test (SNOT-22). Minimal clinically important difference (MCID) for ACQ is 0.5, and for SNOT-22 the MCID is 8.9. Results: There were no significant differences in baseline outcomes between groups. At week 16 significant improvements in DPL vs PBO were observed in ACQ-5 (least squares [LS] mean change difference −1.09, p Conclusions: In CSwNP pts with comorbid asthma, dupilumab improved asthma control, lung function as well as CSwNP disease severity and quality of life.