Dupilumab provides early and durable improvement of symptoms in patients with chronic rhinosinusitis with nasal polyps

Abstract

Abstract Objectives To evaluate within‐patient symptom improvement in the dupilumab SINUS‐24/‐52 studies in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) (NCT02912468/NCT02898454). Methods Patients received dupilumab 300 mg or placebo every 2 weeks for 24 (SINUS‐24) or 52 weeks (SINUS‐52) on background intranasal corticosteroids. Patients daily reported symptoms of nasal congestion (NC), loss of smell (LoS) and rhinorrhoea on a scale of 0–3 (0 – no symptoms, 1 – mild, 2 – moderate, 3 – severe symptoms). The proportions of patients with moderate‐to‐severe symptoms (score ≥ 2) at baseline who improved to no‐to‐mild symptoms (score ≤ 1) were determined at Weeks 2, 24 (pooled studies) and 52 (SINUS‐52). Subgroups with prior sinonasal surgery and coexisting asthma were analysed. Results At baseline in the pooled intention‐to‐treat population (n = 724), the proportions of patients with scores ≥ 2 for NC, LoS and rhinorrhoea were 87, 94 and 64%, respectively. Significantly, more patients achieved scores ≤ 1 (no/mild symptoms) with dupilumab vs placebo for each symptom at each time point {Week 2 NC 12% vs 2% [odds ratio 8.9 (95% CI 3.0–26.3)], LoS 5% vs 1% [4.6 (1.3–16.8)], rhinorrhoea 9% vs 2% [4.8 (1.5–15.4)], all P < 0.05; Week 24 NC 54% vs 14% [8.7 (5.6–13.5)], LoS 43% vs 6% [14.4 (7.9–26.0)], rhinorrhoea 53% vs 16% [6.6 (4.1–10.9)], all P < 0.0001}. Results were similar in subgroups with prior surgery and coexisting asthma. Conclusion Significantly, more patients achieved improvement from moderate‐to‐severe symptoms to no‐to‐mild symptoms with dupilumab than placebo, regardless of prior surgery or coexisting asthma. Improvement was observed as early as Week 2 and continued through to Week 52.

Keywords

• asthma
• chronic inflammation
• inflammation
• interleukins