Peak nasal inspiratory flow assessment of polyp size and response from SYNAPSE

Abstract

BackgroundIn the Phase III SYNAPSE study, mepolizumab plus standard of care (SoC) reduced nasal polyp score (NPS) versus placebo in patients with chronic rhinosinusitis with nasal polyps. ObjectiveInvestigate relationships between NPS and (1) peak nasal inspiratory flow (PNIF) and (2) patient-reported outcomes (PROs). MethodsIn this post hoc analysis, patients randomized 1:1 received mepolizumab 100 mg or placebo subcutaneously every 4 weeks (plus SoC). Changes from baseline in PNIF (Week 52), visual analog scale (VAS) scores (overall symptoms, nasal obstruction, loss of smell; Weeks 49–52), and 22-item Sino-Nasal Outcome Test (SNOT-22) total score (Week 52) were assessed in patients with NPS improvements (≥1-point) or without (<1-point, or worsening). ResultsPatients with NPS improvements had greater improvements in median (interquartile range [IQR]) PNIF (mepolizumab 50 L/min [10.5, 87.5], placebo 40 L/min [0, 85.0]) than those without (0.0 L/min [─10.0, 45.0], 0.0 L/min [─30.0, 30.0]); similar results were seen for median (IQR) change from baseline in overall symptoms (with: ─5.8 [─8.1, ─3.8], ─4.1 [─7.0, ─1.2]; without: ─1.3 [─6.3, 0.0], ─0.1 [─3.4, 0.0]), nasal obstruction (with: ─5.7 [─8.2, ─3.5], ─4.5 [─7.3, ─1.2]; without: ─1.3 [─6.6, 0.0], 0.0 [─3.6, 0.0]), loss of smell (with: ─2.8 [─7.9, 0.0], ─0.7 [─4.0, 0.0]; without: 0.0 [─2.4, 0.0], 0.0 [─0.3, 0.0]) VAS, and SNOT-22 total score (with: ─37.0 [─52.0, ─24.0], ─29.0 [─43.0, ─9.0]; without: ─16.0 [─42.0, 0.0], 0.0 [─27.0, 0.0]). ConclusionNPS improvement was associated with PNIF and PRO improvements irrespective of treatment. PNIF could be a useful non-invasive tool for monitoring nasal polyp size.