Title: Efficacy of Reslizumab in Asthma Patients with Aspirin Sensitivity and Elevated Blood Eosinophils
Abstract: Aspirin Exacerbated Respiratory Disease (AERD) consists of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and intolerance to aspirin (ASA) and other NSAIDs. Eosinophilic inflammation plays an important role in AERD. Our aim was to determine the effect of reslizumab on clinical asthma exacerbations (CAE) in patients with inadequately controlled asthma and historical ASA sensitivity. The methodology and outcomes of studies 3082 and 3083 have been previously reported (Castro M, et al. Lancet Resp Med 2015). Patients with asthma and elevated blood eosinophils (≥400cells/μL) who remained inadequately controlled with medium-dose inhaled corticosteroid were randomized to placebo or reslizumab (3mg/kg [IV] Q4W) for 52 weeks. In this analysis, pooled results assessed change in CAE frequency for patients with ASA sensitivity. 11% (n=103/953) of patients had historical ASA sensitivity. Data for concurrent sinus disease were not available for the entire group, but 56 of these patients (6%) were known to also have CRSwNP. Patients with ASA sensitivity who received reslizumab (n=48) had a 62% reduction in the annual rate of CAE versus placebo (RR 0.38 [95% CI 0.21, 0.70]). Patients with ASA sensitivity and known CRSwNP who received reslizumab (n=28) had a 79% reduction in the annual rate of CAE versus placebo (RR 0.21 [95% CI 0.08, 0.58]). Both groups achieved clinically meaningful improvements in forced expiratory volume in 1 second. Patients with inadequately controlled asthma, elevated blood eosinophils, and ASA sensitivity (±CRSwNP) received significant therapeutic benefit, providing further support for the use of reslizumab in this clinical setting.