Efficacy of Reslizumab with Asthma, Chronic Sinusitis with Nasal Polyps and Elevated Blood Eosinophils

Rationale: Nasal polyps (NP) are frequently linked to chronic sinusitis (CS) and asthma, conditions often associated with elevated eosinophils. Reslizumab was shown to improve asthma control in patients with NP (Castro et al., AJRCCM, 2011). The aim of this evaluation was to determine the effect of reslizumab on clinical asthma exacerbations (CAE) for patients with inadequately controlled asthma and CS with NP (CSwNP).

Methods: The methodology and primary results of studies 3082 and 3083 (NCT01287039/NCT01285323) have been reported (Castro et al., Lancet Resp Med. 2015). Patients with asthma and elevated blood eosinophils (≥400cells/µL) who remained inadequately controlled on at least medium-dose ICS were randomized to placebo or reslizumab (3mg/kg [IV] Q4W) for 52 weeks. In the current analysis, results from 3082/3083 were pooled and change from baseline in the annual frequency of CAE at week 52 for CSwNP was analyzed. 

Results: Of 953 patients randomized, 150 (16%) had CSwNP and 252 (26%) had CS. Patients with CSwNP receiving reslizumab (n=78) had an 83% reduction in the annual rate of CAE versus placebo (RR 0.17 [95% CI: 0.10, 0.32]; p=0.0002). Similarly, patients identified as having CS only who received reslizumab (n=123) had a 70% reduction in the annual rate of CAE versus placebo (RR 0.30 [95% CI: 0.20, 0.44]; p=0.0103). Both groups also had substantial improvements in FEV₁ over 52 weeks.

Conclusions: Patients with inadequately controlled asthma and CS with or without NP received significant therapeutic benefit with reslizumab, providing further support for the use of reslizumab in asthma patients with eosinophil-mediated disease.