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.