Reslizumab (RES) in patients (pts) with inadequately controlled asthma and elevated blood eosinophils (EOS): Analysis of two phase 3, placebo-controlled trials

Abstract

Background: RES reduced exacerbation frequency and improved lung function and asthma control in pts with inadequately controlled asthma and elevated blood EOS in two placebo (PBO)-controlled, phase 3 studies (Castro et al. Lancet Resp Med 2015). Aims/objectives: To determine the efficacy of RES in the subset of pts in these studies meeting the definition of ATS/ERS-defined inadequately controlled asthma. Methods: This was a post-hoc analysis of pooled data from two replicate, 52-week, PBO-controlled studies of RES (3mg/kg IV Q4W) in pts with inadequately controlled asthma and blood EOS ≥400/µL who were using medium-to-high dose inhaled corticosteroids; primary results have been reported. Assessments included rate of clinical asthma exacerbations (CAE) and change from baseline (BL) in FEV 1 , ACQ-7, AQLQ and ASUI. Results: Of 953 randomised pts, 306 (32%) had inadequately controlled asthma (PBO=161; RES=145). Efficacy results in this asthma patient subset consistently favored RES compared with PBO across measures of CAE (rate ratio 0.41 [95% CI: 0.28, 0.60]), lung function (FEV 1 difference [diff] 158mL [76, 240]) and pt-reported asthma control (ACQ-7 diff –0.295 [–0.471, –0.119]; ASUI diff 0.07 [0.038, 0.102]; AQLQ diff 0.432 [0.233, 0.632]). The magnitude of effects in this patient subset for FEV 1 , AQLQ and ASUI were greater than that observed in the overall population (Castro et al. Lancet Resp Med 2015). Conclusions: RES was highly effective at reducing the frequency of CAE and in improving lung function and pt-reported asthma control and quality of life in this subset of pts. Sponsor: Teva Pharmaceuticals Inc.