Reslizumab (RES) in asthma patients (pts) with severe eosinophilic asthma stratified by GINA asthma steps 4 and 5: Analysis of two phase 3, placebo (PBO)-controlled trials

Abstract

Background: RES reduced exacerbation frequency and improved lung function and asthma control in pts with inadequately controlled asthma and elevated blood eosinophils (EOS) in two PBO-controlled, phase 3 trials (Castro et al. Lancet Resp Med 2015). Aims/objectives: To determine the efficacy of RES in asthma pts stratified by GINA Step 4 (G4) and Step 5 (G5) categories of asthma severity. Methods: Pooled data from two 52-week, PBO-controlled trials of RES (3mg/kg IV Q4W) in pts with inadequately controlled asthma and blood EOS ≥400/µL on inhaled corticosteroid (ICS) ± another controller; primary results have been reported. Current analysis includes pts stratified by G4 (medium/high-dose ICS + second controller) and G5 (add-on oral CS [systemic CS]) categories of asthma severity. Efficacy assessments included rate of clinical asthma exacerbations and change from baseline in FEV 1 , ACQ-7, AQLQ and ASUI. Results: Of 953 randomised pts: 657 (69%) were G4, and 106 (11%) were G5. In G4 and G5 pts vs PBO, RES consistently improved the rate of asthma exacerbations (G4 [53% reduction] rate ratio 0.47 [95% CI: 0.36,0.62]; G5 [72% reduction] 0.28 [0.15,0.52]) and lung function (FEV 1 : G4 difference 103mL [52,154]; G5 difference 237mL [68,407]) over 52 wks. RES also improved AQLQ, ACQ-7 and ASUI scores vs PBO for both G4 and G5 pts. Conclusions: RES effectively reduced the rate of asthma exacerbations, and improved lung function and pt-reported asthma control compared with PBO in pts with G4 or G5 asthma severity classification. Sponsor: Teva Pharmaceuticals Inc.