Patients with severe eosinophilic asthma have increased risk of clinical asthma exacerbations (CAEs), impaired lung function and lower quality of life (QoL) compared with patients with non-eosinophilic asthma. The efficacy and safety of intravenous reslizumab have been demonstrated in two duplicate, randomized, double-blind, placebo-controlled, Phase 3 studies.
We present findings from post hoc analyses of the subgroup of patients from the Phase 3 studies with severe (Global Initiative for Asthma Step 4 or 5) eosinophilic asthma who had ≥2 or ≥3 CAEs in the 12 months prior to screening.
Patients aged ≥12 years with severe eosinophilic asthma were randomized (1:1) to reslizumab 3.0 mg/kg or placebo q4w for 1 year. Outcomes assessed included: CAEs, forced expiratory volume in 1 second (FEV), and Asthma Control Questionnaire 6 (ACQ-6) and Asthma QoL Questionnaire (AQLQ) scores.
Of 953 patients randomized, 318 (reslizumab: n=156; placebo: n=162) and 164 (reslizumab: n=72; placebo: n=92) were GINA 4/5 with ≥2 CAEs in the prior year and ≥3 CAEs in the prior year, respectively. Reslizumab significantly improved CAE rate, time to first CAE, and the proportion of patients who experienced ≥1 CAE versus placebo in both CAE subgroups. Improvements in FEV, ACQ-6 and AQLQ scores, and systemic corticosteroid burden were also observed with reslizumab versus placebo after 52 weeks of treatment in both CAE subgroups.
Reslizumab reduced CAE frequency and improved lung function, asthma control and QoL versus placebo in patients with severe eosinophilic asthma with a high CAE rate prior to treatment.
Copyright © 2020. Published by Elsevier Inc.