Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy

Abstract

Reslizumab, an anti-interleukin-5 monoclonal antibody, significantly reduces exacerbation frequency and improves lung function, asthma control and quality of life in adults with severe eosinophilic asthma, as demonstrated in Phase III studies. This secondary analysis assessed reslizumab's efficacy in patients receiving baseline treatment per Global Initiative for Asthma (GINA) Step 4 and Step 5 guidelines. Pooled data from duplicate, Phase III, reslizumab versus placebo studies in patients with severe eosinophilic asthma (blood eosinophils ≥400 cells·µL^-1) were stratified by baseline therapy. Efficacy assessments were exacerbation rates and changes from baseline forced expiratory volume in 1 s (FEV₁) and patient-reported outcomes. Of 953 patients, 69% (n=657) and 11% (n=106) were receiving Step 4 and Step 5 therapy, respectively. Compared with placebo, reslizumab reduced exacerbation rates by 53% (95% CI 0.36-0.62) and 72% (95% CI 0.15-0.52), in Step 4 and Step 5 groups respectively. By study end, reslizumab increased FEV₁ in Step 4 and Step 5 groups by 103 mL (95% CI 52-154 mL) and 237 mL (95% CI 68-407 mL), respectively. Reslizumab also improved patient-reported outcomes compared with placebo in both groups. Reslizumab reduces exacerbation rates and improves lung function and patient-reported outcomes in patients with eosinophilic asthma receiving therapy per Steps 4 and 5 of the GINA guidelines.

FIGURE 1

Effects of reslizumab on: (a) clinical asthma exacerbation (CAE) rates; (b) rates of clinical asthma exacerbation requiring oral corticosteroids (OCS); and (c) rates of CAEs requiring hospitalisation or an emergency room visit, in Global Initiative for Asthma (GINA) Step 4 and 5 patients.

FIGURE 2

Effects of reslizumab on lung function (forced expiratory volume in 1 s; FEV₁) in Global Initiative for Asthma (GINA) Step 4 and 5 patients. (a) Changes from baseline FEV₁ at week 16 and week 52 and (b) changes relative to placebo throughout the study. LS: least square.

FIGURE 3

Effects of reslizumab on asthma control questionnaire-7 (ACQ-7) score in Global Initiative for Asthma (GINA) Step 4 and 5 patients. (a) Changes from baseline ACQ-7 score at week 16 and week 52 and (b) changes relative to placebo throughout the study. Increase in control is represented by a decrease in ACQ-7 score [16, 19]. LS: least square.

FIGURE 4

Effects of reslizumab on asthma quality of life questionnaire (AQLQ) score in Global Initiative for Asthma (GINA) Step 4 and 5 patients. Changes from baseline AQLQ score at week 16, week 32 and week 52. Increased quality of life is represented by increased AQLQ score. The first post-baseline measurement for AQLQ was at week 16. LS: least square.