Improvements in Asthma Quality of Life Questionnaire (AQLQ) Domains with Reslizumab in Patients with Inadequately Controlled Asthma and Elevated Blood Eosinophils

Rationale: Results of two duplicate 52-week, placebo-controlled trials indicate that patients with asthma and elevated blood eosinophils (≥400cells/µl) who were inadequately controlled on at least medium-dose ICS, achieved significant improvements from baseline in the AQLQ score with reslizumab versus placebo (p<0.0001) (Castro et al., Lancet Resp Med. 2015). This analysis further investigates the AQLQ subdomains driving the response in these two studies.

Methods: Patients received reslizumab 3mg/kg[IV] (Q4W) or placebo. We assessed all four AQLQ domains (activity limitations [AL], symptoms [S], emotional function [EF] and environmental stimuli [ES]) for change from baseline at week 52, and for the proportion of patients with a minimally important difference (MID) of ≥0.5 improvement within each domain.

Results: Except for ES in one study, significant changes from baseline in all AQLQ domains were seen at week 52 with reslizumab versus placebo. AL: diffs 0.335(study1) and 0.219(study2), p≤0.05(both studies); S: diffs 0.393(study1) and 0.383(study2), p≤0.05(both studies); EF: diffs: 0.411(study1) and 0.375(study2), p≤0.05(both studies), and ES: diffs 0.419(study1) and 0.013(study2), p≤0.05(study1)/NSD(study2). The proportion of patients with a MID from baseline for each AQLQ domain were: AL: 67% reslizumab(both studies), 59% and 61% placebo groups (p=NSD); S: 79% and 77% reslizumab groups and 68% placebo (both studies; p≤0.05); EF: 72% reslizumab(both studies) and 61% and 60% placebo groups(both studies, p≤0.05); ES: 76% and 60% reslizumab and 67% and 63% placebo groups (p≤0.05 [study1]/p=NSD[study2]).

Conclusions: Reslizumab consistently improved AQLQ domains at 52-weeks. Clinically significant results were supported for S and EF domains, with less robust results for AL and ES domains.