Improvements In Individual Asthma Control Questionnaire (ACQ-5) Questions With Reslizumab In Patients With Inadequately Controlled Asthma and Elevated Blood Eosinophils: Pooled Analysis of Two Phase 3 Trials

RATIONALE: Reslizumab (RES) has been shown to significantly improve ACQ-7 score versus placebo (PBO) (-0.25, p<0.0001) in patients with eosinophilic asthma inadequately controlled (ACQ-7 ≥ 1.5) at baseline (Castro et al., Lancet Resp Med. 2015). This analysis further investigates individual ACQ question results.

METHODS: Patients received RES 3mg/kg [IV] (Q4W) or PBO for 52 weeks. In this posthoc analysis, individual ACQ-5 questions were assessed for change in mean score and change in proportion of patients with ≥moderate severity (score ≥3), at week 52 versus baseline.

RESULTS: Compared to PBO (n=475), RES (n=477) resulted in improvement in Q1 (nighttime awakenings [NA]) by -0.3, Q2 (morning symptoms [MS]) by -0.5, Q3 (activity limitation [AL]) by -0.3, Q4 (shortness of breath [SOB]) by -0.3, and Q5 (wheeze) by -0.4 (all p-values < 0.01). At baseline, 36% of patients had NA ≥ several times during the past week, decreased to 9% vs 13% in the RES and PBO groups, respectively, at week 52. At least moderate MS decreased from 60% at baseline to 13% and 22%, respectively. At least moderate AL decreased from 55% at baseline to 16% and 24%, respectively. At least moderate SOB decreased from 62% at baseline to 17% and 25%, respectively. At least moderate wheeze decreased from 55% at baseline to 13% and 23%, respectively.

CONCLUSIONS: In this asthma population with a high proportion of symptomatic patients at baseline, RES consistently improved all ACQ symptom question scores at 52-weeks and improved the proportion of patients with ≥ moderate symptoms.