Clinically meaningful improvements with reslizumab in patient-reported outcomes and lung function in a sub-population defined by the EU indication with ≥3 exacerbations

Background: Reslizumab (RES) is a humanized anti-interleukin-5 monoclonal antibody approved by the European Medicines Agency (EMA) as an add-on therapy for adult patients (pts) with inadequately controlled severe eosinophilic asthma. Aims/Objectives: To evaluate the impact of RES on pt-reported measures and lung function in pts who experienced ≥3 exacerbations in the previous year despite using high-dose inhaled corticosteroids (ICS). Methods: A post-hoc, subgroup analysis of adult pts from two duplicate placebo (PBO)-controlled 52-wk phase 3 RES trials reported by Castro et al (Lancet Resp Med 2015;3:355–366) was performed in those with inadequately controlled (despite having used high-dose ICS plus another agent), severe eosinophilic asthma who experienced ≥3 exacerbations in the 12 months before study enrollment. Changes from baseline in FEV1, ACQ-7, AQLQ, and ASUI are reported. Results: Of the 953 randomized pts, 86 (RES 36, PBO 50) were included in this subgroup analysis. Compared with PBO, RES treatment improved FEV1 (difference 304 mL [95% CI: 117, 490], p=0.0018), ACQ-7 (difference -0.535 [-0.939, -0.130], p=0.0103), AQLQ (difference 0.681 [0.246, 1.116], p=0.0026) and ASUI (difference 0.101 [0.033, 0.169], p=0.0043). The observed improvements in this subgroup were both statistically significant and clinically meaningful (exceeding the minimally important differences). Conclusions: RES was clinically effective in improving lung function, asthma control, quality of life, and symptoms in this subset of pts with inadequately controlled, severe eosinophilic asthma who reported ≥3 exacerbations in the previous year.