Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma
Parameswaran Nair, Philip Bardin, Marc Humbert, Kevin R Murphy, Lisa Hickey, Margaret Garin, Rebecca Vanlandingham, Pascal Chanez, Parameswaran Nair, Philip Bardin, Marc Humbert, Kevin R Murphy, Lisa Hickey, Margaret Garin, Rebecca Vanlandingham, Pascal Chanez
Abstract
Background: Reslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports in oral corticosteroid-dependent asthma are limited.
Objective: To assess efficacy of reslizumab in oral corticosteroid-dependent patients and benefits on oral corticosteroid burden.
Methods: We report post hoc analyses of pooled data from duplicate, placebo-controlled phase 3 trials. Patients aged 12 to 75 years with inadequately controlled, moderate-to-severe asthma were randomized 1:1 to receive intravenous reslizumab 3.0 mg/kg or placebo every 4 weeks for 52 weeks, stratified by oral corticosteroid use at enrollment and by region. Assessments included efficacy and predictors of clinical asthma exacerbation response in oral corticosteroid-dependent patients, and systemic corticosteroids burden in the overall population.
Results: Patients were randomized to reslizumab (n = 477) or placebo (n = 476); 73 (15%) patients in each group were taking oral corticosteroids at baseline. Reslizumab was favored over placebo for all efficacy end points in oral corticosteroid-dependent patients, with numerically greater improvements in oral corticosteroid-dependent patients than the overall population. Having 2 or more versus 1 clinical asthma exacerbation in the previous 12 months was the strongest positive predictor of reduced exacerbation risk with reslizumab (risk reduction, 77.5% vs 15.2%; P ≤ .02). Significantly fewer new systemic corticosteroid prescriptions were issued per patient receiving reslizumab versus placebo (mean ± SD, 0.5 ± 1.07 vs 1.0 ± 1.52; P < .0001). Total and per-patient systemic corticosteroid burdens were lower: 121,135 versus 290,977 mg and 254 versus 611 mg/patient, respectively (both P < .0001).
Conclusions: Oral corticosteroid-dependent patients benefited from reslizumab across asthma efficacy outcome measures. Reslizumab-treated patients required fewer new systemic corticosteroid prescriptions and had a lower systemic corticosteroid burden compared with placebo.
Trial registration: ClinicalTrials.gov NCT01287039 NCT01285323.
Keywords: Eosinophil; IL-5; Oral corticosteroid; Prednisone; Reslizumab; Severe asthma.
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed