Reslizumab for Poorly Controlled, Eosinophilic Asthma: A Randomized, Placebo-Controlled Study.
Am J Respir Crit Care Med. 2011 Aug 18;
Authors: Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, Wilkins HJ, Henkel T, Nair P,
Abstract
BACKGROUND: Eosinophilic asthma is a phenotype of asthma characterized by the persistence of eosinophils in the airways. Interleukin-5 is involved in the activation and survival of eosinophils. We evaluated the effect of the antibody to IL-5, reslizumab, in patients with eosinophilic asthma that is poorly controlled with high-dose inhaled corticosteroid. METHODS: Patients were randomly assigned to receive infusions of reslizumab 3.0 mg/kg (n=53) or placebo (n=53) at baseline and weeks 4, 8, and 12, with stratification by baseline Asthma Control Questionnaire (ACQ) score ?2 or >2. The primary efficacy measure was the difference between the reslizumab and placebo groups in the change in ACQ score from baseline to end of therapy (week 15 or early withdrawal). Findings: Mean changes from baseline to end of therapy in ACQ score were -0.7 in the reslizumab group and -0.3 in the placebo group (p=0.054) and in forced expiratory volume in 1 second (FEV1) were 0.18 and -0.08 L, respectively (p=0.002). In those patients with nasal polyps, the changes in ACQ score were -1.0 and -0.1, respectively (p=0.012). Median percentage reductions from baseline in sputum eosinophils were 95.4% and 38.7%, respectively (p=0.007). Eight percent of patients in the reslizumab group and 19% of patients in the placebo group had an asthma exacerbation (p=0.083). The most common adverse events with reslizumab were nasopharyngitis, fatigue, and pharyngolaryngeal pain. Interpretation: Patients receiving reslizumab showed significantly greater reductions in sputum eosinophils, improvements in airway function, and a trend toward greater asthma control than those receiving placebo. Reslizumab was generally well tolerated. Clinical trials registration information available at www.clinicaltrials.gov, NCT00587288.
PMID: 21852542 [PubMed - as supplied by publisher]