Reslizumab for poorly controlled, eosinophilic asthma: A randomized, placebo-controlled study

Mario Castro, Sameer Mathur, Frederick Hargreave, Louis Philippe Boulet, Fang Xie, James Young, H. Jeffrey Wilkins, Timothy Henkel, Parameswaran Nair

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470 Scopus citations

Abstract

Rationale: Eosinophilic asthma is a phenotype of asthma characterized by the persistence of eosinophils in the airways. IL-5 is involved in the activation and survival of eosinophils. Objectives: To evaluate 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 at 3.0 mg/kg (n=53) or placebo (n=53) at baseline and at Weeks 4, 8, and 12, with stratification by baseline Asthma Control Questionnaire (ACQ) score less than or equal to 2 or greater than 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). Measurements and Main Results: 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 FEV 1 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 sputumeosinophils 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)1125-1132
Number of pages8
JournalAmerican journal of respiratory and critical care medicine
Volume184
Issue number10
DOIs
StatePublished - Nov 15 2011

Keywords

  • Asthma
  • Eosinophils
  • Interleukin-5
  • Reslizumab

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    Castro, M., Mathur, S., Hargreave, F., Boulet, L. P., Xie, F., Young, J., Jeffrey Wilkins, H., Henkel, T., & Nair, P. (2011). Reslizumab for poorly controlled, eosinophilic asthma: A randomized, placebo-controlled study. American journal of respiratory and critical care medicine, 184(10), 1125-1132. https://doi.org/10.1164/rccm.201103-0396OC