title: Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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).
  
  
  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 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.
  
  
  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.
authors.affiliation: Washington University School of Medicine, St. Louis, MO 63110, USA. castrom@wustl.edu
authors.forename: Mario
authors.initials: M
authors.lastname: Castro
authors.forename: Sameer
authors.initials: S
authors.lastname: Mathur
authors.forename: Frederick
authors.initials: F
authors.lastname: Hargreave
authors.forename: Louis-Philippe
authors.initials: LP
authors.lastname: Boulet
authors.forename: Fang
authors.initials: F
authors.lastname: Xie
authors.forename: James
authors.initials: J
authors.lastname: Young
authors.forename: H Jeffrey
authors.initials: HJ
authors.lastname: Wilkins
authors.forename: Timothy
authors.initials: T
authors.lastname: Henkel
authors.forename: Parameswaran
authors.initials: P
authors.lastname: Nair
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004804:Eosinophils / Q000187:drug effects; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D015848:Interleukin-5 / Q000037:antagonists & inhibitors* / Q000502:physiology; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011657:Pulmonary Eosinophilia / Q000188:drug therapy*; D013183:Sputum / Q000166:cytology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D015848:Interleukin-5; C515492:reslizumab