title: Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study.
abstract: BACKGROUND
  This phase 3 study further characterizes the efficacy and safety of reslizumab (a humanized anti-IL-5 monoclonal antibody) in patients aged 12 to 75 years with asthma inadequately controlled by at least a medium-dose inhaled corticosteroid and with a blood eosinophil count ≥ 400 cells/μL.
  
  
  METHODS
  Patients were randomized to receive reslizumab 0.3 or 3.0 mg/kg or placebo administered once every 4 weeks for 16 weeks (total four doses). The primary end point was change from baseline in pre-bronchodilator FEV1over 16 weeks. Secondary end points included FVC, forced expiratory flow at 25% to 75% of FVC (FEF25%-75%), patient-reported control of asthma symptoms, short-acting β-agonist (SABA) use, blood eosinophil levels, and safety.
  
  
  RESULTS
  Reslizumab significantly improved FEV1(difference vs placebo [reslizumab 0.3 and 3.0 mg/kg], 115 mL [95% CI, 16-215; P = .0237] and 160 mL [95% CI, 60-259; P = .0018]). Clinically meaningful increases in FVC (130 mL) and FEF25%-75%(233 mL/s) were observed with reslizumab 3.0 mg/kg. Reslizumab improved scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) vs placebo (greater effects seen with 3.0 mg/kg; P < .05). The minimally important difference was reached for the AQLQ (reslizumab 3.0 mg/kg) but not on the ACQ. Scores on the Asthma Symptom Utility Index and SABA use were improved with reslizumab. The most common adverse events were worsening of asthma, headache, and nasopharyngitis; most events were mild to moderate in severity.
  
  
  CONCLUSIONS
  Reslizumab improved lung function, asthma control and symptoms, and quality of life. It was well tolerated in patients with inadequately controlled asthma (despite standard therapy) and elevated blood eosinophil levels. Overall, the 3.0-mg/kg dose of reslizumab provided greater improvements in asthma outcomes vs the 0.3-mg/kg dose, with comparable safety.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT01270464; URL: www.clinicaltrials.gov.
authors.affiliation: Skåne University Hospital, Lund University, Lund, Sweden. Electronic address: leif.bjermer@med.lu.se.
authors.forename: Leif
authors.initials: L
authors.lastname: Bjermer
authors.affiliation: Sacré-Coeur Hospital, Université de Montréal, Montreal, QC, Canada.
authors.forename: Catherine
authors.initials: C
authors.lastname: Lemiere
authors.affiliation: Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina.
authors.forename: Jorge
authors.initials: J
authors.lastname: Maspero
authors.affiliation: Teva Pharmaceuticals, Netanya, Israel.
authors.forename: Sivan
authors.initials: S
authors.lastname: Weiss
authors.affiliation: Teva Pharmaceuticals, Frazer, PA.
authors.forename: James
authors.initials: J
authors.lastname: Zangrilli
authors.affiliation: Teva Pharmaceuticals, Frazer, PA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Germinaro
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D002648:Child; D004311:Double-Blind Method; D004802:Eosinophilia / Q000150:complications / Q000276:immunology*; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008450:Maximal Midexpiratory Flow Rate; D000071066:Patient Reported Outcome Measures; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014797:Vital Capacity; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D061067:Antibodies, Monoclonal, Humanized; C515492:reslizumab
keywords: asthma; eosinophil; phase 3; reslizumab