title: A randomized trial of benralizumab, an antiinterleukin 5 receptor α monoclonal antibody, after acute asthma.
abstract: BACKGROUND
  Patients with frequent asthma exacerbations resulting in emergency department (ED) visits are at increased risk for future exacerbations. We examined the ability of 1 dose of benralizumab, an investigational antiinterleukin 5 receptor α monoclonal antibody, to reduce recurrence after acute asthma exacerbations.
  
  
  METHODS
  In this randomized, double-blind, placebo-controlled study, eligible subjects presented to the ED with an asthma exacerbation, had partial response to treatment, and greater than or equal to 1 additional exacerbation within the previous year. Subjects received 1 intravenous infusion of placebo (n = 38) or benralizumab (0.3 mg/kg, n = 36 or 1.0 mg/kg, n = 36) added to outpatient management. The primary outcome was the proportion of subjects with greater than or equal to 1 exacerbation at 12 weeks in placebo vs the combined benralizumab groups. Other outcomes included the time-weighted rate of exacerbations at week 12, adverse events, blood eosinophil counts, asthma symptom changes, and health care resource utilization.
  
  
  RESULTS
  The proportion of subjects with greater than or equal to 1 asthma exacerbation at 12 weeks was not different between placebo and the combined benralizumab groups (38.9% vs 33.3%; P = .67). However, compared with placebo, benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P = .01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P = .02) in the combined groups. Benralizumab reduced blood eosinophil counts but did not affect other outcomes, while demonstrating an acceptable safety profile.
  
  
  CONCLUSIONS
  When added to usual care, 1 dose of benralizumab reduced the rate and severity of exacerbations experienced over 12 weeks by subjects who presented to the ED with acute asthma.
authors.affiliation: Clinical Trial Center, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, USA. Electronic address: rnowak1@hfhs.org.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Nowak
authors.affiliation: Clinical Development, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: parkerj@medimmune.com.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Parker
authors.affiliation: Department of Emergency Medicine, North Shore-Long Island Jewish Medical Center, 270-05 76th Ave New Hyde Park, NY, USA. Electronic address: aresilv@aol.com.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Silverman
authors.affiliation: Department of Emergency Medicine and School of Public Health, University of Alberta, 1G1.42 Walter Mackenzie Centre, Edmonton, Alberta, Canada. Electronic address: brian.rowe@ualberta.ca.
authors.forename: Brian H
authors.initials: BH
authors.lastname: Rowe
authors.affiliation: Department of Emergency Medicine, Baystate Emergency Medicine, 759 Chestnut St, Springfield, MA, USA. Electronic address: howard.smithline@bhs.org.
authors.forename: Howard
authors.initials: H
authors.lastname: Smithline
authors.affiliation: Department of Emergency Medicine, Nassau University Medical Center, 2201 Hempstead Turnpike, Box 14, East Meadow, NY, USA. Electronic address: faizkhan3@aol.com.
authors.forename: Faiz
authors.initials: F
authors.lastname: Khan
authors.affiliation: Clinical Operations, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: fieningj@medimmune.com.
authors.forename: Jon P
authors.initials: JP
authors.lastname: Fiening
authors.affiliation: Clinical Biostatistics, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: kimk@medimmune.com.
authors.forename: Keunpyo
authors.initials: K
authors.lastname: Kim
authors.affiliation: Clinical Research, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: nmolfino@kalobios.com.
authors.forename: Nestor A
authors.initials: NA
authors.lastname: Molfino
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002170:Canada; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014481:United States
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C571386:benralizumab