title: Efficacy and safety of mepolizumab in Japanese patients with severe eosinophilic asthma.
abstract: BACKGROUND
  The MENSA trial assessed the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma. This report describes the efficacy and safety of mepolizumab in Japanese patients from MENSA.
  
  
  METHODS
  A post hoc analysis of the Japanese subgroup from the randomized, double-blind, placebo-controlled, double-dummy, Phase III MENSA trial (NCT01691521). Patients ≥12 years with severe eosinophilic asthma received mepolizumab 75 mg intravenously (IV), 100 mg subcutaneously (SC), or placebo, every 4 weeks for 32 weeks. The primary endpoint was the annualized rate of exacerbations. Secondary and other endpoints included annualized rate of exacerbations requiring emergency department (ED) visit/hospitalization, morning peak expiratory flow (PEF), St George's Respiratory Questionnaire (SGRQ) score and eosinophil counts. Adverse events (AEs) were monitored.
  
  
  RESULTS
  In the Japanese subgroup (N = 50), the rate of clinically significant exacerbations was reduced by 90% (rate ratio [RR]: 0.10; 95% confidence interval [CI]: 0.02-0.57; P = 0.010) with mepolizumab IV and 62% (RR: 0.38; 95% CI: 0.12-1.18; P = 0.094) with mepolizumab SC, versus placebo. No exacerbations requiring ED visit/hospitalization were reported with mepolizumab IV; exacerbations were reduced by 73% (RR: 0.27; 95% CI: 0.06-1.29; P = 0.102) with mepolizumab SC versus placebo. Compared with placebo, mepolizumab IV and SC numerically increased morning PEF from baseline by 40 L/min and 13 L/min, improved quality of life by greater than the minimal clinically important difference (SGRQ: 9.5 [P = 0.083] and 7.9 [P = 0.171] points) and reduced eosinophil counts. AE incidence was similar between treatments. Results were broadly consistent with the overall population.
  
  
  CONCLUSIONS
  Mepolizumab was efficacious and well tolerated in Japanese patients with severe eosinophilic asthma, producing similar responses to the overall MENSA population.
authors.affiliation: Department of Allergy, Fukuoka National Hospital, Fukuoka, Japan. Electronic address: t-shimoda@mfukuoka2.hosp.go.jp.
authors.forename: Terufumi
authors.initials: T
authors.lastname: Shimoda
authors.affiliation: Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Odajima
authors.affiliation: Development and Medical Affairs Division, GSK K.K., Tokyo, Japan.
authors.forename: Arisa
authors.initials: A
authors.lastname: Okamasa
authors.affiliation: Development and Medical Affairs Division, GSK K.K., Tokyo, Japan.
authors.forename: Minako
authors.initials: M
authors.lastname: Kawase
authors.affiliation: Development and Medical Affairs Division, GSK K.K., Tokyo, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Komatsubara
authors.affiliation: Clinical Statistics, GSK, UK.
authors.forename: Bhabita
authors.initials: B
authors.lastname: Mayer
authors.affiliation: Respiratory Therapeutic Area, GSK, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Yancey
authors.affiliation: Respiratory Therapeutic Area, GSK, USA.
authors.forename: Hector
authors.initials: H
authors.lastname: Ortega
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000175:diagnosis* / Q000188:drug therapy* / Q000209:etiology; D015415:Biomarkers; D018450:Disease Progression; D004334:Drug Administration Schedule; D004802:Eosinophilia / Q000473:pathology*; D005260:Female; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012129:Respiratory Function Tests; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; C434107:mepolizumab
keywords: Asthma; Mepolizumab; Placebo; Safety; Treatment efficacy