title: Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps.
abstract: BACKGROUND
  Chronic rhinosinusitis with nasal polyps is characterized by an eosinophilic inflammation and high IL-5 levels.
  
  
  OBJECTIVE
  Antagonizing the effect of IL-5 is a potential new treatment strategy in patients with nasal polyps.
  
  
  METHODS
  In a double-blind, placebo-controlled, randomized, 2-center safety and pharmacokinetic study, 24 subjects with bilateral nasal polyps were randomized to receive a single intravenous infusion of reslizumab, a humanized anti-human IL-5 mAb, at 3 mg/kg or 1 mg/kg or placebo. We evaluated the safety and pharmacokinetics of reslizumab, and biologic activity was assessed by means of endoscopic evaluation of polyp size, symptoms, peripheral eosinophil counts, peripheral and local IL-5 levels, eotaxin levels, and eosinophil cationic protein levels.
  
  
  RESULTS
  We demonstrated that a single injection of reslizumab up to 3 mg/kg is safe and well tolerated. Blood eosinophil numbers and concentrations of eosinophil cationic protein were reduced up to 8 weeks after treatment in serum and nasal secretions. Individual nasal polyp scores improved only in half of the treated patients for 4 weeks. Responders had increased IL-5 concentrations in nasal secretions at baseline compared with nonresponders, and logistic regression analysis revealed that increased nasal IL-5 levels (>40 pg/mL) predict the response to anti-IL-5 treatment.
  
  
  CONCLUSIONS
  A single injection of anti-IL-5 reduces the size of nasal polyps for 4 weeks in half of the patients, and nasal IL-5 levels predict the response to anti-IL-5 treatment.
  
  
  CONCLUSIONS
  Intravenous administration of a humanized anti-human IL-5 mAb is safe and reduces the size of nasal polyps in half of the patients.
authors.affiliation: Upper airways Research Laboratory, Department of Otorhinolaryngology, Ghent University, Ghent, Belgium. philippe.gevaert@UGent.be <philippe.gevaert@UGent.be>
authors.forename: Philippe
authors.initials: P
authors.lastname: Gevaert
authors.forename: Doris
authors.initials: D
authors.lastname: Lang-Loidolt
authors.forename: Andreas
authors.initials: A
authors.lastname: Lackner
authors.forename: Heinz
authors.initials: H
authors.lastname: Stammberger
authors.forename: Heribert
authors.initials: H
authors.lastname: Staudinger
authors.forename: Thibaut
authors.initials: T
authors.lastname: Van Zele
authors.forename: Gabriele
authors.initials: G
authors.lastname: Holtappels
authors.forename: Jan
authors.initials: J
authors.lastname: Tavernier
authors.forename: Paul
authors.initials: P
authors.lastname: van Cauwenberge
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D015848:Interleukin-5 / Q000037:antagonists & inhibitors* / Q000096:biosynthesis / Q000276:immunology / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D009297:Nasal Mucosa / Q000276:immunology* / Q000378:metabolism*; D009298:Nasal Polyps / Q000276:immunology* / Q000378:metabolism / Q000628:therapy*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015848:Interleukin-5; C515492:reslizumab