title: Effect of omalizumab on biomarkers in middle ear effusion in patients with eosinophilic otitis media.
abstract: CONCLUSIONS
  Eosinophil cationic protein (ECP) concentrations in middle ear effusion (MEE) in patients with eosinophilic otitis media (EOM) were significantly decreased at 3 months after the administration of omalizumab from the baseline level (p < 0.05). This study provides new evidence that omalizumab reduces eosinophilic inflammation in the middle ear and that the reduction of ECP may not be caused by suppression of interleukin (IL)-5 production in the middle ear mucosa.
  
  
  OBJECTIVE
  EOM is an intractable otitis media characterized by a highly viscous effusion containing eosinophils. We recently reported that anti-IgE therapy using omalizumab was efficacious in the treatment of EOM. To clarify the underlying mechanism, we determined changes in biomarkers in MEE related to eosinophilic inflammation after therapy.
  
  
  METHODS
  Nine patients with EOM received the anti-IgE agent omalizumab for 3 months. Among them, five patients continued anti-IgE therapy for longer than 1 year. Eight EOM patients without administration of omalizumab were also included in the study as controls. The concentrations of eosinophilic inflammatory markers such as ECP, IgE, IL-4, and IL-5 in MEE were measured before and after the administration of omalizumab.
  
  
  RESULTS
  After 3 months of omalizumab therapy, the ECP concentration in MEE was significantly reduced from the baseline level (p < 0.05), while no significant change of ECP in the serum was observed. The concentrations of IL-4 and IL-5 in MEE showed no significant change before and after the therapy in EOM patients treated with omalizumab.
authors.affiliation: Department of Otolaryngology, Jichi Medical University Saitama Medical Center , Saitama , Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Iino
authors.forename: Mariko
authors.initials: M
authors.lastname: Hara
authors.forename: Masayo
authors.initials: M
authors.lastname: Hasegawa
authors.forename: Shingo
authors.initials: S
authors.lastname: Matsuzawa
authors.forename: Akihiro
authors.initials: A
authors.lastname: Shinnabe
authors.forename: Hiromi
authors.initials: H
authors.lastname: Kanazawa
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yoshida
mesh_terms: D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood*; D047150:Eosinophil Cationic Protein / Q000097:blood; D004802:Eosinophilia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D015847:Interleukin-4 / Q000097:blood; D015848:Interleukin-5 / Q000097:blood; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D010034:Otitis Media with Effusion / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; D015848:Interleukin-5; D015847:Interleukin-4; D000069444:Omalizumab; D007073:Immunoglobulin E; D047150:Eosinophil Cationic Protein