title: An open label study to evaluate the safety and efficacy of intratympanic golimumab therapy in patients with autoimmune inner ear disease.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of intratympanically injected golimumab (GLM), a TNF-α inhibitor, as a steroid-sparing agent for patients with steroid-dependent autoimmune inner ear disease (AIED).
  
  
  METHODS
  Open label.
  
  
  METHODS
  Tertiary referral center.
  
  
  METHODS
  Ten patients with steroid-dependent AIED were enrolled in Stage 2. The average patient age at enrollment was 59, with an average of 12.5 years from the start of bilateral hearing loss symptoms. The average dose of daily prednisone at the start of injections was 18 mg.
  
  
  METHODS
  Intratympanic injection of GLM.
  
  
  METHODS
  Hearing loss progression (treatment failure) was defined as either an increase in pure-tone thresholds by frequency or a decrease in word recognition score.
  
  
  RESULTS
  There were no serious adverse events. Five of seven per-protocol subjects experienced stable pure-tone thresholds in the injected ear, whereas 4 had stable word recognition scores. Two subjects experienced an improvement in word recognition scores. The results support the hypothesis that GLM may be a promising treatment.
  
  
  CONCLUSIONS
  The TNF-α inhibitor GLM stabilized hearing in 3 of 7 per-protocol subjects with AIED and allowed a complete tapering off of prednisone in those 7 subjects. Studies with larger samples sizes are warranted.
authors.affiliation: *House Clinic, Los Angeles; and †Keck School of Medicine of University of Southern California, Department of Otolaryngology-Head and Neck Surgery, Los Angeles, California, U.S.A.
authors.forename: M Jennifer
authors.initials: MJ
authors.lastname: Derebery
authors.forename: Laurel M
authors.initials: LM
authors.lastname: Fisher
authors.forename: Courtney C J
authors.initials: CC
authors.lastname: Voelker
authors.forename: Audrey
authors.initials: A
authors.lastname: Calzada
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001327:Autoimmune Diseases / Q000188:drug therapy*; D005260:Female; D006312:Hearing Loss, Bilateral / Q000188:drug therapy; D006801:Humans; D007759:Labyrinth Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000187:drug effects
chemical_list: D000911:Antibodies, Monoclonal; C529000:golimumab