title: A pilot study of rituximab in immune-mediated inner ear disease.
abstract: Immune-mediated inner ear disease (IMED) is a cause of rapidly progressive auditory dysfunction. Patients are often responsive to high-dose corticosteroids and the disease is believed to be mediated by an antibody to inner ear proteins. To date, no therapies have proven effective as corticosteroid-sparing agents. Rituximab is a monoclonal antibody that depletes B cells, resulting in a reduction in autoantibody production. For that reason, rituximab was evaluated in a small pilot study in patients with IMED to see if there was a signal suggesting benefit. In all, 5/7 patients met the primary endpoint of an improvement in pure tone average (500-3000 Hz) by 10 dB in at least one ear, or an improvement in word identification score by at least 12% at 24 weeks, both relative to screening precorticosteroid values after 1 course of treatment. No significant adverse events were reported. The results of this study suggest further evaluation of rituximab as a treatment for IMED is indicated.
authors.affiliation: Metroplex Clinical Research Center, University of Texas Southwestern Medical School, Dallas, TX 75231, Dallas, USA. Scohen@arthdocs.com
authors.forename: Stanley
authors.initials: S
authors.lastname: Cohen
authors.forename: Peter
authors.initials: P
authors.lastname: Roland
authors.forename: Angela
authors.initials: A
authors.lastname: Shoup
authors.forename: Mitchell
authors.initials: M
authors.lastname: Lowenstein
authors.forename: Herbert
authors.initials: H
authors.lastname: Silverstein
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Harris
mesh_terms: D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D001301:Audiometry, Pure-Tone; D001327:Autoimmune Diseases / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007759:Labyrinth Diseases / Q000276:immunology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D007155:Immunologic Factors; D000069283:Rituximab