Etanercept treatment for autoimmune inner ear disease: results of a pilot placebo-controlled study.
OBJECTIVE
Autoimmune Inner Ear Disease (AIED) is an idiopathic progressive, often bilateral, sensironeural hearing loss that occurs over weeks to months, generally resulting in significant auditory disability. Response to treatment with immunomodulators other than corticosteroids has been poor. Data from a guinea pig model of AIED and a recent open label trial of etanercept suggested potential treatment benefit. Based on these preliminary results, we conducted a pilot placebo controlled trial of etanercept in AIED patients.


METHODS
Twenty AIED patients were enrolled in a 12-week blinded placebo (PLA) controlled randomized clinical trial of etanercept (ETA) with 25 mg SC twice weekly. Patients received treatment for 8 weeks with a 4-week follow-up off-treatment. The primary study endpoint was an improvement in pure tone threshold (PTA) of 10 Db in two consecutive frequencies and/or improvement in speech discrimination of >12% at week 8.


RESULTS
Patient demographics were similar for the ETA and PLA patients. Seventeen subjects (8 ETA, 9 PLA) completed the trial. The 3 dropouts were due to lack of efficacy. One ETA and 2 PLA subjects achieved the primary endpoint (p > 0.999). One ETA and 1 PLA pt demonstrated improved in hearing loss and vertigo severity by VAS and hearing disability. No safety issues were observed.


CONCLUSIONS
The results of this pilot trial demonstrate that etanercept 25 mg twice weekly for 8 weeks was no better than placebo for treatment of AIED in this patient population.
Cohen
Stanley
S
Division of Rheumatology, St. Paul University Medical Center, Dallas, Texas 75235, USA. Arthdoc@aol.com
Shoup
Angela
A
Weisman
Michael H
MH
Harris
Jeffrey
J
D001309:Auditory Threshold; D001327:Autoimmune Diseases / Q000150:complications / Q000188:drug therapy*; D000068800:Etanercept; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000188:drug therapy / Q000209:etiology*; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007759:Labyrinth Diseases / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins; D016896:Treatment Outcome
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins; D000068800:Etanercept