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.
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 10Db in two consecutive frequencies and/or improvement in speech discrimination of >12% at week 8.
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.
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.
*Division of Rheumatology, St. Paul University Medical Center, Dallas, Texas; †Department of Otolaryngology, Division of Communicative and Vestibular Disorders, University of Texas Southwestern Medical School, Dallas, Texas; ‡Division of Rheumatology, Cedars Sinai Medical Center, Los Angeles, California; and §Department of Otolaryngology, University of California, San Diego, San Diego, California, U.S.A.
Address correspondence and reprint requests to Stanley Cohen, M.D., 5939 Harry Hines Blvd, Suite 400, Dallas, Texas 75235, U.S.A.; E-mail: Arthdoc@aol.com
Grant support was provided by Amgen for this investigator-initiated research.