Etanercept treatment for autoimmune inner ear disease: Results of a pilot placebo-controlled study

Stanley Cohen, Angela Shoup, Michael H. Weisman, Jeffrey Harris

Research output: Contribution to journalArticle

67 Citations (Scopus)

Abstract

Purpose: 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 10Db 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)903-907
Number of pages5
JournalOtology and Neurotology
Volume26
Issue number5
DOIs
StatePublished - Sep 2005

Fingerprint

Labyrinth Diseases
Placebos
Therapeutics
Bilateral Hearing Loss
Speech Perception
Etanercept
Vertigo
Immunologic Factors
Hearing Loss
Hearing
Adrenal Cortex Hormones
Guinea Pigs
Randomized Controlled Trials
Demography
Safety

Keywords

  • Autoimmune inner ear disease
  • Etanercept

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Neuroscience(all)

Cite this

Etanercept treatment for autoimmune inner ear disease : Results of a pilot placebo-controlled study. / Cohen, Stanley; Shoup, Angela; Weisman, Michael H.; Harris, Jeffrey.

In: Otology and Neurotology, Vol. 26, No. 5, 09.2005, p. 903-907.

Research output: Contribution to journalArticle

Cohen, Stanley ; Shoup, Angela ; Weisman, Michael H. ; Harris, Jeffrey. / Etanercept treatment for autoimmune inner ear disease : Results of a pilot placebo-controlled study. In: Otology and Neurotology. 2005 ; Vol. 26, No. 5. pp. 903-907.
@article{f334dfc963454a0fa5081fb71013c93e,
title = "Etanercept treatment for autoimmune inner ear disease: Results of a pilot placebo-controlled study",
abstract = "Purpose: 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 10Db 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. Conclusion: 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.",
keywords = "Autoimmune inner ear disease, Etanercept",
author = "Stanley Cohen and Angela Shoup and Weisman, {Michael H.} and Jeffrey Harris",
year = "2005",
month = "9",
doi = "10.1097/01.mao.0000185082.28598.87",
language = "English (US)",
volume = "26",
pages = "903--907",
journal = "Otology and Neurotology",
issn = "1531-7129",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Etanercept treatment for autoimmune inner ear disease

T2 - Results of a pilot placebo-controlled study

AU - Cohen, Stanley

AU - Shoup, Angela

AU - Weisman, Michael H.

AU - Harris, Jeffrey

PY - 2005/9

Y1 - 2005/9

N2 - Purpose: 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 10Db 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. Conclusion: 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.

AB - Purpose: 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 10Db 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. Conclusion: 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.

KW - Autoimmune inner ear disease

KW - Etanercept

UR - http://www.scopus.com/inward/record.url?scp=24944479993&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=24944479993&partnerID=8YFLogxK

U2 - 10.1097/01.mao.0000185082.28598.87

DO - 10.1097/01.mao.0000185082.28598.87

M3 - Article

C2 - 16151336

AN - SCOPUS:24944479993

VL - 26

SP - 903

EP - 907

JO - Otology and Neurotology

JF - Otology and Neurotology

SN - 1531-7129

IS - 5

ER -