Etanercept Treatment for Autoimmune Inner Ear Disease: Results of a Pilot Placebo-Controlled Study

Cohen, Stanley; Shoup, Angela G.; Weisman, Michael H.; Harris, Jeffrey P.

doi:10.1097/01.mao.0000185082.28598.87

Cited by 86 publications

(65 citation statements)

References 13 publications

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“…10 While some investigators reported that, in an animal model, etanercept has a protective effect on hearing loss, 11 others found it less effective than prednisone, with a greater potential for adverse effects. 4,6,12 In 2 small human studies, levels of TNF in patients with sudden SNHL were found to be elevated in one study of 12 patients, 13 while the other study showed that both corticosteroid-responding and nonresponding patients (total of 30 for both groups together) had lower levels of TNF than controls and concluded that this cytokine does not offer useful information in either prognosis or diagnosis of the disease.…”

Section: Arch Otolaryngol Head Neckmentioning

confidence: 99%

“…Vari-ous cytokines have been implicated in IM-SNHL, such as interleukin (IL)-1␤, 2 interferon (IFN)-␥, 3 and tumor necrosis factor (TNF; formerly known as tumor necrosis factor ␣). 4 Several clinical trials have been conducted in this patient population with immunemodulating agents such as methotrexate, 5 etanercept, 4,6,7 and infliximab, 8 all with limited success. Ren et al 9 reported on TNF in patients with sudden SNHL and progressive SNHL in 1998.…”

Section: Arch Otolaryngol Head Neckmentioning

confidence: 99%

See 1 more Smart Citation

Diagnostic and Prognostic Utility of Measuring Tumor Necrosis Factor in the Peripheral Circulation of Patients With Immune-Mediated Sensorineural Hearing Loss

Svrakic¹,

Pathak²,

Goldofsky³

et al. 2012

Arch Otolaryngol Head Neck Surg

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Section: Arch Otolaryngol Head Neckmentioning

confidence: 99%

Section: Arch Otolaryngol Head Neckmentioning

confidence: 99%

Diagnostic and Prognostic Utility of Measuring Tumor Necrosis Factor in the Peripheral Circulation of Patients With Immune-Mediated Sensorineural Hearing Loss

Svrakic¹,

Pathak²,

Goldofsky³

et al. 2012

Arch Otolaryngol Head Neck Surg

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“…Prior to these studies, no effective therapies have been identified for corticosteroidresistant AIED patients. Moreover, no alternative effective therapies have been identified in corticosteroid-sensitive patients (14,16,17). Finally, even gains in steroid-sensitive AIED patients using corticosteroid therapy may be limited.…”

Section: Discussionmentioning

confidence: 99%

Early efficacy trial of anakinra in corticosteroid-resistant autoimmune inner ear disease

Vambutas¹,

Lesser²,

Mullooly³

et al. 2014

J. Clin. Invest.

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BACKGROUND. Autoimmune inner ear disease (AIED) is a rare disease that results in progressive sensorineural hearing loss. Patients with AIED initially respond to corticosteroids; however, many patients become unresponsive to this treatment over time, and there is no effective alternative therapy for these individuals. METHODS.We performed a phase I/II open-label, single-arm clinical trial of the IL-1 receptor antagonist anakinra in corticosteroid-resistant AIED patients. Given that the etiology of corticosteroid resistance is likely heterogeneous, we used a Simon 2-stage design to distinguish between an unacceptable (≤10%) and an acceptable (≥30%) response rate to anakinra therapy. Subjects received 100 mg anakinra by subcutaneous injection for 84 days, followed by a 180-day observational period. RESULTS.Based on patient responses, the Simon 2-stage rule permitted premature termination of the trial after 10 subjects completed the 84-day drug period, as the target efficacy for the entire trial had been achieved. Of these 10 patients, 7 demonstrated audiometric improvement, as assessed by pure tone average (PTA) and word recognition score (WRS). In these 7 responders, reduced IL-1β plasma levels correlated with clinical response. Upon discontinuation of treatment, 3 subjects relapsed, which correlated with increased IL-1β plasma levels. CONCLUSION.We demonstrated that IL-1β inhibition in corticosteroid-resistant AIED patients was effective in a small cohort of patients and that IL-1β plasma levels associated with both clinical hearing response and disease relapse. These results suggest that a larger phase II randomized clinical trial of IL-1β inhibition is warranted.

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“…Infliximab has also been reported to be effective in the treatment of autoimmune sensorineural hearing loss 2 . Etanercept has had contrasting results in this setting, mostly negative 3,4 . We recently encountered 2 cases of sensorineural hearing loss temporally related to adalimumab.…”

Section: To the Editormentioning

confidence: 99%

Use of Adalimumab in Treatment of Autoimmune Sensorineural Hearing Loss: A Word of Caution

Conway¹,

Khan²,

Foley-Nolan³

2011

J Rheumatol

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Etanercept Treatment for Autoimmune Inner Ear Disease: Results of a Pilot Placebo-Controlled Study

Abstract: 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.

Cited by 86 publications

References 13 publications

Diagnostic and Prognostic Utility of Measuring Tumor Necrosis Factor in the Peripheral Circulation of Patients With Immune-Mediated Sensorineural Hearing Loss

Diagnostic and Prognostic Utility of Measuring Tumor Necrosis Factor in the Peripheral Circulation of Patients With Immune-Mediated Sensorineural Hearing Loss

Early efficacy trial of anakinra in corticosteroid-resistant autoimmune inner ear disease

Use of Adalimumab in Treatment of Autoimmune Sensorineural Hearing Loss: A Word of Caution

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