PURPOSE:AutoimmuneInner 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 blindedplacebo (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. 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.
RCT Entities:
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 AIEDpatients. METHODS: Twenty AIEDpatients 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. 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.
Authors: D E Furst; F C Breedveld; J R Kalden; J S Smolen; G R Burmester; P Emery; E C Keystone; M H Schiff; P L C M van Riel; M E Weinblatt; M H Weisman Journal: Ann Rheum Dis Date: 2006-11 Impact factor: 19.103
Authors: D E Furst; F C Breedveld; J R Kalden; J S Smolen; G R Burmester; J Sieper; P Emery; E C Keystone; M H Schiff; P Mease; P L C M van Riel; R Fleischmann; M H Weisman; M E Weinblatt Journal: Ann Rheum Dis Date: 2007-11 Impact factor: 19.103
Authors: Balázs Liktor; Zoltán Szekanecz; Tamás József Batta; István Sziklai; Tamás Karosi Journal: Eur Arch Otorhinolaryngol Date: 2012-07-29 Impact factor: 2.503