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Treatment of corticosteroid-responsive autoimmune inner ear disease with methotrexate: a randomized controlled trial
Journal article   Open access   Peer reviewed

Treatment of corticosteroid-responsive autoimmune inner ear disease with methotrexate: a randomized controlled trial

Jeffrey P Harris, Michael H Weisman, Jennifer M Derebery, Mark A Espeland, Bruce J Gantz, A Julianna Gulya, Paul E Hammerschlag, Maureen Hannley, Gordon B Hughes, Richard Moscicki, …
JAMA : the journal of the American Medical Association, Vol.290(14), pp.1875-1883
10/08/2003
DOI: 10.1001/jama.290.14.1875
PMID: 14532316
url
https://doi.org/10.1001/jama.290.14.1875View
Published (Version of record) Open Access

Abstract

A number of therapies have been proposed for the long-term management of corticosteroid-responsive, rapidly progressive, bilateral sensorineural hearing loss (autoimmune inner ear disease [AIED]). Methotrexate has emerged as the benchmark agent but has not been rigorously evaluated for hearing improvement in patients with AIED. To assess the efficacy of long-term methotrexate in maintaining hearing improvements achieved with glucocorticoid (prednisone) therapy in patients with AIED. A randomized, double-blind, placebo-controlled trial conducted from February 3, 1998, to November 5, 2001, of 67 patients with rapidly progressive, bilateral sensorineural hearing loss at 10 tertiary care centers in the United States. Randomization to either oral methotrexate (15 to 20 mg/wk; n = 33) or placebo (n = 34), in combination with an 18-week prednisone taper. Follow-up examinations, including audiometric evaluation, were performed at 4, 8, 12, 24, 36, 48, and 52 weeks, or until hearing loss was documented. Maintenance of hearing improvement achieved from prednisone treatment. Sixty-seven patients (57.8%) enrolled in the prednisone challenge experienced hearing improvement. Twenty-five patients (37%) experienced hearing improvements in both ears. Of the individuals who reached study end points, 24 (80%) of 30 end points were because of measured hearing loss in the methotrexate group and 29 (93.5%) of 31 end points were because of measured hearing loss in the placebo group (P =.15). Methotrexate was no more effective than placebo in maintaining the hearing improvement achieved with prednisone treatment (hazard ratio, 1.31; 95% confidence interval, 0.79-2.17; P =.30). Methotrexate does not appear to be effective in maintaining the hearing improvement achieved with prednisone therapy in patients with AIED.
 Glucocorticoids - therapeutic use Prospective Studies Audiometry Double-Blind Method Humans Immunosuppressive Agents - therapeutic use Ear, Inner Methotrexate - therapeutic use Hearing Loss, Bilateral - drug therapy Ear Diseases - drug therapy Hearing Loss, Sensorineural - immunology Hearing Loss, Bilateral - immunology Hearing Loss, Sensorineural - drug therapy Autoimmune Diseases - drug therapy Prednisone - therapeutic use

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