TY - JOUR
T1 - Treatment of Corticosteroid-Responsive Autoimmune Inner Ear Disease with Methotrexate
T2 - A Randomized Controlled Trial
AU - Harris, Jeffrey P.
AU - Weisman, Michael H.
AU - Derebery, Jennifer M.
AU - Espeland, Mark A.
AU - Gantz, Bruce J.
AU - Gulya, A. Julianna
AU - Hammerschlag, Paul E.
AU - Hannley, Maureen
AU - Hughes, Gordon B.
AU - Moscicki, Richard
AU - Nelson, Ralph A.
AU - Niparko, John K.
AU - Rauch, Steven D.
AU - Telian, Steven A.
AU - Brookhouser, Patrick E.
PY - 2003/10/8
Y1 - 2003/10/8
N2 - Context: 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. Objective: To assess the efficacy of long-term methotrexate in maintaining hearing improvements achieved with glucocorticoid (prednisone) therapy in patients with AIED. Design, Setting, and Participants: 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. Intervention: 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. Main Outcome Measure: Maintenance of hearing improvement achieved from prednisone treatment. Results: 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). Conclusion: Methotrexate does not appear to be effective in maintaining the hearing improvement achieved with prednisone therapy in patients with AIED.
AB - Context: 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. Objective: To assess the efficacy of long-term methotrexate in maintaining hearing improvements achieved with glucocorticoid (prednisone) therapy in patients with AIED. Design, Setting, and Participants: 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. Intervention: 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. Main Outcome Measure: Maintenance of hearing improvement achieved from prednisone treatment. Results: 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). Conclusion: Methotrexate does not appear to be effective in maintaining the hearing improvement achieved with prednisone therapy in patients with AIED.
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U2 - 10.1001/jama.290.14.1875
DO - 10.1001/jama.290.14.1875
M3 - Article
C2 - 14532316
AN - SCOPUS:0141957208
SN - 0098-7484
VL - 290
SP - 1875
EP - 1883
JO - Journal of the American Medical Association
JF - Journal of the American Medical Association
IS - 14
ER -