Etanercept Therapy for Immune-mediated Cochleovestibular Disorders: Preliminary Results in a Pilot Study

Objective Immune-mediated cochleovestibular disorders (IMCVDs) continue to present a management challenge to the otolaryngologist. Antirheumatic agents, commonly used for IMCVDs, are associated with variable efficacy and sometimes with serious side effects. The authors describe the preliminary result of their experience in patients with IMCVDs who have been treated with etanercept, a tumor necrosis factor &agr; receptor blocker, recently approved by the United States Food and Drug Administration for the treatment of rheumatoid arthritis. Study Design Retrospective case series. Setting Tertiary care hospital. Patients Twelve patients suspected of having IMCVD who did not respond to conventional therapies or experienced side effects of the conventional therapies. Intervention Etanercept 25 mg by subcutaneous injection twice per week. Main Outcome Measures The main outcome measurement was assessment of hearing change by air conduction pure tone audiograms and/or word discrimination. When present, vertigo, tinnitus, and aural fullness were assessed as well. Results Follow-up of more than 5 months was available for all patients (range, 5–12 months). Eleven (92%) of 12 patients had improvement or stabilization of hearing and tinnitus, seven (88%) of eight patients who had vertigo and eight (89%) of nine patients who had aural fullness had resolution or significant improvement of their symptoms. The benefit persisted until the last visit (5–12 months after etanercept was begun). The condition of one patient improved dramatically at first but deteriorated after 5 months. The patient's hearing was rescued and stabilized with the addition of leflunomide to etanercept. Similarly, three other patients required a second antirheumatic agent to stabilize their hearing. There were no significant side effects from the etanercept therapy. Conclusions Our limited data suggest that etanercept therapy is safe and may be efficacious in carefully selected patients with IMCVDs, at least on a short-term basis. These preliminary efficacy and safety results appear encouraging enough to warrant further follow-up and studies for better determination of the potential clinical utility of etanercept for IMCVDs.