Cohen Stanley, Roland Peter, Shoup Angela, Lowenstein Mitchell, Silverstein Herbert, Kavanaugh Arthur, Harris Jeffrey
Metroplex Clinical Research Center, University of Texas Southwestern Medical School, Dallas, TX 75231, Dallas, USA.
Audiol Neurootol. 2011;16(4):214-21. doi: 10.1159/000320606. Epub 2010 Oct 27.
Immune-mediated inner ear disease (IMED) is a cause of rapidly progressive auditory dysfunction. Patients are often responsive to high-dose corticosteroids and the disease is believed to be mediated by an antibody to inner ear proteins. To date, no therapies have proven effective as corticosteroid-sparing agents. Rituximab is a monoclonal antibody that depletes B cells, resulting in a reduction in autoantibody production. For that reason, rituximab was evaluated in a small pilot study in patients with IMED to see if there was a signal suggesting benefit. In all, 5/7 patients met the primary endpoint of an improvement in pure tone average (500-3000 Hz) by 10 dB in at least one ear, or an improvement in word identification score by at least 12% at 24 weeks, both relative to screening precorticosteroid values after 1 course of treatment. No significant adverse events were reported. The results of this study suggest further evaluation of rituximab as a treatment for IMED is indicated.
免疫介导性内耳疾病（IMED）是快速进展性听觉功能障碍的一个病因。患者通常对高剂量皮质类固醇有反应，且该疾病被认为是由内耳蛋白抗体介导的。迄今为止，尚无已证实有效的皮质类固醇节省剂疗法。利妥昔单抗是一种可消耗B细胞的单克隆抗体，从而减少自身抗体的产生。因此，在一项针对IMED患者的小型试点研究中对利妥昔单抗进行了评估，以查看是否有显示获益的信号。总共5/7的患者达到了主要终点，即在1个疗程治疗后，相对于筛查时皮质类固醇治疗前的值，至少一只耳朵的纯音平均听阈（500 - 3000Hz）改善10dB，或在24周时单词识别分数提高至少12%。未报告显著不良事件。该研究结果表明，有必要对利妥昔单抗作为IMED的一种治疗方法进行进一步评估。
