*Centro Oftalmológico Moreiras, International Institute Orbit and Oculoplastics, Santiago de Compostela; †Orbit Unit, Clínica Piñero, Seville; and ‡Section of Rheumatology, Internal Medicine, Hospital Royo Villanova, Zaragoza, Spain.
Ophthalmic Plast Reconstr Surg. 2014 Mar-Apr;30(2):162-7. doi: 10.1097/IOP.0000000000000037.
To assess the efficacy of Tocilizumab, a humanized monoclonal antibody against the interleukin-6 receptor, in thyroid eye disease patients refractory to multiple intravenous steroids.
Prospective interventional nonrandomized study including active GO defined by Clinical Activity Score (CAS) ≥4 patients resistant to previous intravenous steroids treated with Tocilizumab was conducted from February 2010 to September 2012. Snellen visual acuity, Hertel exophthalmometry, CAS evaluation, TSI levels, ocular motility, and side effects were registered at a 4-week interval.
Eighteen patients were included with a mean age of 47.9 ± 8.63 years. All patients had a significant progressive CAS improvement (mean CAS score reduction 5.89 ± 1.41 points, p< 0.00027). Mean TSI levels were significantly lower at the end of the treatment (mean -76.18% ± 17.80%, p = 0.00007). Thirteen patients (72.22%) reduced proptosis a mean of -3.92 ± 1.54 mm (p = 0.002). Fifteen patients (83.33%) had an improvement in extraocular motility, and 7 patients of 13 resolved their diplopia (53.85%). No severe side effects or relapse of active GO were observed at the end of follow up.
This study suggests that intravenous Tocilizumab may be effective on reducing activity in patients with thyroid eye disease refractory to intravenous steroids.
评估托珠单抗（一种针对白细胞介素-6 受体的人源化单克隆抗体）在对多次静脉注射类固醇耐药的甲状腺眼病患者中的疗效。
前瞻性干预性非随机研究，包括由临床活动评分（CAS）≥4 定义的活动期 GO 患者（定义为有活动的 GO），这些患者对先前的静脉注射类固醇耐药，使用托珠单抗进行治疗。在 4 周的间隔内，登记视力表视力、Hertel 突眼计、CAS 评估、TSI 水平、眼球运动和副作用。
18 例患者纳入研究，平均年龄为 47.9±8.63 岁。所有患者的 CAS 评分均显著改善（平均 CAS 评分降低 5.89±1.41 分，p<0.00027）。治疗结束时，TSI 水平显著降低（平均-76.18%±17.80%，p=0.00007）。13 例患者（72.22%）的突眼度平均减少了 3.92±1.54mm（p=0.002）。15 例患者（83.33%）的眼外肌运动得到改善，7 例复视患者中的 3 例（53.85%）得到缓解。在随访结束时，没有观察到严重的副作用或活动期 GO 的复发。
本研究表明，静脉注射托珠单抗可能对减少对静脉注射类固醇耐药的甲状腺眼病患者的活动有疗效。
