Treatment of Active Corticosteroid-Resistant Graves' Orbitopathy

Purpose: 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. Methods: 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. Results: 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. Conclusions: This study suggests that intravenous Tocilizumab may be effective on reducing activity in patients with thyroid eye disease refractory to intravenous steroids.