Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland.
Department of Internal Medicine and Oncological Chemotherapy, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland.
Front Endocrinol (Lausanne). 2022 May 9;13:871009. doi: 10.3389/fendo.2022.871009. eCollection 2022.
Management of Graves' orbitopathy remains a challenge. Our previous case report has shown promising results for rabbit antithymocyte globulin (rATG) in the treatment of Graves' orbitopathy.
We present the response of 7 individuals with active moderate-to-severe steroid-resistant Graves' orbitopathy to rATG, representing preliminary results from a prospective single-center study.
rATG was administered intravenously at a dose of 0.8-1.0 mg/kg daily (cumulative dose of 150-200 mg). The primary outcome measures at weeks 24 and 48 were ≥2-point reduction in Clinical Activity Score from baseline, a proptosis response, a diplopia response, and improvement of distant best-corrected visual acuity and mean retinal sensitivity. Key secondary outcomes included stabilization of ganglion cell complex thickness, a decrease of retinal nerve fiber layer in OCT, and a reduction in CD4/CD8 ratio and TRAb at 48 weeks.
An improvement in clinical activity score was observed in all patients, with disease inactivation in 3 cases. Proptosis reduction equal to or greater than 2 mm was noted for 8 of 10 eyes. Diplopia improved in three of 6 patients. There was an improvement in best-corrected visual acuity (from 0.69 to 0.78) and mean retinal sensitivity (from 20.8 to 23.5 dB). In addition, there was a long-lasting improvement in CD4/CD8 ratio in 6 patients. Two patients experienced adverse events (influenza and serum sickness).
rATG therapy offers a long-lasting improvement in moderate-to-severe steroid-resistant Graves' orbitopathy with improvement in functional vision (reduction of diplopia, improvement of visual acuity, retinal sensitivity, and VEP pattern). The therapy is well-tolerated.
ClinicalTrials.gov, identifier NCT05199103.
Graves 眼病的治疗仍然具有挑战性。我们之前的病例报告显示，兔抗胸腺细胞球蛋白（rATG）治疗 Graves 眼病有良好的效果。
我们报告了 7 例活动性中重度激素抵抗性 Graves 眼病患者接受 rATG 治疗的反应，这是一项前瞻性单中心研究的初步结果。
rATG 按 0.8-1.0mg/kg 静脉滴注，每日一次（累积剂量为 150-200mg）。主要观察指标在 24 周和 48 周时为临床活动评分较基线降低≥2 分，眼球突出度改善，复视改善，以及远视力矫正最佳视力和平均视网膜敏感度提高。关键次要结局包括神经节细胞复合体厚度稳定，OCT 中视网膜神经纤维层减少，以及 48 周时 CD4/CD8 比值和 TRAb 降低。
所有患者的临床活动评分均有改善，3 例患者疾病失活。10 只眼中有 8 只眼的眼球突出度减少≥2mm。6 例患者中的 3 例复视改善。最佳矫正视力（从 0.69 提高到 0.78）和平均视网膜敏感度（从 20.8 提高到 23.5dB）提高。此外，6 例患者的 CD4/CD8 比值有持久改善。2 例患者发生不良反应（流感和血清病）。
rATG 治疗可改善中重度激素抵抗性 Graves 眼病，改善视力（减少复视、提高视力、视网膜敏感度和 VEP 模式）。该疗法具有良好的耐受性。
ClinicalTrials.gov，标识符 NCT05199103。
