Yang Shizhao, Tao Tianyu, Li Zhaohuai, Chen Binyao, Huang Zhaohao, Liu Xiuxing, Li He, Xie Lihui, Feng Wen, Su Wenru
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.
Ann Transl Med. 2022 Jun;10(12):699. doi: 10.21037/atm-22-2668.
High dose systemic glucocorticoid is the main therapy of treatment-naïve Vogt-Koyanagi-Harada (VKH) disease. However, series side effects induced by high dose systemic glucocorticoid frequently occur, which makes alternative therapy necessary for certain patients. This study sought to compare the efficacy and safety of systemic glucocorticoid-free (SGF) therapy with conventional therapy (CT) as an initial treatment for VKH patients.
VKH patients who had not been systemically treated were enrolled. Patients were allocated into 2 therapeutic groups depending on their treatments. In CT group, patients received systemic glucocorticoid plus immunosuppressants (IS), and in SGF group, patients received adalimumab (ADA) plus IS. Patients received approximately 12 months treatment and visit monthly. The outcome parameters included the changes of best-corrected visual acuity (BCVA), intraocular inflammation (including anterior chamber cell grade and vitritis grade) and central macular thickness (CMT) (the change values define as the final-visit values subtracted from baseline counterparts). Other outcomes included the relapses times of ocular inflammation, adverse events (AEs), changes of optic nerve inflammation (ONI) and intraocular/extraocular manifestations.
A total of 30 patients (60 eyes) were included. with 19 patients (38 eyes) in CT group and 11 patients (22 eyes) in SGF group. After approximately 1 year of treatment, the improvements of BCVA were slight better in the SGF group (0.57±0.23) than in the CT group (0.40±0.26), (P=0.014). In both groups, the ocular inflammatory improvements in both groups were similar, with an improvement of AC cell grade of -1.5 (-2, -0.5) in CT group versus -1 (-2, -1) in SGF group (P=0.367); improvement of vitritis grade was 0 (-1.25, 0) in CT group and -1 (-1, -1) in SGF group (P=0.050). The improvement in CMT was similar in both groups, with -523.47±412.09 µm in CT group and -362.73±375.73 µm in SGF group (P=0.572). The mean number of relapses was 1 (0, 2) in the CT group and 0 (0, 2) in the SGF group (P=0.372). No severe AEs were observed in this study.
SGF therapy is effective, safe, and well-tolerated in treatment-naïve VKH patients. SGF therapy seems to be a feasible option in patients with existing systemic diseases intolerant to glucocorticoid.
高剂量全身用糖皮质激素是初治Vogt-小柳-原田（VKH）病的主要治疗方法。然而，高剂量全身用糖皮质激素经常引发一系列副作用，这使得某些患者有必要采用替代疗法。本研究旨在比较无全身用糖皮质激素（SGF）疗法与传统疗法（CT）作为VKH患者初始治疗的疗效和安全性。
纳入未接受过全身治疗的VKH患者。根据治疗方法将患者分为2个治疗组。CT组患者接受全身用糖皮质激素加免疫抑制剂（IS），SGF组患者接受阿达木单抗（ADA）加IS。患者接受约12个月的治疗并每月复诊。观察指标包括最佳矫正视力（BCVA）、眼内炎症（包括前房细胞分级和玻璃体炎分级）及中心黄斑厚度（CMT）的变化（变化值定义为末次复诊值减去基线值）。其他观察指标包括眼部炎症复发次数、不良事件（AE）、视神经炎症（ONI）变化及眼内/眼外表现。
共纳入30例患者（60只眼），其中CT组19例（38只眼），SGF组11例（22只眼）。经过约1年的治疗，SGF组BCVA的改善（0.57±0.23）略优于CT组（0.40±0.26），（P=0.014）。两组的眼部炎症改善情况相似，CT组前房细胞分级改善为-1.5（-2，-0.5），SGF组为-1（-2，-1）（P=0.367）；CT组玻璃体炎分级改善为0（-1.25，0），SGF组为-1（-1，-1）（P=0.050）。两组CMT的改善情况相似，CT组为-523.47±412.09 µm，SGF组为-362.73±375.73 µm（P=0.572）。CT组的平均复发次数为1（0，2），SGF组为0（0，2）（P=0.372）。本研究未观察到严重不良事件。
SGF疗法在初治VKH患者中有效、安全且耐受性良好。对于存在全身性疾病且不耐受糖皮质激素的患者，SGF疗法似乎是一种可行的选择。
