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The efficacy and safety of TNF inhibitor (golimumab) as salvage treatment in patients with refractory noninfectious uveitis

机译:TNF抑制剂(戈利木单抗)作为难治性非感染性葡萄膜炎患者挽救治疗的疗效和安全性

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Background Tumor necrosis factor inhibitor (TNFi) is recently reported to treat noninfectious uveitis (NIU) effectively. However, as a new kind of TNFi, golimumab is just on the market in China for several years, and its administration for NIU treatment lacks sufficient evidence. Therefore, the current study aimed to investigate the efficacy and safety of golimumab in refractory NIU patients. Methods Thirty NIU patients with 49 affected eyes refractory to conventional treatments (corticosteroids and immunosuppressive agents) were consecutively enrolled. They received treatment of TNFi (50 mg golimumab every 4 weeks) for at least 6 months. The anterior chamber cell grade, vitreous haziness grade, central macular thickness, and visual acuity were evaluated at baseline, month (M) 1, M3, and M6. Results After treatment, the anterior chamber cell grade declined from baseline (0.6 +/- 0.7) to M6 (0.3 +/- 0.5) (P < 0.001); the vitreous haziness grade decreased from baseline (1.2 +/- 1.2) to M6 (0.4 +/- 0.5) (P < 0.001); meanwhile, the central macular thickness also reduced from baseline (351.4 +/- 90.8 mu m) to M6 (271.8 +/- 54.4 mu m) (P < 0.001). In terms of visual acuity (LogMAR), it showed a declined trend from baseline (0.5 +/- 0.3) to M6 (0.4 +/- 0.2), but without statistical significance (P = 0.096). Subgroup analyses revealed that TNFi history related to decreased golimumab efficacy. In addition, 13.3 of patients had adverse events, including elevated liver enzymes (6.7), fatigue (3.3), and rash (3.3). Conclusion Golimumab is effective and safe for refractory NIU treatment, while a large-scale trial is still needed for verification.
机译:背景 最近报道肿瘤坏死因子抑制剂 (TNFi) 可有效治疗非感染性葡萄膜炎 (NIU)。然而,戈利木单抗作为一种新型的TNFi,在中国上市仅数年,其用于NIU治疗的给药缺乏足够的证据。因此,本研究旨在探讨戈利木单抗在难治性NIU患者中的疗效和安全性。方法 连续选取30例常规治疗(皮质类固醇和免疫抑制剂)难治的NIU患者,共49只患眼。他们接受了TNFi治疗(每4周50mg戈利木单抗),持续至少6个月。在基线、第 (M) 1 个月、M3 和 M6 评估前房细胞分级、玻璃体朦胧分级、中央黄斑厚度和视力。结果 治疗后前房细胞分级由基线(0.6 +/- 0.7)下降至M6(0.3 +/- 0.5)(P < 0.001);玻璃体朦胧度等级从基线(1.2 +/- 1.2)降低至M6(0.4 +/- 0.5)(P < 0.001);同时,中央黄斑厚度也从基线(351.4 +/- 90.8 μ m)减少到M6(271.8 +/- 54.4 μ m)(P < 0.001)。在视力 (LogMAR) 方面,它显示出从基线 (0.5 +/- 0.3) 到 M6 (0.4 +/- 0.2) 的下降趋势,但没有统计学意义 (P = 0.096)。亚组分析显示,TNFi病史与戈利木单抗疗效降低有关。此外,13.3%的患者发生不良事件,包括肝酶升高(6.7%)、疲劳 (3.3%) 和皮疹 (3.3%)。结论 戈利木单抗治疗难治性NIU疗效安全,尚需大规模试验验证。

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