Department of Ophthalmology, First People's Hospital of Taizhou, Taizhou, China.
Department of Rheumatology, First People's Hospital of Taizhou, No. 218 Hengjie Road, Taizhou, 318020, China.
Inflammopharmacology. 2022 Aug;30(4):1363-1368. doi: 10.1007/s10787-022-01019-6. Epub 2022 Jul 8.
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.
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.
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 μm) to M6 (271.8 ± 54.4 μm) (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%).
Golimumab is effective and safe for refractory NIU treatment, while a large-scale trial is still needed for verification.
肿瘤坏死因子抑制剂（TNFi）最近被报道可有效治疗非感染性葡萄膜炎（NIU）。然而，作为一种新型的 TNFi，戈利木单抗在中国上市仅数年，其用于治疗 NIU 的应用缺乏充分的证据。因此，本研究旨在探讨戈利木单抗治疗难治性 NIU 患者的疗效和安全性。
连续纳入 30 例（49 只眼）对常规治疗（皮质类固醇和免疫抑制剂）无效的 NIU 患者。他们接受了至少 6 个月的 TNFi（戈利木单抗 50mg，每 4 周 1 次）治疗。在基线、第 1 个月（M1）、第 3 个月（M3）和第 6 个月（M6）评估前房细胞分级、玻璃体混浊分级、中心黄斑厚度和视力。
治疗后，前房细胞分级从基线（0.6±0.7）降至 M6（0.3±0.5）（P<0.001）；玻璃体混浊分级从基线（1.2±1.2）降至 M6（0.4±0.5）（P<0.001）；同时，中心黄斑厚度也从基线（351.4±90.8μm）降至 M6（271.8±54.4μm）（P<0.001）。至于视力（LogMAR），从基线（0.5±0.3）呈下降趋势至 M6（0.4±0.2），但无统计学意义（P=0.096）。亚组分析显示，TNFi 史与戈利木单抗疗效降低有关。此外，有 13.3%的患者出现不良反应，包括肝酶升高（6.7%）、疲劳（3.3%）和皮疹（3.3%）。
戈利木单抗治疗难治性 NIU 有效且安全，但仍需要大规模试验验证。
