Purpose

To analyze the factors associated with response (control of ocular inflammation and corticosteroid-sparing effect) to biologics (anti–tumor necrosis factor [TNF]-α agents and tocilizumab) in patients with refractory uveitic macular edema (ME).

Design

Multicenter, retrospective, observational study.

Participants

Adult patients with uveitic ME refractory to systemic corticosteroids, disease-modifying antirheumatic drugs, or both.

Methods

Patients received anti–TNF-α agents (infliximab 5 mg/kg at week 0, 2, 6, and every 4–6 weeks [n = 69] and adalimumab 40 mg/2 weeks [n = 80]) and tocilizumab (8 mg/kg every 4 weeks intravenously [n = 39] and 162 mg/week subcutaneously [n = 16]).

Main Outcome Measures

Analysis of complete and partial response rates, relapse rate, low vision (visual acuity in at least 1 eye of ≥ 1 logarithm of the minimum angle of resolution), corticosteroid-sparing effect, and adverse events at 6 months.

Results

Two hundred four patients (median age, 40 years [interquartile range, 28–58 years]; 42.2% men) were included. Main causes of uveitis included Behçet’s disease (17.2%), birdshot chorioretinopathy (11.3%), and sarcoidosis (7.4%). The overall response rate at 6 months was 46.2% (21.8% of complete response) with anti–TNF-α agents and 58.5% (35.8% of complete response) with tocilizumab. In multivariate analysis, treatment with tocilizumab (odds ratio, 2.10; 95% confidence interval [CI], 1.06–4.06; P = 0.03) was associated independently with complete response of uveitic ME compared with anti–TNF-α agents. Anti–TNF-α agents and tocilizumab did not differ significantly in terms of relapse rate (hazard ratio, 1.00; 95% CI, 0.31–3.18; P = 0.99) or occurrence of low vision (odds ratio, 1.02; 95% CI, 0.51–2.07; P = 0.95) or corticosteroid-sparing effect (P = 0.29). Adverse events were reported in 20.6% of patients, including serious adverse events reported in 10.8% of patients.

Conclusions

Tocilizumab seems to improve complete response of uveitic ME compared with anti–TNF-α agents.

中文翻译：

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抗肿瘤坏死因子 α 与托珠单抗治疗难治性葡萄膜炎性黄斑水肿

目的

分析难治性葡萄膜炎性黄斑水肿 (ME) 患者对生物制剂（抗肿瘤坏死因子 [TNF]-α 药物和托珠单抗）的反应（眼部炎症控制和皮质类固醇节约效应）相关因素。

设计

多中心、回顾性、观察性研究。

参与者

对全身性皮质类固醇、改善疾病的抗风湿药或两者兼而有之的葡萄膜炎 ME 成人患者。

方法

患者接受抗 TNF-α 药物（英夫利昔单抗 5 mg/kg 在第 0、2、6 周和每 4-6 周 [n = 69] 和阿达木单抗 40 mg/2 周 [n = 80]）和托珠单抗（8 mg/kg 每 4 周静脉内 [n = 39] 和 162 mg/周皮下 [n = 16]）。

主要观察指标

分析完全和部分缓解率、复发率、低视力（至少 1 只眼睛的视力≥1 最小分辨角的对数）、皮质类固醇节约效应和 6 个月时的不良事件。

结果

包括 204 名患者（中位年龄，40 岁 [四分位距，28-58 岁]；42.2% 为男性）。葡萄膜炎的主要原因包括白塞病（17.2%）、鸟弹性脉络膜视网膜病变（11.3%）和结节病（7.4%）。6 个月时，抗 TNF-α 药物的总缓解率为 46.2%（完全缓解的 21.8%），托珠单抗为 58.5%（完全缓解的 35.8%）。 在多变量分析中，与抗 TNF-α 药物相比，托珠单抗治疗（优势比，2.10；95% 置信区间 [CI]，1.06-4.06；P = 0.03）与葡萄膜炎 ME 的完全缓解独立相关。抗 TNF-α 药物和托珠单抗在复发率方面没有显着差异（风险比，1.00；95% CI，0.31-3.18；P = 0.99）或出现低视力（优势比，1.02；95% CI，0.51-2.07；P  = 0.95）或皮质类固醇节约效应（P  = 0.29）。20.6% 的患者报告了不良事件，其中 10.8% 的患者报告了严重的不良事件。

结论

与抗 TNF-α 药物相比，托珠单抗似乎可以改善葡萄膜炎 ME 的完全反应。