英夫利昔单抗与阿达木单抗治疗难治性葡萄膜炎：法国葡萄膜炎网络的多中心研究。
Infliximab Versus Adalimumab in the Treatment of Refractory Inflammatory Uveitis: A Multicenter Study From the French Uveitis Network.
机构信息
Hôpital Pitié-Salpêtrière, AP-HP, Centre National de Référence Maladies Systémiques et Autoimmunes Rares, and Université Paris VI, Paris, France.
Hôpital Croix Rousse, Lyon, France.
出版信息
Arthritis Rheumatol. 2016 Jun;68(6):1522-30. doi: 10.1002/art.39667.
OBJECTIVE
To analyze the factors associated with response to anti-tumor necrosis factor (anti-TNF) treatment and compare the efficacy and safety of infliximab (IFX) and adalimumab (ADA) in patients with refractory noninfectious uveitis.
METHODS
This was a multicenter observational study of 160 patients (39% men and 61% women; median age 31 years [interquartile range 21-42]) with uveitis that had been refractory to other therapies, who were treated with anti-TNF (IFX 5 mg/kg at weeks 0, 2, 6, and then every 5-6 weeks [n = 98] or ADA 40 mg every 2 weeks [n = 62]). Factors associated with complete response were assessed by multivariate analysis. Efficacy and safety of IFX versus ADA were compared using a propensity score approach with baseline characteristics taken into account. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (95% CIs) were calculated.
RESULTS
The main etiologies of uveitis included Behçet's disease (BD) (36%), juvenile idiopathic arthritis (22%), spondyloarthropathy (10%), and sarcoidosis (6%). The overall response rate at 6 and 12 months was 87% (26% with complete response) and 93% (28% with complete response), respectively. The median time to complete response was 2 months. In multivariate analysis, BD and occurrence of >5 uveitis flares before anti-TNF initiation were associated with complete response to anti-TNF (SHR 2.52 [95% CI 1.35-4.71], P = 0.004 and SHR 1.97 [95% CI 1.02-3.84], P = 0.045, respectively). Side effects were reported in 28% of patients, including serious adverse events in 13%. IFX and ADA did not differ significantly in terms of occurrence of complete response (SHR 0.65 [95% CI 0.25-1.71], P = 0.39), serious side effects (SHR 0.22 [95% CI 0.04-1.25], P = 0.089), or event-free survival (SHR 0.55 [95% CI 0.28-1.08], P = 0.083).
CONCLUSION
Anti-TNF treatment is highly effective in refractory inflammatory uveitis. BD is associated with increased odds of response. IFX and ADA appear to be equivalent in terms of efficacy.
目的
分析与抗肿瘤坏死因子（anti-TNF）治疗反应相关的因素，并比较英夫利昔单抗（IFX）和阿达木单抗（ADA）治疗难治性非感染性葡萄膜炎的疗效和安全性。
方法
这是一项多中心观察性研究，共纳入 160 例（39%为男性，61%为女性；中位年龄 31 岁[四分位距 21-42]）对其他治疗无效的葡萄膜炎患者，他们接受了抗 TNF 治疗（IFX 5mg/kg 于第 0、2、6 周，然后每 5-6 周 1 次[98 例]或 ADA 40mg 每 2 周 1 次[62 例]）。采用多变量分析评估完全缓解的相关因素。采用倾向评分法比较 IFX 与 ADA 的疗效和安全性，同时考虑基线特征。计算亚分布风险比（SHR）及其 95%置信区间（95%CI）。
结果
葡萄膜炎的主要病因包括贝赫切特病（BD）（36%）、幼年特发性关节炎（22%）、脊柱关节病（10%）和结节病（6%）。6 个月和 12 个月时的总体缓解率分别为 87%（26%完全缓解）和 93%（28%完全缓解）。完全缓解的中位时间为 2 个月。多变量分析显示，BD 和抗 TNF 治疗前发生>5 次葡萄膜炎发作与抗 TNF 治疗的完全缓解相关（SHR 2.52[95%CI 1.35-4.71]，P=0.004 和 SHR 1.97[95%CI 1.02-3.84]，P=0.045）。28%的患者出现了副作用，包括 13%的严重不良事件。IFX 和 ADA 在完全缓解的发生率（SHR 0.65[95%CI 0.25-1.71]，P=0.39）、严重副作用的发生率（SHR 0.22[95%CI 0.04-1.25]，P=0.089）或无事件生存率（SHR 0.55[95%CI 0.28-1.08]，P=0.083）方面无显著差异。
结论
抗 TNF 治疗对难治性炎症性葡萄膜炎具有高度疗效。BD 与更高的缓解几率相关。IFX 和 ADA 的疗效似乎相当。
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