Purpose

To assess efficacy, safety, and cost-effectiveness of adalimumab (ADA) therapy optimization in a large series of patients with uveitis due to Behçet disease (BD) who achieved remission after the use of this biologic agent.

Design

Open-label multicenter study of ADA-treated patients with BD uveitis refractory to conventional immunosuppressants.

Subjects

Sixty-five of 74 patients with uveitis due to BD, who achieved remission after a median ADA duration of 6 (range, 3–12) months. ADA was optimized in 23 (35.4%) of them. This biologic agent was maintained at a dose of 40 mg/subcutaneously/2 weeks in the remaining 42 patients.

Methods

After remission, based on a shared decision between the patient and the treating physician, ADA was optimized. When agreement between patient and physician was reached, optimization was performed by prolonging the ADA dosing interval progressively. Comparison between optimized and nonoptimized patients was performed.

Main Outcome Measures

Efficacy, safety, and cost-effectiveness in optimized and nonoptimized groups. To determine efficacy, intraocular inflammation (anterior chamber cells, vitritis, and retinal vasculitis), macular thickness, visual acuity, and the sparing effect of glucocorticoids were assessed.

Results

No demographic or ocular differences were found at the time of ADA onset between the optimized and the nonoptimized groups. Most ocular outcomes were similar after a mean ± standard deviation follow-up of 34.7±13.3 and 26±21.3 months in the optimized and nonoptimized groups, respectively. However, relevant adverse effects were only seen in the nonoptimized group (lymphoma, pneumonia, severe local reaction at the injection site, and bacteremia by Escherichia coli, 1 each). Moreover, the mean ADA treatment costs were lower in the optimized group than in the nonoptimized group (6101.25 euros/patient/year vs. 12 339.48; P < 0.01).

Conclusion

ADA optimization in BD uveitis refractory to conventional therapy is effective, safe, and cost-effective.

中文翻译：

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成功地优化了Behçet病引起的难治性葡萄膜炎的Adalimumab疗法

目的

评估阿达木单抗（ADA）治疗优化对一系列因贝塞特病（BD）引起的葡萄膜炎患者的疗效，安全性和成本效益，这些患者在使用该生物制剂后均已缓解。

设计

ADA治疗的BD葡萄膜炎对常规免疫抑制剂难以治疗的患者的开放标签多中心研究。

科目

74例因BD引起的葡萄膜炎患者中，有65例在ADA平均中位时间为6（3-12）个月后获得缓解。其中有23个（35.4％）对ADA进行了优化。在其余42名患者中，该生物制剂维持在40 mg /皮下/ 2周的剂量。

方法

缓解后，根据患者和主治医生之间的共同决定，对ADA进行了优化。当患者与医生达成协议后，通过逐步延长ADA给药间隔来进行优化。比较优化患者和未优化患者。

主要观察指标

优化和未优化组的功效，安全性和成本效益。为了确定疗效，评估了眼内炎症（前房细胞，玻璃体炎和视网膜血管炎），黄斑厚度，视力和糖皮质激素的保护作用。

结果

优化组和未优化组在ADA发作时未发现人口统计学或眼部差异。在优化组和未优化组中，平均眼部标准差随访34.7±13.3和26±21.3个月后，大多数眼部预后相似。但是，仅在未优化的组中观察到相关的不良反应（淋巴瘤，肺炎，注射部位严重的局部反应和大肠杆菌引起的菌血症，每组1个）。此外，优化组的平均ADA治疗费用低于未优化组（6101.25欧元/患者/年vs. 12 339.48；P <0.01）。

结论

常规治疗难以治愈的BD葡萄膜炎中的ADA优化是有效，安全且具有成本效益的。