成功优化阿达木单抗治疗贝赫切特病难治性葡萄膜炎。
Successful Optimization of Adalimumab Therapy in Refractory Uveitis Due to Behçet's Disease.
机构信息
Rheumatology and Ophthalmology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
Rheumatology and Ophthalmology, Hospital General Universitario de Valencia, Valencia, Spain.
出版信息
Ophthalmology. 2018 Sep;125(9):1444-1451. doi: 10.1016/j.ophtha.2018.02.020. Epub 2018 Mar 27.
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.
目的
评估阿达木单抗（ADA）治疗方案优化在接受生物制剂治疗后缓解的贝赫切特病（BD）葡萄膜炎患者中的疗效、安全性和成本效益。
设计
接受 ADA 治疗的 BD 葡萄膜炎患者的开放性、多中心研究，这些患者对常规免疫抑制剂治疗无效。
研究对象
65 例 BD 葡萄膜炎患者，ADA 中位治疗时间为 6（范围 3-12）个月后达到缓解。其中 23 例（35.4%）患者进行了 ADA 优化治疗。其余 42 例患者继续以 ADA 40mg/皮下/2 周的剂量维持治疗。
方法
缓解后，根据患者和治疗医生的共同决策，对 ADA 进行优化。当患者和医生达成一致意见时，通过逐渐延长 ADA 给药间隔来进行优化。比较优化组和非优化组的患者。
主要观察指标
优化组和非优化组的疗效、安全性和成本效益。为了评估疗效，评估了眼内炎症（前房细胞、玻璃体炎症和视网膜血管炎）、黄斑厚度、视力和糖皮质激素的节省效应。
结果
在 ADA 开始时，优化组和非优化组之间在人口统计学或眼部方面没有差异。在优化组和非优化组中，分别在平均（±标准差）34.7±13.3 和 26±21.3 个月的随访后，大多数眼部结果相似。然而，仅在非优化组中观察到相关不良事件（淋巴瘤、肺炎、注射部位严重局部反应和大肠埃希菌菌血症各 1 例）。此外，优化组的 ADA 治疗费用低于非优化组（6101.25 欧元/患者/年与 12339.48 欧元；P<0.01）。
结论
ADA 治疗方案优化对常规治疗无效的 BD 葡萄膜炎有效、安全且具有成本效益。
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