Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany.
Arthritis Rheumatol. 2014 Aug;66(8):1987-97. doi: 10.1002/art.38687.
To investigate the safety of long-term subcutaneous (SC) abatacept treatment using integrated clinical trial data obtained in patients with rheumatoid arthritis refractory to traditional disease-modifying antirheumatic drugs.
Data from the double-blind and open-label phases of 5 clinical trials of SC abatacept were pooled. The overall and 6-month incidence rates were calculated as events per 100 patient-years of exposure.
This analysis included 1,879 patients with 4,214.6 patient-years of exposure to SC abatacept. The mean ± SD length of exposure was 27.3 ± 9.1 months. The reported incidence rate of serious infections was 1.79 (95% confidence interval [95% CI] 1.42-2.24); the most frequent infections were pneumonia (incidence rate 0.36 [95% CI 0.22-0.59]), urinary tract infection (incidence rate 0.14 [95% CI 0.06-0.32]), and gastroenteritis (incidence rate 0.10 [95% CI 0.04-0.25]). Tuberculosis occurred rarely (incidence rate 0.09 [95% CI 0.04-0.25]). The reported incidence rate of malignancies was 1.32 (95% CI 1.01-1.72), and the most common was solid organ malignancy (incidence rate 0.69 [95% CI 0.48-0.99]). The incidence rate of autoimmune events was 1.37 (95% CI 1.06-1.78), and the most frequent events were psoriasis (incidence rate 0.33 [95% CI 0.20-0.56]) and Sjögren's syndrome (incidence rate 0.24 [95% CI 0.13-0.44]). The reported incidence rate of local injection site reactions was 1.72 (95% CI 1.36-2.17); these events occurred primarily during the first 6 months of treatment, and almost all were of mild or moderate intensity. The incidence rates of serious infections, malignancies, autoimmune events, and injection site reactions did not increase over time.
Long-term treatment with SC abatacept was associated with low incidence rates of serious infections, malignancies, and autoimmune events and was well tolerated, with infrequent injection site reactions. These findings are consistent with those related to treatment with intravenous abatacept. Long-term treatment with SC abatacept did not lead to new safety signals over time.
通过整合类风湿关节炎患者接受传统疾病修饰抗风湿药物治疗无效的临床试验数据，研究皮下（SC）阿巴西普长期治疗的安全性。
对 5 项 SC 阿巴西普双盲和开放标签研究的双盲和开放标签期数据进行了汇总。根据每 100 患者-年暴露的事件计算总发生率和 6 个月发生率。
本分析纳入了 1879 例患者，SC 阿巴西普暴露 4214.6 患者-年。暴露的平均（±SD）长度为 27.3±9.1 个月。严重感染的报告发生率为 1.79（95%置信区间[95%CI]1.42-2.24）；最常见的感染为肺炎（发生率为 0.36[95%CI0.22-0.59]）、尿路感染（发生率为 0.14[95%CI0.06-0.32]）和胃肠炎（发生率为 0.10[95%CI0.04-0.25]）。结核病罕见（发生率为 0.09[95%CI0.04-0.25]）。恶性肿瘤的报告发生率为 1.32（95%CI1.01-1.72），最常见的是实体器官恶性肿瘤（发生率为 0.69[95%CI0.48-0.99]）。自身免疫事件的发生率为 1.37（95%CI1.06-1.78），最常见的是银屑病（发生率为 0.33[95%CI0.20-0.56]）和干燥综合征（发生率为 0.24[95%CI0.13-0.44]）。局部注射部位反应的报告发生率为 1.72（95%CI1.36-2.17）；这些事件主要发生在治疗的前 6 个月，几乎都是轻度或中度。严重感染、恶性肿瘤、自身免疫事件和注射部位反应的发生率并未随时间而增加。
长期皮下使用阿巴西普治疗与严重感染、恶性肿瘤和自身免疫事件的发生率较低且具有良好的耐受性有关，且注射部位反应罕见。这些发现与静脉内使用阿巴西普的相关发现一致。长期皮下使用阿巴西普治疗不会随时间出现新的安全性信号。
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