a Graduate School of Medical and Dental Sciences , Tokyo Medical and Dental University , Tokyo , Japan .
b Graduate School & Faculty of Medicine , Nagoya University , Nagoya , Japan .
Mod Rheumatol. 2016 Jul;26(4):491-8. doi: 10.3109/14397595.2015.1123211. Epub 2016 Jan 8.
To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA).
Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations.
Overall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved significantly over 6 months. Separate multivariate analysis identified predictors of severe ADR, and severe infections and factors predictive of clinically meaningful DAS28 improvement after 6 months of treatment with abatacept.
Abatacept was efficacious and well tolerated in a clinical setting. No new safety concerns were detected.
开展一项上市后监测研究，评估阿巴西普在日本类风湿关节炎（RA）患者中的安全性和有效性。
收集了所有在 2010 年 9 月至 2011 年 6 月期间接受静脉注射阿巴西普治疗的 RA 患者（772 个治疗点）的安全性和有效性数据。根据说明书，患者按批准的剂量方案进行治疗。在基线时以及第 4、12 和 24 周时，采用红细胞沉降率或血清 C 反应蛋白浓度计算的疾病活动评分 28（DAS28）评估治疗效果。
在安全性和有效性分析中，分别纳入了 3882 例和 3016 例阿巴西普初治 RA 患者。报告了 15.66%的患者发生药物不良反应（ADR），2.52%的患者发生严重 ADR。严重感染的发生率为 1.03%，主要归因于不同类型的细菌性肺炎。疾病活动度在 6 个月内显著改善。单变量和多变量分析分别确定了严重 ADR、严重感染的预测因素，以及在接受阿巴西普治疗 6 个月后对 DAS28 有临床意义改善的预测因素。
阿巴西普在临床环境中是有效且耐受良好的。未发现新的安全性问题。
