Simon Teresa A, Soule Benjamin P, Hochberg Marc, Fleming Douglas, Torbeyns Anne, Banerjee Subhashis, Boers Maarten
Bristol-Myers Squibb Princeton New Jersey.
University of Maryland Baltimore.
ACR Open Rheumatol. 2019 May 29;1(4):251-257. doi: 10.1002/acr2.1034. eCollection 2019 Jun.
To assess the safety of abatacept treatment in rheumatoid arthritis (RA) using integrated data from multiple clinical trials.
Data from nine double-blind, placebo-controlled studies of abatacept treatment (seven intravenous, two subcutaneous) in patients with RA were pooled, focusing on safety events in the double-blind treatment period of each study. Incidence rates (IRs) of adverse events (AEs) per 100 patient-years of exposure were calculated for abatacept- and placebo-treated patients. AEs in abatacept-treated patients were combined regardless of dose and formulation.
In total, 2653 patients received abatacept and 1485 received placebo, with 2357 and 1254 patient-years of exposure, respectively. The mean (SD) durations of exposure in the abatacept and placebo groups were 10.8 (3.3) and 10.3 (3.5) months, respectively. The IRs (95% confidence interval [CI]) for serious AEs were 14.8 (13.3, 16.5) and 14.6 (12.5, 17.0) in the abatacept and placebo groups, respectively. Death occurred in 12 (0.5%) and 12 (0.8%) patients in the abatacept and placebo groups, respectively, and was most commonly caused by cardiac disorders. Malignancies were observed in 31 patients (1.2%) treated with abatacept (IR: 1.32 [95% CI: 0.90, 1.87]) versus 14 (0.9%; IR: 1.12 [0.61, 1.88]) who received placebo. Solid organ tumor was the most frequent malignancy reported in both groups (abatacept: 1.0%; IR: 1.11 [95% CI: 0.72, 1.62]; placebo: 0.8%; 0.96 [0.50, 1.67]).
In this integrated analysis, the IRs of safety events in the abatacept and placebo groups were similar with no new safety concerns identified.
利用多项临床试验的综合数据评估阿巴西普治疗类风湿关节炎（RA）的安全性。
汇总9项关于阿巴西普治疗RA患者的双盲、安慰剂对照研究（7项静脉注射，2项皮下注射）的数据，重点关注每项研究双盲治疗期的安全事件。计算阿巴西普治疗组和安慰剂治疗组每100患者年暴露的不良事件（AE）发生率（IR）。阿巴西普治疗组的AE无论剂量和剂型如何均合并计算。
共有2653例患者接受阿巴西普治疗，1485例接受安慰剂治疗，分别有2357和1254患者年暴露时间。阿巴西普组和安慰剂组的平均（标准差）暴露持续时间分别为10.8（3.3）和10.3（3.5）个月。阿巴西普组和安慰剂组严重AE的IR（95%置信区间[CI]）分别为14.8（13.3，16.5）和14.6（12.5，17.0）。阿巴西普组和安慰剂组分别有12例（0.5%）和12例（0.8%）患者死亡，最常见的死因是心脏疾病。接受阿巴西普治疗的31例患者（1.2%）观察到恶性肿瘤（IR：1.32[95%CI：0.90，1.87]），而接受安慰剂的患者有14例（0.9%；IR：1.12[0.61，1.88]）。实体器官肿瘤是两组报告的最常见恶性肿瘤（阿巴西普组：1.0%；IR：1.11[95%CI：0.72，1.62]；安慰剂组：0.8%；0.96[0.50，1.67]）。
在这项综合分析中，阿巴西普组和安慰剂组安全事件的IR相似，未发现新的安全问题。
