Centre for Clinical Epidemiology, Lady Davis Institute - Jewish General Hospital, 3755 Cote Ste-Catherine, H-461, Montreal, Québec H3T 1E2, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Québec, Canada.
Centre for Clinical Epidemiology, Lady Davis Institute - Jewish General Hospital, 3755 Cote Ste-Catherine, H-461, Montreal, Québec H3T 1E2, Canada; Division of Rheumatology, Jewish General Hospital, Montreal, Québec, Canada.
Semin Arthritis Rheum. 2019 Dec;49(3):366-372. doi: 10.1016/j.semarthrit.2019.03.007. Epub 2019 Mar 16.
The ASSURE randomized trial of abatacept safety in rheumatoid arthritis (RA) reported more frequent respiratory adverse events with abatacept among the subgroup of 54 patients with chronic obstructive pulmonary disease (COPD), leading to a label warning. We assessed the risk of adverse respiratory events associated with abatacept, compared with other biologic DMARDs (bDMARDs), among patients with RA and COPD in a real-world observational setting.
We formed a prevalent new-user cohort of patients with RA and COPD treated with bDMARDs within the US-based MarketScan databases from 2007 to 2014. Abatacept users were matched on time-conditional propensity scores to users of other bDMARDs. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of adverse respiratory events comparing abatacept with other bDMARDs were estimated using the Cox model.
The cohort included 1807 patients initiating abatacept and 3547 matched patients initiating another bDMARD. The HR of the combined endpoint of hospitalized COPD exacerbation, bronchitis and hospitalized pneumonia or influenza with abatacept relative to other bDMARDs was 0.87 (95% CI: 0.68-1.12). For hospitalized COPD exacerbation it was 0.60 (95% CI: 0.32-1.11), 0.80 (95% CI: 0.56-1.14) for bronchitis, while for pneumonia or influenza it was 1.39 (95% CI: 0.91-2.13) if hospitalized and 1.05 (95% CI: 0.86-1.29) as outpatient.
This large safety study from a real world setting finds no increased risk of adverse respiratory events with abatacept compared with other bDMARDs in patients with RA and COPD. This study does not substantiate the safety signal raised by the smaller ASSURE trial.
在类风湿关节炎（RA）的 ASSURE 随机试验中，在亚组 54 例慢性阻塞性肺疾病（COPD）患者中，阿巴西普的呼吸道不良事件更为频繁，导致标签警告。我们在真实世界观察环境中评估了 RA 和 COPD 患者中使用阿巴西普与其他生物 DMARD（bDMARD）相关的不良呼吸事件风险。
我们在 2007 年至 2014 年期间在美国 MarketScan 数据库中形成了一个新的 RA 和 COPD 患者的普遍新使用者队列，他们接受了 bDMARD 治疗。阿巴西普使用者根据时间条件倾向评分与其他 bDMARD 使用者匹配。使用 Cox 模型估计比较阿巴西普与其他 bDMARD 时不良呼吸事件的调整后的危险比（HR）和 95%置信区间（CI）。
队列包括 1807 名开始使用阿巴西普的患者和 3547 名匹配的开始使用另一种 bDMARD 的患者。与其他 bDMARD 相比，阿巴西普的联合终点（住院 COPD 加重、支气管炎和住院肺炎或流感）的 HR 为 0.87（95%CI：0.68-1.12）。对于住院 COPD 加重，其 HR 为 0.60（95%CI：0.32-1.11），对于支气管炎，其 HR 为 0.80（95%CI：0.56-1.14），而对于住院肺炎或流感，如果住院，其 HR 为 1.39（95%CI：0.91-2.13），如果是门诊患者，其 HR 为 1.05（95%CI：0.86-1.29）。
这项来自真实环境的大型安全性研究发现，与其他 bDMARD 相比，RA 和 COPD 患者使用阿巴西普的不良呼吸事件风险没有增加。这项研究没有证实 ASSURE 试验较小的安全性信号。
