阿巴西普在类风湿关节炎中的应用与严重感染风险：基于人群的队列研究。

Abatacept initiation in rheumatoid arthritis and the risk of serious infection: A population-based cohort study.

机构信息

Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, 3755 Cote Ste-Catherine, H-461 Montreal, Québec H3T 1E2, Canada; Service de Pharmacologie Médicale et Clinique, Centre de Pharmaco Vigilance, Pharmacoépidémiologie et d'Informations sur le Médicament de Toulouse, Centre Hospitalier Universitaire, Faculté de Médecine, Toulouse, France.

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; Department of Neurology and Neurosurgery, McGill University, Montreal, Québec, Canada.

出版信息

Semin Arthritis Rheum. 2019 Jun;48(6):1053-1058. doi: 10.1016/j.semarthrit.2019.01.009. Epub 2019 Jan 25.

DOI:10.1016/j.semarthrit.2019.01.009

PMID:30772001

Abstract

OBJECTIVE

To assess whether abatacept as initial biologic disease-modifying antirheumatic drug (DMARD) in the treatment of rheumatoid arthritis is associated with an increased risk of serious infections, including bone and joint, gastrointestinal, respiratory tract, skin and soft tissue, and urinary tract, when compared with other biologic DMARDs.

METHODS

We performed a population-based cohort study among patients newly-treated with biologic DMARDs within the US-based Truven MarketScan® population and Supplemental US Medicare from 2007 to 2014. Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of serious infections requiring hospitalisation associated with initiation of abatacept, compared with initiation of other bDMARDs, after controlling for age and deciles of the propensity score.

RESULTS

The cohort included 5,752 patients who initiated abatacept and 78,556 who initiated another biologic DMARD, of whom 193 and 1531 had a serious infection during follow-up (crude incidence rate 4.45 per 100 person-years and 3.62 per 100 person-years, respectively). Compared with other biologic DMARDs, the use of abatacept was not associated with an increased incidence of serious infections overall (HR 1.04, 95% CI 0.89-1.21). The risk did not vary by duration of use (<1 year: HR 1.03, 95% CI 0.87-1.22; >1 year: HR 1.08, 95% CI 0.77-1.52). In addition, the risk was not increased for the site-specific infections.

CONCLUSION

The use of abatacept as first biologic DMARD in the treatment of rheumatoid arthritis was not associated with different risks of serious infections compared with other biologic DMARDs.

摘要

目的

评估与其他生物 DMARD 相比，阿巴西普作为类风湿关节炎初始生物疾病修饰抗风湿药物 (DMARD) 治疗时，是否会增加严重感染的风险，包括骨骼和关节、胃肠道、呼吸道、皮肤和软组织以及尿路。

方法

我们在 2007 年至 2014 年期间，对美国 Truven MarketScan®人群和补充美国医疗保险中接受生物 DMARD 新治疗的患者进行了一项基于人群的队列研究。采用 Cox 比例风险模型，在控制年龄和倾向评分的十分位数后，比较阿巴西普起始治疗与其他生物 DMARD 起始治疗后，因严重感染需要住院的调整后的危险比（HR）和 95%置信区间（CI）。

结果

队列包括 5752 例起始阿巴西普治疗和 78556 例起始其他生物 DMARD 治疗的患者，其中 193 例和 1531 例在随访期间发生严重感染（粗发生率分别为 4.45 例/100 人年和 3.62 例/100 人年）。与其他生物 DMARD 相比，阿巴西普的使用与严重感染的总体发生率增加无关（HR 1.04，95%CI 0.89-1.21）。使用时间的长短（<1 年：HR 1.03，95%CI 0.87-1.22；>1 年：HR 1.08，95%CI 0.77-1.52）并未改变这种风险。此外，特定部位感染的风险也没有增加。