类风湿关节炎母亲使用TNFi治疗不会增加后代发生严重感染的风险
目的
与妊娠期未暴露于TNFi的RA患者后代和一般人群后代相比,评估妊娠期暴露于TNFi的RA患者后代发生严重感染风险。
方法
本研究使用美国索赔数据(2011-2015),从中筛选出RA母亲的2,989名后代作为实验组,随机选择14,596名儿童作为对照组。根据母亲年龄、分娩年份和居住州进行≥4:1的匹配。根据妊娠期间≥1份处方确定患者是否暴露于TNFi,并根据≥1次住院治疗记录,以感染为主要诊断,确定其是否在≤12个月期间发生严重感染。研究采用多变量分析法,根据孕产妇人口统计学特征、妊娠合并症、并发症及治疗药物进行调整。
结果
在RA后代中,380名(12.7%)在妊娠期间暴露于TNFi。 未暴露于TNFi的RA后代发生严重感染的百分比(2.0%;95%CI 1.5,2.6)与非RA后代相似(1.9%;95%CI 1.9,2.2), 而暴露于TNFi的RA后代发生严重感染的百分比为3.2%(95%CI 1.5,5.6)。在多变量分析中,我们无法确定相对于非RA后代(比值比[OR] 1.7,95%CI 0.8,3.7)和未暴露于TNFi的RA后代(或 1.4,95%CI 0.7,2.8),暴露于TNFi的RA后代出现严重感染的风险有所增加。
结论
本研究显示,类风湿关节炎母亲使用TNFi治疗不会增加后代发生严重感染的风险。
原 文
Serious Infections in Rheumatoid Arthritis Offspring Exposed to Tumor Necrosis Factor Inhibitors
Objective
To evaluate the risk of serious infections in rheumatoid arthritis (RA) offspring exposed to tumor necrosis factor inhibitors (TNFi) in the gestational period compared to unexposed RA offspring, as well as to children from the general population.
Methods
We used US claim data (2011–2015) to identify 2,989 offspring born to women who have RA and a randomly selected group of 14,596 control children, matched ≥4:1 for maternal age, year of delivery, and state of residence. We defined TNFi exposure based on ≥1 filled prescription during pregnancy. We ascertained serious infections based on ≥1 hospitalization, with infection as a primary diagnosis, at ≤12 months of life. We performed multivariable analyses, adjusting for maternal demographics, comorbidities, pregnancy complications, and drugs.
Results
Among RA offspring, 380 (12.7%) were exposed to TNFi during pregnancy. The percentage of serious infections in RA offspring with no TNFi exposure (2.0%; 95% confidence interval [95% CI] 1.5, 2.6) was similar to that in non‐RA offspring (1.9%; 95% CI 1.9, 2.2), while the percentage of serious infections in RA offspring with TNFi exposure was 3.2% (95% CI 1.5, 5.6). In multivariable analyses, we were unable to establish an increased risk of serious infections in RA offspring exposed to TNFi versus both non‐RA offspring (odds ratio [OR] 1.7, 95% CI 0.8, 3.7) and RA offspring unexposed to TNFi (OR 1.4, 95% CI 0.7, 2.8).
Conclusion
We did not demonstrate a marked excess risk for serious infections in RA offspring exposed to TNFi during pregnancy versus unexposed RA offspring or general population controls.
文章出处:
Évelyne Vinet, et al.Arthritis & Rheumatology Volume 70, Issue 10. May 17,2018.
https://onlinelibrary.wiley.com/doi/10.1002/art.40536
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