Ewig Celeste L Y, Wang Yanning, Smolinski Nicole E, Thai Thuy Nhu, Rasmussen Sonja A, Winterstein Almut G
Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville.
Center for Drug Evaluation and Safety, University of Florida, Gainesville.
JAMA Netw Open. 2025 May 1;8(5):e2510504. doi: 10.1001/jamanetworkopen.2025.10504.
Continuation of biologics in patients with an autoimmune condition who become pregnant involves weighing consequences of pregnancy-related changes in disease severity and potential teratogenic effects of medications. Characterization of biologic treatment patterns during pregnancy may provide insight into maternal and fetal risks and benefits.
To describe the utilization pattern of biologics in pregnant individuals with autoimmune conditions.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from Merative MarketScan Research Databases, which contain administrative claims of commercially insured individuals in the US. Pregnant patients aged 16 to 55 years with an autoimmune condition and biologic use 6 months before conception between January 1, 2011, and December 31, 2022, were included. The data were analyzed between October 15, 2024, and February 28, 2025.
Use of biologics for autoimmune disease after conception.
The proportion of patients who used biologics for Crohn disease, ulcerative colitis, psoriasis or psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, and multiple sclerosis was assessed, and the association between underlying autoimmune disease and use of biologics during pregnancy was measured using multivariable logistic regression.
A total of 6131 pregnant patients (median [IQR] age, 32 [29-36] years) with an autoimmune condition were included. The most prevalent conditions were Crohn disease (1372 patients [25.6%]) and rheumatoid arthritis (1295 patients [24.1%]). Of all patients, 4393 (71.6%; 95% CI, 70.5%-72.8%) used biologics at least once during pregnancy. Among pregnancies with live birth outcomes, biologic use declined throughout gestation, with 2981 patients (68.6% [95% CI, 67.2%-70.0%]), 2555 patients (58.8% [95% CI, 57.3%-60.3%]), and 2113 patients (48.6% [95% CI, 47.1%-50.1%]) using biologics during the first, second, and third trimesters, respectively, and 3350 patients (77.1% [95% CI, 75.8%-78.3%]) using them post partum. Compared with pregnant patients with rheumatoid arthritis, those with Crohn disease (odds ratio [OR], 7.88 [95% CI, 5.93-10.47]) and ulcerative colitis (OR, 5.35 [95% CI, 3.73-7.66]) were more likely to use biologics, while those with psoriasis or psoriatic arthritis (OR, 0.65 [95% CI, 0.52-0.80]) were less likely.
In this cohort study, a decline in the use of biologics for autoimmune disease was observed during the pregnancy period that rebounded only partially thereafter. Notable variations in use across autoimmune conditions suggest that indication-specific risk-benefit assessments of biologic use are needed.
患有自身免疫性疾病的患者在怀孕期间继续使用生物制剂需要权衡疾病严重程度与妊娠相关变化的后果以及药物潜在的致畸作用。描述怀孕期间生物制剂的治疗模式可能有助于了解母体和胎儿的风险与益处。
描述患有自身免疫性疾病的孕妇使用生物制剂的模式。
设计、背景和参与者：这项队列研究使用了来自默克多市场扫描研究数据库的数据，该数据库包含美国商业保险个体的行政索赔数据。纳入了2011年1月1日至2022年12月31日期间年龄在16至55岁之间、患有自身免疫性疾病且在受孕前6个月使用过生物制剂的孕妇。数据于2024年10月15日至2025年2月28日进行分析。
受孕后使用生物制剂治疗自身免疫性疾病。
评估使用生物制剂治疗克罗恩病、溃疡性结肠炎、银屑病或银屑病关节炎、类风湿关节炎、强直性脊柱炎、系统性红斑狼疮和多发性硬化症的患者比例，并使用多变量逻辑回归分析潜在自身免疫性疾病与怀孕期间使用生物制剂之间的关联。
共纳入6131名患有自身免疫性疾病的孕妇（中位年龄[四分位间距]为32[29 - 36]岁）。最常见的疾病是克罗恩病（1372例患者[25.6%]）和类风湿关节炎（1295例患者[24.1%]）。在所有患者中，4,393名（71.6%；95%置信区间，70.5% - 72.8%）在怀孕期间至少使用过一次生物制剂。在有活产结局的妊娠中，生物制剂的使用在整个孕期呈下降趋势，在孕早期、孕中期和孕晚期使用生物制剂的患者分别为2981名（68.6%[95%置信区间，67.2% - 70.0%]）、2555名（58.8%[95%置信区间，57.3% - 60.3%]）和2113名（48.6%[95%置信区间，47.1% - 50.1%]），产后使用生物制剂的患者有3350名（77.1%[95%置信区间，75.8% - 78.3%]）。与患有类风湿关节炎的孕妇相比，患有克罗恩病（优势比[OR]，7.88[95%置信区间，5.93 - 10.47]）和溃疡性结肠炎（OR，5.35[95%置信区间，3.73 - 7.66]）的孕妇更有可能使用生物制剂，而患有银屑病或银屑病关节炎的孕妇（OR，0.65[95%置信区间，0.52 - 0.80]）使用生物制剂的可能性较小。
在这项队列研究中，观察到怀孕期间用于自身免疫性疾病的生物制剂使用量下降，产后仅部分反弹。不同自身免疫性疾病的使用情况存在显著差异，这表明需要针对特定适应症对生物制剂使用进行风险效益评估。
Zotero 插件
