Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Pharmacoepidemiol Drug Saf. 2019 Mar;28(3):296-304. doi: 10.1002/pds.4695. Epub 2018 Nov 14.
To describe the use of tumor necrosis factor-alpha inhibitors (TNFis) among pregnancies ending in a live birth and with a diagnosis of ankylosing spondylitis (AS), Crohn's disease (CD), juvenile idiopathic arthritis (JIA), psoriasis (PsO), psoriatic arthritis (PsA), rheumatoid arthritis (RA), or ulcerative colitis (UC).
We identified pregnancies among women aged 15 to 54 years between 01/01/2004 and 09/30/2015 from 16 health plans participating in Sentinel. We inferred indication using ICD-9-CM codes in the 183-day period before conception. We assessed proportion of infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab by calendar year, indication, and maternal age, and compared them to proportions in an age-matched, indication-matched, and date-matched non-pregnant cohort.
Among 19 681 pregnancies with at least one chronic inflammatory condition, 2990 (15.2%) received a TNFi. In both pregnancies and matched non-pregnant cohort, TNFi use was highest (34.4%; 55.8%) for PsA patients and lowest (6.2%; 13.4%) for PsO patients. Etanercept was most frequently used among AS/JIA/PsA/PsO/RA patients, while infliximab was the preferred TNFi for CD/UC patients. Except for infliximab and certolizumab, TNFi use during pregnancy decreased after the first trimester. Pregnancies among older pregnant women (45-54 years) were more likely to be treated compared with the matched non-pregnant cohort.
There was a preference for etanercept among pregnancies with AS/JIA/PsA/PsO/RA, despite the availability of other TNFis. Decline in TNFi use after the first trimester may be related to the desire to reduce TNFis transplacental transfer and to minimize infection risk to the fetus or baby associated with live vaccine immunizations after birth.
描述在强直性脊柱炎(AS)、克罗恩病(CD)、幼年特发性关节炎(JIA)、银屑病(PsO)、银屑病关节炎(PsA)、类风湿关节炎(RA)或溃疡性结肠炎(UC)导致活产的妊娠中使用肿瘤坏死因子-α抑制剂(TNFis)的情况。
我们从参与 Sentinel 的 16 家健康计划中,确定了 2004 年 1 月 1 日至 2015 年 9 月 30 日期间年龄在 15 至 54 岁之间的妊娠。我们使用受孕前 183 天的 ICD-9-CM 代码推断适应证。我们按日历年度、适应证和产妇年龄评估英夫利昔单抗、依那西普、阿达木单抗、certolizumab pegol 和戈利木单抗的比例,并与年龄匹配、适应证匹配和日期匹配的非妊娠队列进行比较。
在 19681 例至少有一种慢性炎症性疾病的妊娠中,有 2990 例(15.2%)接受了 TNFis 治疗。在妊娠和匹配的非妊娠队列中,PsA 患者的 TNFis 使用率最高(34.4%;55.8%),而 PsO 患者的使用率最低(6.2%;13.4%)。依那西普是 AS/JIA/PsA/PsO/RA 患者最常使用的 TNFis,而英夫利昔单抗是 CD/UC 患者的首选 TNFis。除英夫利昔单抗和 certolizumab 外,妊娠早期后 TNFis 的使用量减少。与匹配的非妊娠队列相比,年龄较大的孕妇(45-54 岁)的妊娠更可能接受治疗。
尽管有其他 TNFis 可用,但在 AS/JIA/PsA/PsO/RA 妊娠中,更倾向于使用依那西普。妊娠早期后 TNFis 使用量的下降可能与减少 TNFis 胎盘转移以及降低与活疫苗免疫接种相关的胎儿或婴儿感染风险的愿望有关。