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《银屑病纵向评估和注册研究(PSOLAR)中中重度银屑病女性的妊娠结局》。

Pregnancy Outcomes in Women With Moderate-to-Severe Psoriasis From the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

机构信息

Department of Dermatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

The Guenther Dermatology Research Centre, London, Ontario, Canada.

出版信息

JAMA Dermatol. 2021 Mar 1;157(3):301-306. doi: 10.1001/jamadermatol.2020.5595.

Abstract

IMPORTANCE

Prospective data are limited on pregnancy outcomes among women with psoriasis who may be receiving biologic or conventional systemic therapy.

OBJECTIVE

To report pregnancy outcomes observed in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from PSOLAR, a multicenter, disease-based, observational registry evaluating long-term safety and clinical outcomes for patients receiving or eligible to receive treatment for psoriasis with biologics and/or conventional systemic therapies. Of 12 090 enrollees, 5456 were women (45.1%), and 2224 women were of childbearing age (18-45 years). Participants had a total of 12 929 patient-years of follow-up (median, 7.2 [range, 3.3-8.0] years per patient). Data were collected from June 20, 2007, to August 23, 2019, and analyzed from April 23 to June 23, 2020.

EXPOSURES

Exposure to biologics within the prenatal period (≤1 year before birth or ≤6 months before spontaneous abortion) or at any other time.

MAIN OUTCOMES AND MEASURES

Descriptive summaries of pregnancies and pregnancy-related outcomes were self-reported in PSOLAR, including births, stillbirths, spontaneous abortions, and elective terminations. Live birth characteristics collected in PSOLAR include whether a birth was full-term (≥37 weeks) or premature (<37 weeks) and whether neonatal adverse events or congenital anomalies occurred.

RESULTS

A total of 298 pregnancies occurred among 220 women (mean [SD] age, 27.8 [5.2] years), and the general fertility rate was 18.9 per 1000 women aged 18 to 45 years. Of the 298 pregnancies, 244 (81.9%) resulted in birth, 41 (13.8%) ended in spontaneous abortion, and 13 (4.4%) were electively terminated. Gestational age was available for 243 births; 221 infants (90.9%) were full-term, and 22 (9.1%) were born prematurely. Birth outcomes included 231 healthy newborns, 10 infants with a neonatal problem, 2 infants with a congenital anomaly, and 1 stillbirth. Of the 298 pregnancies, 252 were associated with biologic exposure before or during pregnancy. Pregnancy outcomes for women exposed to biologics were similar to those for women exposed to nonbiologics. Among women who became pregnant, mean (SD) age at the time of pregnancy outcome was 30.9 (4.8) years; at enrollment into the registry, 74 of 219 (33.8%) had obesity, and 121 of 220 (55.0%) were past or current smokers.

CONCLUSIONS AND RELEVANCE

The findings of this cohort study suggest that pregnancy outcomes in PSOLAR have remained consistent with previous reports. Overall and live birth outcomes were similar to those for the general population.

摘要

重要性

关于可能正在接受生物制剂或传统全身治疗的银屑病女性的妊娠结局,前瞻性数据有限。

目的

报告在银屑病纵向评估和登记处(PSOLAR)中观察到的妊娠结局。

设计、地点和参与者:这项队列研究使用了来自 PSOLAR 的数据,这是一个多中心、基于疾病的观察性登记处,评估接受或有资格接受生物制剂和/或传统全身治疗治疗银屑病的患者的长期安全性和临床结局。在 12090 名入组者中,有 5456 名女性(45.1%),2224 名女性处于生育年龄(18-45 岁)。参与者共有 12929 患者年的随访(中位数,每位患者 7.2[范围,3.3-8.0]年)。数据于 2007 年 6 月 20 日至 2019 年 8 月 23 日收集,并于 2020 年 4 月 23 日至 6 月 23 日进行分析。

暴露

在产前(出生前≤1 年或自发性流产前≤6 个月)或任何其他时间接触生物制剂。

主要结果和措施

PSOLAR 中自我报告了妊娠和与妊娠相关的结局的描述性总结,包括分娩、死产、自发性流产和选择性终止妊娠。PSOLAR 中收集的活产特征包括分娩是否足月(≥37 周)或早产(<37 周)以及是否发生新生儿不良事件或先天性异常。

结果

在 220 名女性中共有 298 例妊娠(平均[SD]年龄,27.8[5.2]岁),一般生育率为每 1000 名 18 至 45 岁女性 18.9 例。在 298 例妊娠中,244 例(81.9%)分娩,41 例(13.8%)自然流产,13 例(4.4%)选择性终止妊娠。243 例活产的胎龄可用;221 名婴儿(90.9%)足月,22 名(9.1%)早产。分娩结局包括 231 名健康新生儿、10 名新生儿有问题、2 名婴儿有先天性异常和 1 例死产。在 298 例妊娠中,有 252 例与妊娠前或妊娠期间的生物制剂暴露有关。暴露于生物制剂的女性的妊娠结局与暴露于非生物制剂的女性相似。在怀孕的女性中,妊娠结局时的平均(SD)年龄为 30.9(4.8)岁;在登记入组时,74 名女性中有 219 名(33.8%)肥胖,121 名女性中有 220 名(55.0%)为既往或当前吸烟者。

结论和相关性

这项队列研究的结果表明,PSOLAR 的妊娠结局与先前的报告一致。总体和活产结局与一般人群相似。

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