接受维得利珠单抗、抗 TNF 或常规治疗的炎症性肠病患者的妊娠结局：欧洲 CONCEIVE 研究结果。

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study.

机构信息

Leuven, Belgium.

Rotterdam, The Netherlands.

出版信息

Aliment Pharmacol Ther. 2020 Jan;51(1):129-138. doi: 10.1111/apt.15539. Epub 2019 Nov 6.

DOI:10.1111/apt.15539

PMID:31692017

Abstract

BACKGROUND

Women with inflammatory bowel diseases (IBD) often receive biologicals during pregnancy to maintain disease remission. Data on outcome of vedolizumab-exposed pregnancies (VDZE) are sparse.

AIMS

To assess pregnancy and child outcomes of VDZE pregnancies and to compare these results to anti-TNF exposed (TNFE) or both immunomodulatory and biologic unexposed (CON IBD) pregnancies.

METHODS

A retrospective multicentre case-control observational study was performed.

RESULTS

VDZE group included 79 pregnancies in 73 IBD women. The TNFE and CON IBD group included 186 pregnancies (162 live births) in 164 IBD women and 184 pregnancies (163 live births) in 155 IBD women, respectively. At conception, cases more often had active disease ([VDZE: 36% vs TNFE: 17%, P = .002] and [VDZE: 36% vs CON IBD: 24%, P = .063]). No significant difference in miscarriage rates were found between groups (VDZE and TNFE: 16% vs 13%, P = .567; VDZE and CON IBD: 16% vs 10%, P = .216). In live-born infants, median gestational age and birthweight were similar between groups. Median Apgar score at birth was numerically equal. Prematurity was similar in the VDZE group compared to the control groups, even when correcting for disease activity during pregnancy. The frequency of congenital anomalies was comparable between groups as were the percentages of breastfed babies. During the first year of life, no malignancies were reported and infants' infection risk did not significantly differ between groups.

CONCLUSION

No new safety signal was detected in VDZE pregnancies although larger, prospective studies are required for confirmation.

摘要

背景

患有炎症性肠病（IBD）的女性在怀孕期间常接受生物制剂以维持疾病缓解。有关vedolizumab 暴露妊娠（VDZE）结局的数据很少。

目的

评估 VDZE 妊娠的妊娠和儿童结局，并将这些结果与抗 TNF 暴露（TNFE）或免疫调节剂和生物制剂均未暴露（CON IBD）的妊娠进行比较。

方法

进行了一项回顾性多中心病例对照观察性研究。

结果

VDZE 组包括 73 例 IBD 女性的 79 例妊娠。TNFE 和 CON IBD 组分别包括 164 例 IBD 女性的 186 例（162 例活产）妊娠和 155 例 IBD 女性的 184 例（163 例活产）妊娠。在受孕时，病例组更常患有活动期疾病（[VDZE：36%比 TNFE：17%，P=0.002]和[VDZE：36%比 CON IBD：24%，P=0.063]）。各组间流产率无显著差异（VDZE 和 TNFE：16%比 13%，P=0.567；VDZE 和 CON IBD：16%比 10%，P=0.216）。在活产婴儿中，各组间的中位胎龄和出生体重相似。出生时的中位 Apgar 评分数值相等。与对照组相比，VDZE 组的早产率相似，即使在校正妊娠期疾病活动度后也是如此。各组间先天性异常的频率相似，母乳喂养婴儿的百分比也相似。在生命的第一年，未报告恶性肿瘤，各组间婴儿感染风险无显著差异。