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.

中文翻译：

---

使用维多珠单抗，抗TNF或常规疗法治疗的炎症性肠病患者的妊娠结局：欧洲一项概念研究的结果。

背景技术患有炎性肠病（IBD）的妇女通常在怀孕期间接受生物制剂以维持疾病缓解。维多珠单抗暴露妊娠结局（VDZE）的数据稀少。目的评估VDZE怀孕的孕妇和儿童结局，并将这些结果与抗TNF暴露（TNFE）或免疫调节和未暴露生物制剂（CON IBD）怀孕进行比较。方法进行回顾性多中心病例对照观察研究。结果VDZE组包括73名IBD妇女中的79例怀孕。TNFE和CON IBD组分别包括164名IBD妇女的186例妊娠（162例活产）和155名IBD妇女的184例妊娠（163例活产）。受孕时，患有活动性疾病的病例较多（[VDZE：36％vs TNFE：17％，P = .002]和[VDZE：36％vs CON IBD：24％，P = .063]）。两组之间的流产率无显着差异（VDZE和TNFE：16％vs 13％，P = .567； VDZE和CON IBD：16％vs 10％，P = 0.216）。在活产婴儿中，两组之间的中位胎龄和出生体重相似。出生时的Apgar得分中位数在数值上相等。即使校正妊娠期间的疾病活动，VDZE组的早产与对照组相似。两组之间的先天性异常发生频率与母乳喂养婴儿的百分比相当。在生命的第一年中，未报告有恶性肿瘤，两组之间的婴儿感染风险没有显着差异。结论VDZE妊娠中未检测到新的安全性信号，尽管需要进行更大的前瞻性研究才能确认。