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炎症性肠病患者孕期使用乌司奴单抗:一项前瞻性多中心队列研究。

Ustekinumab during pregnancy in patients with inflammatory bowel disease: a prospective multicentre cohort study.

机构信息

IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Aliment Pharmacol Ther. 2022 Nov;56(9):1361-1369. doi: 10.1111/apt.17224. Epub 2022 Sep 27.

DOI:10.1111/apt.17224
PMID:36168705
Abstract

BACKGROUND

Women with inflammatory bowel diseases (IBD) often receive biologics to maintain remission during pregnancy.

AIMS

To assess maternal and neonatal outcomes in patients with IBD treated with ustekinumab (UST) during pregnancy METHODS: In a multicentre, prospective cohort study, we recruited women with IBD treated with UST during pregnancy between 2019 and 2021. Outcomes were compared among patients treated with UST, anti-tumour necrosis factor α, (anti-TNF) and non-UST, non-anti-TNF therapies. UST-treated patients were matched 1:2 to controls according to age, body mass index and parity. Newborns were followed up to 12 months.

RESULTS

We recruited 129 pregnant patients: UST 27; anti-TNF 52; non-UST, non-anti-TNF 50 (thiopurine or mesalazine 30, no therapy 20); Crohn's disease 25 (96.9%). Overall, pregnancy, neonatal and newborn outcomes were satisfactory, with no significant differences among patients treated with UST, anti-TNF and non-UST non-anti-TNF agents for obstetrical maternal complications [UST 3 (11.5%), anti TNF 12 (23.1%), non UST, non-anti-TNF 4 (8.2%), p = 0.095], pre-term delivery [1 (4.3%), 9 (18.4%), 4 (5.7%), p = 0.133], low birth weight [1 (4.2%), 5 (10.2%), 4 (8.3%), p = 0.679], or first year newborn hospitalisation [2 (9.1%), 4 (8.2%), 3 (6.1%), p = 0.885].

CONCLUSION

Pregnant patients with IBD treated with UST demonstrated favourable pregnancy and neonatal outcomes that were comparable with those in patients treated with anti-TNF or other therapy. Data are reassuring for patients with IBD and their physicians when considering UST during pregnancy.

摘要

背景

患有炎症性肠病 (IBD) 的女性常在怀孕期间接受生物制剂以维持缓解。

目的

评估在怀孕期间接受乌司奴单抗 (UST) 治疗的 IBD 患者的母婴结局。

方法

在一项多中心前瞻性队列研究中,我们招募了 2019 年至 2021 年期间在怀孕期间接受 UST 治疗的 IBD 患者。比较了接受 UST、抗肿瘤坏死因子 α(抗 TNF)和非 UST、非抗 TNF 治疗的患者的结局。根据年龄、体重指数和产次,将接受 UST 治疗的患者与对照组 1:2 匹配。随访新生儿至 12 个月。

结果

我们招募了 129 名孕妇:UST 27 例;抗 TNF 52 例;非 UST、非抗 TNF 50 例(硫唑嘌呤或美沙拉嗪 30 例,无治疗 20 例);克罗恩病 25 例(96.9%)。总体而言,妊娠、新生儿和新生儿结局令人满意,接受 UST、抗 TNF 和非 UST 非抗 TNF 治疗的患者在产科母体并发症[UST 3(11.5%)、抗 TNF 12(23.1%)、非 UST、非抗 TNF 4(8.2%),p=0.095]、早产[1(4.3%)、9(18.4%)、4(5.7%),p=0.133]、低出生体重[1(4.2%)、5(10.2%)、4(8.3%),p=0.679]或新生儿第一年住院治疗[2(9.1%)、4(8.2%)、3(6.1%),p=0.885]方面无显著差异。

结论

接受 UST 治疗的 IBD 孕妇表现出良好的妊娠和新生儿结局,与接受抗 TNF 或其他治疗的患者相当。这些数据为考虑在怀孕期间使用 UST 的 IBD 患者及其医生提供了令人安心的信息。

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