Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: A prospective, comparative, observational study

被引：81

作者：

Diav-Citrin, Orna ^{[1
,2
]}

Otcheretianski-Volodarsky, Anna ^{[3
]}

Shechtman, Svetlana ^{[1
]}

Ornoy, Asher ^{[1
,2
]}

机构：

[1] Israel Minist Hlth, Israeli Teratol Informat Serv, IL-9446724 Jerusalem, Israel

[2] Hebrew Univ Jerusalem, Hadassah Med Sch, IL-91010 Jerusalem, Israel

[3] Hebrew Univ Jerusalem, Div Clin Pharm, IL-91905 Jerusalem, Israel

来源：

REPRODUCTIVE TOXICOLOGY | 2014年 / 43卷

关键词：

Anti-TNF-alpha; Infliximab; Etanercept; Adalimumab; Autoimmune diseases; Pregnancy; Congenital anomalies; INFLAMMATORY-BOWEL-DISEASE; NECROSIS-FACTOR ANTAGONISTS; RHEUMATOID-ARTHRITIS; SAFETY ASSESSMENT; CROHNS-DISEASE; INFLIXIMAB USE; WOMEN; ASSOCIATION; MEDICATIONS; ETANERCEPT;

D O I：

10.1016/j.reprotox.2013.11.004

中图分类号：

Q [生物科学];

学科分类号：

090105 [作物生产系统与生态工程];

摘要：

Objective: To evaluate pregnancy safety of anti-TNF-alpha medications. Design: Prospective, comparative, observational study done at the Israeli Teratology Information Service between 2002 and 2011. Results: 83 anti-TNF-alpha-exposed-pregnancies (97.6% in the first trimester, T1) were followed-up and compared with 86 disease-matched (DM) and 341 non-teratogenic-exposed (NTE) pregnancies. The anti-TNF-alpha group consisted of 35 infliximab-, 25 etanercept-, and 23 adalimumab-exposed pregnancies. The rate of major congenital anomalies did not significantly differ between the three groups [3/65 (4.6%) (anti-TNF-alpha, T1), 5/79(6.3%) (DM), 8/336(2.4%) (NTE)1, even after excluding genetic or cytogenetic anomalies 13/65 (4.6%) (anti-TNF-alpha, T1), 4/79 (5.1%) (DM), 6/336 (1.8%) (NTE)]. There were no cases of VATER/VACTERL association. Conclusion: The present study suggests that anti-TNF-alpha treatment does not pose a major teratogenic risk in humans. This conclusion is based on relatively small numbers of exposed pregnancies and should be interpreted with caution. Larger studies are needed to establish anti-TNF-alpha pregnancy safety. (C) 2013 Elsevier Inc. All rights reserved.

引用

页码：78 / 84

页数：7

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