Bortlik Martin, Machkova Nadezda, Duricova Dana, Malickova Karin, Hrdlicka Ludek, Lukas Martin, Kohout Pavel, Shonova Olga, Lukas Milan
IBD Clinical and Research Centre, ISCARE, Charles University, Prague, Czech Republic.
Scand J Gastroenterol. 2013 Aug;48(8):951-8. doi: 10.3109/00365521.2013.812141. Epub 2013 Jul 8.
Substantial number of women with inflammatory bowel disease (IBD) conceives while on anti-TNF-α therapy. The aim was to assess the safety and efficacy of anti-TNF-α treatment during pregnancy and to analyze relationship of neonatal and maternal anti-TNF-α levels at delivery with gestational age at the last exposure.
Women with IBD exposed to anti-TNF-α therapy during pregnancy were included. Data on anti-TNF-α treatment, disease activity, concomitant medication, pregnancy and newborn outcome were recorded. Anti-TNF-α levels from cord blood were assessed by ELISA.
Forty-one pregnancies (27 Crohn's disease; 14 ulcerative colitis) were exposed to infliximab (IFX; 32) and adalimumab (ADA; 9). Ten (24%) women had active disease at conception and 31 (76%) were in remission with 3 patients experiencing relapse during pregnancy. Anti-TNF-α therapy started prior to and after conception in 32 and 9 women, respectively. There were 34 (83%) live births (median birth weight 3145 g) of which 28 were at-term and 6 preterm deliveries. Five (12%) pregnancies ended in spontaneous and two in therapeutic abortion. No congenital malformations except for one case of hip dysplasia were observed. Similarly, no serious perinatal complication occurred. IFX cord levels measured in 11 children positively correlated with gestational week at the last drug administration and maternal levels at delivery, while no such correlation was found in case of ADA.
The results confirm that anti-TNFs are effective and safe during pregnancy. A positive correlation between IFX cord levels and gestational week of last exposure as well as maternal serum levels was observed.
大量炎症性肠病（IBD）女性在接受抗TNF-α治疗期间怀孕。本研究旨在评估抗TNF-α治疗在孕期的安全性和有效性，并分析分娩时新生儿和母亲的抗TNF-α水平与末次暴露时孕周的关系。
纳入孕期接受抗TNF-α治疗的IBD女性。记录抗TNF-α治疗、疾病活动度、合并用药、妊娠及新生儿结局等数据。采用酶联免疫吸附测定法（ELISA）评估脐血中的抗TNF-α水平。
41例妊娠（27例克罗恩病；14例溃疡性结肠炎）接受了英夫利昔单抗（IFX；32例）和阿达木单抗（ADA；9例）治疗。10例（24%）女性在受孕时患有活动性疾病，31例（76%）处于缓解期，3例患者在孕期复发。抗TNF-α治疗分别在32例和9例女性受孕前和受孕后开始。共有34例（83%）活产（中位出生体重3145g），其中28例足月分娩，6例早产。5例（12%）妊娠自然终止，2例治疗性流产。除1例髋关节发育不良外，未观察到先天性畸形。同样，未发生严重围产期并发症。11例儿童的IFX脐血水平与末次给药时的孕周及母亲分娩时的水平呈正相关，而ADA未发现此类相关性。
结果证实抗TNFs在孕期有效且安全。观察到IFX脐血水平与末次暴露孕周及母亲血清水平呈正相关。
