title: Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-α therapy during pregnancy: three-center study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: IBD Clinical and Research Centre, ISCARE, Charles University, Prague, Czech Republic. mbortlik@seznam.cz
authors.forename: Martin
authors.initials: M
authors.lastname: Bortlik
authors.forename: Nadezda
authors.initials: N
authors.lastname: Machkova
authors.forename: Dana
authors.initials: D
authors.lastname: Duricova
authors.forename: Karin
authors.initials: K
authors.lastname: Malickova
authors.forename: Ludek
authors.initials: L
authors.lastname: Hrdlicka
authors.forename: Martin
authors.initials: M
authors.lastname: Lukas
authors.forename: Pavel
authors.initials: P
authors.lastname: Kohout
authors.forename: Olga
authors.initials: O
authors.lastname: Shonova
authors.forename: Milan
authors.initials: M
authors.lastname: Lukas
mesh_terms: D000022:Abortion, Spontaneous / Q000139:chemically induced; D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001724:Birth Weight; D004334:Drug Administration Schedule; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005312:Fetal Blood / Q000378:metabolism; D006801:Humans; D007231:Infant, Newborn; D015212:Inflammatory Bowel Diseases / Q000097:blood / Q000188:drug therapy*; D000069285:Infliximab; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood / Q000188:drug therapy*; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000139:chemically induced; D011295:Prenatal Care; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069285:Infliximab; D000068879:Adalimumab