title: Effects of discontinuing anti-tumor necrosis factor therapy during pregnancy on the course of inflammatory bowel disease and neonatal exposure.
abstract: OBJECTIVE
  We assessed the course of inflammatory bowel disease (IBD) among pregnant women who stopped taking anti-tumor necrosis factor (TNF) agents. We also analyzed levels of anti-TNF agents in cord blood samples.
  
  
  METHODS
  We followed 31 pregnancies in 28 women with IBD between April 2006 and April 2011 who were treated with anti-TNF agents (18 received infliximab, and 13 received adalimumab) during pregnancy. We used enzyme-linked immunosorbent assays to measure levels of anti-TNF agents in cord blood collected from 18 newborns (12 whose mothers took infliximab, and 6 whose mothers took adalimumab).
  
  
  RESULTS
  Among the patients taking infliximab, 12 (71%) discontinued treatment before gestational week 30; all patients remained in remission. All the patients taking adalimumab discontinued treatment before gestational week 30; two patients had relapses of IBD. There were 28 live births, 1 miscarriage among patients taking infliximab (at gestational week 6), and 2 miscarriages among patients taking adalimumab (at weeks 6 and 8); there were no congenital malformations. The mean cord blood level of infliximab was 6.4 ± 1.6 μg/mL; it was significantly lower among women who received the drug 10 weeks or less before delivery (2.8 ± 1.1 μg/mL) than those who received infliximab closer to delivery (10 ± 2.3 μg/mL; P = .02). Adalimumab was detected in 5 samples of cord blood (mean concentration, 1.7 ± 0.4 μg/mL); 1 cord blood sample from a woman who discontinued the treatment at gestational week 22 had an undetectable level of the drug.
  
  
  CONCLUSIONS
  Discontinuation of anti-TNF therapy appears to be safe for pregnant women with quiescent IBD. However, these drugs are still detected in cord blood samples.
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, Netherlands. z.zelinkova@erasmusmc.nl
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Zelinkova
authors.forename: Cokkie
authors.initials: C
authors.lastname: van der Ent
authors.forename: Karlien F
authors.initials: KF
authors.lastname: Bruin
authors.forename: Onno
authors.initials: O
authors.lastname: van Baalen
authors.forename: Hestia G
authors.initials: HG
authors.lastname: Vermeulen
authors.forename: Herman J T
authors.initials: HJ
authors.lastname: Smalbraak
authors.forename: Rob J
authors.initials: RJ
authors.lastname: Ouwendijk
authors.forename: Aad C
authors.initials: AC
authors.lastname: Hoek
authors.forename: Sjoerd D
authors.initials: SD
authors.lastname: van der Werf
authors.forename: Ernst J
authors.initials: EJ
authors.lastname: Kuipers
authors.forename: C Janneke
authors.initials: CJ
authors.lastname: van der Woude
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D005312:Fetal Blood / Q000737:chemistry; D006801:Humans; D007155:Immunologic Factors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007231:Infant, Newborn; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D028761:Withholding Treatment; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; C439524:TNF protein, human; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab