title: Safety of thiopurines and anti-TNF-α drugs during pregnancy in patients with inflammatory bowel disease.
abstract: OBJECTIVE
  The safety of thiopurines and anti-tumor necrosis factor-α (TNF-α) drugs during pregnancy remains controversial, as the experience with these drugs in this situation is limited. Our aim is to assess the safety of thiopurines and anti-TNF-α drugs for the treatment of inflammatory bowel disease (IBD) during pregnancy.
  
  
  METHODS
  Retrospective, multicenter study in IBD patients. Pregnancies were classified according to the therapeutic regimens during pregnancy or during the 3 months before the conception: non-exposed group, pregnancies exposed to thiopurines alone (group A), and pregnancies exposed to anti-TNF-α drugs (group B). An unfavorable Global Pregnancy Outcome (GPO) was considered if pregnancy developed with obstetric complications in the mother and in the newborn.
  
  
  RESULTS
  A total of 187 pregnancies in the group A, 66 pregnancies in the group B, and 318 pregnancies in the non-exposed group were included. The rate of unfavorable GPO was different among the three groups (31.8% in non-exposed group, 21.9% in group A, and 34.8% in group B), being lower in pregnancies under thiopurines than among non-exposed (P = 0.01). The rate of pregnancy complications was similar among the three groups (27.7% in non-exposed, 20.9% in group A, and 30.3% in group B). The rate of neonatal complications was different among the three groups (23.3% in non-exposed group, 13.9% in group A, and 21.2% in group B), being lower in pregnancies under thiopurines than among non-exposed (P = 0.01). In the multivariate analysis, the treatment with thiopurines (odds ratio = 0.6; 95% confidence interval = 0.4-0.9, P = 0.02) was the only predictor of favorable GPO, whereas maternal age >35 years at conception was the only predictor of unfavorable GPO. The treatment with anti-TNF-α drugs was not associated with an unfavorable GPO.
  
  
  CONCLUSIONS
  The treatment with thiopurines and anti-TNF-α drugs does not seem to increase the risk of complications during pregnancy and does seem to be safe for the newborn.
authors: Department of Gastroenterology, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa, IP, Madrid, Spain.
authors: M J
authors: MJ
authors: Casanova
authors: M
authors: M
authors: Chaparro
authors: E
authors: E
authors: Domènech
authors: M
authors: M
authors: Barreiro-de Acosta
authors: F
authors: F
authors: Bermejo
authors: E
authors: E
authors: Iglesias
authors: F
authors: F
authors: Gomollón
authors: L
authors: L
authors: Rodrigo
authors: X
authors: X
authors: Calvet
authors: M
authors: M
authors: Esteve
authors: E
authors: E
authors: García-Planella
authors: S
authors: S
authors: García-López
authors: C
authors: C
authors: Taxonera
authors: M
authors: M
authors: Calvo
authors: M
authors: M
authors: López
authors: D
authors: D
authors: Ginard
authors: M
authors: M
authors: Gómez-García
authors: E
authors: E
authors: Garrido
authors: J L
authors: JL
authors: Pérez-Calle
authors: B
authors: B
authors: Beltrán
authors: M
authors: M
authors: Piqueras
authors: C
authors: C
authors: Saro
authors: B
authors: B
authors: Botella
authors: C
authors: C
authors: Dueñas
authors: A
authors: A
authors: Ponferrada
authors: M
authors: M
authors: Mañosa
authors: V
authors: V
authors: García-Sánchez
authors: J
authors: J
authors: Maté
authors: J P
authors: JP
authors: Gisbert
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D001379:Azathioprine / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D015122:Mercaptopurine / Q000009:adverse effects* / Q000627:therapeutic use; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D012189:Retrospective Studies; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D015122:Mercaptopurine; D001379:Azathioprine