title: Is safety infliximb during pregnancy in patients with inflammatory bowel disease?
abstract: BACKGROUND
  in most cases, inflammatory bowel disease (IBD) debuts at reproductive age. The data available in the literature show infliximab (IFX) to be a safe drug during pregnancy but there is very little evidence about the activity of the disease following drug withdrawal during pregnancy.
  
  
  OBJECTIVE
  determine the drug's safety in pregnant women in our setting and assess its effect on the foetus, drawing on the experience of several hospitals. Secondly, observe the effect of treatment withdrawal on disease activity during pregnancy.
  
  
  METHODS
  a retrospective study was conducted of women with IBD who had received IFX treatment during pregnancy in five hospitals in Spain. Disease activity was assessed using Crohn's Disease Activity Index, while UC was assessed using the Truelove-Witts Index in each trimester of pregnancy. Gestational age, weight and diseases in the foetus were determined at birth.
  
  
  RESULTS
  the study included 12 women with a mean age of 29 years; 4 had ulcerative colitis and 8 Crohn's disease, with mean disease duration of 7 years. All but one, who was diagnosed during pregnancy, was receiving IFX treatment at conception. Six patients received uninterrupted treatment throughout the pregnancy, 2 requested voluntary interruption and in 3 cases treatment was interrupted in the third trimester as a precaution. They received a mean IFX dose of 400 mg every 8 weeks. Of the 6 patients who received continuous treatment, in 50% disease was held in remission. The 6 remaining patients suspended treatment for different reasons, presenting disease recurrence in all but one case (83.3%). Eight deliveries were vaginal and 4 by caesarean section. Newborns presented no congenital anomalies, intrauterine growth retardation or low birth weight and there was only one premature delivery.
  
  
  CONCLUSIONS
  although cases included in the study are not significant, in our experience, IFX during pregnancy is a safe treatment for the mother and the foetus. In fact, in our study and in some cases, its withdrawal may lead to a worsening of the disease. However, further control studies are required with larger samples to obtain more representative findings.
authors.affiliation: Department of Digestive Diseases, Hospital Universitario Virgen Macarena, Seville, Spain. jarguelles@telefonica.net
authors.forename: Federico
authors.initials: F
authors.lastname: Argüelles-Arias
authors.forename: Luisa
authors.initials: L
authors.lastname: Castro-Laria
authors.forename: Manuel
authors.initials: M
authors.lastname: Barreiro-de Acosta
authors.forename: Ma Valle
authors.initials: MV
authors.lastname: García-Sánchez
authors.forename: Pedro
authors.initials: P
authors.lastname: Guerrero-Jiménez
authors.forename: Ma Rosa
authors.initials: MR
authors.lastname: Gómez-García
authors.forename: Patricia
authors.initials: P
authors.lastname: Cordero-Ruiz
authors.forename: Eva
authors.initials: E
authors.lastname: Iglesias-Flores
authors.forename: Federico
authors.initials: F
authors.lastname: Gómez-Camacho
authors.forename: Enrique J
authors.initials: EJ
authors.lastname: Domínguez-Muñoz
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Herrerías-Gutiérrez
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001724:Birth Weight; D005260:Female; D005865:Gestational Age; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000209:etiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D016312:Treatment Refusal
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab