title: Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study.
abstract: OBJECTIVE
  As many inflammatory rheumatic diseases affect patients in childbearing age, some concern has been expressed about the safety of biologic drugs during pregnancy. This study evaluated the effects of anti-tumor necrosis factor alpha (TNFα) agents on pregnancy/foetal outcomes.
  
  
  METHODS
  Thirty-eight pregnancies were followed prospectively from November 2008 to February 2015. Information about the patients' exposure to anti-TNFα, disease activity, DMARD therapy, pregnancy/foetal outcomes were registered.
  
  
  RESULTS
  Twenty-four/38 (71.1%) pregnancies were exposed to anti-TNFα at conception/I trimester, 11/38 (28.9%) prior to conception and 3 (11.1%) following paternal exposure. There were two congenital malformations: one infant (4.2%) was diagnosed with congenital diaphragmatic hernia and obstructive megaureter; the mother was exposed to adalimumab at conception/I trimester. While one foetus (9.1%) showed a trisomy 16, the mother 38 year-old had suspended etanercept 4 weeks before conception. There was no significant difference in pregnancy/foetal outcome between the two groups. Nor were there any significant differences in pregnancy/foetal outcomes in the various groups being treated with different anti-TNFα antagonists. No congenital malformations were found in connection to paternal exposure.
  
  
  CONCLUSIONS
  Study results suggest that anti-TNFα drugs could be safe when administered during conception/I trimester and following paternal exposure.
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. Electronic address: arielahoxha@hotmail.com.
authors.forename: Ariela
authors.initials: A
authors.lastname: Hoxha
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy.
authors.forename: Antonia
authors.initials: A
authors.lastname: Calligaro
authors.affiliation: Clinic of Rheumatology, DSMB, University Hospital "Santa Maria della Misericordia", 33100 Udine, Italy.
authors.forename: Emma
authors.initials: E
authors.lastname: Di Poi
authors.affiliation: Rheumatology Unit, S. Chiara Hospital, 38122 Trento, Italy.
authors.forename: Susanna
authors.initials: S
authors.lastname: Peccatori
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Favaro
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Del Ross
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Ramonda
authors.affiliation: Department of Medicine, S. Martino Hospital, 32100 Belluno, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Grava
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy.
authors.forename: Bernd
authors.initials: B
authors.lastname: Raffeiner
authors.affiliation: Rheumatology Unit, S. Chiara Hospital, 38122 Trento, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Ravagni
authors.affiliation: Clinic of Rheumatology, DSMB, University Hospital "Santa Maria della Misericordia", 33100 Udine, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Vita
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy.
authors.forename: Amelia
authors.initials: A
authors.lastname: Ruffatti
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D005315:Fetal Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D025242:Spondylarthropathies / Q000188:drug therapy*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha
keywords: Ankylosing spondylitis; Anti-TNFα agents; Foetal outcome; Pregnancy; Psoriatic arthritis; Rheumatoid arthritis