title: Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: a prospective, comparative, observational study.
abstract: OBJECTIVE
  To evaluate pregnancy safety of anti-TNF-α medications.
  
  
  METHODS
  Prospective, comparative, observational study done at the Israeli Teratology Information Service between 2002 and 2011.
  
  
  RESULTS
  83 anti-TNF-α-exposed-pregnancies (97.6% in the first trimester, T1) were followed-up and compared with 86 disease-matched (DM) and 341 non-teratogenic-exposed (NTE) pregnancies. The anti-TNF-α group consisted of 35 infliximab-, 25 etanercept-, and 23 adalimumab-exposed pregnancies. The rate of major congenital anomalies did not significantly differ between the three groups [3/65 (4.6%) (anti-TNF-α, T1), 5/79 (6.3%) (DM), 8/336 (2.4%) (NTE)], even after excluding genetic or cytogenetic anomalies [3/65 (4.6%) (anti-TNF-α, T1), 4/79 (5.1%) (DM), 6/336 (1.8%) (NTE)]. There were no cases of VATER/VACTERL association.
  
  
  CONCLUSIONS
  The present study suggests that anti-TNF-α treatment does not pose a major teratogenic risk in humans. This conclusion is based on relatively small numbers of exposed pregnancies and should be interpreted with caution. Larger studies are needed to establish anti-TNF-α pregnancy safety.
authors.affiliation: The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel. Electronic address: orna.diav-citrin@moh.health.gov.il.
authors.forename: Orna
authors.initials: O
authors.lastname: Diav-Citrin
authors.affiliation: The Division of Clinical Pharmacy, the Hebrew University of Jerusalem, Israel.
authors.forename: Anna
authors.initials: A
authors.lastname: Otcheretianski-Volodarsky
authors.affiliation: The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Shechtman
authors.affiliation: The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel.
authors.forename: Asher
authors.initials: A
authors.lastname: Ornoy
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy; D001528:Behcet Syndrome / Q000188:drug therapy; D003093:Colitis, Ulcerative / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D000069285:Infliximab; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept
keywords: Adalimumab; Anti-TNF-α; Autoimmune diseases; Congenital anomalies; Etanercept; Infliximab; Pregnancy