title: Pregnancy outcomes after exposure to tocilizumab: A retrospective analysis of 61 patients in Japan.
abstract: OBJECTIVE
  To assess the effects of tocilizumab on pregnancy outcomes in Japanese patients with rheumatic disease.
  
  
  METHODS
  Data from Chugai's tocilizumab safety database (April 2005 to October 2014) were retrospectively analyzed to identify pregnancy outcomes in patients exposed to tocilizumab.
  
  
  RESULTS
  Data were available for 61 pregnancies exposed to tocilizumab, and outcomes were reported for 50 of those pregnancies. In 36 births, no congenital anomalies were identified; however, six neonatal abnormalities were reported: five cases of low birth weight (<2500 g) and one case of neonatal asphyxia. Of 36 births, tocilizumab was resumed during lactation in two patients, with no subsequent adverse events reported in newborns. The spontaneous abortion rate was 18.0% (9 of 50 pregnancies), which is comparable to the rate in the general population. The five terminated pregnancies included one case of caudal regression syndrome.
  
  
  CONCLUSIONS
  The present retrospective study of 61 pregnancies exposed to tocilizumab at conception indicated no increased rates of spontaneous abortion or congenital abnormalities in patients with rheumatic disease. However, further study is necessary to confirm the benefit-risk profile of tocilizumab treatment during pregnancy.
authors.affiliation: a Japan Drug Information Institute in Pregnancy , Tokyo , Japan .|b Department of Pharmaceuticals , National Center for Child Health and Development , Tokyo , Japan .|c Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy , Keio University , Tokyo , Japan .
authors.forename: Ken
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: a Japan Drug Information Institute in Pregnancy , Tokyo , Japan .|d Division of Maternal Medicine, Department of Perinatology , National Center for Child Health and Development , Tokyo , Japan , and.
authors.forename: Omi
authors.initials: O
authors.lastname: Watanabe
authors.affiliation: c Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy , Keio University , Tokyo , Japan .
authors.forename: Mayumi
authors.initials: M
authors.lastname: Mochizuki
authors.affiliation: e Chugai Pharmaceutical , Tokyo , Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Nakasone
authors.affiliation: e Chugai Pharmaceutical , Tokyo , Japan.
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Ishizuka
authors.affiliation: a Japan Drug Information Institute in Pregnancy , Tokyo , Japan .|d Division of Maternal Medicine, Department of Perinatology , National Center for Child Health and Development , Tokyo , Japan , and.
authors.forename: Atsuko
authors.initials: A
authors.lastname: Murashima
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000022:Abortion, Spontaneous / Q000139:chemically induced / Q000453:epidemiology*; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007564:Japan; D008297:Male; D018811:Maternal Exposure; D011247:Pregnancy; D011256:Pregnancy Outcome; D012189:Retrospective Studies; D018570:Risk Assessment
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C502936:tocilizumab
keywords: Abortions; Pregnancy outcome; Rheumatoid arthritis; Tocilizumab