Prospectively-followed pregnancies in patients with inflammatory arthritis taking biological drugs: An Italian multicentre study

Chiara Bazzani, Rossana Scrivo, Laura Andreoli, Elena Baldissera, Martina Biggioggero, Valentina Canti, Maria Gerosa, Irene Pontikaki, Véronique Ramoni, Laura Trespidi, Sonia Zatti, Roberto Caporali, Roberto Gorla, Florenzo Iannone, Andrea Lojacono, Pierluigi Meroni, Carlomaurizio Montecucco, Mario Motta, Maria Grazia Sabbadini, Guido ValesiniAngela Tincani

Research output: Contribution to journalArticlepeer-review


Objective: Information on new drugs does not include their possible effects on pregnancy because pregnant women are excluded from clinical trials. Although not classified as teratogenic in animals, limited data is available on biological anti-rheumatic agents and their safety in human pregnancy. The aim of the study is to evaluate the safety of biological drugs in pregnant patients with chronic arthritis. Methods: Pregnancy outcome and maternal disease variations were prospectively followed in six Italian Rheumatology Centres. Patients exposed to biological agents during the periconceptional period or during pregnancy were included in the study. The occurrence of congenital malformations as well as the obstetric and neonatal outcomes were assessed. Results: Between 1999 and 2013 we identified 79 exposed pregnancies in 67 women affected by different rheumatic diseases with peripheral chronic arthritis. At the time of the start of pregnancy, 56 patients were taking etanercept, 13 adalimumab, 3 infliximab, 2 each certolizumab-pegol and rituximab, 1 each golimumab, anakinra and abatacept. Biological treatment was stopped after a mean of 41 days since documented pregnancy. Live births were reported in 66% of pregnancies. The rate of spontaneous pregnancy loss was 20%. Only one congenital malformation was reported. Conclusion: TNF-alpha inhibitors can be considered safe in the periconception period, representing a possible therapeutic choice also in young women affected by an aggressive form of chronic arthritis and hoping for a pregnancy. Reports of exposure during 2nd/3rd trimester are still limited and suggest caution. Experience with abatacept, tocilizumab, anakinra and rituximab in pregnancy is insufficient.

Original languageEnglish
Pages (from-to)688-693
Number of pages6
JournalClinical and Experimental Rheumatology
Issue number5
Publication statusPublished - 2015


  • Biologic anti-rheumatic drugs
  • Chronic arthritis
  • Pregnancy

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy
  • Medicine(all)


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