Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study

Joint Bone Spine. 2017 Mar;84(2):169-173. doi: 10.1016/j.jbspin.2016.03.014. Epub 2016 Jun 22.

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.

Conclusion: Study results suggest that anti-TNFα drugs could be safe when administered during conception/I trimester and following paternal exposure.

Keywords: Ankylosing spondylitis; Anti-TNFα agents; Foetal outcome; Pregnancy; Psoriatic arthritis; Rheumatoid arthritis.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Female
  • Fetal Diseases / chemically induced
  • Humans
  • Middle Aged
  • Pregnancy
  • Pregnancy Outcome
  • Prospective Studies
  • Spondylarthropathies / drug therapy*
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*

Substances

  • Antirheumatic Agents
  • Tumor Necrosis Factor-alpha