Pregnancy and Foetal Outcomes Following Anti-Tumor Necrosis Factor Alpha Therapy: A Prospective Multicentre Study

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 (TNF alpha) 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-TNF alpha, disease activity, DMARD therapy, pregnancy/foetal outcomes were registered.Results: Twenty-four/38 (71.1%) pregnancies were exposed to anti-TNF alpha 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-TNF alpha antagonists. No congenital malformations were found in connection to paternal exposure.Conclusion: Study results suggest that anti-TNF alpha drugs could be safe when administered during conception/I trimester and following paternal exposure. (C) 2016 Societe francaise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.