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Impact of AntiTumor Necrosis Factor Alpha Antibodies Administered to Pregnant Women With Inflammatory Bowel Disease on Long-term Outcome of Exposed Children

Bortlik, Martin MD, PhD*,†; Duricova, Dana MD, PhD*; Machkova, Nadezda MD*; Kozeluhova, Jana MD; Kohout, Pavel MD§; Hrdlicka, Ludek MD*; Durilova, Marianna MD; Mitrova, Katarina MD; Hradsky, Ondrej MD, PhD; Bronsky, Jiri MD, PhD; Malickova, Karin MD¶,**; Lukas, Milan MD, PhD*,¶,**

doi: 10.1097/01.MIB.0000440984.86659.4f
Original Clinical Articles

Background: Prenatal exposure to anti–tumor necrosis factor α (TNF-α) antibodies seems to be safe for fetal development. Data on long-term outcome of exposed children are missing. Our aim was to assess long-term postnatal development of children exposed to anti–TNF-α during pregnancy.

Methods: Consecutive children aged ≥12 months exposed to anti-TNFs prenatally for maternal inflammatory bowel disease in 3 centers in the Czech Republic were enrolled. Data on psychomotor development, infections, antibiotics, vaccination, and allergy were retrospectively obtained from mothers, treating pediatricians, and children's vaccination cards. Furthermore, standardized laboratory tests on humoral and cellular immunity were performed.

Results: Twenty-five children exposed to biologicals were included (median age, 34 mo; range, 14–70 mo). All children had normal growth, and all but 1 had normal psychomotor development. Majority (80%) experienced at least 1 infection (mainly respiratory), and 60% of infants received antibiotics, 32% of those within the first year of life. Vaccination was undertaken according to vaccination protocol to 23 infants (92%). Fifteen children also had tuberculosis vaccination without serious complication. Immunological investigation was performed with 17 children (68%). Cellular immunity was normal in all infants, and 7 children had mild decrease in IgA and/or IgG immunoglobulins without clinical significance. All children had a detectable serologic response to vaccination.

Conclusions: Exposure to anti–TNF-α antibodies seems to be safe for growth and psychomotor development of children, although clinical significance of relatively high frequency of infections and antibiotic use among infants remains questionable because of the lack of a control group. Continuous follow-up of exposed children is absolutely warranted.

Article first published online 8 January 2014

*IBD Clinical and Research Centre, ISCARE, Charles University, Prague, Czech Republic;

Department of Internal Medicine, Military Hospital, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic;

Department of Internal Medicine, University Hospital Plzen, Plzen, Czech Republic;

§Department of Internal Medicine, Thomayer University Hospital, Prague, Czech Republic;

Department of Paediatrics, 2nd Faculty of Medicine, University Hospital Motol, Charles University, Prague, Czech Republic;

Institute of Medical Biochemistry and Laboratory Diagnostics, 1st Faculty of Medicine, Charles University, Prague, Czech Republic; and

**General University Hospital in Prague, Prague, Czech Republic.

Reprints: Martin Bortlik, MD, PhD, IBD Clinical and Research Centre ISCARE a.s. Jankovcova 1569/2c, Prague, 170 00 Czech Republic (e-mail: mbortlik@seznam.cz).

Supported by the Grant IGA NT14300-3/2013.

The authors have no conflicts of interest to disclose.

Received August 12, 2013

Accepted November 26, 2013

© Crohn's & Colitis Foundation of America, Inc.
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