Safety of Anti-TNF-Alpha Therapy During Pregnancy on Long-term Outcome of Exposed Children: A Controlled, Multicenter Observation

• Published in: Inflammatory bowel diseases Vol. 25; no. 4; pp. 789 - 796
• Main Authors: Duricova, Dana, Dvorakova, Eva, Hradsky, Ondrej, Mitrova, Katarina, Durilova, Marianna, Kozeluhova, Jana, Kohout, Pavel, Zarubova, Kristyna, Bronsky, Jiri, Hradska, Nora, Bronska, Eva, Adamcova, Miroslava, Machkova, Nadezda, Hruba, Veronika, Bortlik, Martin, Lukas, Martin, Malickova, Karin, Lukas, Milan
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 14.03.2019
• Subjects: Adalimumab; Adalimumab - administration & dosage; Allergy; Anti-inflammatory agents; BCG; Case-Control Studies; Child; Child development; Child, Preschool; Cohort Studies; Complications and side effects; Drug therapy; Female; Follow-Up Studies; Gastrointestinal Agents - administration & dosage; Gastrointestinal diseases; Health aspects; Hemophilus infections; Humans; Immunosuppressive agents; Infant; Infants; Infection; Inflammatory bowel diseases; Inflammatory Bowel Diseases - drug therapy; Inflammatory Bowel Diseases - immunology; Infliximab - administration & dosage; Male; Measles-mumps-rubella vaccines; Mothers; Mumps; Necrosis; Pediatricians; Pregnancy; Pregnancy Complications - diagnosis; Pregnancy Complications - drug therapy; Pregnancy Complications - immunology; Pregnant women; Prenatal drug exposure; Prenatal Exposure Delayed Effects - drug therapy; Prenatal Exposure Delayed Effects - immunology; Prognosis; Tumor necrosis factor; Tumor necrosis factor inhibitors; Tumor Necrosis Factor-alpha - antagonists & inhibitors; Tumors; Vaccination; Czech Republic; infections; anti-TNF-alpha; children; inflammatory bowel disease; vaccination
• ISSN: 1078-0998; 1536-4844
• DOI: 10.1093/ibd/izy294

Abstract Background Evidence of the impact of in utero exposure to anti-tumor necrosis factor (TNF)-alpha on long-term childhood development is limited. The aim was to assess the impact of in utero exposure to anti-TNF-alpha due to mothers' inflammatory bowel disease (IBD) on long-term postnatal development of exposed children. Methods We included consecutive children (≥12 months of age) born to mothers with IBD (2007-2016) treated with anti-TNF-alpha during pregnancy in 3 centers in the Czech Republic. A control group was comprised of unexposed children of non-IBD mothers undergoing mandatory check-ups at general pediatricians' offices. Data on perinatal period, psychomotor development, vaccination, infections, antibiotics, and allergy were collected by treating pediatricians using a predefined questionnaire. Results Seventy-two exposed and 69 unexposed children were included (median age, 35 and 50 months, respectively). Exposed children had growth and psychomotor development similar to controls. There was no significant difference in infectious complications within the first year of life (23.9% vs 17.4%; P = 0.36) or during the whole follow-up between exposed infants and controls (P = 0.32). Concomitant immunosuppressants during pregnancy and anti-TNF-alpha levels in cord blood were not associated with elevated infection rate within the first year of life (P > 0.05). Over 95% of exposed children had adequate serologic response to vaccination, except for haemophilus and mumps vaccines. Clinically manifested allergy was similar between the groups (P = 0.98). Conclusions Anti-TNF-alpha exposure in utero does not seem to have a negative impact on postnatal development of children with regard to infectious complications, allergy, growth, or psychomotor development when compared with unexposed children of non-IBD women.