Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry
Laura Palomino1, Marta Velasco Rodríguez-Belvís1, María José Casanova2
1Hospital Infantil Universitario Niño Jesús and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain.
Insights
Biologic treatment for inflammatory bowel disease (IBD) during pregnancy and lactation does not negatively impact infant psychomotor development. This study found no adverse effects on infant development from maternal IBD biologic exposure.
Area of Science:
- Pediatrics
- Gastroenterology
- Immunology
Background:
- Limited data exists on the impact of biologic therapies for inflammatory bowel disease (IBD) during pregnancy and lactation on infant psychomotor development.
- Investigating this impact is crucial for guiding treatment decisions in pregnant and breastfeeding IBD patients.
Purpose of the Study:
- To evaluate the effect of in utero or breastfeeding exposure to biologics on infant psychomotor development during the first year of life.
- To assess the safety of maternal IBD biologic use for infant neurodevelopment.
Main Methods:
- Prospective observational registry (DUMBO) of pregnant women with IBD across 60 Spanish centers.
- Infant psychomotor development assessed using the Ages and Stages Questionnaire 3rd edition (ASQ-3) at 12 months.
- Comparison of ASQ-3 scores between infants exposed and unexposed to biologics.
Main Results:
- No significant negative impact on overall psychomotor development (ASQ-3 total scores) or gross motor skills was observed in infants exposed to biologics.
- Infants exposed to biologics showed similar or better ASQ-3 scores compared to unexposed infants.
- Preterm birth and maternal ulcerative colitis were associated with an increased risk of abnormal ASQ-3 scores, not biologic exposure.
Conclusions:
- Maternal exposure to biologics for IBD during pregnancy or breastfeeding does not adversely affect infant psychomotor development.
- The findings support the continued use of biologic therapies in pregnant and breastfeeding women with IBD.
- Further research may explore long-term neurodevelopmental outcomes.
Background & Aims:
The impact of biologic treatment for inflammatory bowel disease (IBD) during pregnancy and lactation on infant psychomotor development is barely studied. We investigated the effect of exposure to biologics in utero or during breastfeeding on the psychomotor development of offspring during their first year.
Methods:
The study included patients and infants from DUMBO, an ongoing prospective, observational registry of GETECCU enrolling pregnant women (aged ≥18 years) with IBD from 60 centers across Spain. Mothers were followed up at each trimester during pregnancy and after delivery. Psychomotor development of infants was assessed using the Spanish version of the Ages and Stages Questionnaire 3rd edition (ASQ-3) during the first year of life. An ASQ-3 score below the normal limit in any domain was considered abnormal.
Results:
In total, 352 children born to 343 women were assessed; 134 infants (38.1%) were exposed to biologics during pregnancy and 80 (22.7%) during lactation, including 5 who were exclusively breastfed. At 12 months, the proportions of infants with normal ASQ-3 total scores (86% vs 74%; P = .031) and normal gross motor domain scores (91% vs 81%; P = .033) were significantly higher in the biologics-exposed vs nonexposed subgroups. Multivariate analysis revealed that preterm birth (odds ratio, 0.3; 95% confidence interval, 0.1-0.6) and maternal ulcerative colitis (odds ratio, 0.5; 95% confidence interval, 0.3-0.9) were associated with an increased risk of abnormal ASQ-3. Other variables, including exposure to biologics in utero, had no impact on ASQ-3 scores at month 12.
Conclusions:
Exposure to biologics for IBD in utero or during breastfeeding has no negative impact on psychomotor development in infants.
Gov, Number:
NCT03894228.
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