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. 2025 Jun 13:S1542-3565(25)00488-4.
doi: 10.1016/j.cgh.2025.05.012. Online ahead of print.

Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry

Laura Palomino  1 , Marta Velasco Rodríguez-Belvís  2 , María José Casanova  3 , Eduardo Leo-Carnerero  4 , Cristina Calviño-Suárez  5 , Montserrat Rivero  6 , Marta Calvo  7 , María Teresa Arroyo  8 , Agnes Fernández-Clotet  9 , Isabel Pérez-Martínez  10 , Ángeles Masedo González  11 , Vicent Hernández  12 , Alexandra Ruiz-Cerulla  13 , Pilar López Serrano  14 , Pablo Vega  15 , Iago Rodríguez-Lago  16 , Raquel Vicente Lidón  17 , Miguel Ángel De Jorge  18 , Iván Guerra  19 , Lara Arias García  20 , Gema Molina Arriero  21 , Daniel Hervías Cruz  22 , David Busquets  23 , Ana Gutiérrez Casbas  24 , Manuel Van Domselaar  25 , Gemma Valldosera Gomis  26 , Juan María Vázquez Morón  27 , Marta Piqueras Cano  28 , Alfredo J Lucendo  29 , María Dolores Martín Arranz  30 , Patricia Ramírez de la Piscina  31 , María Del Pilar Martínez Tirado  32 , Virginia Robles Alonso  33 , Sandra Marín Pedrosa  34 , Raquel Camargo Camero  35 , Edisa Armesto Gonzalez  36 , Carlos Tardillo Marín  37 , Esther Bernardos Martín  38 , María Carmen Rodríguez Grau  39 , José M Huguet  40 , Lucía Márquez-Mosquera  41 , Pau Sendra Rumbeu  42 , Luis Bujanda  43 , Carlos Castaño-Milla  44 , Empar Sáinz Arnau  45 , Luis Hernández  46 , Laura Ramos  47 , M M Boscá-Watts  48 , Noemí Manceñido Marcos  49 , Miquel Sans  50 , Victor Jair Morales  51 , Diana Acosta  3 , Ana Garre  3 , Rosana Muñoz Codoceo  52 , Alberto García-Salido  52 , Javier P Gisbert  3 , María Chaparro  53 ; DUMBO study group of GETECCU
Collaborators, Affiliations

Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry

Laura Palomino et al. Clin Gastroenterol Hepatol. .

Abstract

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.

Keywords: Biologic; Inflammatory Bowel Disease; Offspring; Pregnancy; Psychomotor Development.

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