The safety of drugs for inflammatory bowel disease during pregnancy and breastfeeding: the DUMBO registry study protocol of GETECCU
EntityUAM. Departamento de Farmacología; UAM. Departamento de Medicina
PublisherSage Publications Ltd
10.1177/17562848211018097Therapeutic Advances In Gastroenterology 14 (2021): 17562848211018097
Funded byThe authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this work was funded by a grant from the Instituto de Salud Carlos III [grant number ICI9/00083]. Co-funded by FEDER funds
Subjectsanti-TNF; biological agents; breastfeeding; immunosuppressants; inflammatory bowel disease; pregnancy; tofacitinib; ustekinumab; vedolizumab; Medicina
Rights© The Author(s), 2021
Esta obra está bajo una licencia de Creative Commons Reconocimiento-NoComercial 4.0 Internacional.
Background: Active disease during conception and pregnancy in women with inflammatory bowel disease (IBD) increases the risk of pregnancy complications and adverse neonatal outcomes. The use of IBD treatments during pregnancy should be weighed against their adverse effects on the neonate, but longer-term safety data and data on serious infection rates and malignancies postnatally are lacking, particularly for newer drugs, such as tofacitinib, vedolizumab and ustekinumab. Methods: This ongoing, prospective registry study being conducted at 70 centres in Spain is enrolling pregnant women who are ⩾18 years, are at any point in pregnancy up to the end of the second trimester and have a diagnosis of Crohn’s disease, ulcerative colitis or unclassified IBD. Patients will receive treatment decided independently by their IBD specialist. Each incident gestation will be followed up through pregnancy and the first 4 years postnatally. Three cohorts will be compared: biologicals exposed, immunomodulatory exposed and non-exposed. The primary endpoint is the risk of severe infection in newborns postnatally up to 4 years of age; other endpoints include serious adverse events (SAEs) such as pregnancy and delivery complications, neonatal SAEs, development [Ages and Stages Questionnaire-3 (ASQ3)], and malignancy incidence, up to 4 years of age. IBD specialists will collect maternal data (baseline/end of each trimester/1 month post-delivery), neonatal birth data, and the SAE and ASQ3 data in children exposed during pregnancy, reported every 3 months by the mother. Statistical analysis will include summary statistics for quantitative variables, comparisons of qualitative variables with significance set at p < 0.025 and a binary logistic regression model to determine the risk factors for severe infections. Results: Enrolment began in September 2019 and study completion is expected in September 2028. Conclusions: This prospective, controlled study will provide evidence on the long-term safety profile in children after intrauterine and lactation exposure to biological and immunomodulatory IBD treatments, including data on postnatal severe infections, development and malignancies. ClinicalTrials.gov identifier: NCT03894228
Files in this item
Google Scholar:Chaparro Sánchez, María - Donday, María G. - Abad Santos, Francisco - Martín de Carpi, Francisco Javier - Maciá-Martínez, Miguel Ángel - Montero, Dolores - Acosta, Diana - Brenes, Yanire - Pérez Gisbert, Francisco Javier
This item appears in the following Collection(s)
Showing items related by title, author, creator and subject.
Inflammatory bowel disease integral care units: Evaluation of a nationwide quality certification programme. The GETECCU experience
EpidemIBD: rationale and design of a large-scale epidemiological study of inflammatory bowel disease in Spain Chaparro Sánchez, María; Barreiro-de Acosta, Manuel; Benítez, José Manuel; Cabriada, José Luis; Casanova, María José; Ceballos, Daniel; Esteve, María; Fernández, Hipólito; Ginard, Daniel; Gomollón, Fernando; Lorente, Rufo; Nos, Pilar; Riestra, Sabino; Rivero, Montserrat; Robledo, Pilar; Rodríguez, Cristina; Sicilia, Beatriz; Torrella, Emilio; Garre, Ana; García García-Esquinas, Esther; Rodríguez Artalejo, Fernando; Gisbert, Javier P.
Differential Effects of Anti-TNFα and Anti-α4β7 Drugs on Circulating Dendritic Cells Migratory Capacity in Inflammatory Bowel Disease Soleto, Irene; Fernández-Tomé, Samuel; Mora-Gutiérrez, Irene; Baldan-Martin, Montserrat; Ramírez, Cristina; Santander Vaquero, Cecilio; Moreno-Monteagudo, José Andrés; Casanova, María José; Casals, Fernando; Casabona, Sergio; Becerro, Irene; Chaparro Sánchez, María; Bernardo, David; Pérez Gisbert, Francisco Javier