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DOP52 Safety of Inflammatory Bowel Disease drugs during pregnancy and breastfeeding: Mothers and babies’ outcomes (DUMBO registry)

Chaparro, M.(1);García Donday, M.(1);Calviño Suarez, C.(2);Rubio, S.(3);Figueira, M.(4);Pérez Martínez, I.(5);Leo Carnerero, E.(6);Rodríguez Lago, I.(7);Ruiz Cerulla, A.(8);Aguas, M.(9);López Serrano, P.(10);Ramírez de la Piscina Urraca, P.(11);Rivero, M.(12);Suarez Ferrer, C.(13);Alfambra Cabrejas, E.(14);Armesto, R.(15);Diz-Lois Palomares, M.T.(16);Guerra, I.(17); Vázquez Morón, J.M.(18); Casanova, M.J.(1);Hervías Cruz, D.(19); Huguet, J.M.(20); de Jorge Turrión, M.Á.(21); Marín Pedrosa, S.(22);Molina Arriero, G.(23);Ramos, L.(24);Zúñiga de Mora-Figueroa, B.(25);Camargo Camero, R.(26);Fernández-Clotet, A.(27);Gutiérrez Casbas, A.(28);Martínez Montiel, P.(29);Rodríguez Insa, R.(30);Sendra Rumbeu, P.(31);Tardillo Marín, C.(32);Vicente Lidón, R.(33);Arias García, L.(34);Bujanda, L.(35);Lucendo, A.J.(36);Manceñido Marcos, N.(37);Gisbert, J.P.(1)

(1)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IIS-IP- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBEREHD, Gastroenterology Unit, Madrid, Spain;(2)Complexo Hospitalario Universitario de Santiago de Compostela, Gastroenterology Unit, Santiago de Compostela, Spain;(3)Complejo Hospitalario Universitario de Navarra, Gastroenterology Unit, Pamplona, Spain;(4)Xerencia Xestión Integrada de Vigo- SERGAS. Grupo de Investigación de Patología Digestiva. Instituto de Investigación Sanitaria Galicia Sur IIS Galicia Sur. SERGAS UVIGO, Gastroenterology Unit, Vigo, Spain;(5)Hospital Universitario Central de Asturias e Instituto de Investigación Sanitaria del Principado de Asturias ISPA, Gastroenterology Unit, Oviedo, Spain;(6)Hospital Universitario Virgen del Rocío, Gastroenterology Unit, Sevilla, Spain;(7)Hospital de Galdakao-Usansolo, Gastroenterology Unit, Vizcaya, Spain;(8)Hospital Universitario de Bellvitge, Gastroenterology Unit, Barcelona, Spain;(9)Hospital Universitario y Politécnico La Fe and CIBEREHD, Gastroenterology Unit, Valencia, Spain;(10)Hospital Universitario Fundación Alcorcón, Gastroenterology Unit, Madrid, Spain;(11)Hospital Universitario de Álava, Gastroenterology Unit, Álava, Spain;(12)Hospital Universitario Marqués de Valdecilla e IDIVAL, Gastroenterology Unit, Santander, Spain;(13)Hospital Universitario La Paz, Gastroenterology Unit, Madrid, Spain;(14)Hospital Clínico Universitario Lozano Blesa and Fundación del Instituto de Investigación Sanitaria de Aragón IIS Aragón and CIBEREHD, Gastroenterology Unit, Zaragoza, Spain;(15)Complexo Hospitalario Universitario de Ourense, Gastroenterology Unit, Ourense, Spain;(16)Complexo Hospitalario Universitario de A Coruña, Gastroenterology Unit, A Coruña, Spain;(17)Hospital Universitario de Fuenlabrada e Instituto de Investigación Hospital Universitario La Paz IdiPAZ, Gastroenterology Unit, Madrid, Spain;(18)Hospital Universitario Juan Ramón Jiménez, Gastroenterology Unit, Huelva, Spain;(19)Hospital General Universitario de Cuidad Real, Gastroenterology Unit, Cuidad Real, Spain;(20)Hospital General Universitario de Valencia, Gastroenterology Unit, Valencia, Spain;(21)Hospital Universitario de Cabueñes, Gastroenterology Unit, Gijón, Spain;(22)Hospital Universitario Reina Sofía, Gastroenterology Unit, Córdoba, Spain;(23)Complejo Hospitalario Universitario de Ferrol, Gastroenterology Unit, A Coruña, Spain;(24)Hospital Universitario de Canarias, Gastroenterology Unit, Tenerife, Spain;(25)Hospital Clínico Universitario San Cecilio, Gastroenterology Unit, Granada, Spain;(26)Hospital Universitario Virgen de La Victoria, Gastroenterology Unit, Málaga, Spain;(27)Hospital Universitario Clìnic i Provincial and CIBEREHD, Gastroenterology Unit, Barcelona, Spain;(28)Hospital General Universitario de Alicante- CIBERehd and Instituto de Investigación Sanitaria y Biomédica de Alicante ISABIAL, Gastroenterology Unit, Alicante, Spain;(29)Hospital Universitario 12 de Octubre, Gastroenterology Unit, Madrid, Spain;(30)Hospital General Universitario de Castellón, Gastroenterology Unit, Castellón, Spain;(31)Hospital Universitario Son Espases, Gastroenterology Unit, Palma de Mallorca, Spain;(32)Hospital Universitario Nuestra Señora de Candelaria, Gastroenterology Unit, Tenerife, Spain;(33)Hospital Universitario Miguel Servet, Gastroenterology Unit, Zaragoza, Spain;(34)Hospital Universitario de Burgos, Gastroenterology Unit, Burgos, Spain;(35)Instituto Biodonostia- Universidad del País Vasco UPV/EHU y CIBEREHD, Gastroenterology Unit, Guipúzcoa, Spain;(36)Hospital General de Tomelloso. Instituto de Investigación Sanitaria Princesa IIS-IP. CIBEREHD, Gastroenterology Unit, Ciudad Real, Spain;(37)Hospital Universitario Infanta Sofía, Gastroenterology Unit, Madrid, Spain; on behalf of DUMBO study group

Background

Prospective registries are necessary to evaluate the safety of inflammatory bowel disease (IBD) treatment during pregnancy and in children in the long term.

Aims: The overall aim of DUMBO registry is to know the risk of serious adverse events (SAEs) during pregnancy and in children up to 4 years of age exposed during pregnancy to drugs for IBD (mainly focused on biologics), compared to unexposed children. In this analysis we aim to evaluate the risk of SAEs during pregnancy and the predictive factors of it (mainly focused on IBD drugs).

Methods

Prospective, observational and multicentre registry, which enrols pregnant women with IBD (Crohn’s disease, ulcerative colitis, IBD-unclassified) over 5 years in 70 centres in Spain. The registry was kicked off in September 2019. SAE was defined based on “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting by European Medicines Agency”. Study protocol is summarized in figure 1.

Results

433 women have been included so far; 241 got pregnant at least 9 months before this interim analysis (table 1).


Mean age was 34 years, and 17% of women had active disease at any time during pregnancy. 23% of pregnancies were exposed to immumodulators (thiopurines), 25% to biologics and 10% to combo therapy (biologics and immunomodulators). 85 pregnancies (35%) were exposed to biologics (60 anti-TNF, 17 ustekinumab, and 8 vedolizumab) either in combo or in monotherapy. There were 237 newborns (227 singleton and 5 pair of twins), 9 miscarriages and 1 abortion. 72% of patients had vaginal delivery and 28% C-sections (18% due to perianal CD or active disease). A total of 59 pregnancies (24.5%) reported at least one SAE: 32% in exposed to biologics and 20.5% in non-exposed group (p>0.05) (figure 2).



Four out of 17 pregnancies exposed to ustekinumab and 3 out of 8 exposed to vedolizumab had SAEs (non-related with the drug). In the multivariate analysis, adjusted by disease activity, in comparison with no immunosuppressive treatment, neither immunosuppressants [Odds ratio (OR)=1.1, 95% confidence interval (CI)=0.3-4.3] nor biologics in monotherapy or in combo (OR=0.8; 95%CI=0.2-3) were associated with higher risk of SAEs. 40 patients (17%) were hospitalised due to complications during pregnancy or delivery (figure 3).




Two patients underwent surgery during pregnancy due to IBD complications

Conclusion

IBD treatment (either immunomodulators or biologics) does not increase the risk of SAEs during pregnancy. Nevertheless, one-quarter of IBD women suffer SAEs during pregnancy and about 20% need hospitalisation, which should be taken into account when managing IBD during pregnancy.

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