
Ustekinumab (Stelara®)
Selected References:
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- American Academy of Pediatrics. 2018. Report of the Committee of Infectious Disease. RedBook. p704.
- Andrulonis R, Ferris LK. 2012 Treatment of severe psoriasis with ustekinumab during pregnancy. J Drugs Dermatol. 11(10):1240.
- Avni-Biron, I.,et al. 2022. Ustekinumab during pregnancy in patients with inflammatory bowel disease: a prospective multicentre cohort study. Alimentary pharmacology & therapeutics, 56(9), 1361–1369.
- Beaulieu D, et al. 2018. Use of Biologic Therapy by Pregnant Women with Inflammatory Bowel Disease does Not affect Infant Response to Vaccines. Clin Gast & Hep; 16:99-105.
- Chaparro Sanchez M, et al. 2022. Live vaccines in children exposed to biological agents for IBD in utero and/or during breastfeeding: Are they safe? Results from the Dumbo registry of GETECCU. United European Gastroenterol J 2022;10:757-8.
- Chugh, R., et al. 2024. Maternal and Neonatal Outcomes in Vedolizumab- and Ustekinumab-Exposed Pregnancies: Results From the PIANO Registry. The American journal of gastroenterology, 119(3), 468–476.
- Ernest-Suarez, K., et al. 2024. Live Rotavirus Vaccination Appears Low-risk in Infants Born to Mothers With Inflammatory Bowel Disease on Biologics. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, S1542-3565(24)00677-3.
- Fitzpatrick, T., et al. 2023. Immunological effects and safety of live rotavirus vaccination after antenatal exposure to immunomodulatory biologic agents: a prospective cohort study from the Canadian Immunization Research Network. The Lancet. Child & adolescent health, 7(9), 648–656.
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- Galluzzo M, et al. 2019. Psoriasis in pregnancy: case series and literature review of data concerning exposure during pregnancy to ustekinumab. J Dermatolog Treat. 2019 Feb;30(1):40-44.
- Gisbert J, Chaparro M. 2020. Safety of New Biologics (Vedolizumab and Ustekinumab) and Small Molecules (Tofacitinib) During Pregnancy: A Review. Drugs 2020 Jul; 80(11):1085-1100.
- Gorodensky, J. H., Bernatsky, S., Afif, W., St-Pierre, Y., Filion, K. B., & Vinet, É. (2023). Assessing Serious Infections in Children Exposed In Utero to Ustekinumab. The Journal of rheumatology, jrheum.2022-1271.
- Gotestam Skorpen C, et al. 2016. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 75:795-810.
- Grosen, A., et al. 2022. Normal Sperm DNA Integrity in Patients With Inflammatory Bowel Disease on Ustekinumab Maintenance Therapy. Inflammatory bowel diseases, 28(10), 1603–1606.
- Jeong, Y. D. et al. 2024. Biologics Use for Psoriasis during Pregnancy and Its Related Adverse Outcomes in Pregnant Women and Newborns: Findings from WHO Pharmacovigilance Study. International archives of allergy and immunology, 1–15.
- Julsgaard, M., et al. 2025. Infant Ustekinumab Clearance, Risk of Infection, and Development After Exposure During Pregnancy. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 23(1), 134–143.
- Klenske E, et al. 2019. Drug Levels in the Maternal Serum, Cord Blood and Breast Milk of a Ustekinumab-Treated Patient with Crohn’s Disease. J Crohns Colitis. 2019 Feb 1;13(2):267-269.
- Lund T and Thomsen SF. 2017. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: a patient series. Dermatologic Therapy 30:e12454.
- Mahadevan U, et al. 2017. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 152(2):451-462.e2.
- Mahadevan U, et al. 2019. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Amer J of Obstetrics and Gynecology. 2019 April; 220(4):308-323.
- Mahadevan, U., et al. 2022. Pregnancy outcomes following periconceptional or gestational exposure to ustekinumab: Review of cases reported to the manufacturer’s global safety database. Alimentary pharmacology & therapeutics, 56(3), 477–490. https://doi.org/10.1111/apt.16960
- Martin PL, et al. 2010. Development in the cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactation. Birth Defects Res B Dev Reprod Toxicol. 89(5):351-363.
- Matro R, et al. 2018. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel disease and effects of breastfeeding on infections and development. Gastroenterology 155;696-704.
- Meserve, J., 2021. Paternal Exposure to Immunosuppressive and/or Biologic Agents and Birth Outcomes in Patients With Immune-Mediated Inflammatory Diseases. Gastroenterology, 161(1), 107–115.e3.
- Meyer, A., et al. 2025. Safety of Vedolizumab and Ustekinumab Compared With Anti-TNF in Pregnant Women With Inflammatory Bowel Disease. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 23(1), 144–153.e22.
- Mitrova, K., et al. 2022. Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study. Journal of Crohn’s & colitis, 16(12), 1808–1815.
- Prentice, R., et al. 2025. Vedolizumab and Ustekinumab Levels in Pregnant Women With Inflammatory Bowel Disease and Infants Exposed In Utero. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 23(1), 124–133.e7
- Rocha K, et al. 2015. Pregnancy during ustekinumab treatment for severe psoriasis. Dermatology; 231:103-104.
- Rosen M, et al. 2012. A case of ustekinumab for the treatment of Crohn’s disease during pregnancy [abstract]. Amer J Gastroenterol. 107(suppl 1):S516.
- Rowan CR, et al. 2018. Ustekinumab drug levels in maternal and cord blood in a woman with Crohn’s Disease treated until 33 weeks of gestation. Journal of Crohn’s and Colitis;376-378
- Sánchez-García, V., et al. 2023. Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta-analysis. Journal of the European Academy of Dermatology and Venereology : JEADV, 37(10), 1971–1990.
- Sheeran C, Nicolopoulos J. 2014. Pregnancy outcomes of two patients exposed to ustekinumab in the first trimester. Australasian J of Dermatology; 55(3);235-236.
- Wils P, et al. 2021. Safety of ustekinumab or vedolizumab in pregnant inflammatory bowel disease patients: a multicentre cohort study. Aliment Pharmacol Ther; 53(4):460-470.
Ustekinumab (Stelara®)
Selected References:
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- Bonthius DJ. 2009. Lymphocytic choriomeningitis virus: a prenatal and postnatal threat. Advances in Pediatrics 56:75-86.
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- Bonthius DJ. 2024. Lymphocytic choriomeningitis virus injures the developing brain: effects and mechanisms. Pediatr Res 95(2):551-557.
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- Olivieri NR, et al. 2024. Transmission, seroprevalence, and maternal-fetal impact of lymphocytic choriomeningitis virus. Pediatr Res; 95(2):456-463.
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- Schulte D, et al. 2006. Congenital lymphocytic choriomeningitis virus: an underdiagnosed cause of neonatal hydrocephalus. The Pediatric Infectious Disease Journal 25(6):560-562.
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Ustekinumab (Stelara®)
Selected References:
- Alder SP and Nigro G. 2013. Prevention of maternal-fetal transmission of cytomegalovirus. Clinical Infectious Diseases 57(S4):S189-S192.
- American College of Obstetricians and Gynecologists. 2015. Practice bulletin no. 151: Cytomegalovirus, parvovirus B19, varicella zoster, and toxoplasmosis in pregnancy. Obstet Gynecol. 125(6):1510-25.
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- Balegamire SJ, et al. 2024. Association Between Maternal Cytomegalovirus Seropositivity, Preterm Birth, and Preeclampsia in Two Cohorts From Quebec, Canada: A Mediation Analysis. Am J Reprod Immunol.;92(4):e13941.
- Barlinn R, et al. 2022. Maternal cytomegalovirus infection and delayed language development in children at 3 years of age–a nested case-control study in a large population-based pregnancy cohort. PLoS ONE 17(12):e0278623.
- Boppana SB et al. 2013. Congenital cytomegalovirus infection: clinical outcome. Clinical Infectious Diseases 57(S4):S178-181.
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- Centers for Disease Control and Prevention (CDC). 2016. Handwashing. Available at: https://www.cdc.gov/handwashing/when-how-handwashing.html.
- Centers for Disease Control and Prevention (CDC). 2018. Cytomegalovirus (CMV) and Congenital CMV Infection. Available at: https://www.cdc.gov/cmv/clinical/features.html.
- Centers of Disease Control and Prevention (CDC). 2020. About cytomegalovirus and congenital CMV infection.
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- Demmler-Harrison GJ, Miller JA. 2020. Houston Congenital Cytomegalovirus Longitudinal Study Group. Maternal cytomegalovirus immune status and hearing loss outcomes in congenital cytomegalovirus-infected offspring. PLoS One.15(10):e0240172.
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- Farsimadan M, Motamedifar, 2021. The effects of human immunodeficiency virus, human papillomavirus, herpes simplex virus-1 and -2, human herpesvirus-6 and -8, cytomegalovirus, and hepatitis B and C virus on female fertility and pregnancy. Br J Biomed Sci;78(1):1-11.
- Feldman DM, et al. 2010. Toxoplasmosis, parvovirus and cytomegalovirus in pregnancy. Clin Lab Med 30(3):709-720.
- Foulon I, et al. 2008. Hearing loss in children with congenital cytomegalovirus infection in relation to maternal trimester in which the maternal primary infection occurred. Pediatrics 122(6):e1123-e1127.
- Fowler KB, et al. 2003. Congenital cytomegalovirus infection. Curr Probl Pediatr Adoles Health Care 33:70-93.
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- Harnprecht K, et al. 2001. Epidemiology of transmission of cytomegalovirus from mother to preterm infant by breastfeeding. Lancet 357:513-8.
- Hughes BL, et al. 2021. Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network. A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. N Engl J Med. 385(5):436-444.
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- National CMV Foundation. 2023. For healthcare providers. Physician and OB-GYN Resources, National CMV Foundation, National CMV Foundation.
- National CMV Foundation. 2023. Possible outcomes. Congenital CMV Outcomes, National CMV Foundation, National CMV Foundation.
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- Nigro G. 2017. Hyperimmune globulin in pregnancy for the prevention of congenital cytomegalovirus disease. Expert Rev Anti Infect Ther 15(11):977-986.
- Nigro G and Alder SP. 2013. Hyerimmuneglobulin for prevention of congenital cytomegalovirus disease. Clinical Infectious Diseases 57(S4):S193-S195.
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Ustekinumab (Stelara®)
Selected References:
- Ackerman JP, et al. 2010. A review of the effects of prenatal cocaine exposure among school-aged children. Pediatrics 125(3):554-565.
- Akyuz N, et al. 2014. Structural brain imaging in children and adolescents following prenatal cocaine exposure: preliminary longitudinal findings. Dev Neurosci. 316-28.
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- Bracken MB, et al. 1990. Association of cocaine use with sperm concentration, motility, and morphology. Fertil Steril 53:315-322
- British Columbia Reproductive Care Program. 1999. Substance Use Guideline 5B: Prenatal Cocaine Exposure, Care of the Newborn. Retrieved from: www.perinatalservicesbc.ca/Documents/Guidelines-Standards/Newborn/CocaineExposureNewbornCareGuideline.pdf.
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- Cone EJ, et al. 1996. Cocaine excretion in the semen of drug users. J Anal Toxicol 20:139-140.
- De Genna, N. M., Goldschmidt, L., & Richardson, G. A. (2022). Prenatal cocaine exposure, early cannabis use, and risky sexual behavior at age 25. Neurotoxicology and teratology, 89, 107060. https://doi.org/10.1016/j.ntt.2021.107060
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- Karpova N, 2021. Prenatal drug exposure and executive function in early adolescence. Neurotoxicology and teratology; 88, 107036.
- Landi N, et al. 2017. Prenatal Cocaine Exposure Impacts Language and Reading Into Late Adolescence: Behavioral and ERP Evidence. Dev Neuropsychol. 42(6):369-386.
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