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Ustekinumab (Stelara®)

Selected References:  

  • Alsenaid A, Prinz JC. 2016. Inadvertent pregnancy during ustekinumab therapy in a patient with plaque psoriasis and impetigo herpetiformis. J Eur Acad Dermatol Venereol. 30(3):488-90.  
  • 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. 
  • Fotiadou C, et al. 2012. Spontaneous abortion during ustekinumab therapy. J Dermatol Case Rep. 6(4):105-107.Galli-Novak E, et al. 2016. Successful pregnancy outcome under prolonged ustekinumab treatment in a patientwith Crohn’s disease and paradoxical psoriasis. J Eur Acad Dermatol Venereol. 30(12):e191-e192.   
  • 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. 

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