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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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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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