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Etanercept (Enbrel®)

Selected References

  • Bazzani C, et al. 2015. Prospectively-followed pregnancies in patients with inflammatory arthritis taking biological drugs: an Italian multicentre study. Clin Exp Rheumatol, 33(5):688-693.
  • Beltagy A, et al. 2021. Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road. Frontiers in pharmacology vol. 12 621247.
  • Berthelsen BG, et al. 2010. Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding. Rheumatology (Oxford), 49:2225-2227.
  • Bertrand K, et al. 2023. The Concentration of Etanercept in Human Milk and Infant Outcomes. The Journal of rheumatology vol 50: 712-714.
  • Brӧms G, et al. 2016. Low risk of birth defects for infants whose mothers are treated with anti-tumor necrosis factor agents during pregnancy. Clinical Gastroenterology and Hepatology, 14(2):234-241.e5.
  • Carman WJ, et al. 2017. Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use. Pharmacoepidemiol Drug Saf, 26:1109-1118.
  • Carter JD, et al. 2009. A safety assessment of tumor necrosis factor antagonists during pregnancy: A review of the Food and Drug Administration Database. The Journal of Rheumatology, 36:3.
  • Carter JD, et al. 2006. Tumor necrosis factor-alpha inhibition and VATER association: a causal relationship. J Rheumatol, 33(5):1014-1017.
  • Chambers CD, et al. 2004. Pregnancy outcome in women exposed to anti-TNF-alpha medications: The OTIS Rheumatoid Arthritis in Pregnancy Study [abstract]. Arthritis Rheum, 50(9):S479-S480.
  • Chambers CD, et al. 2015. Pregnancy outcomes in women exposed to etanercept: the OTIS autoimmune diseases in pregnancy project. Abstract presented at Annual Meeting, Am College of Rheum, San Francisco, CA.
  • Clark, DA. 2010. Anti-TNF_ therapy in immune-mediated subfertility: State of the art. J Reprod Immunol, 85(1):15-24.
  • Dall’ara F, et al. 2016. Safety of anti-TNF alfa agents during pregnancy and breastfeeding: longterm follow up of exposed children in a case-series of mothers with chronic arthritides. Ann Rheum Dis, 75(Suppl 2): 493.
  • Dai F, et al. 2022. TNF-a/anti-TNF-a drugs and its effect on pregnancy outcomes. Expert reviews in molecular medicine vol 24 e26.
  • Dernoncourt A, et al. 2023. Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database. VigiBase. BioDrugs: clinical immunotherapeutics, biopharmaceuticals and gene therapy vol 31: 73-87.
  • Diav-Citrin O, et al. 2014. Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: A prospective, comparative, observational study. Reprod Toxicol, 43:78-84.
  • Food and Drug Administration 2012. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf [Accessed 7/2023].
  • Johnson DL, et al. 2008. Pregnancy outcomes in women exposed to etanercept: The OTIS Autoimmune Diseases in Pregnancy Project [abstract]. Arthritis and Rheumatism, 58(9):S682.
  • Keeling S and Wolbink GJ. 2010. Measuring multiple etanercept levels in the breast milk of a nursing mother with rheumatoid arthritis. J Rheumatol, 37(7):1551.
  • Micu MC, et al. 2014. TNF-alpha inhibitors do not impair sperm quality in males with ankylosing spondylitis after short-term or long-term treatment. Rheumatology (Oxford), 53(7):1250-1255.
  • Ӧnalan G, et al. 2018. Effect of etanercept on the success of assisted reproductive technology in patients with endometrioma. Gynecol Obstet Invest, 83(4):358-364.
  • Orozco C, et al. 2005. Safety of TNF inhibitors during pregnancy in patients with inflammatory arthritis. Abstract presented at 69th Annual Meeting, Am College of Rheum, San Diego, CA, November 13th-17th.
  • Pentsuk N and van der Laan JW. 2009. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol, 86(4):328-344.
  • Romanowska-Prochnicka K et al. 2021. The Role of TNF-a and Anti-TNF-a Agents during Preconception, Pregnancy, and Breastfeeding. International jourinal of mokecular sciences vol.22, 6 2922.
  • Roux CH, et al. 2006. Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-{alpha} therapy. Rheumatology, 46: 695-698.
  • Russell M, et al. 2023. British Society for Rheumatology guideline on prescribing drug in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology vol 62.: e48-e88.
  • Verstappen SM, et al. 2011. BSRBR Control Centre Consortium, BSR Biologics Register. Concise report: anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register. Ann Rheum Dis, 70(5): 823-826.
  • Villiger PM, et al. 2010. Effects of TNF antagonists on sperm characteristics in patients with spondyloarthritis. Ann Rheum Dis, 69(10): 1842-1844.
  • Viktil KK, et al. 2012. Outcomes after anti-rheumatic drug use before and during pregnancy: a cohort study among 150 000 pregnant women and expectant fathers. Scandinavian Journal of Rheumatology, 41(3): 196-201.
  • Vinet E, et al. 2018. Serious infections in rheumatoid arthritis offspring exposed to tumour necrosis factor alpha inhibitors: A cohort study. Arthr Rheumatol, 70(10):1565-1571.
  • Weber-Schoendorfer C, et al. 2015. Pregnancy outcome after TNF-alpha inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol, 80(4): 727-739.

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