MotherToBaby

Medications and More during pregnancy and breastfeeding

Search

866.626.6847

Adalimumab (Humira®)

Selected References:

  • Akiyama S, et al. 2023. Pregnancy and medications for inflammatory bowel disease: An updated narrative review. World Journal of Clinical Cases, 11(8):
  • Ben-Horin S, et al. 2010. Adalimumab level in breast milk of a nursing mother. Clin Gastroenterol Hepatol;8:475-6.
  • Burmester GR, et al. 2017. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 76(2):414-417.
  • Bröms G, et al. 2016. Low risk of birth defects for infants whose mothers are treated with anti-tumor necrosis factor agents during pregnancy. Clin Gastroenterol Hepatol 14(2):234-241.
  • Bröms G, et al. 2020. Anti‐TNF treatment during pregnancy and birth outcomes: a population‐based study from Denmark, Finland, and Sweden. Pharmacoepidemiology and Drug Safety. 29(3): 316-27.
  • Beaulieu DB, et al. 2018. Use of biologic therapy by pregnant women with inflammatory bowel disease does not affect infant response to vaccines. Clin Gastroenterol Hepatol. 16: 99-105.
  • 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):1014-7.
  • Chambers CD, et al. 2019. Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study. PLoS One 14 (10)
  • Chaparro M, et al. 2018. Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter European TEDDY Study. Am J Gastroenterol. 113: 396–403
  • Clark DA. 2010. Anti-TNFalpha therapy in immune-mediated subfertility: state of the art. J Reprod Immunol. 85(1):15-24.
  • Cooley LF, et al. 202. Anti-TNF agents and potential effects on male fertility: are men being counseled?.” BMC urology.20: 1-6.
  • 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.
  • Fritzsche J, et al. 2012. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol; 46:718-9.
  • Götestam 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.
  • Hart A, et al. 2022. Observational data from adalimumab post‐marketing PYRAMID registry of patients with Crohn’s disease who became pregnant: A post hoc analysis. United European Gastroenterology Journal. 10(5): 485-95.
  • Hoxha A, et al. 2017. Pregnancy and feotal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicenter study. Joint Bone Spine 84(2):169-173.
  • Johansen CB, et al. 2018. The use and safety of TNF inhibitors during pregnancy in women with psoriasis: A review. Int J Mol Sci. 19(5):1349
  • Julsgaard M, et al. 2013. Adalimumab levels in an infant. J Crohns Colitis;7(7):597-8.
  • Kawai Y, et al. 2019. Pregnancy outcomes of patients exposed to adalimumab in Japan. Dig Dis 37(2): 123-130.
  • Laube R, et al. 2023. Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breast feeding. Gut 72(6): 1040-53.
  • Leung Y, et al. 2014. Management of the pregnant inflammatory bowel disease patient on anti-tumor necrosis factor: state of the art and future directions. Can J Gastroenterol Hepatol; 28(9):505-9.
  • Lund T, et al. 2016. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: A patient series. Derm Therapy. May; 30 (3)
  • Luu M, et al. 2018. Continuous anti-TNFα use throughout pregnancy: possible complications for the mother but not for fetus. A retrospective cohort on the French National Health Insurance Database (EVASION). ACG, 113(11):1669-77.
  • Mahadevan U, et al. 2014. Achievement of developmental milestones among offspring of women with inflammatory bowel disease: the PIANO registry. Gastroenterology146(5):1.
  • Mahadevan U, et al. 2019. Inflammatory bowel disease in pregnancy clicinal care pathway: A report from the American Gastroenterological Association IBD parenthood project working group. Gastroenterology 156:1508-1524
  • Matro R, et al. 2018. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology 155:696-704
  • 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). Jul;53(7):1250-5.
  • Mishkin DS, et al. 2006. Successful use of adalimumab (Humira) for Crohn’s disease in pregnancy. Inflamm Bowel Dis. 12:827-828.
  • Nielsen O, et al. 2022. Bilogics for inflammatory bowel disease and their safety in pregnancy: a systematic review and meta-analysis. Clinical Gastroenterology and Hepatology. 20(1): 74-87.
  • Picardo S, et al. 2019. A pharmacological approach to managing inflammatory bowel disease during conception, pregnancy and breastfeeding: Biologic and oral small molecule therapy. Drugs 79:1053-1063.
  • Ramonda R, et al. 2014. Influence of tumor necrosis factor alpha inhibitors on testicular function and semen in spondyloarthritis patients. Fertil Steril; 101(2):359-65.
  • Roux CH, et al. 2006. Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-{alpha} therapy. Rheumatology 46:695-698.
  • Russell MD, et al. 2023. Brtish Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology. 62: e48–88.
  • Sammaritano LR, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 72:529–56.
  • Schnitzler F et al. 2011. Outcome of pregnancy in women with inflammatory bowel disease treated with antitumor necrosis factor therapy. Inflamm Bowel Dis. 17(9):1846-54.
  • Shihab Z, et al. 2016. Anti-tumour necrosis factor α therapies and inflammatory bowel disease pregnancy outcomes: a meta-analysis. Journal of Crohn’s and Colitis. 10(8): 979-88.
  • Smith CH, et al. 2020. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: A rapid update. Br J Dermatol. 183:628–37.
  • Truta B, et al. 2022. Outcomes of Continuation vs Discontinuation of Adalimumab Therapy During Third Trimester of Pregnancy in Inflammatory Bowel Disease. Gastro Hep Advances. 1(5):785-91.
  • Villiger PM, et al. 2010. Effects of TNF antagonists on sperm characteristics in patients with spondyloarthritis. Ann Rheum Dis 69(10): 1842-4.
  • 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
  • Wang H, et al. 2022. Comparative safety of infliximab and adalimumab on pregnancy outcomes of women with inflammatory bowel diseases: a systematic review & meta-analysis. BMC Pregnancy and Childbirth. 22(1): 1-10.
  • Weber-Schoendorfer C, et al. 2015. Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol.
  • Winger EE et al., 2011. Birth defect rates in women using adalimumab (Humira®) to treat immunologic-based infertility in IVF patients. Am J Reprod Immunol. 66(3):237-41.
  • Yeung J, et al. 2020. Management of plaque psoriasis with biologic therapies in women of child-bearing potential consensus paper. J Cutan Med Surg. 24(1) 3S–14S.

This website is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $6,000,000 with zero percentage financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, HRSA, HHS, or the U.S. Government.