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MotherToBaby

Medications and More during pregnancy and breastfeeding

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): 1730. 
  • 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): 316-327. 
  • 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):1014-1017. 
  • Chambers CD, et al. 2019. Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study. PLoS One 14 (10)  e0223603. 
  • 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.  
  • Flatman LK, et al. 2025 Serious Infections in Offspring Exposed to Tumour Necrosis Factor Inhibitors During Pregnancy: Comparison of Timing During Pregnancy and Placental Transfer Ability. Arthritis Rheumatol.  
  • Fritzsche J, et al. 2012. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol; 46:718-719.  
  • 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): 485-495. 
  • 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. 
  • Huang W, et al. 2024. Anti-tumor necrosis factor-α therapy may not be safe during pregnancy in women with inflammatory bowel disease: an updated meta-analysis and systematic review. BMC Pregnancy Childbirth. 2024;24(1):251.  
  • Jeong YD, et al. 2025. Biologics Use for Psoriasis during Pregnancy and Its Related Adverse Outcomes in Pregnant Women and Newborns: Findings from WHO Pharmacovigilance Study. Int Arch Allergy Immunol. 186(6):579-593.  
  • 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):597-598.  
  • 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): 1040-1053. 
  • 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):505-509. 
  • Liu Q, et al. 2025. Abortion adverse events associated with adalimumab, etanercept, ustekinumab, and dupilumab during pregnancy: A pharmacovigilance study based on FDA adverse event reporting system. Drug Discov Ther. 2025;19(3):160-173.  
  • 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):1669-1677. 
  • Mahadevan U, et al. 2014. Achievement of developmental milestones among offspring of women with inflammatory bowel disease: the PIANO registry. Gastroenterology 146(5):1. 
  • 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. 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):1250-1255.  
  • 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. Biologics for inflammatory bowel disease and their safety in pregnancy: a systematic review and meta-analysis. Clinical Gastroenterology and Hepatology. 20(1): 74-87. 
  • Palomino L, et al. 2025. Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry. Clin Gastroenterol Hepatol. Online ahead of print.  
  • 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):359-365.  
  • Roux CH, et al. 2006. Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-{alpha} therapy. Rheumatology 46:695-698. Rüegg L, et al. 2025. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025;84(6):910-926.  
  • Russell MD, et al. 2023. British 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. 72:529–556. 
  • 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):1846-1854. 
  • 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): 979-988. 
  • Smith CH, et al. 2020. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: A rapid update. Br J Dermatol. 183:628–637. 
  • 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):785-791. 
  • 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. 
  • 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. 

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