782
Views
9
CrossRef citations to date
0
Altmetric
Drug Safety Evaluations

How safe is infliximab therapy during pregnancy and lactation in inflammatory bowel disease?

, MD PhD &

Bibliography

  • Moffatt DC, Bernstein CN. Drug therapy for inflammatory bowel disease in pregnancy and the puerperium. Best Pract Res Clin Gastroenterol 2007;21(5):835-47
  • Mottet C, Juillerat P, Pittet V, et al. Pregnancy and breastfeeding in patients with Crohn’s disease. Digestion 2007;76(2):149-60
  • Habal FM, Ravindran NC. Management of inflammatory bowel disease in the pregnant patient. World J Gastroenterol 2008;14(9):1326-32
  • Ferguson CB, Mahsud-Dornan S, Patterson RN. Inflammatory bowel disease in pregnancy. Bmj 2008;337:a427
  • Habal FM, Kapila V. Inflammatory bowel disease and pregnancy: evidence, uncertainty and patient decision-making. Can J Gastroenterol 2009;23(1):49-53
  • Vermeire S, Carbonnel F, Coulie PG, et al. Management of inflammatory bowel disease in pregnancy. J Crohns Colitis 2012;6(8):811-23
  • Van Assche G, Dignass A, Reinisch W, et al. The second European evidence-based Consensus on the diagnosis and management of Crohn’s disease: special situations. J Crohns Colitis 2010;4(1):63-101
  • van der Woude CJ, Kolacek S, Dotan I, et al. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis 2010;4(5):493-510
  • Gisbert JP, Chaparro M. Safety of anti-TNF agents during pregnancy and breastfeeding in women with inflammatory bowel disease. Am J Gastroenterol 2013;108(9):1426-38
  • Mahadevan U, Cucchiara S, Hyams JS, et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn’s and Colitis Organisation: pregnancy and pediatrics. Am J Gastroenterol 2011;106(2):214-23; quiz 24
  • Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis 2010;16(5):881-95
  • Chaparro M, Gisbert JP. Transplacental transfer of immunosuppressants and biologics used for the treatment of inflammatory bowel disease. Curr Pharm Biotechnol 2011;12(5):765-73
  • Cornillie F, Shealy D, D’Haens G, et al. Infliximab induces potent anti-inflammatory and local immunomodulatory activity but no systemic immune suppression in patients with Crohn’s disease. Aliment Pharmacol Ther 2001;15(4):463-73
  • Sandborn WJ, Feagan BG, Hanauer SB, et al. An engineered human antibody to TNF (CDP571) for active Crohn’s disease: a randomized double-blind placebo-controlled trial. Gastroenterology 2001;120(6):1330-8
  • Sandborn WJ, Hanauer SB, Katz S, et al. Etanercept for active Crohn’s disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2001;121(5):1088-94
  • Rutgeerts P, Van Assche G, Vermeire S. Optimizing anti-TNF treatment in inflammatory bowel disease. Gastroenterology 2004;126(6):1593-610
  • Baert FJ, D’Haens GR, Peeters M, et al. Tumor necrosis factor alpha antibody (infliximab) therapy profoundly down-regulates the inflammation in Crohn’s ileocolitis. Gastroenterology 1999;116(1):22-8
  • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002;359(9317):1541-9
  • Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn’s disease. N Engl J Med 1999;340(18):1398-405
  • Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn’s disease. N Engl J Med 2004;350(9):876-85
  • Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353(23):2462-76
  • Reinisch W, Sandborn WJ, Rutgeerts P, et al. Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies. Inflamm Bowel Dis 2012;18(2):201-11
  • Järnerot G, Hertervig E, Friis-Liby I, et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology 2005;128(7):1805-11
  • Laharie D, Bourreille A, Branche J, et al. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet 2012;380(9857):1909-15
  • Saji F, Samejima Y, Kamiura S, Koyama M. Dynamics of immunoglobulins at the feto-maternal interface. Rev Reprod 1999;4(2):81-9
  • Takizawa T, Anderson CL, Robinson JM. A novel Fc gamma R-defined, IgG-containing organelle in placental endothelium. J Immunol 2005;175(4):2331-9
  • Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol 2009;86(4):328-44
  • Malek A. Ex vivo human placenta models: transport of immunoglobulin G and its subclasses. Vaccine 2003;21(24):3362-4
  • Israel EJ, Simister N, Freiberg E, et al. Immunoglobulin G binding sites on the human foetal intestine: a possible mechanism for the passive transfer of immunity from mother to infant. Immunology 1993;79(1):77-81
  • Gurevich P, Elhayany A, Ben-Hur H, et al. An immunohistochemical study of the secretory immune system in human fetal membranes and decidua of the first trimester of pregnancy. Am J Reprod Immunol 2003;50(1):13-19
  • Stephens P, Nesbitt A, Foulkes R. Placental transfer of the anti-TNF antibody TN3 in rats: comparison of immunoglobulin G1 and pegylated Fab versions. Gut 2006;55(Suppl):A8
  • Hou JK, Mahadevan U. A 24-year-old pregnant woman with inflammatory bowel disease. Clin Gastroenterol Hepatol 2009;7(9):944-7
  • Vasiliauskas EA, Church JA, Silverman N, et al. Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol 2006;4(10):1255-8
  • Kane S, Ford J, Cohen R, Wagner C. Absence of infliximab in infants and breast milk from nursing mothers receiving therapy for Crohn’s disease before and after delivery. J Clin Gastroenterol 2009;43(7):613-16
  • Steenholdt C, Al-Khalaf M, Ainsworth MA, Brynskov J. Therapeutic infliximab drug level in a child born to a woman with ulcerative colitis treated until gestation week 31. J Crohns Colitis 2012;6(3):358-61
  • Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013;11(3):286-92; quiz e24
  • Zelinkova Z, van der Ent C, Bruin KF, et al. Effects of discontinuing anti-tumor necrosis factor therapy during pregnancy on the course of inflammatory bowel disease and neonatal exposure. Clin Gastroenterol Hepatol 2013;11(3):318-21
  • Mahadevan U, Kane S, Sandborn WJ, et al. Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn’s disease. Aliment Pharmacol Ther 2005;21(6):733-8
  • Srinivasan R. Infliximab treatment and pregnancy outcome in active Crohn’s disease. Am J Gastroenterol 2001;96(7):2274-5
  • Burt MJ, Frizelle FA, Barbezat GO. Pregnancy and exposure to infliximab (anti-tumor necrosis factor-alpha monoclonal antibody). J Gastroenterol Hepatol 2003;18(4):465-6
  • Katz JA, Antoni C, Keenan GF, et al. Outcome of pregnancy in women receiving infliximab for the treatment of Crohn’s disease and rheumatoid arthritis. Am J Gastroenterol 2004;99(12):2385-92
  • Tursi A. Effect of intentional infliximab use throughout pregnancy in inducing and maintaining remission in Crohn’s disease. Dig Liver Dis 2006;38(6):439-40
  • Stengel JZ, Arnold HL. Is infliximab safe to use while breastfeeding? World J Gastroenterol 2008;14(19):3085-7
  • Angelucci E, Cocco A, Viscido A, Caprilli R. Safe use of infliximab for the treatment of fistulizing Crohn’s disease during pregnancy within 3 months of conception. Inflamm Bowel Dis 2008;14(3):435-6
  • Correia LM, Bonilha DQ, Ramos JD, et al. Inflammatory bowel disease and pregnancy: report of two cases treated with infliximab and a review of the literature. Eur J Gastroenterol Hepatol 2010;22(10):1260-4
  • Aratari A, Margagnoni G, Koch M, Papi C. Intentional infliximab use during pregnancy for severe steroid-refractory ulcerative colitis. J Crohns Colitis 2011;5(3):262
  • Schnitzler F, Fidder H, Ferrante M, et al. Outcome of pregnancy in women with inflammatory bowel disease treated with antitumor necrosis factor therapy. Inflamm Bowel Dis 2011;17(9):1846-54
  • Machkova N, Bortlik M, Duricova D. Pregnancy and newborn outcome of mothers with inflammatory bowel disease exposed to anti-TNF therapy during pregnancy: three-center study. J Crohns Colitis 2012;6:P370
  • Mahadevan U, Martin CF, Sandler RS, et al. PIANO: a 1000 Patient Prospective Registry of Pregnancy Outcomes in Women With IBD Exposed to Immunomodulators and Biologic Therapy. Gastroenterology 2012;134:A69
  • Casanova MJ, Chaparro M, Domenech E, et al. Safety of thiopurines and anti-TNF-alpha drugs during pregnancy in patients with inflammatory bowel disease. Am J Gastroenterol 2013;108(3):433-40
  • Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infection and mortality in patients with Crohn’s disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol 2012;107(9):1409-22
  • de Lima A, Zelinkova Z, van der Ent C, Van der Woude CJ. Anti-TNF is safe to stop in the second trimester of pregnancy in IBD women. Gastroenterology 2014;146(Suppl 5):340
  • Kelly OB, Hartery K, Boland K, et al. The safety of biologic use in the pregnant IBD patient: analysis of patient characteristics, pregnancy and neonatal outcomes. Gastroenterology 2014;146(Suppl 5):1405
  • Makhseed M, Raghupathy R, Azizieh F, et al. Th1 and Th2 cytokine profiles in recurrent aborters with successful pregnancy and with subsequent abortions. Hum Reprod 2001;16(10):2219-26
  • Neumann B, Luz A, Pfeffer K, Holzmann B. Defective Peyer’s patch organogenesis in mice lacking the 55-kD receptor for tumor necrosis factor. J Exp Med 1996;184(1):259-64
  • Matsumoto M, Mariathasan S, Nahm MH, et al. Role of lymphotoxin and the type I TNF receptor in the formation of germinal centers. Science 1996;271(5253):1289-91
  • Tiron A, Vasilescu C. [Role of the spleen in immunity. Immunologic consequences of splenectomy]. Chirurgia (Bucur) 2008;103(3):255-63
  • Martin PL, Oneda S, Treacy G. Effects of an anti-TNF-alpha monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol 2007;58(2):138-49
  • Arsenescu R, Arsenescu V, de Villiers WJ. TNF-alpha and the development of the neonatal immune system: implications for inhibitor use in pregnancy. Am J Gastroenterol 2011;106(4):559-62
  • Zelinkova Z, de Haar C, de Ridder L, et al. High intra-uterine exposure to infliximab following maternal anti-TNF treatment during pregnancy. Aliment Pharmacol Ther 2011;33(9):1053-8
  • Mahadevan U, Kane S, Church J. The effect of maternal peripartum infliximab use on neonatal immune response. Gastroenterology 2008;134:A69
  • Gartner LM, Morton J, Lawrence RA, et al. Breastfeeding and the use of human milk. Pediatrics 2005;115(2):496-506
  • Ben-Horin S, Yavzori M, Kopylov U, et al. Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis 2011;5(6):555-8
  • Ben-Horin S, Yavzori M, Katz L, et al. Adalimumab level in breast milk of a nursing mother. Clin Gastroenterol Hepatol 2010;8(5):475-6
  • Peltier M, James D, Ford J. Infliximab levels in breast-milk of a nursing Crohn’s patient. Am J Gastroenterol 2001;96:P258

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.