Safety and efficacy of immunomodulators and biologics during pregnancy and lactation for the treatment of inflammatory bowel disease

Bibliography

• Garland CF, Lilienfeld AM, Mendeloff AI, Incidence rates of ulcerative colitis and Crohn's disease in fifteen areas of the US. Gastroenterology 1981;81(6):1115-24
   PubMed Web of Science ®Google Scholar
• Calkins BM, Mendeloff AI. Epidemiology of inflammatory bowel disease. Epidemiol Rev 1986;80:60
   Google Scholar
• Norgard B, Hundborg HH, Jacobsen BA, Disease activity in pregnant women with Crohn's disease and birth outcomes: a regional Danish cohort study. Am J Gastroenterol 2007;102:1947-54
   PubMed Web of Science ®Google Scholar
• Mahadevan U, Sandborn WJ, Li DK, Pregnancy outcomes in women with inflammatory bowel disease: a large community-based study from northern California. Gastroenterology 2007;133:1106-12
   PubMed Web of Science ®Google Scholar
• Food and drug adminstration. Federal Register 1980;44:37434-67
   Google Scholar
• Avilable from http://www.fda.gov/Drugs/DevelopmentApproval-Process/DevelopmentResources/Labeling/ucm093311.htm
   Google Scholar
• Colombel JF, Sandborn WJ, Reinisch W, Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010;362:1383-95
   PubMed Web of Science ®Google Scholar
• Diav-Citrin O, Park YH, Veerasuntharam G, The safety of mesalamine in human pregnancy: a prospective controlled cohort study. Gastroenterology 1998;114:23-8
   PubMed Web of Science ®Google Scholar
• Mahadevan U. Fertility and pregnancy in the patient with inflammatory bowel disease. Gut 2006;55(8):1198-206
   PubMed Web of Science ®Google Scholar
• Levi AJ, Fisher AM, Hughes K, Male infertility due to sulphasalazine. Lancet 1979;2:276-8
   PubMed Web of Science ®Google Scholar
• Collen MJ. Azulfidine-induced oligospermia. Am J Gastroenterol 1980;74:441-2
   PubMed Web of Science ®Google Scholar
• Ragni G, Biancho Porro G, Ruspa M, Abnormal semen quality and low serum testosterone in men with inflammatory bowel disease treated for a long time with sulfasalazine. Andrologia 1984;16:162-7
   PubMed Web of Science ®Google Scholar
• Mogadam M, Dobbins WO, Korelitz BI, Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Obstetrical & Gynecological Survey 1981;36:385-6
   Google Scholar
• Carmichael SL, Shaw GM. Maternal corticosteroid use and risk of selected congenital anomalies. Am J Med Genet 1999;86:242-4
   PubMed Web of Science ®Google Scholar
• Carmichael SL, Shaw GM, Ma C, Maternal corticosteroid use and orofacial clefts. Am J Obstet Gynecol 2007;197:585-7
   PubMed Web of Science ®Google Scholar
• Czeizel AE, Rockenbauer M. Population-based case-control study of teratogenic potential of corticosteroids. Teratology 1997;56:335-40
   PubMedGoogle Scholar
• Källén B. Maternal drug use and infant cleft lip/palate with special reference to corticoids. Cleft Palate Craniofac J 2003;40:624-8
   PubMed Web of Science ®Google Scholar
• Pradat P, Robert-Gnansia E, Di Tanna GL, First trimester exposure to corticosteroids and oral clefts. Birth Defects Res A Clin Mol Teratol 2003;67:968-70
   PubMed Web of Science ®Google Scholar
• Rodríguez-Pinilla E, Martinez-Frias ML. Corticosteroids during pregnancy and oral clefts: a case-control study. Teratology 1998;58:2-5
   PubMedGoogle Scholar
• Muirhead N, Sabharwal AR, Rieder MJ, The outcome of pregnancy following renal transplantation - the experience of a single center. Transplantation 1992;54:429-32
   PubMed Web of Science ®Google Scholar
• Laskin CA, Bombardier C, Hannah ME. Prednisone and aspirin in women with autoantibodies and unexplained recurrent fetal loss. N Engl J Med 1997;337:148-53
   PubMed Web of Science ®Google Scholar
• Al Hadithy AFY, De Boer KNH. Derijks, et al. Thiopurines in inflammatory bowel disease: pharmacogenetics. Dig Liver Disease 2005;37:285-92
   Google Scholar
• Cuffari C, Li DY, Mahoney J, Peripheral blood mononuclear cell DNA 6-thioguanine metabolite levels correlate with decreased interferon-amma production in patients with Crohn's disease on AZA therapy. Dig Dis Sci 2004;49:133-7
   PubMed Web of Science ®Google Scholar
• Githens JH, Rosenkrantz JG, Tunnock SM. Teratogenic effects of azathioprine (Imuran). J Pediatr 1965; 66:959-61
   Google Scholar
• Rosenkrantz JG, Githens JH, Cox SM, Kellum DL. Azathioprine (Imuran) and pregnancy. Am J Obstet Gynecol 1967; 97:387-94
   Google Scholar
• Polifka JE, Friedman JM. Teratogen Update: azathioprine and 6-Mercaptopurine. Teratology 2002;65:240-61
   PubMedGoogle Scholar
• Githens JH, Rosenkrantz JG, Tunnock SM. Teratogenic effects of AZP (Imuran). J Pediatr 1965;66:561-95
   Google Scholar
• Rosenkrantz JG, Githens JH, Cox SM, AZP (Imuran) and pregnancy. Am J Obstet Gynecol 1967;96:387-94
   Google Scholar
• Thiersch JB. The effect of 6-mercaptopurine on the rat fetus and on reproduction of the rat. Ann NY Acad Sci 1954;60:220-7
   Google Scholar
• McKay DB, Josephson MA. Pregnancy in recipients of solid organs–effects on mother and child. N Engl J Med 2006;354:1281-93
   PubMed Web of Science ®Google Scholar
• Polifka JE, Friedman JM. Teratogen update: azathioprine and 6-mercaptopurine. Teratology 2002;65:240-61
   PubMedGoogle Scholar
• Norgard B, Pedersen L, Fonager K, Azathioprine, mercaptopurine and birth outcome: a population-based cohort study. Aliment Pharmacol Ther 2003;17:827-34
   PubMed Web of Science ®Google Scholar
• Francella A, Dyan A, Bodian C, The safety of 6-mercaptopurine for childbearing patients with inflammatory bowel disease: a retrospective cohort study. Gastroenterology 2003;124:9-17
   PubMed Web of Science ®Google Scholar
• Alstead EM, Ritchie JK, Lennard-Jones JE, Safety of azathioprine in pregnancy in inflammatory bowel disease. Gastroenterology 1990;99:443-6
   PubMed Web of Science ®Google Scholar
• Khan ZH, Mayberry JF, Spiers N, Retrospective case series analysis of patients with inflammatory bowel disease on azathioprine. A district general hospital experience. Digestion 2000;62:249-54
   PubMed Web of Science ®Google Scholar
• Cleary BJ, Kallen B. Early pregnancy azathioprine use and pregnancy outcomes. Birth Defects Res A Clin Mol Teratol 2009;85:647-54
   PubMed Web of Science ®Google Scholar
• Van Os EC, Zins BJ, Sandborn WJ, Azathioprine pharmacokinetics after intravenous, oral, delayed release oral and rectal foam administration. Gut 1996;39:63-8
   Google Scholar
• Sandborn WJ. Azathioprine: state of the art in inflammatory bowel disease. Scand J Gastroenterol 1998;225(Suppl):92-9
   Google Scholar
• Zimm S, Collins JM, Riccardi R, Variable bioavailability of oral mercaptopurine. Is maintenance chemotherapy in acute lymphoblastic leukemia being optimally delivered? N Engl J Med 1983;308:1005-9
   PubMed Web of Science ®Google Scholar
• Boer NKH, Jarbandhan SVA, de Graaf P, Azathioprine use during pregnancy: unexpected intrauterine exposure to metabolites. Am J Gastroenterol 2006;101:1390-2
   PubMed Web of Science ®Google Scholar
• Briggs GG, Freeman RK, Yaffe SJ, editors. Drugs in pregnancy and lactation. 3rd edition. Williams and Wilkins, Baltimore; 1990
   Google Scholar
• Lemann M, Mary JY, Colombel JF, A randomized double-blind, controlled withdrawal trial in Crohn's disease patients in long-term remission on azathioprine. Gastroenterology 2005;128:1812-18
   PubMed Web of Science ®Google Scholar
• Christensen LA, Dahlerup JF, Nielsen MJ, Azathioprine treatment during lactation. Aliment Pharmacol Ther 2008;28(10):1209-13
   PubMed Web of Science ®Google Scholar
• Sau A, Clarke S, Bass J, Azathioprine and breastfeeding: is it safe? BJOG 2007;114(4):498-501
   PubMed Web of Science ®Google Scholar
• Feagan BG, Rochon J, Fedorak RN. Methotrexate for the treatment of crohn's disease. N Engl J Med 1995;332:292-7
   PubMed Web of Science ®Google Scholar
• Kalb RE, Strober B, Weinstein G. Methotrexate and psoriasis: 2009 national psoriasis foundation consensus conference. J Am Acad Dermatol 2009;60:824-37
   PubMed Web of Science ®Google Scholar
• Briggs GG FR, Yaffe SJ. Drugs in pregnancy and lactation. 7th edition. Williams, Wilkins, Lippincott; 2005
   Google Scholar
• Mahadevan U, Kane SV. American Gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology 2006;131:283-311
   PubMed Web of Science ®Google Scholar
• Lloyed ME, Carr M, McElhatton P. The effect of methotrexate on pregnancy and lactation. QJM 1999;9210:551-63
   Google Scholar
• Sussman A, Leonard JM. Psoriasis, methotrexate and oligospermia. Arch Dermatol 1980;116:215-17
   PubMed Web of Science ®Google Scholar
• French AE, Koren G. Effect of methotrexate on male fertility. Can Family Phys 2003;49:577-8
   PubMed Web of Science ®Google Scholar
• El-Beheiry A, El-Mansy E, Kamel N, Methotrexate and fertility in men. Arch Androl 1979;3:177-9
   PubMed Web of Science ®Google Scholar
• Hirsh A. Male subfertility. BMJ 2003;327:669-72
   PubMed Web of Science ®Google Scholar
• Kalb RE, Strober B, Weinstein G. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol 2009;60:824-37
   PubMed Web of Science ®Google Scholar
• Johns DG, Rutherford LD, Keighton PC, Secretion of methotrexate into human milk. Am J Obstet Gynecol 1972;112:978-80
   PubMed Web of Science ®Google Scholar
• Committee on drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137-50
   PubMed Web of Science ®Google Scholar
• Ehrenpreis ED, Kane SV, Cohen LB, Thalidomide therapy for patients with refractory Crohn's disease: an open-label trial. Gastroenterology 1999;117:1271-7
   Google Scholar
• Vasiliauskas EA, Kam LY, Abreu-Martin MT, An open-label pilot study of low-dose thalidomide in chronically active, steroid dependent Crohn's disease. Gastroenterology 1999;117:1278-87
   Google Scholar
• Fishman SJ, Feins NR, D'Amato RJ, Thalidomide therapy for crohn's disease (letter). Gastroenterology 2000;119:596-602
   PubMed Web of Science ®Google Scholar
• Organization of Teratology Information Specialists. Thalidomide and pregnancy. Available from: http://www.otispregnancy.org/files/thalidomide.pdf [Accessed 10 February 2012]
   Google Scholar
• Zeldis JB, Williams BA, Thomas SD, S.T.E.P.S.: a comprehensive program for controlling and monitoring access to thalidomide. Clin Ther 1999;21:319-30
   PubMed Web of Science ®Google Scholar
• Lary JM, Daniel KL, Erickson JD, The return of thalidomide: can birth defects be prevented? Drug Saf 1999;21:161-9
   PubMed Web of Science ®Google Scholar
• Kountouras J, Zavos C, Chatzopoulos D. Immunomodulatory benefits of cyclosporine A in inflammatory bowel disease. J Cell Mol Med 2004;83:317-28
   Google Scholar
• Ina K, Kusugami K, Shimada M, Suppressive effects of cyclosporine A on neutrophils and T cells may be related to therapeutic benefits in patients with steroid-resistant ulcerative colitis. Inflamm Bowel Dis 2002;81:1-9
   Google Scholar
• Lichtiger S, Present DH, Kornbluth A, Cyclosporine in severe ulcerative colitis refractory to steroid therapy. N Engl J Med 1994;330:1841-5
   PubMed Web of Science ®Google Scholar
• Garcia-Lopez S, Gomollon-Garcia F, Perez-Gisbert J. Cyclosporine in the treatment of severe attack of ulcerative colitis: a systematic review. Gastroenterol Hepatol 2005;28:607-14
   PubMedGoogle Scholar
• Sandborn WJ. Cyclosporine in ulcerative colitis: state of the art. Acta Gastroenterol Belg 2001;64(2):201-4
   PubMed Web of Science ®Google Scholar
• Ramsey-Goldman R, Schilling E. Immunosuppressive drug use during pregnancy. Rheum Dis Clin North Am 1997;23:149-67
   PubMed Web of Science ®Google Scholar
• Petri M. Immunosuppressive drug use in pregnancy. Autoimmunity 2003;36:51-6
   PubMed Web of Science ®Google Scholar
• Bar Oz B, Hackman R, Einarson T, Pregnancy outcome after cyclosporine therapy during pregnancy: a meta-analysis. Transplantation 2001;71:1051-5
   PubMed Web of Science ®Google Scholar
• Bertschinger P, Himmelmann A, Risti B, Cyclosporine treatment of severe ulcerative colitis during pregnancy. Am J Gastroenterol 1995;90:330
   PubMed Web of Science ®Google Scholar
• Jayaprakash A, Gould S, Lim AG, Use of cyclosporin in pregnancy. Gut 2004;53:1386-7
   PubMed Web of Science ®Google Scholar
• Branche J, Cortot A, Bourreille A, Cyclosporine treatment of steroid-refractory ulcerative colitis during pregnancy. Inflamm Bowel Dis 2009;15:1044-8
   PubMed Web of Science ®Google Scholar
• Munoz-Flores-Thiagarajan KD, Easterling T, Davis C, Breastfeeding by a cyclosporine-treated mother. Obstetrics & Gynecology 2001;97(5):816-18
   PubMed Web of Science ®Google Scholar
• Moretti ME, Sgro M, Johnson DW, Cyclosporine excretion into breast milk. Transplantation 2003;75:2144-6
   PubMed Web of Science ®Google Scholar
• Committee on Drugs. American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 2001;108:776-89
   PubMed Web of Science ®Google Scholar
• Seghal SN. Rapamune® (RAPA, rapamycin, sirolimus): mechanism of action immunosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem 1998;31:335-40
   PubMed Web of Science ®Google Scholar
• Mihatsch MJ, Kyo M, Morozumi K, The side-effects of cyclosporine-A and tacrolimus. Clin Nephrol 1998;49(6):356-63
   PubMed Web of Science ®Google Scholar
• Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis 2010;16:881-95
   PubMed Web of Science ®Google Scholar
• Jain A, Venkataramanan R, Fung JJ, Pregnancy after liver transplantation under tacrolimus. Transplantation 1997;64:559-65
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Sturm A, Wiedenmann B, Uneventful pregnancy and neonatal outcome with tacrolimus in refractory ulcerative colitis. Gut 2005;54:1822-3
   PubMed Web of Science ®Google Scholar
• Grimer M. Pregnancy, lactation and calcineurin inhibitors. Nephrology 2007;12:S98-S105
   PubMedGoogle Scholar
• Armenti VT, Radomski JS, Moritz MJ Report from the National transplantation pregnancy registry (NTPR): outcomes of pregnancy after transplantation. Clin. Transpl. 2003;131-41
   Google Scholar
• French AE, Soldin SJ, Soldin OP, Milk transfer and neonatal safety of tacrolimus. Ann. Pharmacother 2003;37:815-18
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Feagan BG, Cohen RD, Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol 2006;4:621-30
   PubMed Web of Science ®Google Scholar
• Katz JA, Antoni C, Keenan GF, Outcome of pregnancy in women receiving infliximab for the treatment of Crohn's disease and rheumatoid arthritis. Am J Gastroenterol 2004;99:2385-92
   PubMed Web of Science ®Google Scholar
• Mahadevan U, Kane S, Sandborn WJ, Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn's disease. Aliment Pharmacol Ther 2005;21:733-8
   PubMed Web of Science ®Google Scholar
• Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nature Reviews Immunology 2007;7:715-25
   PubMed Web of Science ®Google Scholar
• Simister NE. Placental transport of immunoglobulin G. Vaccine 2003;21:3365-9
   PubMed Web of Science ®Google Scholar
• Mahadevan U. Pregnancy and IBD: how to best communicate risks and benefits to patients and obstetricians. AGA Perspectives 2011;7(4):8-9
   Google Scholar
• Kane S, Ford J, Cohen R, 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;43:613-16
   PubMed Web of Science ®Google Scholar
• Moffatt DC, Bernstein CN. Drug therapy for inflammatory bowel disease in pregnancy and the puerperium. Best Pract Res Clin Gastroenterol 2007;21:835-47
   PubMed Web of Science ®Google Scholar
• Vesga L, Terdiman JP, Mahadevan U. Adalimumab use in pregnancy. Gut 2005;54:890
   PubMed Web of Science ®Google Scholar
• Mishkin DS, Van Deinse W, Becker JM, Successful use of adalimumab (Humira) for Crohn's disease in pregnancy. Inflamm Bowel Dis 2006;12:827-8
   PubMed Web of Science ®Google Scholar
• Beaulieu DB, Kane SV. Inflammatory bowel disease in pregnancy. Gastroenterol Clin N Am 2011;10:399-413
   Google Scholar
• Ben-Horin S, Yazvori M, Katz L, Adalimumab Level in Breast Milk of a Nursing Mother Clin Gastroenterol and Hepatol. 2010;8:475-6
   Google Scholar
• Mahadevan U, Cucchiara S, Hyams JS, The london position statement of the world congress of gastroenterology on biological therapy for IBD with the european crohn's and colitis organization: pregnancy and pediatrics. Am J Gastroenterol 2011;106:214-23
   PubMed Web of Science ®Google Scholar
• Mahadevan U, Abreu MT. Certolizumab use in pregnancy: low levels detected in cord blood (abstract). Gastroenterology 2009; 136: A-146
   Google Scholar
• Clifford DB. Natalizumab and PML: a risky business? Gut 2008;57:1347-9
   PubMed Web of Science ®Google Scholar
• Gorelik L, Lerner M, Bixler S, Anti-JC virus antibodies: implications for PML Risk Stratification. Ann Neurol 2010;68:295-303
   PubMed Web of Science ®Google Scholar
• Hellwig K, Haghikia A, Gold R. Pregnancy and natalizumab: results of an observational study in 35 accidental pregnancies during natalizumab treatment. Mult Scler. 2011;17(8):958-63
   Google Scholar
• Zlatanic J, Korelitz BI, Rajapakse R, Complications of pregnancy and child development after cessation of treatment with 6-mercaptopurine for inflammatory bowel disease. J Clin Gastroenterol. 2003;36:303-9
   Google Scholar
• Mastrobattista JM, Veronica Gomez-Lobo V. Pregnancy after solid organ transplantation. Obstet Gynecol 2008;112:919-32
   PubMed Web of Science ®Google Scholar
• Djokanovic N, Klieger-Grossmann C, Pupco A, Safety of infliximab use during pregnancy. Reprod Toxicol 2011;32:93-7
   PubMed Web of Science ®Google Scholar
• Janneke van der Woude C, Kolacek S, Dotan I, European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohn's Colitis 2010;4:493-510
   Google Scholar