THE NEW BIOLOGICS IN PREGNANCY
Main Article Content
Keywords
Pregnancy, biologics, chronic diseases, abatacept, anakinra, tolicizumab, rituximab, tumour necrosis factor-alpha inhibitors, registries
Abstract
Growing numbers of women of reproductive age are prescribed new biological agents. This is resulting in more pregnancies exposed to these drugs. What are the new biologics (also referred to as biologicals) and what are their indications? How are they currently used in pregnant women? What are the concerns when treating pregnant women with biologics? What do we know about the reproductive safety of these agents? Current and future research is discussed.
References
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2. 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[cited 2014 Aug 2];11(3):318- 321. Available from: http://dx.doi.org/10.1016/j.cgh.2012.10.024
3. 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 [cited 2014 Aug 2];11(3):286- 292. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC 3913646
4. 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 2 011;33(9):1053- 1058.
5. Product Monograph. Remicade®. Toronto (ON): Janssen Inc.; 2013 Aug 6 [cited 2014 Aug 2]. Available from: http://webprod5.hc - sc.gc.ca/dpd -bdpp/item -iteme .do?pm - mp=00021549
6. Steenholdt C, Al- Khalaf M, Ainsworth MA, et al. 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- 361.
7. Cheent K, Nolan J, Shariq S, et al. Case Report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease. J Crohns Colitis 2010 Nov;4(5):603- 605.
8. 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- 223.
9. Motherisk (Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, MD). Personal communication with: Bristol- Myers Squibb Canada, Montreal, QC. 2011 Jun.
10. Ojeda -Uribe M, Afi f N, Dahan E, et al. Exposure to abatacept or rituximab in the first trimester of pregnancy in three women with autoimmune diseases. Clin Rheumatol 2013;32(5):695- 700.
11. Rubbert -Roth, A, Goupille PM, Moosavi S, et al. First experiences with pregnancies in RA patients (pts) receiving tocilizumab (TCZ) therapy [abstract]. Arthritis Rheum 2010 [cited 2014 Aug 3];62(Suppl 10):384. Available from: http://www.blackwellpublishing.com/acrmeeting /abstract.asp?MeetingID=774&id=89036&meeti ng=ART201062
12. Berger CT, Recher M, Steiner U, et al. A patient’s wish: anakinra in pregnancy. Ann Rheum Dis 2009;68(11):1794 -1795.
13. Fischer -Betz R, Specker C, Schneider M. Successful outcome of two pregnancies in patients with adult-onset Still's disease treated with IL -1 receptor antagonist (anakinra). Cl in Exp Rheumatol 2011;29(6):1021- 1023.
14. Chakravarty EF, Murray ER, Kelman A, et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011 [cited 2014 Aug 3];117(5):1499- 1506. Available from: http://bloodjournal.hematologylibrary.org/cgi/p midlookup?view=long&pmid=21098742
15. Johnson D, Luo Y, Jones K, et al. Pregnancy outcomes in women exposed to adalimumab: an update on the Autoimmune Diseases in Pregnancy Project [abstract]. Arthritis Rheum. 2011 [cited 2014 Aug 3];63(Suppl 10):1874. Available from: http://www.blackwellpublishing.com /acrmeeting /abstract.asp?MeetingID=781&id=96614&meeti ng=ART201163
16. Winger EE, Reed JL, Ashoush S, et al. Birth defect rates in women using adalimumab (Humira(®) ) to treat immunologic -based infertility in IVF patients. Am J Reprod Immunol 2011;66(3):237- 241.
17. Mahadevan U, Kane SV, Church JA, et al. The effect of maternal peripartum infliximab use on neonatal immune response [abstract]. Gastroenterology 2008;134(4 Suppl 1):A -69.
18. Certolizumab Pegol (Cimzia ®) [Internet]. Atlanta (GA): American College of Rheumatology; updated 2014 Oct (cited 2014 Oct 13). Available from: http://www.rheumatology.org/practice/clinical/drugsafety/cimzia.asp
19. Wolf DC, Förger F, Cush JJ, et al. Retrospective analysis of certolizumab pegol use during pregnancy: update of impact on birth outcomes [abstract]. Arthritis Rheum 2013 [cited 2014 Aug 3];65(10 Suppl): S187 -S188. Available from: http://onlinelibrary.wiley.com/doi/10.1002/art.3 8216/pdf
20. Product Monograph. Simponi®. Toronto (ON): Janssen Inc.; 2013 Sep 19 [cited 2014 Aug 3]. Available from: http://webprod5.hc - sc.gc.ca/dpd -bdpp/item -iteme.do?pm - mp=00022099
21. Johnson TL, Jones KL, Chambers CD, The OTIS Collaborative Research Group. Pregnancy outcomes in women exposed to etanercept: the OTIS Autoimmune Diseases in Pregnancy Project [Internet]. (Cited 2014 Oct 13). Available from: www.mothertobaby.org/readResource.php?r=10 8642
22. PIANO Study [Internet]. New York (NY): Crohn’s & Colitis Foundation of America; 2104 9cited 2014 Oct 13). Available from: http://www.ccfa.org/science -and - professionals/research/current -research - studies/piano -study.html
23. 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 [abstract]. Gastroenterology 2012 [cited 2014 Aug 3];142(5 Suppl 1): S149. Available from: http://www.gastrojourn al.org/article/S0016 - 5085(12)60561- 7/pdf
24. Mother to Baby. Autoimmune Diseases in Pregnancy Studies [Internet]. Brentwood (TN): Organization of Teratology Information Specialists (OTIS); 2012 9cited 2014 Oct 13). Available from: http://www.pregnancystudies .org/ongoing - pregnancy- studies/autoimmune -studies/
25. Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2012. Ann Rheum Dis 2013;72(Suppl 2):ii2– ii34.