Pregnancy outcomes following exposure to abatacept during pregnancy

Seminars in Arthritis and Rheumatism

Volumn 45, Issue 3, 2015, Pages 351-356

  Kumar, Monica ^a,b   Ray, Laura ^a   Vemuri, Sudha ^a   Simon, Teresa A ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b SANOFI   (France)

Author keywords

Abatacept; Biological disease modifying antirheumatic drugs; Congenital anomalies; Exposure; Pregnancy

Indexed keywords

ABATACEPT; METHOTREXATE;

AORTA ANOMALY; ARTERY MALFORMATION; ARTICLE; CESAREAN SECTION; CHILD DEATH; CLEFT LIP; CLEFT PALATE; CONGENITAL MALFORMATION; DISEASE REGISTRY; DOWN SYNDROME; DRUG WITHDRAWAL; FETUS DEATH; HEART VENTRICLE SEPTUM DEFECT; HUMAN; INDUCED ABORTION; LIVE BIRTH; MENINGOCELE; POSTMARKETING SURVEILLANCE; PREGNANCY COMPLICATION; PREGNANCY OUTCOME; PREMATURE FETUS MEMBRANE RUPTURE; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; PYLORUS STENOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SKULL MALFORMATION; SPONTANEOUS ABORTION; ABNORMALITIES, DRUG-INDUCED; ADULT; ADVERSE EFFECTS; FEMALE; MALE; MATERNAL EXPOSURE; PREGNANCY; RETROSPECTIVE STUDY;

ABATACEPT; ABNORMALITIES, DRUG-INDUCED; ADULT; FEMALE; HUMANS; MALE; MATERNAL EXPOSURE; PREGNANCY; PREGNANCY OUTCOME; RETROSPECTIVE STUDIES;

EID: 84955698163     PISSN: 00490172     EISSN: 1532866X     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2015.06.016     Document Type: Article

References (34)

1. Finer L.B., Zolna M.R. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception 2011, 84:478-485.
2. Singh J.A., Furst D.E., Bharat A., Curtis J.R., Kavanaugh A.F., Kremer J.M., et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012, 64:625-639.
3. Smolen J.S., Landewe R., Breedveld F.C., Dougados M., Emery P., Gaujoux-Viala C., et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010, 69:964-975.
4. Williams M., Chakravarty E.F. Rheumatoid arthritis and pregnancy: impediments to optimal management of both biologic use before, during and after pregnancy. Curr Opin Rheumatol 2014, 26:341-346.
5. Dao K., Cush J.J., Weisman M. ACR reproductive health summit on the management of pregnant and lactating women with autoimmune diseases. Drug Saf Q 2014, 5:1-2.
6. Cush J.J., Kavanaugh A. Drug safety during pregnancy in the rheumatoid patient: top ten considerations. Drug Saf Q 2013, 4:1-4.
7. Hyrich K.L., Verstappen S.M. Biologic therapies and pregnancy: the story so far. Rheumatology (Oxford) 2014, 53:1377-1385.
8. Makol A., Wright K., Amin S. Rheumatoid arthritis and pregnancy: safety considerations in pharmacological management. Drugs 2011, 71:1973-1987.
9. Hazes J.M., Coulie P.G., Geenen V., Vermeire S., Carbonnel F., Louis E., et al. Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use. Rheumatology 2011, 50:1955-1968.
10. Chakravarty E.F. Rheumatoid arthritis and pregnancy: beyond smaller and preterm babies. Arthritis Rheum 2011, 63:1469-1471.
11. de Man Y.A., Hazes J.M., van der Heide H., Willemsen S.P., Groot C.J., Steegers E.A., et al. Association of higher rheumatoid arthritis disease activity during pregnancy with lower birth weight: results of a national prospective study. Arthritis Rheum 2009, 60:3196-3206.
12. Cush J.J., Kavanaugh A. Pregnancy and rheumatoid arthritis-do not let the perfect become the enemy of the good. Curr Opin Rheumatol 2014, 26:299-301.
13. Food and Drug Administration. Pregnancy and lactation labeling, 2014, ; [accessed 30.01.15]. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm.
14. Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling, ; [accessed 30.01.15]. https://federalregister.gov/a/2014-28241.
15. Krause M.L., Amin S., Makol A. Use of DMARDs and biologics during pregnancy and lactation in rheumatoid arthritis: what the rheumatologist needs to know. Ther Adv Musculoskelet Dis 2014, 6:169-184.
16. Bermas B.L. Non-steroidal anti inflammatory drugs, glucocorticoids and disease modifying anti-rheumatic drugs for the management of rheumatoid arthritis before and during pregnancy. Curr Opin Rheumatol 2014, 26:334-340.
17. Ostensen M., Lockshin M., Doria A., Valesini G., Meroni P., Gordon C., et al. Update on safety during pregnancy of biological agents and some immunosuppressive anti-rheumatic drugs. Rheumatology (Oxford) 2008, 47(Suppl. 3):iii28-iii31.
18. Tjeertes I.F., Bastiaans D.E., van Ganzewinkel C.J., Zegers S.H. Neonatal anemia and hydrops fetalis after maternal mycophenolate mofetil use. J Perinatol 2007, 27:62-64.
19. Sifontis N.M., Coscia L.A., Constantinescu S., Lavelanet A.F., Moritz M.J., Armenti V.T. Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus. Transplantation 2006, 82:1698-1702.
20. Kuriya B., Hernandez-Diaz S., Liu J., Bermas B.L., Daniel G., Solomon D.H. Patterns of medication use during pregnancy in rheumatoid arthritis. Arthritis Care Res 2011, 63:721-728.
21. Djokanovic N., Klieger-Grossmann C., Pupco A., Koren G. Safety of infliximab use during pregnancy. Reprod Toxicol 2011, 32:93-97.
22. Fischer-Betz R.E., Schneider M. Biologics during pregnancy and breast-feeding. Z Rheumatol 2010, 69:780-787.
23. Marchioni R.M., Lichtenstein G.R. Tumor necrosis factor-α inhibitor therapy and fetal risk: a systemic literature review. World J Gastroenterol 2013, 19:2591-2602.
24. Ojeda-Uribe M., Afif N., Dahan E., Sparsa L., Haby C., Sibilia J., et al. Exposure to abatacept or rituximab in the first trimester of pregnancy in three women with autoimmune diseases. Clin Rheumatol 2013, 32:695-700.
25. Chakravarty E.F., Murray J.R., Kelman A., Farmer P. Pregnancy outcomes after maternal exposure to rituximab. Blood 2011, 117:499-506.
26. Bristol-Myers Squibb. Orencia prescribing information, ; [accessed 30.01.15]. http://packageinserts.bms.com/pi/pi_orencia.pdf.
27. Brouwer J., Hazes J.M., Laven J.S., Dolhain R.J. Fertility in women with rheumatoid arthritis: influence of disease activity and medication. Ann Rheum Dis 2014, http://dx.doi.org/10.1136/annrheumdis-2014-205383 [Epub ahead of print].
28. Rom A.L., Wu C.S., Olsen J., Kjaergaard H., Jawaheer D., Hetland M.L., et al. Fetal growth and preterm birth in children exposed to maternal or paternal rheumatoid arthritis: a nationwide cohort study. Arthritis Rheumatol 2014, 66:3265-3273.
29. de Steenwinkel F.D., Hokken-Koelega A.C., de Ridder M.A., Hazes J.M., Dolhain R.J. Rheumatoid arthritis during pregnancy and postnatal catch-up growth in the offspring. Arthritis Rheumatol 2014, 66:1705-1711.
30. Weber-Schoendorfer C., Chambers C., Wacker E., Beghin D., Bernard N., Shechtman S., et al. Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study. Arthritis Rheumatol 2014, 66:1101-1110.
31. Verstappen S.M., King Y., Watson K.D., Symmons D.P., Hyrich K.L. Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2011, 70:823-826.
32. Wilcox A.J., Weinberg C.R., O'Connor J.F., Baird D.D., Schlatterer J.P., Canfield R.E., et al. Incidence of early loss of pregnancy. N Engl J Med 1988, 319:189-194.
33. Leen-Mitchell M., Martinez L., Gallegos S., Robertson J., Carey J.C. Mini-review: history of organized teratology information services in North America. Teratology 2000, 61:314-317.
34. Ostensen M. Contraception and pregnancy counselling in rheumatoid arthritis. Curr Opin Rheumatol 2014, 26:302-307.