Safety considerations when using drugs in pregnant patients with systemic lupus erythematosus

References

• Andreoli L, Crisafulli F, Tincani A. Pregnancy and reproductive aspects of systemic lupus erythematosus. Curr Opin Rheumatol. 2017;29(5):473–479.
   PubMed Web of Science ®Google Scholar
• Lazzaroni MG, Dall’Ara F, Fredi M, et al. A comprehensive review of the clinical approach to pregnancy and systemic lupus erythematosus. J Autoimmun. 2016;74:106–117.
   PubMed Web of Science ®Google Scholar
• Knight CL, Nelson-Piercy C. Management of systemic lupus erythematosus during pregnancy: challenges and solutions. 2017;9:37–53. Open Access Rheumatol Res Rev.
   PubMed Web of Science ®Google Scholar
• Andreoli L, Bertsias GK, Agmon-Levin N, et al., EULAR recommendations for women’s health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 76(3): 476–485. 2017. .
   PubMed Web of Science ®Google Scholar
• Andreoli L, Lazzaroni MG, Carini C, et al. “Disease knowledge index” and perspectives on reproductive issues: a nationwide study on 398 women with autoimmune rheumatic diseases. Jt Bone Spine. 2019;86(4):475–481.
   PubMed Web of Science ®Google Scholar
• Zusman EZ, Sayre EC, Aviña-Zubieta JA, et al. Patterns of medication use before, during and after pregnancy in women with systemic lupus erythematosus: a population-based cohort study. Lupus. 2019;28(10):1205–1213.
   PubMed Web of Science ®Google Scholar
• Bruce IN, Urowitz M, Van Vollenhoven R, et al. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016;25(7):699–709.
   PubMed Web of Science ®Google Scholar
• Chen HL, Shen LJ, Hsu PN, et al. Cumulative burden of glucocorticoid-related adverse events in patients with systemic lupus erythematosus: findings from a 12-year longitudinal study. J Rheumatol. 2018;45(1):83–89.
   PubMed Web of Science ®Google Scholar
• Fanouriakis A, Kostopoulou M, Alunno A, et al., update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019(78): 736–745. 2019. .
   Google Scholar
• Burton PJ, Waddell BJ. Dual function of 11β-hydroxysteroid dehydrogenase in placenta: modulating placental glucocorticoid passage and local steroid action. Biol Reprod. 1999;60(2):234–240.
   PubMed Web of Science ®Google Scholar
• Saxena A, Izmirly PM, Mendez B, et al. Prevention and treatment in utero of autoimmune-associated congenital heart block. Cardiol Rev. 2014;22(6):263–267.
   PubMed Web of Science ®Google Scholar
• Hoxha A, Mattia E, Zanetti A, et al. Fluorinated steroids are not superior to any treatment to ameliorate the outcome of autoimmune mediated congenital heart block: a systematic review of the literature and meta-analysis. Clin Exp Rheumatol. 2020;38(4):783–791.
   PubMed Web of Science ®Google Scholar
• Pinsky L, Digeorce AM. Cleft palate in the mouse: a teratogenic index of glucocorticoid potency. Science. 1965;147(3656):402–403.
   PubMed Web of Science ®Google Scholar
• Park-Wyllie L, Mazzotta P, Pastuszak A, et al. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies. Teratology. 2000;62(6):385–392.
   PubMedGoogle Scholar
• Hviid A, Mølgaard-Nielsen D. Corticosteroid use during pregnancy and risk of orofacial clefts. Cmaj. 2011;183(7):796–804.
   PubMed Web of Science ®Google Scholar
• Skuladottir H, Wilcox AJ, Ma C, et al. Corticosteroid use and risk of orofacial clefts. Birth Defects Res Part A - Clin Mol Teratol. 2014;100(6):499–506.
   PubMed Web of Science ®Google Scholar
• Østensen M, Khamashta M, Lockshin M, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006;8(3):209.
   PubMed Web of Science ®Google Scholar
• Bandoli G, Palmsten K, Forbess Smith CJ, et al. A review of systemic corticosteroid use in pregnancy and the risk of select pregnancy and birth outcomes. Rheum Dis Clin North Am. 2017;43(3):489–502.
   PubMed Web of Science ®Google Scholar
• Sammaritano LR, Bermas BL, Chakravarty EE, et al., American college of rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis Rheumatol. 2020(72): 529–556. 2020. .
   Google Scholar
• Skorpen CG, Hoeltzenbein M, Tincani A, et al., The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 75(5): 795–810. 2016. .
   PubMed Web of Science ®Google Scholar
• Flint J, Panchal S, Hurrell A, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatol (United Kingdom). 2016;55:1693–1697.
   PubMed Web of Science ®Google Scholar
• Østensen ME, Skomsvoll JF. Anti-inflammatory pharmacotherapy during pregnancy. Expert Opin Pharmacother. 2004;5(3):571–580.
   PubMed Web of Science ®Google Scholar
• Kozer E, Nikfar S, Costei A, et al. Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. Am J Obstet Gynecol. 2002;187(6):1623–1630.
   PubMed Web of Science ®Google Scholar
• Daniel S, Matok I, Gorodischer R, et al. Major malformations following exposure to nonsteroidal antiinflammatory drugs during the first trimester of pregnancy. J Rheumatol. 2012;39(11):2163–2169.
   PubMed Web of Science ®Google Scholar
• Dathe K, Hultzsch S, Pritchard LW, et al. Risk estimation of fetal adverse effects after short-term second trimester exposure to non-steroidal anti-inflammatory drugs: a literature review. Eur J Clin Pharmacol. 2019;75(10):1347–1353.
   PubMed Web of Science ®Google Scholar
• Koren G, Florescu A, Costei AM, et al. Nonsteroidal antiinflammatory drugs during third trimester and the risk of premature closure of the ductus arteriosus: a meta-analysis. Ann Pharmacother. 2006;40(5):824–829.
   PubMed Web of Science ®Google Scholar
• Grab D, Paulus WE, Erdmann M, et al. Effects of low-dose aspirin on uterine and fetal blood flow during pregnancy: results of a randomized, placebo-controlled, double-blind trial. Ultrasound Obstet Gynecol. 2000;15(1):19–27.
   PubMed Web of Science ®Google Scholar
• Miyazaki M, Kuwabara Y, Takeshita T. Influence of perinatal low-dose acetylsalicylic acid therapy on fetal hemodynamics evaluated by determining the acceleration-time/ejection-time ratio in the ductus arteriosus. J Obstet Gynaecol Res. 2018;44(1):87–92.
   PubMed Web of Science ®Google Scholar
• Townsend RJ, Benedetti TJ, Erickson SH, et al. Excretion of ibuprofen into breast milk. Am J Obstet Gynecol. 1984;149(2):184–186.
   PubMed Web of Science ®Google Scholar
• Flint J, Panchal S, Hurrell A, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding — part II : analgesics and other drugs used in rheumatology practice. Rheumatology (Oxford). 2016;55:1–31.
   PubMed Web of Science ®Google Scholar
• Hale TW, McDonald R, Boger J. Transfer of celecoxib into human milk. J Hum Lact. 2004;20(4):397–403.
   PubMed Web of Science ®Google Scholar
• Gardiner SJ, Doogue MP, Zhang M, et al. Quantification of infant exposure to celecoxib through breast milk. Br J Clin Pharmacol. 2006;61(1):101–104.
   PubMed Web of Science ®Google Scholar
• Ruiz-Irastorza G, Ramos-Casals M, Brito-Zeron P, et al. Clinical efficacy and side effects of antimalarials in systemic lupus erythematosus: a systematic review. Ann Rheum Dis. 2010;69(1):20–28.
   PubMed Web of Science ®Google Scholar
• Schrezenmeier E, Dörner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020;16(3):155–166.
   PubMed Web of Science ®Google Scholar
• Costedoat-Chalumeau N, Amoura Z, Huong DLT, et al. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases. Review of the literature. Autoimmun Rev. 2005;4(2):111–115.
   Google Scholar
• Kaplan YC, Ozsarfati J, Nickel C, et al. Reproductive outcomes following hydroxychloroquine use for autoimmune diseases: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;81(5):835–848.
   PubMed Web of Science ®Google Scholar
• Diav-Citrin O, Blyakhman S, Shechtman S, et al. Pregnancy outcome following in utero exposure to hydroxychloroquine: a prospective comparative observational study. Reprod Toxicol. 2013;39:58–62.
   PubMed Web of Science ®Google Scholar
• Clowse MEB, Magder L, Witter F, et al. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum. 2006;54(11):3640–3647.
   PubMed Web of Science ®Google Scholar
• Clowse MEB. Lupus Activity in Pregnancy. Rheum Dis Clin North Am 2007;33(2):237–252.
   PubMed Web of Science ®Google Scholar
• Nalli C, Iodice A, Andreoli L, et al. The effects of lupus and antiphospholipid antibody syndrome on foetal outcomes. Lupus. 2014;23(6):507–517.
   PubMed Web of Science ®Google Scholar
• Ruffatti A, Tonello M, Hoxha A, et al. Effect of additional treatments combined with conventional therapies in pregnant patients with high-risk antiphospholipid syndrome: a multicentre study. Thromb Haemost. 2018;118(4):639–646.
   PubMed Web of Science ®Google Scholar
• Seo MR, Chae J, Kim YM, et al. Hydroxychloroquine treatment during pregnancy in lupus patients is associated with lower risk of preeclampsia. Lupus. 2019;28(6):722–730.
   PubMed Web of Science ®Google Scholar
• Izmirly PM, Costedoat-Chalumeau N, Pisoni CN, et al. Maternal use of hydroxychloroquine is associated with a reduced risk of recurrent anti-SSA/ro-antibody - Associated cardiac manifestations of neonatal lupus. Circulation. 2012;126(1):76–82.
   PubMed Web of Science ®Google Scholar
• Barsalou J, Costedoat-Chalumeau N, Berhanu A, et al. Effect of in utero hydroxychloroquine exposure on the development of cutaneous neonatal lupus erythematosus. Ann Rheum Dis. 2018;77(12):1742–1749.
   PubMed Web of Science ®Google Scholar
• Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014;26(3):354–360.
   PubMed Web of Science ®Google Scholar
• Andreoli L, Fredi M, Nalli C, et al. Pregnancy implications for systemic lupus erythematosus and the antiphospholipid syndrome. J Autoimmun. 2012;38.
   Web of Science ®Google Scholar
• Jharap B, De Boer NKH, Stokkers P, et al. Intrauterine exposure and pharmacology of conventional thiopurine therapy in pregnant patients with inflammatory bowel disease. Gut. 2014;63(3):451–457.
   PubMed Web of Science ®Google Scholar
• Oz BB, Hackman R, Einarson T, et al. Pregnancy outcome after cyclosporine therapy during pregnancy: a meta-analysis. Transplantation. 2001;71(8):1051–1055.
   PubMed Web of Science ®Google Scholar
• Kainz A, Harabacz I, Cowlrick IS, et al. Review of the course and outcome of 100 pregnancies in 84 women treated with tacrolimus. Transplantation 2000;70(12):1718–1721.
   PubMed Web of Science ®Google Scholar
• Jain AB, Shapiro R, Scantlebury VP, et al. Pregnancy after kidney and kidney-pancreas transplantation under tacrolimus: a single center’s experience. Transplantation. 2004;77(6):897–902.
   PubMed Web of Science ®Google Scholar
• Brown PM, Pratt AG, Isaacs JD. Mechanism of action of methotrexate in rheumatoid arthritis, and the search for biomarkers. Nat Rev Rheumatol. 2016;12(12):731–742.
   PubMed Web of Science ®Google Scholar
• Verberne EA, De Haan E, Van Tintelen JP, et al. Fetal methotrexate syndrome: a systematic review of case reports. Reprod Toxicol. 2019;87:125–139.
   PubMed Web of Science ®Google Scholar
• Vargesson N. Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Res Part C - Embryo Today Rev. 2015;105(2):140–156.
   PubMedGoogle Scholar
• Chasset F, Tounsi T, Cesbron E, et al. Efficacy and tolerance profile of thalidomide in cutaneous lupus erythematosus: a systematic review and meta-analysis. J Am Acad Dermatol. 2018;78(342–350):e4.
   Google Scholar
• Vaux KK, Kahole NCO, Jones KL, et al. Cytarabine embropathy: is apoptosis the common pathway? Birth Defects Res Part A - Clin Mol Teratol. 2003;67(6):403–408.
   PubMed Web of Science ®Google Scholar
• Preconception Counseling ØM. Rheum Dis Clin North Am. 2017;43:189–199.
   Google Scholar
• De Lorenzo R, Ramirez GA, Punzo D, et al. Neonatal outcomes of children born to mothers on biological agents during pregnancy: state of the art and perspectives. Pharmacol Res. 2020;152.
   Web of Science ®Google Scholar
• Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011;377(9767):721–731.
   PubMed Web of Science ®Google Scholar
• Turner-Stokes T, Lu TY, Ehrenstein MR, et al. The efficacy of repeated treatment with B-cell depletion therapy in systemic lupus erythematosus: an evaluation. Rheumatology (Oxford). 2011;50(8):1401–1408.
   PubMed Web of Science ®Google Scholar
• Gerosa M, Argolini LM, Artusi C, et al. The use of biologics and small molecules in pregnant patients with rheumatic diseases. Expert Rev Clin Pharmacol. 2018;11(10):987–998.
   PubMed Web of Science ®Google Scholar
• Powell M, Hill D, Eudy A, et al. OP0041 pregnancy outcomes for systemic lupus erythematosus (SLE) subjects with conception during belimumab intravenous (iv) and subcutaneous (SC) placebo-controlled clinical trials and long term extension trials. Ann Rheum Dis. 2014;73(75):3–76.
   PubMedGoogle Scholar
• Kumthekar A, Danve A, Deodhar A. Use of belimumab throughout 2 consecutive pregnancies in a patient with systemic lupus erythematosus. J Rheumatol. 2017;44(9):1416–1417.
   PubMed Web of Science ®Google Scholar
• Chakravarty EF, Murray ER, Kelman A, et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011;117(5):1499–1506.
   PubMed Web of Science ®Google Scholar
• De CD, Birmingham L, Watson KD, et al. Pregnancy outcomes in women with rheumatoid arthritis ever treated with rituximab. Rheumatol (United Kingdom). 2017;56:661–663.
   PubMed Web of Science ®Google Scholar
• Pham-Huy A, Sadarangani M, Huang V, et al. From mother to baby: antenatal exposure to monoclonal antibody biologics. Expert Rev Clin Immunol. 2019;15(3):221–229.
   PubMed Web of Science ®Google Scholar
• Østensen M. The use of biologics in pregnant patients with rheumatic disease. Expert Rev Clin Pharmacol. 2017;10(6):661–669.
   PubMed Web of Science ®Google Scholar
• Soh MC, Moretto M. The use of biologics for autoimmune rheumatic diseases in fertility and pregnancy. Obstet Med. 2020;13(1):5–13.
   PubMed Web of Science ®Google Scholar
• Tektonidou MG, Andreoli L, Limper M, et al., EULAR recommendations for the management of antiphospholipid syndrome in adults. Ann Rheum Dis. 78(10): 1296–1304. 2019. .
   PubMed Web of Science ®Google Scholar
• Iturbe-Alessio I, Fonseca MDC, Mutchinik O, et al. Risks of anticoagulant therapy in pregnant women with artificial heart valves. N Engl J Med. 1986;315(22):1390–1393.
   PubMed Web of Science ®Google Scholar
• Bates SM, Greer A, Middeldorp S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy - Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141:e691S–e736S.
   PubMed Web of Science ®Google Scholar
• Stevenson RE, Taylor HA, Burton OM, et al. Hazards of oral anticoagulants during pregnancy. JAMA J Am Med Assoc. 1980;243(15):1549–1551.
   PubMed Web of Science ®Google Scholar
• Martel N, Lee J, Wells PS. Risk for heparin-induced thrombocytopenia with unfractionated and low-molecular-weight heparin thromboprophylaxis: a meta-analysis. Blood. 2005;106(8):2710–2715.
   PubMed Web of Science ®Google Scholar
• Yoshihara H, Sugiura-Ogasawara M, Kitaori T, et al. Danaparoid is effective and safe for patients with obstetric antiphospholipid syndrome. Mod Rheumatol. 2020;30(2):332–337.
   PubMed Web of Science ®Google Scholar
• Clowse MEB, Jamison M, Myers E, et al. A national study of the complications of lupus in pregnancy. Am J Obstet Gynecol. 2008;199(2):127.e1-127.e6. .
   PubMed Web of Science ®Google Scholar
• Askie LM, Duley L, Henderson-Smart DJ, et al. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data. Lancet 2007;369(9575):1791–1798.
   PubMed Web of Science ®Google Scholar
• Roberge S, Villa P, Nicolaides K, et al. Early administration of low-dose aspirin for the prevention of preterm and term preeclampsia: a systematic review and meta-analysis. Fetal Diagn Ther. 2012;31(3):141–146.
   PubMed Web of Science ®Google Scholar
• Wu CQ, Kustec VE, Brown RN, et al. The medical management of antiphospholipid syndrome in pregnancy. Obstet Gynecol. 2014;123(Supplement 1):178S–179S.
   Google Scholar
• ACOG Committee Opinion No. 743. Low-dose aspirin use during pregnancy. Obstet Gynecol. 2018;132(1):e44–e52.
   PubMed Web of Science ®Google Scholar
• Regitz-Zagrosek V, Roos-Hesselink JW, Bauersachs J, et al. ESC guidelines for the management of cardiovascular diseases during pregnancy. Eur Heart J. 2018;2018(39):3165–3241.
   Google Scholar
• American Diabetes Association. 14. Management of diabetes in pregnancy: standards of medical care in Diabetes—2020. Diabetes Care. 2020;43(Supplement 1):S183–S192.
   PubMedGoogle Scholar
• Porta S, Danza A, Arias Saavedra M, et al. Glucocorticoids in systemic lupus erythematosus. ten questions and some issues. J Clin Med. 2020;9(9):2709.
   Web of Science ®Google Scholar
• Köseoglu HK, Yücel AE, Künefeci G, et al. Cyclophosphamide therapy in a serious case of lupus nephritis during pregnancy. Lupus. 2001;10(11):818–820.
   PubMed Web of Science ®Google Scholar
• Clowse MEB, Magder L, Petri M. Cyclophosphamide for lupus during pregnancy. Lupus. 2005;14(8):593–597.
   PubMed Web of Science ®Google Scholar
• Le HL, Francke MI, Andrews LM, et al. Usage of tacrolimus and mycophenolic acid during conception, pregnancy, and lactation, and its implications for therapeutic drug monitoring: a systematic critical review. Ther Drug Monit. 2020;42(4):518–531.
   PubMed Web of Science ®Google Scholar
• Sangle SR, Vounotrypidis P, Briley A, et al. Pregnancy outcome in patients with systemic vasculitis: a single-centre matched case-control study. Rheumatol (United Kingdom). 2015;54:1582–1586.
   PubMed Web of Science ®Google Scholar
• Ritchie J, Smyth A, Tower C, et al. Maternal deaths in women with lupus nephritis: a review of published evidence. Lupus. 2012;21(5):534–541.
   PubMed Web of Science ®Google Scholar
• El-Sayed YY, Lu EJ, Genovese MC, et al. Central nervous system lupus and pregnancy: 11-year experience at a single center. J Matern Neonatal Med. 2002;12(2):99–103.
   PubMedGoogle Scholar
• Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013;30(1–2):260–279.
   PubMed Web of Science ®Google Scholar
• Henderson JT, Whitlock EP, O’Connor E, et al. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S. Preventive Services Task Force.. Ann Intern Med. 2014;160(10):695–703.
   PubMed Web of Science ®Google Scholar
• Duley L, Meher S, Hunter KE, et al. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2019;2019.
   Web of Science ®Google Scholar
• Yelnik CM, Lambert M, Drumez E, et al., Bleeding complications and antithrombotic treatment in 264 pregnancies in antiphospholipid syndrome. Lupus. 27(10): 1679–1686. 2018. .
   PubMed Web of Science ®Google Scholar
• ACOG Practice Bulletin No. 209. Obstetric Analgesia and Anesthesia. Obstet Gynecol. 2019;133(3):e208–e225.
   PubMed Web of Science ®Google Scholar
• Gogarten W, Vandermeulen E, Van Aken H, et al. Regional anaesthesia and antithrombotic agents: recommendations of the European Society of Anaesthesiology. Eur J Anaesthesiol. 2010;27(12):999–1015.
   PubMed Web of Science ®Google Scholar
• Horlocker TT, Vandermeuelen E, Kopp SL, et al. Regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Fourth Edition). Reg Anesth Pain Med. 2018;43(3):263–309.
   PubMed Web of Science ®Google Scholar
• Fonseca NM, Pontes JPJ, Perez MV, et al. SBA 2020: regional anesthesia guideline for using anticoagulants update. Brazilian J Anesthesiol (English Ed. 2020(70):364–387.
   Google Scholar
• Reggia R, Bazzani C, Andreoli L, et al. The efficacy and safety of cyclosporin A in pregnant patients with systemic autoimmune diseases. Am J Reprod Immunol. 2016;75(6):654–660.
   PubMed Web of Science ®Google Scholar
• Landy HJ, Isada NB, McGinnis J, et al. The effect of chronic steroid therapy on glucose tolerance in pregnancy. Am J Obstet Gynecol. 1988;159(3):612–615.
   PubMed Web of Science ®Google Scholar
• Dong Y, Dai Z, Wang Z, et al. Risk of gestational diabetes mellitus in systemic lupus erythematosus pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2019;19(1):19.
   PubMed Web of Science ®Google Scholar
• Ruiz-Irastorza G, Danza A, Khamashta M. Glucocorticoid use and abuse in SLE. Rheumatol (United Kingdom). 2012;51:1145–1153.
   PubMed Web of Science ®Google Scholar
• Ruiz-Irastorza G, Khamashta MA, Nelson-Piercy C, et al. Lupus pregnancy: is heparin a risk factor for osteoporosis? Lupus. 2001;10(9):597–600.
   PubMed Web of Science ®Google Scholar
• Buckley L, Guyatt G, Fink HA, et al. American college of rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2017;2017(69):1521–1537.
   Google Scholar
• Green SB, Papas AL. Effects of maternal bisphosphonate use on fetal and neonatal outcomes. Am J Heal Pharm. 2014;71:2029–2036.
   PubMed Web of Science ®Google Scholar
• Sokal A, Elefant E, Leturcq T, et al. Pregnancy and newborn outcomes after exposure to bisphosphonates: a case-control study. Osteoporos Int. 2019;30(1):221–229.
   PubMed Web of Science ®Google Scholar
• Arkema EV, Palmsten K, Sjöwall C, et al. What to expect when expecting with systemic lupus erythematosus (SLE): a population-based study of maternal and fetal outcomes in SLE and pre-SLE. Arthritis Care Res. 2016;68(7):988–994.
   Web of Science ®Google Scholar
• Saavedra MA, Cruz-Reyes C, Vera-Lastra O, et al. Impact of previous lupus nephritis on maternal and fetal outcomes during pregnancy. Clin Rheumatol. 2012;31(5):813–819.
   PubMed Web of Science ®Google Scholar
• Andrade R, Sanchez ML, Alarcón GS, et al. Adverse pregnancy outcomes in women with systemic lupus erythematosus from a multiethnic US cohort: LUMINA (LUI). Clin Exp Rheumatol. 2008;26(2):268–274.
   PubMed Web of Science ®Google Scholar
• Wagner SJ, Craici I, Reed D, et al. Maternal and foetal outcomes in pregnant patients with active lupus nephritis. Lupus. 2009;18(4):342–347.
   PubMed Web of Science ®Google Scholar
• Chakravarty EF, Colón I, Langen ES, et al. Factors that predict prematurity and preeclampsia in pregnancies that are complicated by systemic lupus erythematosus. Am J Obstet Gynecol. 2005;192(6):1897–1904.
   PubMed Web of Science ®Google Scholar
• Madazli R, Yuksel MA, Oncul M, et al. Obstetric outcomes and prognostic factors of lupus pregnancies. Arch Gynecol Obstet. 2014;289(1):49–53.
   PubMed Web of Science ®Google Scholar
• Ruiz-Irastorza G, Olivares N, Ruiz-Arruza I, et al. Predictors of major infections in systemic lupus erythematosus. Arthritis Res Ther. 2009;11(4):R109.
   PubMed Web of Science ®Google Scholar
• Desai RJ, Bateman BT, Huybrechts KF, et al. Risk of serious infections associated with use of immunosuppressive agents in pregnant women with autoimmune inflammatory conditions: cohort study. BMJ. 2017;356:j895.
   PubMed Web of Science ®Google Scholar
• Bundhun PK, Soogund MZS, Huang F. Impact of systemic lupus erythematosus on maternal and fetal outcomes following pregnancy: a meta-analysis of studies published between years 2001–2016. J Autoimmun. 2017;79:17–27.
   PubMed Web of Science ®Google Scholar
• Chaparro M, Verreth A, Lobaton T, et al. 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. 2018;113(3):396–403.
   PubMed Web of Science ®Google Scholar
• Duricova D, Dvorakova E, Hradsky O, et al. Safety of anti-Tnf-Alpha therapy during pregnancy on long-term outcome of exposed children: a controlled, multicenter observation. Inflamm Bowel Dis. 2019;25(4):789–796.
   PubMed Web of Science ®Google Scholar
• Das G, Damotte V, Gelfand JM, et al. Rituximab before and during pregnancy. Neurol - Neuroimmunol Neuroinflammation 2018;5(3):e453.
   PubMed Web of Science ®Google Scholar
• Danve A, Perry L, Deodhar A. Use of belimumab throughout pregnancy to treat active systemic lupus erythematosus-A case report. Semin Arthritis Rheum. 2014;44(2):195–197.
   PubMed Web of Science ®Google Scholar
• Emmi G, Silvestri E, Squatrito D, et al. Favorable pregnancy outcome in a patient with systemic lupus erythematosus treated with belimumab: a confirmation report. Semin Arthritis Rheum. 2016;45(6):e26–e27.
   PubMedGoogle Scholar
• Gandino IJ, Lutgen S, Basta MC, et al. Exposure to belimumab in the first trimester of pregnancy in a young woman with systemic lupus erythematosus. Reumatol Clínica;2020. 10.1016/j.reuma.2020.02.002
   Google Scholar
• Ciobanu AM, Dumitru AE, Gica N, et al. Benefits and risks of IgG transplacental transfer. Diagnostics. 2020;10(8):583.
   Web of Science ®Google Scholar
• Furer V, Rondaan C, Heijstek MW, et al. update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2019;2020(79):39–52.
   Google Scholar
• Bitter H, Bendvold AN, Østensen ME. Lymphocyte changes and vaccination response in a child exposed to belimumab during pregnancy. Ann Rheum Dis. 2018;77(11):1692–1693.
   PubMed Web of Science ®Google Scholar
• Yousef Yengej FA, Van Royen-kerkhof A, Derksen RHWM, et al., The development of offspring from mothers with systemic lupus erythematosus. A systematic review. Autoimmun Rev. 16(7): 701–711. 2017. .
   PubMed Web of Science ®Google Scholar
• Couture J, Bernatsky S, Scott S, et al. Brief report: risk of childhood rheumatic and nonrheumatic autoimmune diseases in children born to women with systemic lupus erythematosus. Arthritis Rheumatol. 2018;70(11):1796–1800.
   PubMed Web of Science ®Google Scholar
• Nalli C, Iodice A, Andreoli L, et al. Long-term neurodevelopmental outcome of children born to prospectively followed pregnancies of women with systemic lupus erythematosus and/or antiphospholipid syndrome. Lupus. 2017;26(5):552–558.
   PubMed Web of Science ®Google Scholar
• Rynes RI, Bernstein HN. Ophthalmologic safety profile of antimalarial drugs. Lupus. 1993;2 Suppl 1:2.
   Web of Science ®Google Scholar
• Johansen PB, Gran JT. Ototoxicity due to hydroxychloroquine: report of two cases. Clin Exp Rheumatol. 1998;16(4):472–474.
   PubMed Web of Science ®Google Scholar
• Costedoat-Chalumeau N, Amoura Z, Aymard G, et al. Evidence of transplacental passage of hydroxychloroquine in humans. Arthritis Rheum. 2002;46(4):1123–1124.
   PubMed Web of Science ®Google Scholar
• Ullberg S, Lindquist NG, Sjòstrand SE. Accumulation of chorio-retinotoxic drugs in the foetal eye. Nature. 1970;227(5264):1257–1258.
   PubMed Web of Science ®Google Scholar
• Gaffar R, Pineau CA, Bernatsky S, et al. Risk of ocular anomalies in children exposed in utero to antimalarials: a systematic literature review. Arthritis Care Res. 2019;71(12):1606–1610.
   Web of Science ®Google Scholar
• Motta M, Tincani A, Faden D, et al. Follow-up of infants exposed to hydroxychloroquine given to mothers during pregnancy and lactation. J Perinatol. 2005;25(2):86–89.
   PubMedGoogle Scholar
• Renault F, Flores-Guevara R, Renaud C, et al. Visual neurophysiological dysfunction in infants exposed to hydroxychloroquine in utero. Acta Paediatr Int J Paediatr. 2009;98(9):1500–1503.
   PubMed Web of Science ®Google Scholar
• Borba EF, Turrini-Filho JR, Kumma KAM, et al. Chloroquine gestational use in systemic lupus erythematosus: assessing the risk of child ototoxicity by pure tone audiometry. Lupus. 2004;13(4):223–227.
   PubMed Web of Science ®Google Scholar
• Nacinovich R, Galli J, Bomba M, et al. Neuropsychological development of children born to patients with antiphospholipid syndrome. Arthritis Care Res. 2008;59(3):345–351.
   Web of Science ®Google Scholar
• Motta M, Rodriguez-Perez C, Tincani A, et al. Neonates born from mothers with autoimmune disorders. Early Hum Dev. 2009;85(10 Suppl):85.
   PubMed Web of Science ®Google Scholar
• Tincani A, Rebaioli CB, Frassi M, et al. Pregnancy and autoimmunity: maternal treatment and maternal disease influence on pregnancy outcome. Autoimmun Rev. 2005;4(7):423–428.
   PubMed Web of Science ®Google Scholar
• Nalli C, Iodice A, Andreoli L, et al. Children born to SLE and APS mothers. Lupus 2014;23(12):1246–1248.
   PubMed Web of Science ®Google Scholar
• É V, Pineau CA, Clarke AE, et al. Increased risk of autism spectrum disorders in children born to women with systemic lupus erythematosus: results from a large population-based cohort. Arthritis Rheumatol. 2015;67(12):3201–3208.
   PubMed Web of Science ®Google Scholar
• Marder W, Romero VC, Ganser MA, et al. Increased usage of special educational services by children born to mothers with systemic lupus erythematosus and antiphospholipid antibodies. Lupus Sci Med. 2014;1(1):12–17.
   Google Scholar
• Belizna C, Meroni PL, Shoenfeld Y, et al., In utero exposure to Azathioprine in autoimmune disease. where do we stand? Autoimmun Rev. 19(9): 102525. 2020. .
   Web of Science ®Google Scholar
• French NP, Hagan R, Evans SF, et al. Repeated antenatal corticosteroids: size at birth and subsequent development. Am J Obstet Gynecol. 1999;180(1):114–121.
   PubMed Web of Science ®Google Scholar
• Spinillo A, Viazzo F, Colleoni R, et al. Two-year infant neurodevelopmental outcome after single or multiple antenatal courses of corticosteroids to prevent complications of prematurity. Am J Obstet Gynecol. 2004;191(1):217–224.
   PubMed Web of Science ®Google Scholar
• Jones RAK. Randomized, controlled trial of dexamethasone in neonatal chronic lung disease: 13- to 17-year follow-up study: I. Neurologic, psychological, and educational outcomes. Pediatrics. 2005;116(2):370–378.
   PubMed Web of Science ®Google Scholar
• Ross G, Sammaritano L, Nass R, et al. Effects of mothers’ autoimmune disease during pregnancy on learning disabilities and hand preference in their children. Arch Pediatr Adolesc Med. 2003;157(4):397–402.
   PubMedGoogle Scholar
• Brucato A, Astori MG, Cimaz R, et al. Normal neuropsychological development in children with congenital complete heart block who may or may not be exposed to high-dose dexamethasone in utero. Ann Rheum Dis. 2006;65(11):1422–1426.
   PubMed Web of Science ®Google Scholar
• Tincani A, Andreoli L. A guide to managing reproductive health in rheumatology. Nat Rev Rheumatol. 2020;16(8):411–412.
   PubMed Web of Science ®Google Scholar
• Petri M. Systemic Lupus Erythematosus. Clinical Updates in Women’s Health Care Primary and Preventive Care Review. Obstet Gynecol. 2020;136(1):226.
   PubMedGoogle Scholar
• Meer Y, Strangfeld A, Costedoat-Chalumeau N, et al. European network of pregnancy registers in rheumatology (EuNeP)- an overview of procedures and data collection. Arthritis Res Ther. 2019; (1):21. 10.1186/s13075-019-2019-3.
   PubMed Web of Science ®Google Scholar
• Landy H, Powell M, Hill D, et al. Belimumab pregnancy registry. Obstet Gynecol. 2014;123(Supplement 1):62S.
   Google Scholar