Рекомендации EULAR 2024 года по применению противоревматических препаратов в репродуктивном периоде, во время беременности и лактации, комментарии к ним
https://doi.org/10.47360/1995-4484-2025-576-591
Аннотация
В статье представлена обновленная в 2024 г. версия рекомендаций по применению противоревматических препаратов в репродуктивном периоде, во время беременности и лактации, разработанных Европейским альянсом ревматологических ассоциаций, и комментарии к ним.
Ключевые слова
При поддержке: Исследование не имело спонсорской поддержки
Об авторах
Н. М. Кошелева
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»
Россия
Конфликт интересов:
Россия
Кошелева Надежда Михайловна,
115522, Москва, Каширское шоссе, 34а
Конфликт интересов:
нет
Т. М. Решетняк
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России
Россия
Конфликт интересов:
Россия
115522, Москва, Каширское шоссе, 34а; 125993, Москва, ул. Баррикадная, 2/1, стр. 1
Конфликт интересов:
нет
Н. И. Клименченко
ФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии имени академика В.И. Кулакова» Минздрава России
Россия
Конфликт интересов:
Россия
117997, Москва, ул. Академика Опарина, 4
Конфликт интересов:
нет
Е. Л. Насонов
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»
Россия
Конфликт интересов:
Россия
115522, Москва, Каширское шоссе, 34а
Конфликт интересов:
нет
Список литературы
1. Насонов ЕЛ (ред.). Ревматология. Российские клинические рекомендации. М.:ГЭОТАР-Медиа;2017.
2. Gotestam Skorpen C, Hoeltzenbein M, Tincani A, FischerBetz R, Elefant E, Chambers C, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795-810. doi: 10.1136/annrheumdis-2015-208840
3. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, 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. Rheumatology (Oxford) 2016;55(9):1693-1697. doi: 10.1093/rheumatology/kev404
4. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, et al. BSR and BHPR guideline rheumatology practice on prescribing drugs in pregnancy and breastfeeding – Part II: Analgesics and other drugs used in rheumatology practice. Rheumatology (Oxford) 2016;55(9):1698-1702. doi: 10.1093/rheumatology/kev405
5. Andreoli L, Chighizola CB, Iaccarino L, Botta A, Gerosa M, Ramoni V, et al. Immunology of pregnancy and reproductive health in autoimmune rheumatic diseases. Update from the 11th International Conference on Reproduction, Pregnancy and Rheumatic Diseases. Autoimmun Rev. 2023;22(3):103259. doi: 10.1016/j.autrev.2022.103259
6. Ruegg L, Pluma A, Hamroun S, Cecchi I, Perez-Garcia LF, Anderson PO, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025;00:1-17. doi: 10.1016/j.ard.2025.02.023
7. European Alliance of Associations for Rheumatology. EULAR SOPs – standard operating procedures for task forces, version 52. URL: https://www.eular.org/web/static/lib/pdfjs/web/viewer.html?file=https://www.eular.org/document/download/680/b9eb08d0-faca-4606-8ed9-d0539b3f312a/660 (Accessed: 19th September 2024).
8. Oxford Centre for Evidence-Based Medicine: Levels of evidence (March 2009). URL: https://www.cebm.ox.ac.uk/resources/levelsof-evidence/oxford-centre-for-evidence-based-medicine-levelsof-evidence-march-2009 (Accessed: 1st June 2024).
9. Singh M, Wambua S, Lee SI, Okoth K, Wang Z, Fazla F, et al. Autoimmune diseases and adverse pregnancy outcomes: An umbrella review. Lancet. 2023;402(Suppl 1):84. doi: 10.1016/s0140-6736(23)02128-1
10. Meek JY, Noble L. Technical report: Breastfeeding and the use of human milk. Pediatrics. 2022;150(1):e2022057989. doi: 10.1542/peds.2022-057989
11. World Health Organization. Breastfeeding. URL: https://www.who.int/health-topics/breastfeeding#tab=tab_2 (Accessed: 1st June 2024).
12. Schreiber K, Graversgaard C, Parodis I, Agmon-Levin N, Aguilera S, Antovic A, et al. Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey. Ther Adv Musculoskelet Dis. 2025;17:1-17. doi: 10.1177/1759720X251350087
13. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis Rheumatol 2020;72(4):529-556. doi: 10.1002/art.41191
14. Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, et al. Executive summary: British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2023;62(4):1370-1387. doi: 10.1093/rheumatology/ keac558
15. Chambers CD, Johnson DL, Xu R, Luo Y, Felix R, Fine M, et al. Birth outcomes in women who have taken hydroxycholoroquine during pregnancy: A prospective cohort study. Arthritis Rheumatol. 2022;74(4):711-724. doi: 10.1002/art.42015.
16. Andersson NW, Skov L, Andersen JT. Fetal safety of chloroquine and hydroxychloroquine use during pregnancy: A nationwide cohort study. Rheumatology (Oxford). 2021;60(5):2317-2326. doi: 10.1093/rheumatology/keaa592
17. Huybrechts KF, Bateman BT, Zhu Y, Straub L, Mogun H, Kim SC, et al. Hydroxychloroquine early in pregnancy and risk of birth defects. Am J Obstet Gynecol. 2021;224(3):290.e1-22. doi: 10.1016/j.ajog.2020.09.007
18. Schreiber K, Giles I, Costedoat-Chalumeau N, Nelson-Piercy C, Dolhain RJ, Mosca M, et al. Global comment on the use of hydroxychloroquine during the periconception period and pregnancy in women with autoimmune diseases. Lancet Rheumatol. 2023;5(9):501-506. doi: 10.1016/S2665-9913(23)00215-1
19. Indraratna PL, Virk S, Gurram D, Day RO. Use of colchicine in pregnancy: A systematic review and meta-analysis. Rheumatology (Oxford). 2018;57(2):382-387. doi: 10.1093/rheumatology/kex353
20. Norgard BM, Friedman S, Kjeldsen J, Nielsen J. The safety of paternal and maternal use of 5-aminosalicylic acid during conception and pregnancy: A nationwide cohort study. Aliment Pharmacol Ther. 2022;56(9):1349-1360. doi: 10.1111/apt.17189
21. Torres J, Chaparro M, Julsgaard M, Katsanos K, Zelinkova Z, Agrawal M, et al. European Crohn’s and colitis guidelines on sexuality, fertility, pregnancy, and lactation. J Crohns Colitis. 2023;17(1):1-27. doi: 10.1093/ecco-jcc/jjac115
22. Peterson EA, Lynton J, Bernard A, Santillan MK, Bettendorf B. Rheumatologic medication use during pregnancy. Obstet Gynecol. 2020;135(5):1161-1176. doi: 10.1097/AOG.0000000000003755
23. Hernandez-Díaz S, Werler MM, Walker AM, Mitchell AA. Folic acid antagonists during pregnancy and the risk of birth defects. N Engl J Med. 2000;343(22):1608-1614. doi: 10.1056/ NEJM200011303432204
24. De-Regil LM, Peña-Rosas JP, Fernández-Gaxiola AC, RaycoSolon P. Effects and safety of periconceptional oral folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2015;12:CD007950. doi: 10.1002/14651858.CD007950.pub3
25. Genetics Committee, Wilson RD, Audibert F, Brock JA, Carroll J, Gagnon A. et al. Pre-conception folic acid and multivitamin supplementation for the primary and secondary prevention of neural tube defects and other folic acid-sensitive congenital anomalies. J Obstet Gynaecol Can. 2015;37(6):534-352. doi: 10.1016/s17012163(15)30230-9
26. Guideline: Daily iron and folic acid supplementation in pregnant women: WHO guidelines approved by the Guidelines Review Committee. Geneva:World Health Organization;2012.
27. Cordero AM, Crider KS, Rogers LM, Cannon MJ, Berry RJ. Optimal serum and red blood cell folate concentrations in women of reproductive age for prevention of neural tube defects: World Health Organization guidelines. MMWR Morb Mortal Wkly Rep. 2015;64(15):421-423.
28. Нормальная беременность: Клинические рекомендации Минздрава России 2023–2024–2025. М.;2024.
29. Perez-Aytes A, Marin-Reina P, Boso V, Ledo A, Carey JC, Vento M. Mycophenolate mofetil embryopathy: A newly recognized teratogenic syndrome. Eur J Med Genet. 2017;60(1):16-21. doi: 10.1016/j.ejmg.2016.09.014
30. Weber-Schoendorfer C, Chambers C, Wacker E, Beghin D, Bernard N, Centers Network of French Pharmacovigilance, 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(5):1101-1110. doi: 10.1002/art.38368
31. Zanetti A, Zambon A, Scire CA, Bortoluzzi A. Impact of rheumatoid arthritis and methotrexate on pregnancy outcomes: Retrospective cohort study of the Italian Society for Rheumatology. RMD Open. 2022;8(2):e002412. doi: 10.1136/rmdopen-2022-002412
32. McInerney KA, Hatch EE, Wesselink AK, Rothman KJ, Mikkelsen EM, Wise LA. Preconception use of pain-relievers and timeto-pregnancy: A prospective cohort study. Hum Reprod. 2017;32(1):103-111. doi: 10.1093/humrep/dew272
33. Micu MC, Micu R, Ostensen M. Luteinized unruptured follicle syndrome increased by inactive disease and selective cyclooxygenase 2 inhibitors in women with inflammatory arthropathies. Arthritis Care Res (Hoboken). 2011;63(9):1334-1338. doi: 10.1002/acr.20510
34. Odufalu FD, Long M, Lin K, Mahadevan U. Exposure to corticosteroids in pregnancy is associated with adverse perinatal outcomes among infants of mothers with inflammatory bowel disease: Results from the PIANO registry. Gut. 2022;71(9):1766-1772. doi: 10.1136/gutjnl-2021-325317
35. Jølving LR, Nielsen J, Andersen ML, Friedman S, Nørgrd BM. Adverse birth outcomes and early-life infections after in utero exposure to corticosteroids for inflammatory bowel disease: A Danish nationwide cohort study. BMC Med. 2023;21(1):140. doi: 10.1186/s12916-023-02817-7
36. Gur C, Diav-Citrin O, Shechtman S, Arnon J, Ornoy A. Pregnancy outcome after first trimester exposure to corticosteroids: A prospective controlled study. Reprod Toxicol. 2004;18(1):93-101. doi: 10.1016/j.reprotox.2003.10.007
37. Bandoli G, Palmsten K, Forbess Smith CJ, Chambers CD. 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. doi: 10.1016/j.rdc.2017.04.013
38. Desai RJ, Bateman BT, Huybrechts KF, Patorno E, HernandezDiaz S, Park Y, 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. doi: 10.1136/bmj.j895
39. Carsote M, Turturea MR, Valea A, Buescu C, Nistor C, Turturea IF. Bridging the gap: Pregnancyand lactation-associated osteoporosis. Diagnostics (Basel). 2023;13(9):1615. doi: 10.3390/diagnostics13091615
40. Palmsten K, Bandoli G, Vazquez-Benitez G, Xi M, Johnson DL, Xu R, et al. Oral corticosteroid use during pregnancy and risk of preterm birth. Rheumatology (Oxford). 2020;59(6):1262-1271. doi: 10.1093/rheumatology/kez405
41. Smith CJF, Bandoli G, Kavanaugh A, Chambers CD. Birth outcomes and disease activity during pregnancy in a prospective cohort of women with psoriatic arthritis and ankylosing spondylitis. Arthritis Care Res (Hoboken). 2020;72(7):1029-1037. doi: 10.1002/ acr.23924
42. Palmsten K, Rolland M, Hebert MF, Clowse MEB, Schatz M, Xu R, et al. Patterns of prednisone use during pregnancy in women with rheumatoid arthritis: Daily and cumulative dose. Pharmacoepidemiol Drug Saf. 2018;27(4):430-438. doi: 10.1002/pds.4410
43. de Steenwinkel FDO, Dolhain RJEM, Hazes JMW, HokkenKoelega ACS. Does prednisone use in pregnant women with rheumatoid arthritis induce insulin resistance in the offspring? Clin Rheumatol. 2023;42(1):47-54. doi: 10.1007/s10067-022-06347-0
44. Dunn L, Greer R, Flenady V, Kumar S. Sildenafil in pregnancy: A systematic review of maternal tolerance and obstetric and perinatal outcomes. Fetal Diagn Ther. 2017;41(2):81-88. doi: 10.1159/000453062
45. Ferreira RDDS, Negrini R, Bernardo WM, Simoes R, Piato S. The effects of sildenafil in maternal and fetal outcomes in pregnancy: A systematic review and meta-analysis. PLoS One. 2019;14(7):e0219732. doi: 10.1371/journal.pone.0219732
46. Tektonidou MG, Andreoli L, Limper M, Amoura Z, Cervera R, Costedoat-Chalumeau N, et al. EULAR recommendations for the management of antiphospholipid syndrome in adults. Ann Rheum Dis. 2019;78(10):1296-1304. doi: 10.1136/annrheumdis-2019-215213
47. Andreoli L, Bertsias GK, Agmon-Levin N, Brown S, Cervera R, Costedoat Chalumeau 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. 2017;76(3):476-485. doi: 10.1136/annrheumdis-2016-209770
48. Nelson-Piercy C, Agarwal S, Lams B. Lesson of the month: Selective use of cyclophosphamide in pregnancy for severe autoimmune respiratory disease. Thorax. 2016;71(7):667-668.
49. Orozco-Guillen AO, Abraham VS, Moguel Gonzalez B, Valdez Ortiz R, Ibarguengoitia F, Del Carmen ZM, et al. Kidney-limited full-house lupus-like membranous nephropathy and membranoproliferative glomerulonephritis in pregnancy. Kidney Int Rep. 2023;8(4):932-938. doi: 10.1136/thoraxjnl-2016-208441
50. Clowse MEB, Richeson RL, Pieper C, Merkel PA, Vasculitis Clinical Research Consortium. Pregnancy outcomes among patients with vasculitis. Arthritis Care Res (Hoboken). 2013;65(8):1370-1374. doi: 10.1002/acr.21983
51. Le HL, Francke MI, Andrews LM, de Winter BCM, van Gelder T, Hesselink DA. 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. doi: 10.1097/FTD.0000000000000769
52. Malek A, Sager R, Kuhn P, Nicolaides KH, Schneider H. Evolution of maternofetal transport of immunoglobulins during human pregnancy. Am J Reprod Immunol. 1996;36(5):248-255. doi: 10.1111/j.1600-0897.1996.tb00172.x
53. Porter C, Armstrong-Fisher S, Kopotsha T, Smith B, Baker T, Kevorkian L, et al. Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): consequences for FcRn-mediated in vitro transcytosis and ex vivo human placental transfer. J Reprod Immunol. 2016;116:7-12. doi: 10.1016/j.jri.2016.04.284
54. Murashima A, Watanabe N, Ozawa N, Saito H, Yamaguchi K. Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: Drug levels in maternal serum, cord blood, breast milk and the infant’s serum. Ann Rheum Dis. 2009;68(11):1793-1794. doi: 10.1136/ard.2008.105924
55. Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, et al. Lack of placental transfer of certolizumab pegol during pregnancy: Results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196
56. Julsgaard M, Christensen LA, Gibson PR, Gearry RB, Fallingborg J, Hvas CL, et al. Concentrations of adalimumab and infliximab in mothers and newborns, and effects on infection. Gastroenterology. 2016;151(1):110-119. doi: 10.1053/j.gastro.2016.04.002
57. Ghalandari N, Kemper E, Crijns IH, Wolbink G, Rispens T, Smeele HT, et al. Analysing cord blood levels of TNF inhibitors to validate the EULAR points to consider for TNF inhibitor use during pregnancy. Ann Rheum Dis. 2022;81(3):402-405. doi: 10.1136/annrheumdis-2021-221036
58. Nielsen OH, Gubatan JM, Juhl CB, Streett SE, Maxwell C. Biologics for inflammatory bowel disease and their safety in pregnancy: A systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2022;20(1):74-87.e3. doi: 10.1016/j.cgh.2020.07.047
59. O’Byrne LJ, Alqatari SG, Maher GM, O’Sullivan AM, Khashan AS, Murphy GP, et al. Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta-analysis. BJOG. 2022;129(8):1236-1246. doi: 10.1111/1471-0528.17093
60. Tsao NW, Rebic N, Lynd LD, De Vera MA. Maternal and neonatal outcomes associated with biologic exposure before and during pregnancy in women with inflammatory systemic diseases: A systematic review and meta-analysis of observational studies. Rheumatology (Oxford). 2020;59(8):1808-1817. doi: 10.1093/rheumatology/keaa064
61. Nguyen H, Ahmed K, Luo W, Flint J, Giles I. A systematic review of the safety of non-TNF inhibitor biologic and targeted synthetic drugs in rheumatic disease in pregnancy. Semin Arthritis Rheum. 2021;51(6):1205-1217. doi: 10.1016/j.semarthrit.2021.09.004
62. Das G, Damotte V, Gelfand JM, Bevan C, Cree BAC, Do L, et al. Rituximab before and during pregnancy: A systematic review, and a case series in MS and NMOSD. Neurol Neuroimmunol Neuroinflamm. 2018;5(3):e453. doi: 10.1212/NXI.0000000000000453
63. Youngstein T, Hoffmann P, Gul A, Lane T, Williams R, Rowczenio DM, et al. International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors. Rheumatology (Oxford). 2017;56(12):2102-2108. doi: 10.1093/rheumatology/kex305
64. Kao JH, Lan TY, Lu CH, Cheng CF, Huang YM, Shen CY, et al. Pregnancy outcomes in patients treated with belimumab: Report from real-world experience. Semin Arthritis Rheum. 2021;51(5):963-968.
65. Chakravarty EF, Murray ER, Kelman A, Farmer P. Pregnancy outcomes after maternal exposure to rituximab. Blood 2011;117(5):1499-1506. doi: 10.1182/blood-2010-07-295444
66. Avni-Biron I, Mishael T, Zittan E, Livne-Margolin M, Zinger A, Tzadok R, et al. Ustekinumab during pregnancy in patients with inflammatory bowel disease: A prospective multicentre cohort study. Aliment Pharmacol Ther. 2022;56(9):1361-1369. doi: 10.1111/apt.17224
67. Gall B, Yee A, Berry B, Bircham D, Hayashi A, Dansereau J, et al. Rituximab for management of refractory pregnancy-associated immune thrombocytopenic purpura. J Obstet Gynaecol Can. 2010;32(12):1167-1171. doi: 10.1016/S1701-2163(16)34741-7
68. Klink DT, van Elburg RM, Schreurs MW, van Well GT. Rituximab administration in third trimester of pregnancy suppresses neonatal B-cell development. Clin Dev Immunol. 2008;2008:271363. doi: 10.1155/2008/271363
69. 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. doi: 10.1136/annrheumdis-2018-213004
70. Vittorakis SK, Giannakopoulou G, Samitas K, Zervas E. Successful and safe treatment of severe steroid depended eosinophilic asthma with mepolizumab in a woman during pregnancy. Respir Med Case Rep. 2023;41:101785. doi: 10.1016/j.rmcr.2022.101785
71. Ozden G, Pinar Deniz P. May mepolizumab used in asthma correct subfertility? Ann Med. 2021;53(1):456-458. doi: 10.1080/07853 890.2021.1900591
72. Miyasaka N, Miura O, Kawaguchi T, Arima N, Morishita E, Usuki K, et al. Pregnancy outcomes of patients with paroxysmal nocturnal hemoglobinuria treated with eculizumab: A Japanese experience and updated review. Int J Hematol. 2016;103(6):703-712. doi: 10.1007/s12185-016-1946-x
73. Kelly R, Arnold L, Richards S, Hill A, Bomken C, Hanley J, et al. The management of pregnancy in paroxysmal nocturnal haemoglobinuria on long term eculizumab. Br J Haematol. 2010;149(3):446-450. doi: 10.1111/j.1365-2141.2010.08099.x
74. European Medicine Agency. URL: https://www.ema.europa.eu/en/homepage (Accessed: 1st June 2024).
75. Beaulieu DB, Ananthakrishnan AN, Martin C, Cohen RD, Kane SV, Mahadevan U. Use of biologic therapy by pregnant women with inflammatory bowel disease does not affect infant response to vaccines. Clin Gastroenterol Hepatol. 2018;16(1):99-105. doi: 10.1016/j.cgh.2017.08.041
76. Goulden B, Chua N, Parker E, Giles I. A systematic review of live vaccine outcomes in infants exposed to biologic disease modifying anti-rheumatic drugs in utero. Rheumatology (Oxford). 2022;61(10):3902-3906. doi: 10.1093/rheumatology/keac141
77. Cheent K, Nolan J, Shariq S, Kiho L, Pal A, Arnold J. 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;4(5):603-605. doi: 10.1016/j.crohns.2010.05.001
78. Fitzpatrick T, Alsager K, Sadarangani M, Pham-Huy A, Murguía-Favela L, Morris SK, et al. Immunological effects and safety of live rotavirus vaccination after antenatal exposure to immunomodulatory biologic agents: A prospective cohort study from the Canadian Immunization Research Network. Lancet Child Adolesc Health. 2023;7(9):648-656. doi: 10.1016/S23524642(23)00136-0
79. Zerbo O, Modaressi S, Goddard K, Lewis E, Getahun D, Palmsten KK, et al. Safety of live-attenuated vaccines in children exposed to biologic response modifiers in utero. Pediatrics. 2022;150(1):e2021056021. doi: 10.1542/peds.2021-056021
80. Weber-Schoendorfer C, Beck E, Tissen-Diabate T, Schaefer C. Leflunomide – a human teratogen? A still not answered question. An evaluation of the German Embryotox pharmacovigilance database. Reprod Toxicol. 2017;71:101-107. doi: 10.1016/j.reprotox.2017.04.007
81. Henson LJ, Afsar S, Davenport L, Purvis A, Poole EM, Truffinet P. Pregnancy outcomes in patients treated with leflunomide, the parent compound of the multiple sclerosis drug teriflunomide. Reprod Toxicol. 2020;95:45-50. doi: 10.1016/j.reprotox.2020.04.073
82. Chambers CD, Johnson DL, Robinson LK, Braddock SR, Xu R, Lopez-Jimenez J, et al. Birth outcomes in women who have taken leflunomide during pregnancy. Arthritis Rheum. 2010;62(5):1494-1503. doi: 10.1002/art.27358
83. Andersen JB, Wandall-Holm MF, Magyari M. Pregnancy outcomes following maternal or paternal exposure to teriflunomide in the Danish MS population. Mult Scler Relat Disord. 2022;59:103529.
84. Vukusic S, Coyle PK, Jurgensen S, Truffinet P, Benamor M, Afsar S, et al. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: Clinical study data and 5 years of post-marketing experience. Mult Scler. 2020;26(7):829-836. doi: 10.1016/j.msard.2022.103529
85. Drugs and Lactation Database (LactMed). URL: https://www. ncbi.nlm.nih.gov/books/NBK501922 (Accessed: 1st June 2024).
86. Boz C, Terzi M, Zengin Karahan S, Sen S, Sarac Y, Emrah Mavis M. Safety of IV pulse methylprednisolone therapy during breastfeeding in patients with multiple sclerosis. Mult Scler. 2018;24(9):1205-1211. doi: 10.1177/1352458517717806
87. Zengin Karahan S, Boz C, Terzi M, Aktoz G, Sen S, Ozbudun B, et al. Methylprednisolone concentrations in breast milk and serum of patients with multiple sclerosis treated with IV pulse methylprednisolone. Clin Neurol Neurosurg. 2020;197:106118. doi: 10.1016/j.clineuro.2020.106118
88. Aluko A, Ranganathan P. Pharmacogenetics of drug therapies in rheumatoid arthritis. Methods Mol Biol. 2022;2547:527-567. doi: 10.1007/978-1-0716-2573-6_19
89. Datta P, Baker T, Hale TW. Balancing the use of medications while maintaining breastfeeding. Clin Perinatol. 2019;46(2):367-382. doi: 10.1016/j.clp.2019.02.007
90. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi: 10.1089/bfm.2021.0110
91. Rød BE, Torkildsen Ø, Myhr KM, Bø L, Wergeland S. Safety of breast feeding during rituximab treatment in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022;94(1):38-41. doi: 10.1136/jnnp-2022-329545
92. Bosshard N, Zbinden A, Eriksson KK, Forger F. Rituximab and canakinumab use during lactation: No detectable serum levels in breastfed infants. Rheumatol Ther. 2021;8(2):1043-1048. doi: 10.1007/s40744-021-00313-z
93. Clowse ME, Forger F, Hwang C, Thorp J, Dolhain RJ, van Tubergen A, et al. Minimal to no transfer of certolizumab pegol into breast milk: Results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76(11):1890-1896. doi: 10.1136/annrheumdis-2017-211384
94. Perez-Garcia LF, Roder E, Smeele HTW, Goekoop R, Hazes JMW, Kok MR, et al. Paternal inflammatory arthritis is associated with a higher risk of miscarriage: Results of a large multicentre study (iFAME-Fertility). Rheumatology (Oxford). 2022;61(8):3390-3395. doi: 10.1093/rheumatology/keab910
95. Villiger PM, Caliezi G, Cottin V, Forger F, Senn A, Østensen M. Effects of TNF antagonists on sperm characteristics in patients with spondyloarthritis. Ann Rheum Dis. 2010;69(10):1842-1844. doi: 10.1093/rheumatology/keab910
96. Grosen A, Bungum M, Christensen LA, Cordelli E, Larsen OH, Leter G, et al. Semen quality and sperm DNA integrity in patients with severe active inflammatory bowel disease and effects of tumour necrosis factor-alpha inhibitors. J Crohns Colitis. 2019;13(5):564-571. doi: 10.1093/ecco-jcc/jjy198
97. Tiseo BC, Cocuzza M, Bonfa E, Srougi M, Silva CA. Male fertility potential alteration in rheumatic diseases: A systematic review. Int Braz J Urol. 2016;42(1):11-21. doi: 10.1590/S1677-5538.IBJU.2014.0595
98. Perez-Garcia LF, Dolhain RJEM, Vorstenbosch S, Bramer W, van Puijenbroek E, Hazes JMW, et al. The effect of paternal exposure to immunosuppressive drugs on sexual function, reproductive hormones, fertility, pregnancy and offspring outcomes: A systematic review. Hum Reprod Update. 2020;26(6):961-1001. doi: 10.1093/humupd/dmaa022
99. Mouyis M, Flint JD, Giles IP. Safety of anti-rheumatic drugs in men trying to conceive: A systematic review and analysis of published evidence. Semin Arthritis Rheum. 2019;48(5):911-920. doi: 10.1016/j.semarthrit.2018.07.011
100. Grosen A, Bellaguarda E, Nersting J, Hvas CL, Liljeqvist-Soltic I, Stein A, et al. Low-dose methotrexate therapy does not affect semen parameters and sperm DNA. Inflamm Bowel Dis. 2022;28(7):1012-1018. doi: 10.1093/ibd/izab205
101. Perez-Garcia LF, Roder E, Krijthe BP, Kranenburg-van Koppen LJ, van Adrichem R, Zirkzee E, et al. Is methotrexate safe for men with an immunemediated inflammatory disease and an active desire to become a father? Results of a prospective cohort study (iFAME-MTX). Ann Rheum Dis. 2023;82(8):1068-1075. doi: 10.1136/ard-2023-224032
102. Meserve J, Luo J, Zhu W, Veeravalli N, Bandoli G, Chambers CD, et al. Paternal exposure to immunosuppressive and/ or biologic agents and birth outcomes in patients with immunemediated inflammatory diseases. Gastroenterology. 2021;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020
103. EMA. Teriflunomide (Aubagio). Summary of product characteristics. URL: https://www.ema.europa.eu/en/documents/productinformation/aubagio-epar-product-information_en.pdf (Accessed: 1st June 2024).
104. Barbonetti A, Tienforti D, Castellini C, Giulio FD, Muselli M, Pizzocaro A, et al. Effect of antioxidants on semen parameters in men with oligoastheno-teratozoospermia: A network metaanalysis. Andrology. 2024;12(3):538-552. doi: 10.1111/andr.13498
105. Mulder RL, Font-Gonzalez A, Green DM, Loeffen EAH, Hudson MM, Loonen J, et al. Fertility preservation for male patients with childhood, adolescent, and young adult cancer: Recommendations from the PanCareLIFE Consortium and the International Late Effects of Childhood Cancer Guideline Harmonization Group. Lancet Oncol. 2021;22(2):e57-е67. doi: 10.1016/S14702045(20)30582-9
106. Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, et al. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: Results from the phase 2, randomised, double-blind, placebocontrolled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023;82(8):1049-1058. doi: 10.1136/ard-2023-224017
107. Mahadevan U, Dubinsky MC, Su C, Lawendy N, Jones TV, Marren A, et al. Outcomes of pregnancies with maternal/paternal exposure in the tofacitinib safety databases for ulcerative colitis. Inflamm Bowel Dis. 2018;24(12):2494-2500. doi: 10.1093/ibd/izy160
108. Giles I, Yee CS, Gordon C. Stratifying management of rheumatic disease for pregnancy and breastfeeding. Nat Rev Rheumatol. 2019;15:391-402. doi: 10.1038/s41584-019-0240-8
109. Giles I, Thorne I, Schmidt NS, Reid C, Crossley A, Panca M, et al. The time of equipoise on the use of biological DMARDs in for inflammatory arthritis during pregnancy is finally over: A reappraisal of evidence to optimise pregnancy management. Lancet Rheumatol. 2024;6:e546-e559. doi: 10.1016/S26659913(24)00097-3
110. Bermas BL, Tassinari M, Clowse M, Chakravarty E. The new FDA labeling rule: Impact on prescribing rheumatological medications during pregnancy. Rheumatology. 2018;57(Suppl 5):2-8. doi: 10.1093/rheumatology/key010
111. Andreoli L, Crisafulli F, Tincani A. Pregnancy and reproductive aspects of systemic lupus erythematosus. Curr Opin Rheumatol. 2017;29:473-479. doi: 10.1097/BOR.0000000000000415
112. Rosta K, Binder J, Kuczwara V, Horvath M, Heinzl F, Hörhager C, et al. Periconceptional counselling in women with autoimmune inflammatory rheumatic diseases. J Clin Med. 2024;13:2483. doi: 10.3390/jcm13092483
113. Schreiber K, Frishman M, Russell MD, Dey M, Flint J, Allen A, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Comorbidity medications used in rheumatology practice. Rheumatology (Oxford). 2023;62(4):e89-e104. doi: 10.1093/rheumatology/keac552
114. Sammaritano LR. Contraception and preconception counseling in women with autoimmune disease. Best Pract Res Clin Obstet Gynaecol. 2020;64:11-23. doi: 10.1016/j.bpobgyn.2019.09.003
115. Yeung CHT, Houle SKD, Anderson PO, Best BM, Dubinsky S, Edginton AN. Addressing maternal medication use during breastfeeding using clinical resources and a novel physiologically based pharmacokinetic model-derived metric: A qualitative study. Front Pediatr. 2023;11:1147566. doi: 10.3389/fped.2023.1147566
116. Schreiber K, Graversgaard C, Hunt BJ, Wason JMS, CostedoatChalumeau N, Aguilera S, et al. Challenges of designing and conducting cohort studies and clinical trials in populations of pregnant people. Lancet Rheumatol. 2024;6(8):e560-e572. doi: 10.1016/S2665-9913(24)00118-8
Рецензия
Для цитирования:
Кошелева Н.М., Решетняк Т.М., Клименченко Н.И., Насонов Е.Л. Рекомендации EULAR 2024 года по применению противоревматических препаратов в репродуктивном периоде, во время беременности и лактации, комментарии к ним. Научно-практическая ревматология. 2025;63(6):576-591. https://doi.org/10.47360/1995-4484-2025-576-591
For citation:
Kosheleva N.M., Reshetnyak T.M., Klimenchenko N.I., Nasonov E.L. EULAR 2024 recommendations on the use of antirheumatic drugs in reproduction, pregnancy and lactation and comments on them. Rheumatology Science and Practice. 2025;63(6):576-591. (In Russ.) https://doi.org/10.47360/1995-4484-2025-576-591
Просмотров:
16
Послать статью по эл. почте 