Characteristics of inflammatory bowel diseases and therapeutic approaches in the era of biologics in pregnant women: risks and recommendations

Cover Page

Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

This review article analyzes the available data on the use of biological therapy in pregnant women with inflammatory bowel diseases (IBD). Special attention is given to the safety and efficacy of biological agents, as well as potential risks and complications.

Objective: To identify possible optimal therapeutic strategies based on current scientific evidence and clinical observations.

Materials and methods: For the study, a thorough search was carried out for both Russian and international scientific publications on the PubMed platform, including articles, reviews, and meta-analyses published up to 2024. The study is based on the current clinical guidelines of the Russian Federation, as well as international guidelines such as ECCO and NICE. Particular attention was paid to modern data and approaches related to the use of biological drugs in pregnant women with IBD.

Results: The treatment of IBD in pregnant women should be based on an integrated approach, including close collaboration of specialists from various fields, namely gastroenterologists, obstetricians-gynecologists, and colorectal surgeons. To date, the most commonly studied biological drugs used by pregnant women are TNF-α inhibitors. These drugs have a good safety profile for both the mother and the fetus. Vedolizumab and ustekinumab have a similar safety profile to anti-TNF drugs. However, their prescription should be discussed with the patient, taking into account the risks associated with discontinuation or continuation of therapy, as well as the possible impact on the course of pregnancy. Janus kinase inhibitors are the least studied biological drugs used during pregnancy. Due to the potential risks and lack of data, their use should be avoided during pregnancy and after childbirth, especially during breastfeeding.

Conclusion: Biologics are a proven and relatively safe method for maintaining remission, which increases the chances of successful pregnancy and minimizes the risk of complications. However, the safety issues for the fetus and the potential long-term consequences of using such medications remain poorly understood. This requires further research and close medical supervision.

Full Text

Restricted Access

About the authors

Emirasan E. Ibraimov

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: emir24092002@gmail.com
ORCID iD: 0009-0008-1965-2566

Student

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Liya S. Barieva

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: barieva2003@gmail.com
ORCID iD: 0009-0000-4852-5162

Student

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Zoya S. Rumyantseva

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: zoyarum@inbox.ru
ORCID iD: 0000-0002-1711-021X

PhD, Associate Professor

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Anna N. Sulima

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Author for correspondence.
Email: gsulima@yandex.ru
ORCID iD: 0000-0002-2671-6985

Dr. Med. Sci., Professor

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Natalia A. Reznichenko

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: professorreznichenko@mail.ru
ORCID iD: 0000-0003-3396-1046

Dr. Med. Sci., Professor

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Dmitry A. Beglitse

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: 9999@gmail.com
ORCID iD: 0000-0003-1278-0393

PhD, Associate Professor

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Ekaterina S. Rumyantseva

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: rumiantseva.e.s@mail.ru
ORCID iD: 0009-0007-5371-3820

Student

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Ruslan A. Berberov

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: emir99185@gmail.com
ORCID iD: 0009-0000-7175-5310

Head of the Coloproctology Department

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

Eldar R. Yuzbashev

Georgievsky Medical Institute of the Vernadsky Crimean Federal University

Email: eldar21063@mail.ru
ORCID iD: 0009-0003-6990-194X

Coloproctologist

Russian Federation, 5/7, Lenin Blvd., Simferopol, Republic of Crimea, 295051

References

  1. Sandborn W.J., Feagan B.G., Hanauer S.B., Lochs H., Löfberg R., Modigliani R. et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn’s disease. Gastroenterology. 2002; 122(2): 512-30. https://dx.doi.org/10.1053/gast.2002.31072
  2. Белоусова Е.А., Шелыгин Ю.А., Ачкасов С.И., Хатьков И.Е., Бакулин И.Г., Скалинская М.И., Князев О.В., Каграманова А.В., Шкурко Т.В., Нанаева Б.А., Никитина Н.В., Захарова М.Н., Тарасова Л.В., Алексеева О.П., Злобин М.В., Павленко В.В., Мищенко Е.В., Долгушина А.И., Лахин А.В., Ткачев А.В., Абдулганиева Д.И., Васильева О.В., Губонина И.В. Клинико-демографические характеристики и лечебные подходы у пациентов с воспалительными заболеваниями кишечника (болезнь Крона, язвенный колит) в РФ. Первые результаты анализа Национального Регистра. Колопроктология. 2023; 22(1): 65-82. [Belousova E.A., Shelygin Yu.A., Achkasov S.I., Khatkov I.E., Bakulin I.G., Skalinskaya M.I., Knyazev O.V., Kagramanova A.V., Shkurko T.V., Nanaeva B.A., Nikitina N.V., Zakharova M.N., Tarasova L.V., Alekseeva O.P., Zlobin M.V., Pavlenko V.V., Mishchenko E.V., Dolgushina A.I., Lakhin A.V., Tkachev A.V., Abdulganieva D.I., Vasilyeva O.V., Gubonina I.V. Clinical and demographic features and treatment approaches for inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the Russia. The primery results of the analysis of the National Register. Koloproktologia. 2023; 22(1): 65-82 (in Russian)]. https://dx.doi.org/10.33878/2073-7556-2023-22-1-65-82
  3. Tavernier N., Fumery M., Peyrin-Biroulet L., Colombel J.F., Gower-Rousseau C. Systematic review: fertility in non-surgically treated inflammatory bowel disease. Aliment. Pharmacol. Ther. 2013; 38(8): 847-53. https://dx.doi.org/10.1111/apt.12478
  4. Hudson M., Flett G., Sinclair T.S., Brunt P.W., Templeton A., Mowat N.A. Fertility and pregnancy in inflammatory bowel disease. Int. J. Gynaecol. Obstet. 1997; 58(2): 229-37. https://dx.doi.org/10.1016/s0020-7292(97)00088-x
  5. Oresland T., Palmblad S., Ellström M., Berndtsson I., Crona N., Hultén L. Gynaecological and sexual function related to anatomical changes in the female pelvis after restorative proctocolectomy. Int. J. Colorectal. Dis. 1994; 9(2): 77-81. https://dx.doi.org/10.1007/BF00699417
  6. Alves A., Panis Y., Bouhnik Y., Maylin V., Lavergne-Slove A., Valleur P. Subtotal colectomy for severe acute colitis: a 20-year experience of a tertiary care center with an aggressive and early surgical policy. J. Am. Coll. Surg. 2003; 197(3): 379-85. https://dx.doi.org/10.1016/S1072-7515(03)00434-4
  7. Berg D.F., Bahadursingh A.M., Kaminski D.L., Longo W.E. Acute surgical emergencies in inflammatory bowel disease. Am. J. Surg. 2002; 184(1): 45-51. https://dx.doi.org/10.1016/s0002-9610(02)00879-6
  8. Hyman N.H., Cataldo P., Osler T. Urgent subtotal colectomy for severe inflammatory bowel disease. Dis. Colon. Rectum. 2005; 48(1): 70-3. https://dx.doi.org/10.1007/s10350-004-0750-5
  9. Pacilli M., Sanchez-Velázquez P., Abad M., Luque E., Burdio F., Ielpo B. Minimally invasive subtotal cholecystectomy. What surgeons need to know. Updates Surg. 2024; 76(7): 2709-13. https://dx.doi.org/10.1007/ s13304-024-01995-0
  10. Marceau C., Alves A., Ouaissi M., Bouhnik Y., Valleur P., Panis Y. Laparoscopic subtotal colectomy for acute or severe colitis complicating inflammatory bowel disease: a case-matched study in 88 patients. Surgery. 2007; 141(5): 640-4. https://dx.doi.org/10.1016/j.surg.2006.12.012
  11. Barberio B., Segal J.P., Quraishi M.N., Black C.J., Savarino E.V., Ford A.C. Efficacy of oral, topical, or combined oral and topical 5-aminosalicylates, in ulcerative colitis: systematic review and network meta-analysis. J. Crohn’s Colitis. 2021; 15(7): 1184-96. https://dx.doi.org/10.1093/ecco-jcc/jjab010
  12. Wang Y., Parker C.E., Feagan B.G., MacDonald J.K. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst. Rev. 2016; 2016(5): CD000544. https://dx.doi.org/10.1002/ 14651858.CD000544.pub4
  13. Nørgård B., Fonager K., Pedersen L., Jacobsen B.A., Sørensen H.T. Birth outcome in women exposed to 5-aminosalicylic acid during pregnancy: a Danish cohort study. Gut. 2003; 52(2): 243-7. https://dx.doi.org/10.1136/gut.52.2.243
  14. Lennard-Jones J.E., Longmore A.J., Newell A.C., Wilson C.W., Jones F.A. An assessment of prednisone, salazopyrin, and topical hydrocortisone hemisuccinate used as out-patient treatment for ulcerative colitis. Gut. 1960; 1(3): 217-22. https://dx.doi.org/10.1136/gut.1.3.217
  15. Truelove S.C., Watkinson G., Draper G. Comparison of corticosteroid and sulphasalazine therapy in ulcerative colitis. Br. Med. J. 1962; 2(5321): 1708-11. https://dx.doi.org/10.1136/bmj.2.5321.1708
  16. 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. https://dx.doi.org/10.1016/ j.reprotox.2003.10.007
  17. Bermas B.L., Hill J.A. Effects of immunosuppressive drugs during pregnancy. Arthritis Rheum. 1995; 38(12): 1722-32. https://dx.doi.org/10.1002/art.1780381203
  18. Mahadevan U., Long M.D., Kane S.V., Roy A., Dubinsky M.C., Sands B.E. et al.; Crohn’s Colitis Foundation Clinical Research Alliance. Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease. Gastroenterology. 2021; 160(4): 1131-9. https://dx.doi.org/10.1053/j.gastro.2020.11.038
  19. Luu M., Benzenine E., Doret M., Michiels C., Barkun A., Degand T. et al. Continuous anti-TNFα use throughout pregnancy: possible complications for the mother but not for the fetus. A retrospective cohort on the French National Health Insurance Database (EVASION). Am. J. Gastroenterol. 2018; 113(11): 1669-77. https://dx.doi.org/10.1038/s41395-018-0176-7
  20. Liu E., Chatten K., Limdi J.K. Conception, pregnancy and inflammatory bowel disease – current concepts for the practising clinician. Indian J. Gastroenterol. 2024 May 15. https://dx.doi.org/10.1007/s12664-024-01563-9
  21. Nielsen O.H., Gubatan J.M., Juhl C.B., Streett S.E., 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. https://dx.doi.org/10.1016/j.cgh.2020.09.021
  22. Zelinkova Z., Ent C. van der, Bruin K.F., Baalen O. van, Vermeulen H.G., Smalbraak H.J. 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; 11(3): 318-21. https:// dx.doi.org/10.1016/j.cgh.2012.10.024
  23. Халиф И.Л., Шапина М.В. Применение ведолизумаба при воспалительных заболеваниях кишечника. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2016; 26(6): 92-100. [Halif I.L., Shapina M.V. The use of vedolizumab in inflammatory bowel diseases. Russian journal of gastroenterology, hepatology, and coloproctology. 2016; 26(6): 92-100 (in Russian)]. https://dx.doi.org/10.22416/1382-4376-2016-6-92-100
  24. Mahadevan U., Vermeire S., Lasch K., Abhyankar B., Bhayat F., Blake A. et al. Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease. Aliment. Pharmacol. Ther. 2017; 45(7): 941-50. https://dx.doi.org/10.1111/apt.13960
  25. Скалинская М.И., Бакулин И.Г., Жигалова Т.Н., Сказываева Е.В., Ситкин С.И., Каменский А.А. Воспалительные заболевания кишечника и беременность: от мирового опыта к собственным наблюдениям. Экспериментальная и клиническая гастроэнтерология. 2017; (7): 184-91. [Skalinskaya M.I., Bakulin I.G., Zhigalova T.N., Skazyvaeva E.V., Sitkin S.I., Kamensky A.A. Inflammatory bowel disease and pregnancy: from world experience to own observations. Experimental and Clinical Gastroenterology. 2017; 143(7): 184-91 (in Russian)].
  26. Moens A., van der Woude C.J., Julsgaard M., Humblet E., Sheridan J., Baumgart D.C. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Aliment. Pharmacol. Ther. 2020; 51(1): 129-38. https://dx.doi.org/10.1111/apt.15539
  27. Martin P.L., Sachs C., Imai N., Tsusaki H., Oneda S., Jiao Q. et al. Development in the cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactation. Birth Defects Res. B. Dev. Reprod. Toxicol. 2010; 89(5): 351-63. https:// dx.doi.org/10.1002/bdrb.20250
  28. Gisbert J.P., Chaparro M. Safety of new biologics (vedolizumab and ustekinumab) and small molecules (tofacitinib) during pregnancy: a review. Drugs. 2020; 80(11): 1085-100. https://dx.doi.org/10.1007/s40265-020-01346-4
  29. Flanagan E., Prentice R., Wright E.K., Gibson P.R., Ross A.L., Begun J. et al. Ustekinumab levels in pregnant women with inflammatory bowel disease and infants exposed in utero. Aliment. Pharmacol. Ther. 2022; 55(6): 700-4. https://dx.doi.org/10.1111/apt.16739
  30. Sandborn W.J., Su C., Sands B.E., D'Haens G.R., Vermeire S., Schreiber S. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N. Engl. J. Med. 2017; 376(18): 1723-36. https://dx.doi.org/10.1056/NEJMoa1606910
  31. Winter R., Nørgård B.M., Friedman S. Treatment of the pregnant patient with inflammatory bowel disease. Inflamm. Bowel Dis. 2016; 22(3): 733-44. https://dx.doi.org/10.1097/MIB.0000000000000625

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2025 Bionika Media