Characteristics of inflammatory bowel diseases and therapeutic approaches in the era of biologics in pregnant women: risks and recommendations
Ibraimov E.E., Barieva L.S., Rumyantseva Z.S., Sulima A.N., Reznichenko N.A., Beglitse D.A., Rumyantseva E.S., Berberov R.A., Yuzbashev E.R.
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.
Authors’ contributions: Ibraimov E.E., Barieva L.S., Rumyantseva E.S. – collecting and processing the material, writing the text; Rumyantseva Z.S., Reznichenko N.A., Beglitse D.A. – developing the concept and design of the study; Sulima A.N., Berberov R.A., Yuzbashev E.R. – final editing.
Conflicts of interest: Authors declare lack of the possible conflicts of interest.
Funding: None of the authors has a financial interest in the submitted materials or methods. The study was conducted without sponsorship.
For citation: Ibraimov E.E., Barieva L.S., Rumyantseva Z.S., Sulima A.N., Reznichenko N.A., Beglitse D.A., Rumyantseva E.S., Berberov R.A., Yuzbashev E.R. Characteristics of inflammatory bowel diseases and
therapeutic approaches in the era of biologics in pregnant women: risks and recommendations.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; (7): 19-26 (in Russian)
https://dx.doi.org/10.18565/aig.2025.63
Keywords
pregnancy
inflammatory bowel diseases
biological agents
biologics
therapy
References
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)].
- 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
- 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
- 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
- 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
- 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
- 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
Received 06.03.2025
Accepted 04.06.2025
About the Authors
Emirasan E. Ibraimov, student, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, emir24092002@gmail.com, https://orcid.org/0009-0008-1965-2566Liya S. Barieva, student, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia,
Republic of Crimea, Simferopol, Lenin blvd., 5/7, barieva2003@gmail.com, https://orcid.org/0009-0000-4852-5162
Zoya S. Rumyantseva, PhD, Associate Professor, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, zoyarum@inbox.ru, https://orcid.org/0000-0002-1711-021X
Anna N. Sulima, Dr. Med. Sci., Professor, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, gsulima@yandex.ru, https://orcid.org/0000-0002-2671-6985
Natalia A. Reznichenko, Dr. Med. Sci., Professor, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, professorreznichenko@mail.ru, https://orcid.org/0000-0003-3396-1046
Dmitrii A. Beglitse, PhD, Associate Professor, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, 9999@gmail.com, https://orcid.org/0000-0003-1278-0393
Ekaterina S. Rumyantseva, student, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, rumiantseva.e.s@mail.ru, https://orcid.org/0009-0007-5371-3820
Ruslan A. Berberov, Head of Coloproctology Department, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, emir99185@gmail.com, https://orcid.org/0009-0000-7175-5310
Eldar R. Yuzbashev, coloproctologist, Order of the Labor Red Banner Medical Institute named after S.I. Georgievsky of V.I. Vernadsky Crimean Federal University, 295051, Russia, Republic of Crimea, Simferopol, Lenin blvd., 5/7, eldar21063@mail.ru, https://orcid.org/0009-0003-6990-194X
Corresponding author: Anna N. Sulima, gsulima@yandex.ru
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