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Original Article
Pregnancy outcome in women with inflammatory bowel disease treated with anti-tumor necrosis factor and/or thiopurine therapy: a multicenter study from Japan
Shunsuke Komoto, Satoshi Motoya, Yuji Nishiwaki, Toshiyuki Matsui, Reiko Kunisaki, Katsuyoshi Matsuoka, Naoki Yoshimura, Takashi Kagaya, Makoto Naganuma, Nobuyuki Hida, Mamoru Watanabe, Toshifumi Hibi, Yasuo Suzuki, Soichiro Miura, Ryota Hokari
Intest Res 2016;14(2):139-145.   Published online April 27, 2016
DOI: https://doi.org/10.5217/ir.2016.14.2.139
AbstractAbstract PDFPubReaderePub
<b>Background/Aims</b><br/>

Anti-tumor necrosis factor drugs (anti-TNF) and thiopurines are important treatment options in patients with inflammatory bowel disease (IBD), including during pregnancy. However, there are limited data on the benefit/risk profile of anti-TNF and thiopurines during pregnancy in Asia. The aim of this study was to analyze pregnancy outcomes of female Japanese IBD patients treated with anti-TNF and/or thiopurines.

Methods

This cross-sectional study assessed pregnancy outcomes in 72 women with IBD. Pregnancy outcomes were compared among 31 pregnancies without exposure to infliximab (IFX), adalimumab (ADA), or thiopurines; 24 pregnancies with exposure to anti-TNF treatment (23 IFX, 1 ADA); 7 pregnancies with exposure to thiopurines alone; and 10 pregnancies with exposure to both IFX and thiopurines.

Results

Thirty-five of the 41 pregnancies (85.3%) that were exposed to anti-TNF treatment and/or thiopurines resulted in live births after a median gestational period of 38 weeks. Of the 35 live births, 3 involved premature deliveries; 7, low birth weight; and 1, a congenital abnormality. There were 6 spontaneous abortions in pregnancies that were exposed to anti-TNF treatment (17.7%). Pregnancy outcomes among the 4 groups were similar, except for the rate of spontaneous abortions (P =0.037).

Conclusions

Exposure to anti-TNF treatment or thiopurines during pregnancy was not related to a higher incidence of adverse pregnancy outcomes in Japanese IBD patients except for spontaneous abortion.

Citations

Citations to this article as recorded by  
  • North American clinical practice guidelines for the medical management of hidradenitis suppurativa in special patient populations
    Raed Alhusayen, Serena Dienes, Megan Lam, Afsaneh Alavi, Ali Alikhan, Maria Aleshin, Emad Bahashwan, Steve Daveluy, Noah Goldfarb, Amit Garg, Wayne Gulliver, Tarannum Jaleel, Alexa B. Kimball, Mark G. Kirchhof, Joslyn Kirby, Joi Lenczowski, Hadar Lev-Tov,
    Journal of the American Academy of Dermatology.2025; 92(4): 825.     CrossRef
  • A retrospective study of neonatal and pregnancy outcomes in pregnant women suffering from inflammatory arthropathy treated with adalimumab
    Navid Najarpour, Elham Rajaei, Karim Mowla, Alireza Ghanbaran
    Revista Colombiana de Reumatología.2024; 31(3): 290.     CrossRef
  • Anti-tumor necrosis factor-α therapy may not be safe during pregnancy in women with inflammatory bowel disease: an updated meta-analysis and systematic review
    Wei Huang, Xinxing Zhang, Li Zhang, Xiaosong Dai, Heping Chen, Qin Xie
    BMC Pregnancy and Childbirth.2024;[Epub]     CrossRef
  • A retrospective study of neonatal and pregnancy outcomes in pregnant women suffering from inflammatory arthropathy treated with adalimumab
    Navid Najarpour, Elham Rajaei, Karim Mowla, Alireza Ghanbaran
    Revista Colombiana de Reumatología (English Edition).2024; 31(3): 290.     CrossRef
  • Ulcerative Colitis in Pregnancy: A Japanese Multicenter Cohort Study Focusing on Their Mutual Influence
    Yuichi Shimodate, Akiko Shiotani, Ken-ichi Tarumi, Hiroshi Matsumoto, Osamu Handa, Noriaki Tomioka, Naoyuki Nishimura, Kazuhiro Matsueda, Hirokazu Mouri, Motowo Mizuno
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  • The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
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    Biomedicine & Pharmacotherapy.2023; 157: 114081.     CrossRef
  • Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy
    Nahla A. Azzam, Abdulelah Almutairdi, Hajer Y. Almudaiheem, Turki AlAmeel, Shakir A. Bakkari, Othman R. Alharbi, Khalidah A. Alenzi, Maha A. AlMolaiki, Bedor A. Al-Omari, Rayan G. Albarakati, Ahmed H. Al-Jedai, Omar I. Saadah, Majid A. Almadi, Badr Al-Baw
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  • Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis
    Ole Haagen Nielsen, John Mark Gubatan, Carsten Bogh Juhl, Sarah Elizabeth Streett, Cynthia Maxwell
    Clinical Gastroenterology and Hepatology.2022; 20(1): 74.     CrossRef
  • British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids
    Mark D Russell, Mrinalini Dey, Julia Flint, Philippa Davie, Alexander Allen, Amy Crossley, Margreta Frishman, Mary Gayed, Kenneth Hodson, Munther Khamashta, Louise Moore, Sonia Panchal, Madeleine Piper, Clare Reid, Katherine Saxby, Karen Schreiber, Naz Se
    Rheumatology.2022;[Epub]     CrossRef
  • Association between Thiopurines Use and Pregnancy Outcomes in Female Patients with Inflammatory Bowel Disease: A Meta-Analysis
    Yang Zhang, Dandan Li, Heng Guo, Weina Wang, Xingang Li, Su Shen
    Current Pharmaceutical Design.2021; 27(19): 2317.     CrossRef
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    Drug Safety.2020; 43(2): 147.     CrossRef
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    The Korean Journal of Internal Medicine.2020; 35(1): 41.     CrossRef
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    Journal of Rheumatic Diseases.2020; 27(1): 4.     CrossRef
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    Nicole W Tsao, Nevena Rebic, Larry D Lynd, Mary A De Vera
    Rheumatology.2020; 59(8): 1808.     CrossRef
  • Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review
    N. Ghalandari, R. J. E. M. Dolhain, J. M. W. Hazes, E. P. van Puijenbroek, M. Kapur, H. J. M. J. Crijns
    Drugs.2020; 80(16): 1699.     CrossRef
  • Pregnancy and Neuromyelitis Optica Spectrum Disorder – Reciprocal Effects and Practical Recommendations: A Systematic Review
    Rohan D'Souza, Danielle Wuebbolt, Katarina Andrejevic, Rizwana Ashraf, Vanessa Nguyen, Nusrat Zaffar, Dalia Rotstein, Ahraaz Wyne
    Frontiers in Neurology.2020;[Epub]     CrossRef
  • Relationship between the Clinical Course of Ulcerative Colitis during Pregnancy and the Outcomes of Pregnancy: A Retrospective Evaluation
    Ayumi Ito, Bunei Iizuka, Teppei Omori, Shinichi Nakamura, Katsutoshi Tokushige
    Internal Medicine.2018; 57(2): 159.     CrossRef
  • The use of biologics and small molecules in pregnant patients with rheumatic diseases
    Maria Gerosa, Lorenza Maria Argolini, Carolina Artusi, Cecilia Beatrice Chighizola
    Expert Review of Clinical Pharmacology.2018; 11(10): 987.     CrossRef
  • Long-term clinical outcome after infliximab discontinuation in patients with inflammatory bowel disease
    Ji Min Lee, Yoon Jae Kim, Kang-Moon Lee, Hyuk Yoon, Bo-In Lee, Dae Bum Kim, Donghoon Kang
    Scandinavian Journal of Gastroenterology.2018; 53(10-11): 1280.     CrossRef
  • Impact of inflammatory bowel disease activity and thiopurine therapy on birth weight: A meta-analysis
    Begoña Gonzalez-Suarez, Shreyashee Sengupta, Alan C Moss
    World Journal of Gastroenterology.2017; 23(45): 8082.     CrossRef
  • Maternal and fetal outcomes in pregnant Japanese women with inflammatory bowel disease: our experience with a series of 23 cases
    Naoki Minami, Minoru Matsuura, Yorimitsu Koshikawa, Satoshi Yamada, Yusuke Honzawa, Shuji Yamamoto, Hiroshi Nakase
    Intestinal Research.2017; 15(1): 90.     CrossRef
  • Concerns in pregnancy and childbirth of women with inflammatory bowel disease
    Sung-Ae Jung
    Intestinal Research.2016; 14(2): 107.     CrossRef
  • Common Adverse Effects of Anti-TNF Agents on Gestation
    Zacharias Fasoulakis, Panagiotis Antsaklis, Nikolaos Galanopoulos, Emmanuel Kontomanolis
    Obstetrics and Gynecology International.2016; 2016: 1.     CrossRef
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Statement
Use of Thiopurines in Inflammatory Bowel Disease: A Consensus Statement by the Korean Association for the Study of Intestinal Diseases (KASID)
Kang-Moon Lee, You Sun Kim, Geom Seog Seo, Tae Oh Kim, Suk-Kyun Yang, IBD Study Group of the Korean Association for the Study of Intestinal Diseases
Intest Res 2015;13(3):193-207.   Published online June 9, 2015
DOI: https://doi.org/10.5217/ir.2015.13.3.193
AbstractAbstract PDFPubReader
<b>Background/Aims</b><br/>

For decades, thiopurines have been the mainstay of inflammatory bowel disease (IBD) treatment and will play an important role in the future. However, complex metabolism and various side effects limit the use of these potent drugs in clinical practice. The Korean Association for the Study of Intestinal Diseases developed a set of consensus statements with the aim of guiding clinicians on the appropriate use of thiopurines in the management of IBD.

Methods

Sixteen statements were initially drafted by five committee members. The quality of evidence and classification of recommendation were assessed according to the Grading of Recommendations Assessment, Development and Evaluation system. The statements were then circulated to IBD experts in Korea for review, feedback, and then finalized and accepted by voting at the consensus meeting.

Results

The consensus statements comprised four parts: (1) pre-treatment evaluation and management strategy, including value of thiopurine S-methyltransferase screening, dosing schedule, and novel biomarkers for predicting thiopurine-induced leukopenia; (2) treatment with thiopurines with regards to optimal duration of thiopurine treatment and long-term outcomes of combination therapy with anti-tumor necrosis factors; (3) safety of thiopurines, especially during pregnancy and lactation; and (4) monitoring side effects or efficacy of therapy using biomarkers.

Conclusions

Thiopurines are an effective treatment option for patients with IBD. Management decisions should be individualized according to the risk of relapse and adverse events.

Citations

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