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Non-adherence to Medications in Pregnant Ulcerative Colitis Patients Contributes to Disease Flares and Adverse Pregnancy Outcomes

Digestive Diseases and Sciences volume 66, pages 577–586 (2021)Cite this article

Abstract

Background

Adherence to medications is important to maintain disease under control and to prevent complications in pregnant patients with ulcerative colitis (UC). To evaluate the incidence of non-adherence during pregnancy and its effect on relapse and pregnancy outcomes, we conducted a multicenter prospective study using a patient self-reporting system without physician interference.

Methods

Sixty-eight pregnant UC women were recruited from 17 institutions between 2013 and 2019. During the course of pregnancy, questionnaires were collected separately from patients and physicians, to investigate the true adherence to medications, disease activity, and birth outcomes. Multivariable logistic regression analysis was performed to identify the risk factors for the relapse or adverse pregnancy outcomes.

Results

Of 68 pregnancy, 15 adverse pregnancy outcomes occurred in 13 patients. The rate of self-reported non-adherence was the greatest to mesalamines in the first trimester, which was significantly higher than physicians’ estimate (p = 0.0116), and discontinuation was observed in 42.1% of non-adherent group. Logistic regression analysis revealed non-adherence as an independent risk factor for relapse [odds ratio (OR) 7.659, 95% CI 1.928–30.427, p = 0.038], and possibly for adverse pregnancy outcome (OR 8.378, 95% CI 1.350–51.994, p = 0.023). Among the subgroup of patients treated with oral mesalamine alone, the non-adherence was confirmed to be an independent risk factor for relapse (p = 0.002).

Conclusion

Non-adherence to mesalamine was underestimated by physicians in pregnant UC patients and contributed to disease relapse and possibly on pregnancy outcomes. Preconceptional education regarding safety of medications and risk of self-discontinuation is warranted.

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Abbreviations

OR:

Odds ratio

CI:

Confidence interval

IBD:

Inflammatory bowel disease

UC:

Ulcerative colitis

LBW:

Low birth weight

VAS:

Visual analogue scale

TNF:

Tumor necrosis factor

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Acknowledgments

This study was supported by a Grant-in-Aid for the Intractable Disease Project of the Ministry of Health, Labour and Welfare of Japan, and by Grants-in-Aid for Scientific Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology. Special thanks to Makiko Oda for her professional help with analyzing data statistically.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, National Defense Medical College, 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan

    Chikako Watanabe & Ryota Hokari

  2. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan

    Masakazu Nagahori & Toshimitsu Fujii

  3. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitazato, Minami, Sagamihara, Kanagawa, 252-0374, Japan

    Kaoru Yokoyama

  4. Division of IBD, Department of Internal Medicine, Tokyo Yamate Medical Center, 3-22-1 Hyakunincho, Shinjuku-ku, Tokyo, 169-0073, Japan

    Naoki Yoshimura

  5. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8462, Japan

    Taku Kobayashi & Toshifumi Hibi

  6. Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan

    Hirokazu Yamagami

  7. Department of Gastroenterology, Kanazawa University Hospital, 13-1 Takaracho, Kanazawa, Ishikawa, 920-8641, Japan

    Kazuya Kitamura

  8. Department of Gastroenterology, National Hospital Organization Kanazawa Medical Center, 1-1 Shimoishihikicho, Kanazawa, Ishikawa, 920-8650, Japan

    Kagaya Takashi

  9. Department of Inflammatory Bowel Disease, Hyogo College of Medicine, 1-1 Mukogawacho, Nishinomiya, Hyogo, 663-8501, Japan

    Shiro Nakamura

  10. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan

    Makoto Naganuma

  11. Department of Gastroenterology, Shimane University School of Medicine, 1060 Nishikawatsu-cho, Matsue-shi, Shimane, 690-8504, Japan

    Shunji Ishihara

  12. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582, Japan

    Motohiro Esaki

  13. Department of Internal Medicine and Gastroenterology, Tokyo Women’s Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan

    Maria Yonezawa

  14. Inflammatory Bowel Disease Center, Yokohama City University Medical Center, 4-57 Urafunecho, Minami-ku, Yokohama-City, Kanagawa, 232-0024, Japan

    Reiko Kunisaki

  15. Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, 5841 S. Maryland Ave. MC 4076, Chicago, IL, 60637, USA

    Atsushi Sakuraba

  16. Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan

    Naoaki Kuji

  17. International University of Health and Welfare Graduate School, 4-1-26 Akasaka, Minato ku, Tokyo, 107-8402, Japan

    Soichiro Miura

  18. Department of Internal Medicine, Sakura Medical Center, Toho University, 564-1 Shimoshizu, Sakura, Chiba, 285-8741, Japan

    Yasuo Suzuki

Authors
  1. Chikako Watanabe
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  2. Masakazu Nagahori
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  3. Toshimitsu Fujii
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  4. Kaoru Yokoyama
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  5. Naoki Yoshimura
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  6. Taku Kobayashi
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  7. Hirokazu Yamagami
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  8. Kazuya Kitamura
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  9. Kagaya Takashi
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  10. Shiro Nakamura
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  11. Makoto Naganuma
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  12. Shunji Ishihara
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  13. Motohiro Esaki
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  14. Maria Yonezawa
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  15. Reiko Kunisaki
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  16. Atsushi Sakuraba
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  17. Naoaki Kuji
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  18. Soichiro Miura
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  19. Toshifumi Hibi
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  20. Yasuo Suzuki
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  21. Ryota Hokari
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Corresponding author

Correspondence to Chikako Watanabe.

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Cite this article

Watanabe, C., Nagahori, M., Fujii, T. et al. Non-adherence to Medications in Pregnant Ulcerative Colitis Patients Contributes to Disease Flares and Adverse Pregnancy Outcomes. Dig Dis Sci 66, 577–586 (2021). https://doi.org/10.1007/s10620-020-06221-6

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  • DOI: https://doi.org/10.1007/s10620-020-06221-6

Keywords

  • Adherence
  • Pregnant
  • Ulcerative colitis
  • Mesalamine