Chikako Watanabe1, Masakazu Nagahori2, Toshimitsu Fujii2, Kaoru Yokoyama3, Naoki Yoshimura4, Taku Kobayashi5, Hirokazu Yamagami6, Kazuya Kitamura7, Kagaya Takashi8, Shiro Nakamura9, Makoto Naganuma10, Shunji Ishihara11, Motohiro Esaki12, Maria Yonezawa13, Reiko Kunisaki14, Atsushi Sakuraba15, Naoaki Kuji16, Soichiro Miura17, Toshifumi Hibi5, Yasuo Suzuki18, Ryota Hokari19. 1. Department of Internal Medicine, National Defense Medical College, 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan. yqw03070@nifty.com. 2. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan. 3. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitazato, Minami, Sagamihara, Kanagawa, 252-0374, Japan. 4. Division of IBD, Department of Internal Medicine, Tokyo Yamate Medical Center, 3-22-1 Hyakunincho, Shinjuku-ku, Tokyo, 169-0073, Japan. 5. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8462, Japan. 6. Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan. 7. Department of Gastroenterology, Kanazawa University Hospital, 13-1 Takaracho, Kanazawa, Ishikawa, 920-8641, Japan. 8. Department of Gastroenterology, National Hospital Organization Kanazawa Medical Center, 1-1 Shimoishihikicho, Kanazawa, Ishikawa, 920-8650, Japan. 9. Department of Inflammatory Bowel Disease, Hyogo College of Medicine, 1-1 Mukogawacho, Nishinomiya, Hyogo, 663-8501, Japan. 10. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. 11. Department of Gastroenterology, Shimane University School of Medicine, 1060 Nishikawatsu-cho, Matsue-shi, Shimane, 690-8504, Japan. 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. 13. Department of Internal Medicine and Gastroenterology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. 14. Inflammatory Bowel Disease Center, Yokohama City University Medical Center, 4-57 Urafunecho, Minami-ku, Yokohama-City, Kanagawa, 232-0024, Japan. 15. Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, 5841 S. Maryland Ave. MC 4076, Chicago, IL, 60637, USA. 16. Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. 17. International University of Health and Welfare Graduate School, 4-1-26 Akasaka, Minato ku, Tokyo, 107-8402, Japan. 18. Department of Internal Medicine, Sakura Medical Center, Toho University, 564-1 Shimoshizu, Sakura, Chiba, 285-8741, Japan. 19. Department of Internal Medicine, National Defense Medical College, 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan.
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.
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 UCwomen 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 UCpatients and contributed to disease relapse and possibly on pregnancy outcomes. Preconceptional education regarding safety of medications and risk of self-discontinuation is warranted.
Authors: Dustin M Lee; Kyle J Sevits; Micah L Battson; Yuren Wei; Kimberly A Cox-York; Christopher L Gentile Journal: PLoS One Date: 2019-12-31 Impact factor: 3.240
Authors: Sarah Wolloff; Emma Moore; Tracey Glanville; Jimmy Limdi; Klaartje B Kok; Aileen Fraser; Alexandra Kent; Khasia Mulgabal; Catherine Nelson-Piercy; Christian Selinger Journal: Frontline Gastroenterol Date: 2020-08-26