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Medical treatment selection and outcomes for hospitalized patients with severe ulcerative colitis as defined by the Japanese criteria

  • Original Article—Alimentary Tract
  • Published:
Journal of Gastroenterology Aims and scope Submit manuscript

Abstract

Background

Hospitalization for ulcerative colitis (UC) is potentially life-threatening. Severe disease in the Japanese criteria which modifies the Truelove–Witts’ criteria might encompass more fulminant cases than the definition for acute severe UC. However, few studies have investigated the predictive factors for clinical remission (CR) after medical treatments for severe hospitalized patients by Japanese criteria.

Methods

Medical treatment selection, CR rates, and factors contributing to CR on day 14 were assessed in severe patients by Japanese criteria. We also investigated whether the reduction rate in patient-reported outcome 2 (PRO2) on day 3 could predict short-term prognosis.

Results

Eighty-five severe hospitalized patients were selected. Corticosteroids, tacrolimus, and infliximab were mainly selected as first-line treatments (76/85; 89.4%). The CR rates on day 14 were 26.8%, 21.4%, and 33.3% in patients receiving corticosteroids, tacrolimus, and infliximab, respectively. Extensive disease (odds ratio [OR] 0.022; 95% confidence interval [CI] 0.002–0.198), higher PRO2 (OR 0.306; 95% CI 0.144–0.821), and higher reduction rate in PRO2 on day 3 (OR 1.047; 95% CI 1.019–1.075) were independent factors predicting CR on day 14. If the cutoff value for the reduction rate in PRO2 on day 3 was 18.3%, sensitivity was 0.714 and specificity was 0.731 to predict CR on day 14. A higher reduction rate in PRO2 on day 3 (OR 0.922; 95% CI 0.853–0.995) was a negative factor to predict surgery within 28 days.

Conclusions

Tacrolimus and infliximab in addition to corticosteroids were used as first-line treatment in severe hospitalized patients. PRO2 on day 3 is a useful marker for switching to second-line therapy or colectomy.

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Acknowledgements

Collaborators of the Study: Reiko Kunisaki (Yokohama City University Medical Center), Shojiro Yamamoto, Souichiro Ogawa, Hotaka Tamura, Keisuke Uchida (Miyazaki University), Toshiro Fukui, Norimasa Fukata, Naohiro Nakamura, Yasuki Sano, Yusuke Honzawa (Kansai Medical University), Katsuyoshi Matsuoka (Toho University Sakura Medical Center), Ami Kawamoto, Masakazu Nagahori, Ryuichi Okamoto (Tokyo Medical and Dental University), Daisuke Saito, Miki Miura, Tadakazu Hisamatsu (Kyorin University), Kosaku Nanki, Yusuke Yoshimatsu (Keio University), Kazuyuki Narimatsu, Ryota Hokari (National Defense University), Hisashi Shiga, Yoichi Kakuta (Tohoku University), Tomohiro Fukuda, Aya Hojyo, Shintaro Sagami, Taku Kobayashi, Toshufumi Hibi (Kitasato University, Kitasato Institute Hospital), Yasuhisa Sakata, Motohiro Esaki (Saga University), Shinichiro Yoshioka, Kozo Tsuruta, Masaru Morita, Keiichi Mitsuyama (Kurume University), Shingo Kato (Saitama Medical Centre, Saitama Medical University), Naoki Shibuya, Ryosuke Miyazaki, Masayuki Saruta (Tokyo Jikei Medical University), Ryohei Hayashi, Shinji Tanaka (Hiroshima University Hospital), Eriko Yasutomi, Sakiko Hiraoka (Okayama University), Kaoru Yokoyama, Kiyonori Kobayashi (Kitasato University), Mariko Kajiwara, Tomohisa Takagi (Kyoto Manufactural University), Kei Moriya (Nara Medical University), Yoshikazu Tsuzuki, Hiroyuki Imaeda (Saitama Medical University), Eri Tokunaga, Mitsuru Ooi (Kobe University), Nobuhiro Ueno, Mikihiro Fujiya (Asahikawa Medical University), Toshiyuki Tahara (Saiseikai Utsunomiya Hospital), Ayumu Yokoyama, Atsushi Nakazawa (Saiseikai General Hospital), Shun Murasugi, Tomoko Kuriyama, Teppei Omori (Tokyo Women’s Medical University), Ken Takeuchi (Tsujinala Hospital Kashiwanoha), Shinichi Hashimoto (Yamaguchi University), Daisuke Hirayama, Tomoe Kazama, Hiroshi Nakase (Sapporo Medical University), Takako Miyazaki, Shiro Nakamura (Osaka Medical University), Akihiko Oka, Kosaku Kawashima, Shunji Ishihara (Shimane University). Shunichi Yanai, Takayuki Matsumoto (Iwate Medical University), Toshiyuki Sato, Yoko Yokoyama, Kenji Watanabe (Hyogo Medical University), Yasunori Yamamoto, Yoichi Hiasa (Ehime University), Hideki Bamba, Akira Ando (Shiga University), Yuki Ohta, Kengo Kanayama, Jun Kato (Chiba University), Naoki Omiya (Fujita Medical University), Sohachi Nanjyo (Toyama University)

Funding

This work was supported in part by the Japan Agency for Medical Research and Development (20314259), and Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan.

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Third Department of Internal Medicine, Kansai Medical University, 2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan

    Makoto Naganuma & Naohiro Nakamura

  2. Inflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan

    Reiko Kunisaki

  3. Department of Gastroenterology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan

    Katsuyoshi Matsuoka

  4. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan

    Shojiro Yamamoto

  5. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan

    Ami Kawamoto

  6. Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan

    Daisuke Saito & Tadakazu Hisamatsu

  7. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan

    Taku Kobayashi

  8. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

    Kosaku Nanki

  9. Department of Internal Medicine, National Defence Medical University, Tokorozawa, Japan

    Kazuyuki Narimatsu

  10. Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan

    Hisashi Shiga

  11. Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan

    Motohiro Esaki

  12. Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan

    Shinichiro Yoshioka

  13. Department of Gastroenterology and Hepatology, Saitama Medical Centre, Saitama Medical University, Saitama, Japan

    Shingo Kato

  14. Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan

    Masayuki Saruta

  15. Endoscopy and Medicine, Hiroshima University Hospital, Hiroshima, Japan

    Shinji Tanaka

  16. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan

    Eriko Yasutomi

  17. Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan

    Kaoru Yokoyama

  18. Department of Gastroenterology, Nara Medical University, Kashihara, Nara, Japan

    Kei Moriya

  19. Department of Gastroenterology, Saitama Medical University, Saitama, Japan

    Yoshikazu Tsuzuki

  20. Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan

    Makoto Ooi

  21. Division of Gastroenterology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan

    Mikihiro Fujiya

  22. Department of Gastroenterology, Saiseikai General Hospital, Tokyo, Japan

    Atsushi Nakazawa

  23. Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan

    Tomohisa Takagi

  24. Institute of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan

    Teppei Omori

  25. Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan

    Toshiyuki Tahara

Authors
  1. Makoto Naganuma
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  2. Naohiro Nakamura
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  3. Reiko Kunisaki
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  4. Katsuyoshi Matsuoka
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  5. Shojiro Yamamoto
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  8. Taku Kobayashi
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  11. Hisashi Shiga
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  12. Motohiro Esaki
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  13. Shinichiro Yoshioka
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  14. Shingo Kato
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  15. Masayuki Saruta
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  16. Shinji Tanaka
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  17. Eriko Yasutomi
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  18. Kaoru Yokoyama
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  19. Kei Moriya
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  20. Yoshikazu Tsuzuki
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  21. Makoto Ooi
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  27. Tadakazu Hisamatsu
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Consortia

The Japanese UC Study Group

  • Reiko Kunisaki
  • , Shojiro Yamamoto
  • , Souichiro Ogawa
  • , Hotaka Tamura
  • , Keisuke Uchida
  • , Toshiro Fukui
  • , Norimasa Fukata
  • , Naohiro Nakamura
  • , Yasuki Sano
  • , Yusuke Honzawa
  • , Katsuyoshi Matsuoka
  • , Ami Kawamoto
  • , Masakazu Nagahori
  • , Ryuichi Okamoto
  • , Daisuke Saito
  • , Miki Miura
  • , Tadakazu Hisamatsu
  • , Kosaku Nanki
  • , Yusuke Yoshimatsu
  • , Kazuyuki Narimatsu
  • , Ryota Hokari
  • , Hisashi Shiga
  • , Yoichi Kakuta
  • , Tomohiro Fukuda
  • , Aya Hojyo
  • , Shintaro Sagami
  • , Taku Kobayashi
  • , Toshufumi Hibi
  • , Yasuhisa Sakata
  • , Motohiro Esaki
  • , Shinichiro Yoshioka
  • , Kozo Tsuruta
  • , Masaru Morita
  • , Keiichi Mitsuyama
  • , Shingo Kato
  • , Naoki Shibuya
  • , Ryosuke Miyazaki
  • , Masayuki Saruta
  • , Ryohei Hayashi
  • , Shinji Tanaka
  • , Eriko Yasutomi
  • , Sakiko Hiraoka
  • , Kaoru Yokoyama
  • , Kiyonori Kobayashi
  • , Mariko Kajiwara
  • , Tomohisa Takagi
  • , Kei Moriya
  • , Yoshikazu Tsuzuki
  • , Hiroyuki Imaeda
  • , Eri Tokunaga
  • , Mitsuru Ooi
  • , Nobuhiro Ueno
  • , Mikihiro Fujiya
  • , Toshiyuki Tahara
  • , Ayumu Yokoyama
  • , Atsushi Nakazawa
  • , Shun Murasugi
  • , Tomoko Kuriyama
  • , Teppei Omori
  • , Ken Takeuchi
  • , Shinichi Hashimoto
  • , Daisuke Hirayama
  • , Tomoe Kazama
  • , Hiroshi Nakase
  • , Takako Miyazaki
  • , Shiro Nakamura
  • , Akihiko Oka
  • , Kousaku Kawashima
  • , Shunji Ishihara
  • , Shunichi Yanai
  • , Takayuki Matsumoto
  • , Toshiyuki Sato
  • , Yoko Yokoyama
  • , Kenji Watanabe
  • , Yasunori Yamamoto
  • , Yoichi Hiasa
  • , Hideki Bamba
  • , Akira Ando
  • , Yuki Ohta
  • , Kengo Kanayama
  • , Jun Kato
  • , Naoki Omiya
  •  & Sohachi Nanjyo

Contributions

MN conceived the study. MN designed the main concept of this study. MN, TK, KM, SY, and TH drafted the main protocol. MN participated in the statistical analysis. All authors participated in patient enrollment and clinical data acquisition. MN and NN drafted and wrote the manuscript. MN, KM, TK, and TH reviewed and edited the manuscript. All authors contributed to critical review and approved the final draft.

Corresponding author

Correspondence to Makoto Naganuma.

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Conflict of interest

Makoto Naganuma received grants from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Kyorin Pharmaceutical Co., Ltd., Alfresa Pharma Corporation and lecture fees from Tanabe Pharma Corporation, AbbVie GK, Takeda Pharmaceutical Co., Ltd., JIMRO Co., Ltd., Janssen Pharmaceutical K.K., Gilead Sciences, Inc. EA Pharma Co., Ltd., and Mochida Pharmaceutical Co., Ltd. Reiko Kunisaki received lecture fees from Tanabe Pharma Corporation, AbbVie GK, Astellas Pharma Inc.,Takeda Pharmaceutical Co., Ltd., JIMRO Co., Ltd., Janssen Pharmaceutical K.K., EA Pharma Co., Ltd., Eli Lilly Japan K.K.,KISSEI Pharmaceutical Co., Ltd., Nippon Kayaku Co., and Pfizer Inc. Katsuyoshi Matsuoka received research grants from Janssen Pharmaceutical, Scholarship grants from Mitsubishi Tanabe Pharma Corp., AbbVie Inc., Mochida Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., KISSEI Pharmaceutical Co., Ltd., Nippon Kayaku Co., and JIMRO Co., Ltd., lecture fees from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, EA Pharma Co., Ltd., Kyorin Pharmaceutical Co. Ltd., JIMRO Co., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Kissei pharmaceutical Co., LTD., Eli Lilly Japan K.K., Gilead Sciences, Inc., and Pfizer Inc. Hisashi Shiga received lecture fees from Mitsubishi Tanabe Pharma Corp., AbbVie Inc., EA Pharma Co. Ltd., Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co. Ltd., and Pfizer Inc, Motohiro Esaki received lecture fees from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, EA Pharma Co., Ltd., Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., and Pfizer Inc. Taku Kobayashi received research grants from Abbvie GK, Activaid, Alfresa Pharma Corporation, JMDC Inc., Gilead Sciences, Inc., Nippon Kayaku Co., Ltd., Eli Lilly Japan K.K., Mochida Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Google Asia Pacific Pte Ltd., and Bristol- Myers Squibb and received scholarship grants from Tanabe-Mitsubishi Pharma Corporation, Zeria Pharmaceutical Co. Ltd, Nippon Kayaku Co. Ltd, EA Pharma and received lecture fees from lecture fees from Tanabe-Mitsubishi Pharma Corporation, Takeda Pharmaceutical Co., Ltd., Pfizer Inc, EA Pharma, Janssen Pharmaceutical K.K., and received the fees for endowed chair from Otsuka Holdings, EA Pharma, JIMRO Co., AbbVie GK, Pharmaceutical Co. Ltd, Kyorin Pharmaceutical Co., Ltd., Pharmaceutical Co., Ltd. Shingo Kato received scholarship grant from AbbVie GK and lecture fees from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Janssen Pharmaceutical K.K. Motohiro Esaki received research grants from Mitsubishi Tanabe Pharma Corporation, EA Pharma Co., Ltd., AbbVie GK, Kyorin Pharmaceutical Co., Ltd., and Alfresa Pharma Corporation, and lecture fee from Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Pfizer Japan Inc. and EA Pharma Co., Ltd. Masayuki Saruta received research grants from EPS Corporation, CMIC Holdings Co., LTD.PPD-SNBL K.K. and scholarship grants from Mochida Pharmaceutical Co., Ltd., Abbvie GK, Kissei Pharmaceutical Co., Ltd, Zeria Pharmaceutical Co. Ltd, and EA Pharma Co., Ltd. and lecture fees from Abbvie GK, Jassen Pharma K.K., Mitsubishi Tanabe Pharma., Takeda Pharmaceutical Co., Ltd., EA Pharma Co. Ltd, Gilead Sciences K.K. Kaoru Yokoyama received lecture fees from Abbvie GK, EA Pharma Co., Ltd., Gilead Sciences, Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd. Mikihiro Fujiya received research grants from Takeda Pharmaceutical Co., Ltd., EA Pharma Co., Ltd., AbbVie GK, Nippon Kayaku Co, AbbVie GK ,Janssen Pharmaceutical K.K., scholar grants from Mochida Pharmaceutical Co, lecture fees from EA Pharma Co., Ltd., AbbVie GK, Ayumi Pharmaceutical Corporation, Kamui Pharma Inc, Nihon Kayaku Co. Ltd, FUJIFILM Corporation, Fuji Chemical Industries Co. Ltd., Takeda Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Biofermin Phrma. Co. Ltd., Ono Pharmaceutical Co. Ltd. Teppei Omori received lecture fees from AbbVie GK Takeda Pharmaceutical Co., Ltd. Tadakazu Hisamatsu received research grants from Mitsubishi Tanabe Pharma Corporation, EA Pharma Co., Ltd., AbbVie GK, JIMRO Co., Ltd., Takeda Pharmaceutical Co., Ltd., Pfizer Inc., and Mochida Pharmaceutical Co., Ltd. and received lecture fees from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Celgene K.K., EA Pharma Co., Ltd., Kyorin Pharmaceutical Co. Ltd., JIMRO Co., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Kissei pharmaceutical Co., LTD., Nichi-Iko Co., LTD., Gilead Sciences, Inc., and Pfizer Inc. Other authors do not have any Conflict of Interests.

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Naganuma, M., Nakamura, N., Kunisaki, R. et al. Medical treatment selection and outcomes for hospitalized patients with severe ulcerative colitis as defined by the Japanese criteria. J Gastroenterol 59, 302–314 (2024). https://doi.org/10.1007/s00535-024-02079-x

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