Observational Study

. 2023 Dec;58(12):1198-1210.

doi: 10.1007/s00535-023-02048-w. Epub 2023 Oct 13.

Real-world efficacy and safety of advanced therapies in hospitalized patients with ulcerative colitis

Makoto Naganuma¹, Taku Kobayashi², Reiko Kunisaki³, Katsuyoshi Matsuoka⁴, Shojiro Yamamoto⁵, Ami Kawamoto⁶, Daisuke Saito⁷, Kosaku Nanki⁸, Kazuyuki Narimatsu⁹, Hisashi Shiga¹⁰, Motohiro Esaki¹¹, Shinichiro Yoshioka¹², Shingo Kato¹³, Masayuki Saruta¹⁴, Shinji Tanaka¹⁵, Eriko Yasutomi¹⁶, Kaoru Yokoyama¹⁷, Kei Moriya¹⁸, Yoshikazu Tsuzuki¹⁹, Makoto Ooi²⁰, Mikihiro Fujiya²¹, Atsushi Nakazawa²², Takayuki Abe²³, Tadakazu Hisamatsu⁶; Japanese UC Study Group

Collaborators, Affiliations

Collaborators

Japanese UC Study Group:
Souichiro Ogawa, Hotaka Tamura, Keisuke Uchida, Toshiro Fukui, Norimasa Fukata, Masakazu Nagahori, Ryuichi Okamoto, Miki Miura, Yusuke Yoshimatsu, Ryota Hokari, Yoichi Kakuta, Tomohiro Fukuda, Aya Hojyo, Shintaro Sagami, Toshufumi Hibi, Yasuhisa Sakata, Kozo Tsuruta, Masaru Morita, Keiichi Mitsuyama, Naoki Shibuya, Ryosuke Miyazaki, Ryohei Hayashi, Sakiko Hiraoka, Kiyonori Kobayashi, Mariko Kajiwara, Tomohisa Takagi, Hiroyuki Imaeda, Eri Tokunaga, Mitsuru Ooi, Nobuhiro Ueno, Toshiyuki Tahara, Ayumu Yokoyama, Shun Murasugi, Tomoko Kuriyama, Teppei Ohmori, Ken Takeuchi, Shinichi Hashimoto, Daisuke Hirayama, Tomoe Kazama, Hiroshi Nakase, Takako Miyazaki, Shiro Nakamura, Akihiko Oka, Kohsaku 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 Ohmiya, Sohachi Nanjyo

Affiliations

¹ Division of Gastroenterology and Hepatology, Third Department of Internal Medicine, Kansai Medical University, 2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan. naganuma@hirakata.kmu.ac.jp.
² Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
³ Inflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
⁴ Division of Gastroenterology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.
⁵ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
⁶ Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
⁷ Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
⁸ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
⁹ Department of Internal Medicine, National Defence Medical University, Tokorozawa, Japan.
¹⁰ Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
¹¹ Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
¹² Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
¹³ Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
¹⁴ Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
¹⁵ Endoscopy and Medicine, Hiroshima University Hospital, Hiroshima, Japan.
¹⁶ Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
¹⁷ Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
¹⁸ Department of Gastroenterology, Nara Medical University, Kashihara, Nara, Japan.
¹⁹ Department of Gastroenterology, Saitama Medical University, Saitama, Japan.
²⁰ Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
²¹ Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Hokkaido, Japan.
²² Department of Gastroenterology, Saiseikai General Hospital, Tokyo, Japan.
²³ School of Data Science, Yokohama City University, Yokohama, Japan.

PMID: 37831183
DOI: 10.1007/s00535-023-02048-w

Observational Study

Real-world efficacy and safety of advanced therapies in hospitalized patients with ulcerative colitis

Makoto Naganuma et al. J Gastroenterol. 2023 Dec.

. 2023 Dec;58(12):1198-1210.

doi: 10.1007/s00535-023-02048-w. Epub 2023 Oct 13.

Authors

Collaborators

Japanese UC Study Group:
Souichiro Ogawa, Hotaka Tamura, Keisuke Uchida, Toshiro Fukui, Norimasa Fukata, Masakazu Nagahori, Ryuichi Okamoto, Miki Miura, Yusuke Yoshimatsu, Ryota Hokari, Yoichi Kakuta, Tomohiro Fukuda, Aya Hojyo, Shintaro Sagami, Toshufumi Hibi, Yasuhisa Sakata, Kozo Tsuruta, Masaru Morita, Keiichi Mitsuyama, Naoki Shibuya, Ryosuke Miyazaki, Ryohei Hayashi, Sakiko Hiraoka, Kiyonori Kobayashi, Mariko Kajiwara, Tomohisa Takagi, Hiroyuki Imaeda, Eri Tokunaga, Mitsuru Ooi, Nobuhiro Ueno, Toshiyuki Tahara, Ayumu Yokoyama, Shun Murasugi, Tomoko Kuriyama, Teppei Ohmori, Ken Takeuchi, Shinichi Hashimoto, Daisuke Hirayama, Tomoe Kazama, Hiroshi Nakase, Takako Miyazaki, Shiro Nakamura, Akihiko Oka, Kohsaku 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 Ohmiya, Sohachi Nanjyo

Affiliations

¹ Division of Gastroenterology and Hepatology, Third Department of Internal Medicine, Kansai Medical University, 2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan. naganuma@hirakata.kmu.ac.jp.
² Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
³ Inflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
⁴ Division of Gastroenterology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.
⁵ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
⁶ Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
⁷ Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
⁸ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
⁹ Department of Internal Medicine, National Defence Medical University, Tokorozawa, Japan.
¹⁰ Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
¹¹ Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
¹² Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
¹³ Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
¹⁴ Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
¹⁵ Endoscopy and Medicine, Hiroshima University Hospital, Hiroshima, Japan.
¹⁶ Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
¹⁷ Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
¹⁸ Department of Gastroenterology, Nara Medical University, Kashihara, Nara, Japan.
¹⁹ Department of Gastroenterology, Saitama Medical University, Saitama, Japan.
²⁰ Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
²¹ Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Hokkaido, Japan.
²² Department of Gastroenterology, Saiseikai General Hospital, Tokyo, Japan.
²³ School of Data Science, Yokohama City University, Yokohama, Japan.

PMID: 37831183
DOI: 10.1007/s00535-023-02048-w

Abstract

Background: This multicenter observational cohort study aimed to evaluate the utilization and short-term efficacy of advanced therapy (AT) in hospitalized patients with acute severe ulcerative colitis (ASUC).

Methods: In total, 221 patients with ASUC were enrolled between August 2020 and July 2021. The primary endpoint was clinical remission (CR, defined as a patient-reported outcome score < 2 with no blood in the stool) rate on Day 7 and 14 in hospitalized patients who received corticosteroids (CS) and AT.

Results: Among patients with ASUC, 120 and 101 patients received CS or any AT as first-line treatment, respectively. The CR rates on Day 7 and 14 were 22.5% and 35.0%, respectively, in hospitalized patients who received CS as first-line treatment. Most patients who used ATs had CS-dependent or frequent recurrences. Eight different ATs (apheresis, tacrolimus, infliximab, golimumab, tofacitinib, vedolizumab, ustekinumab, and cyclosporine) were used as first-line treatment in patients with ASUC, and the CR rates on Day 7 and 14 were 16.8% and 29.7%, respectively. Twenty-five patients received the second ATs after hospitalizations, and the CR rates on Day 7 and 14 were 0% and 12%, respectively. The CR rates on Day 14 were significantly higher in patients who changed to AT than in those whose dose of CS increased (34.0% vs 10.7%, p = 0.020) among patients who had already used CS before hospitalization.

Conclusion: Most first-use ATs were effective for patients with ASUC, while second-use ATs might have had limited benefits in inducing CR. These findings may contribute to considerations for the management of hospitalized patients.

Keywords: Acute severe ulcerative colitis; Advanced therapy; Biologics; Janus kinase inhibitor.

PubMed Disclaimer

Comment in

Promising modality for severe ulcerative colitis: infliximab and plant-based diet as first-line (IPF) therapy.
Chiba M, Kimura K. Chiba M, et al. J Gastroenterol. 2024 Jul;59(7):641-642. doi: 10.1007/s00535-024-02111-0. Epub 2024 May 4. J Gastroenterol. 2024. PMID: 38702533 No abstract available.

References

1. Naganuma M, Mizuno S, Nanki K, Sugimoto S, Kanai T. Recent trends and future directions for the medical treatment of ulcerative colitis. Clin J Gastroenterol. 2016;9:329–36. - DOI - PubMed
1. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–76. - DOI - PubMed
1. Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142:257–65. - DOI - PubMed
1. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85–95. - DOI - PubMed
1. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:96–109. - DOI - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions

Grants and funding

20314259/he Japan Agency for Medical Research and Development

LinkOut - more resources

Full Text Sources
- Springer
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Real-world efficacy and safety of advanced therapies in hospitalized patients with ulcerative colitis

Collaborators

Affiliations

Real-world efficacy and safety of advanced therapies in hospitalized patients with ulcerative colitis

Authors

Collaborators

Affiliations

Abstract

Comment in

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical