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Characteristics of adult patients newly diagnosed with Crohn’s disease: interim analysis of the nation-wide inception cohort registry study of patients with Crohn’s disease in Japan (iCREST-CD)

  • Original Article—Alimentary Tract
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A Correction to this article was published on 05 May 2023

This article has been updated

Abstract

Background

The Inception Cohort Registry Study of Patients with Crohn’s Disease aimed to clarify clinical characteristics and disease course of newly diagnosed Crohn’s disease patients in Japan throughout a 4-year period. Results from an interim analysis of the largest nation-wide registry study that covers approximately 1% of Crohn’s disease patient population in Japan are reported.

Methods

This prospective, observational registry study was conducted at 19 tertiary centers in Japan. Patients newly diagnosed with Crohn’s disease after June 2016 (age ≥ 16 years at informed consent) were enrolled between December 17, 2018 and June 30, 2020. Patient demographics, diagnostic procedures and categories, disease location and lesion behavior (Montreal classification) at the time of diagnosis were recorded.

Results

Of 673 patients enrolled, 672 (99.9%) were analyzed (458: men, 214: women), male-to-female ratio: 2.1, median age at diagnosis 25 (range 13–86) years; peak age of disease diagnosis: 20–24 years. Most common disease location was L3 (ileocolonic; 60.1%). Non-stricturing, non-penetrating (B1) disease was most common behavior (62.8%); 48.9% reported perianal lesions. Notably, age-wise analysis revealed disease phenotypes varied between patients aged < 40 and ≥ 40 years in terms of male-to-female ratio (2.5/1.3)/disease location (L3: 66.3%/37.0%)/disease behavior (B1: 66.4%/50.0%)/perianal lesion: (55.7%/20.5%) at Crohn’s disease diagnosis, respectively.

Conclusions

Interim analysis of this nation-wide Inception Cohort Registry Study of Patients with Crohn’s Disease revealed the demographics and disease characteristics of newly diagnosed Crohn’s disease patients in Japan and demonstrated that disease phenotype varied between patients aged < 40 and ≥ 40 years, serving as important information for management of individual patients.

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Data availability

The datasets generated and/or analyzed during the current study are not publicly available due confidentiality clauses signed with the participating medical institutions.

Change history

Abbreviations

BMI:

Body mass index

CD:

Crohn’s disease

CI:

Confidence interval

CT:

Computed tomography

GI:

Gastrointestinal

IBD:

Inflammatory bowel disease

iCREST-CD:

Inception Cohort Registry Study of Patients with Crohn's Disease

MR:

Magnetic resonance

MRE:

Magnetic resonance enterography

MRI:

Magnetic resonance imaging

SAS:

Statistical Analysis Software

SD:

Standard deviation

US:

United States

WHO:

World Health Organization

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Acknowledgements

The authors would like to thank the Japanese Society for Inflammatory Bowel Disease for support to the study. The authors also thank the collaborators to enroll patients. The iCREST-CD Study Group consists of the following members excluding the authors are listed in the Supplemental material 1. Mizuki Amano and Tomoko Takano (Janssen Pharmaceutical K.K., Tokyo, Japan) provided administrative, technical, or material support for this study. Hiroki Nakane (EPS Corp.) for performing the statistical analysis. Writing assistance and editorial support for this manuscript was provided by Nigar Malik, B. Pharm (SIRO Clinpharm Pvt Ltd, India). Statistical analysis support and medical writing assistance were both funded by Janssen Pharmaceutical K.K. The manuscript, including related data, figures, and tables, has not been previously published and the manuscript is not under consideration elsewhere.

Funding

This work was supported by Janssen Pharmaceutical K.K., Tokyo, Japan. Janssen Pharmaceutical K.K. contributed to the study design, data collection, analysis and interpretation, and writing, reviewing and approval of the final version.

Author information

Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Chiba, Japan

    Katsuyoshi Matsuoka & Akihiro Yamada

  2. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan

    Toshimitsu Fujii & Ryuichi Okamoto

  3. Inflammatory Bowel Disease Center, Yokohama City University Medical Center, Minami-ku, Yokohama, Kanagawa, Japan

    Reiko Kunisaki

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

    Minoru Matsuura & Tadakazu Hisamatsu

  5. Center for Inflammatory Bowel Disease, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo Medical University, Nishinomiya, Hyogo, Japan

    Kenji Watanabe & Shinichiro Shinzaki

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

    Hisashi Shiga

  7. Department of Inflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, Japan

    Noritaka Takatsu

  8. Division of Digestive Endoscopy, Shiga University of Medical Science, Otsu, Shiga, Japan

    Shigeki Bamba

  9. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Shinjiku-ku, Tokyo, Japan

    Yohei Mikami

  10. Department of Surgery and Inflammatory Bowel Disease Center, Yokkaichi Hazu Medical Center, Yokkaichi, Mie, Japan

    Takayuki Yamamoto & Takahiro Shimoyama

  11. IBD Center, Hokkaido Preventive Welfare Federation of Agricultural Cooperative, Sapporo-Kosei General Hospital, Sapporo, Hokkaido, Japan

    Satoshi Motoya

  12. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Japan

    Takehiro Torisu

  13. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Minato-ku, Tokyo, Japan

    Taku Kobayashi

  14. Department of Advanced Endoscopy, Fujita Health University School of Medicine, Toyoake, Aichi, Japan

    Naoki Ohmiya

  15. Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Minato-ku, Tokyo, Japan

    Masayuki Saruta

  16. Department of Gastroenterology, Toyama Prefectural Central Hospital, Toyama, Toyama, Japan

    Koichiro Matsuda

  17. Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Morioka, Iwate, Japan

    Takayuki Matsumoto

  18. Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan

    Hiroshi Nakase

  19. IBD Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido, Japan

    Atsuo Maemoto

  20. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

    Shinichiro Shinzaki

  21. Medical Affairs Division, Janssen Pharmaceutical K.K., Chiyoda-ku, Tokyo, Japan

    Yoko Murata, Shinichi Yoshigoe & Ayako Sasaki

  22. Statistics & Decision Sciences, Janssen Pharmaceutical K.K., Chiyoda-ku, Tokyo, Japan

    Tsutomu Yajima

Authors
  1. Katsuyoshi Matsuoka
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  2. Toshimitsu Fujii
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  3. Ryuichi Okamoto
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Contributions

All authors have made significant contributions to the research described in this manuscript. TH, KM, SM, TY, MM, SS, TF, YM, HN, TK, MS, RK, KW, TT, NT, YM, SY and AS contributed to the design of the study. KM, TF, RO, AY, RK, MM, KW, HS, NT, SB, YM, TY, TS, SM, TT, TK, NO, MS, KM, TM, HN, AM and TH have collected data. SY, AS and TY analyzed the data. All authors met the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, participated in the monitoring of data quality, interpretation of study results, and in the drafting, critical revision, and approval of the final version of the manuscript. All authors had access to the study data, made the final decision about where to publish these data, and approved submission to this journal.

Corresponding author

Correspondence to Tadakazu Hisamatsu.

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Conflict of interest

KM received research grant from Janssen Pharmaceutical K.K.; received scholarship grants from AbbVie, EA, Mitsubishi Tanabe, Mochida, Nippon Kayaku; received honoraria from AbbVie, EA, Janssen Pharmaceutical K.K., Mitsubishi Tanabe, Mochida, Pfizer, Takeda. TF received honorarium and research grants from Janssen Pharmaceutical K.K. SS received research grant from Sekisui Medical; received honoraria from Tanabe Mitsubishi, Janssen. RO received research grant from Mitsubishi Tanabe; received scholarship grant from Zeria, Mochida, Takeda. AY received research grants from AbbVie, EA, Mitsubishi Tanabe, Mochida. YM, TY, KM received honorarium from Janssen. MM received personal honorarium from Janssen Pharmaceutical K.K. KW received research grants from EA Pharma, EP-CRSU Co., Ltd., Takeda; received scholarship grants from AbbVie, EA, Mitsubishi Tanabe, JIMRO, Nippon Kayaku; received honoraria from AbbVie, EA Pharma, Kissei, Pfizer, Takeda, MTPC, Kyorin, Mochida; endowed chair from AbbVie, EA Pharma, Zeria, Kyorin, MTPC, JIMRO, Otsuka Pharmaceutical Factory, Asahi Kasei Medical Co., Ltd, Mochida. SB received honorarium from Janssen Pharmaceutical K.K. SM received honoraria from Takeda, Mitsubishi Tanabe, Janssen; received research grants from Janssen, Pfizer, Eli Lilly, EA Pharma, Takeda, Astrazeneca. TT received research grant from Mitsubishi Tanabe, AbbVie. TK received honoraria from AbbVie, Takeda, Tanabe Mitsubishi, Pfizer, Janssen; received research grants from Nippon Kayaku, Pfizer, AbbVie, Activaid, Takeda, Alfresa, Ferring, JMDC, Janssen, Gilead Sciences, Bristol-Myers Squibb, Eli Lilly Japan, Mochida; received scholarship grants from Tanabe Mitsubishi, Zeria, Nippon Kayaku; endowed chair from Otsuka Holdings, JIMRO, EA, AbbVie, Zeria, Kyorin, Mochida. NO received commissioned/joint research grants from AbbVie, Daiichi Sankyo, Eli Lilly, EA, University of Miyazaki, Mylan EPD, Nippon Kayaku, Ajinomoto, Okawa foundation for information and telecommunications, Suzuken Memorial Foundation, Japanese society of gastroenterology, Japanese gastroenterological association; received scholarship grants from Bristol-Myers Squibb, AbbVie, Takeda, Eli Lilly, Tanabe Mitsubishi, Nippon Kayaku. MS received honoraria from AbbVie, Janssen, Tanabe Mitsubishi, Mochida, Zeria, Takeda, Kissei, Pfizer; received fees for promotional materials from EA Pharma; received research grants from EP-CRSU; received scholarship donations from EA Pharma, Kissei, Zeria, Mochida, Otsuka, Takeda. TM received honoraria from EA Pharma, Janssen, Takeda, Tanabe Mitsubishi, Sekisui Medical, AbbVie; received scholarship grants from Tanabe Mitsubishi, Nippon Kayaku. HN received honoraria from AbbVie, Tanabe Mitsubishi, Janssen, Takeda, Pfizer, Mylan EPD; received grants for commissioned/joint research from HOYA Pentax Medical, AbbVie, Tanabe Mitsubishi, Mochida, AYUMI Pharmaceutical Corporation; received scholarship grants from AbbVie, Otsuka, EA Pharma, Taiho, Nippon Kayaku, Tanabe Mitsubishi, Takeda. SS received honoraria from Tanabe Mitsubishi, Janssen; received research grant from Sekisui Medical. TH received honoraria from Mitsubishi Tanabe, Pfizer, AbbVie GK, Janssen Pharmaceutical K.K., EA Pharma, Takeda; received research grants from Alfresa and Ajinomoto; received scholarship grants from Mitsubishi Tanabe, AbbVie GK, EA Pharma, Takeda, JIMRO, Mochida, Daiichi Sankyo, Pfizer. YM, SY, AS and TY are employees of Janssen Pharmaceutical K.K. No conflicts of interest declared for RK, HS, NT, Yohei Mikami (YM), Takayuki Yamamoto (TY), TS, AM.

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Matsuoka, K., Fujii, T., Okamoto, R. et al. Characteristics of adult patients newly diagnosed with Crohn’s disease: interim analysis of the nation-wide inception cohort registry study of patients with Crohn’s disease in Japan (iCREST-CD). J Gastroenterol 57, 867–878 (2022). https://doi.org/10.1007/s00535-022-01907-2

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