Significance of Conducting 2 Types of Fecal Tests in Patients With Ulcerative Colitis.


Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
05 2020
Historique:
received: 28 03 2019
revised: 21 07 2019
accepted: 28 07 2019
pubmed: 9 8 2019
medline: 19 8 2021
entrez: 9 8 2019
Statut: ppublish

Résumé

We compared the diagnostic accuracy of the fecal calprotectin (FCP) test vs the fecal immunochemical blood test (FIT) in determining the endoscopic severity and predicting outcomes of patients with ulcerative colitis (UC). We performed a nationwide study of 879 patients with UC, enrolled at medical centers across Japan, from March 2015 to March 2017. We collected data on fecal biomarkers, endoscopic severities, and other clinical indices from Cohort 1 (n = 427) and assessed the diagnostic accuracy of FCP measurement and FIT results in determining clinical severity, based on Mayo score, and endoscopic remission, based on Mayo endoscopic sub-score (MES) or UC endoscopic index of severity. We also followed 452 patients in clinical remission from UC (Cohort 2) for 12 months and evaluated the associations of FCP levels and FIT results with clinical recurrence. The levels of FCP and FIT each correlated with the MES and UC endoscopic index of severity. There were no significant differences in the areas under the curve of FCP vs FIT in distinguishing patients with MES≤1 from those with MES≥2 (P = .394) or in distinguishing patients with MES=0 from those with MES≥1 (P = .178). Among 405 patients in clinical remission at baseline, 38 (9.4%) had UC recurrences within 3 months and 90 (22.2%) had recurrences within 12 months. FCP≥146 mg/kg (hazard ratio [HR], 4.83; 95% confidence interval [CI], 2.80-8.33) and FIT≥77 ng/mL (HR, 2.92; 95% CI, 1.76-4.83) were independently associated with clinical recurrence within 12 months. UC recurred within 12 months in 69% of patients with levels of FCP≥146 mg/kg and FIT ≥77 ng/mL; this value was significantly higher than the rate of recurrence in patients with levels of FCP≥146 mg/kg and FIT <77 ng/mL (31.5%, P < .001) or patients with levels of FCP<146 mg/kg and FIT ≥77 ng/mL (30.0%, P < .001). In a nationwide study of patients with UC in Japan, we found that the level of FCP and FIT could each identify patients with endoscopic markers of disease severity (MES≥2). The combination of FCP and FIT results can identify patients in remission who are at risk for disease recurrence. Clinical Trials Registry no: UMIN000017650 (http://www.umin.ac.jp/ctr/).

Sections du résumé

BACKGROUND & AIMS
We compared the diagnostic accuracy of the fecal calprotectin (FCP) test vs the fecal immunochemical blood test (FIT) in determining the endoscopic severity and predicting outcomes of patients with ulcerative colitis (UC).
METHODS
We performed a nationwide study of 879 patients with UC, enrolled at medical centers across Japan, from March 2015 to March 2017. We collected data on fecal biomarkers, endoscopic severities, and other clinical indices from Cohort 1 (n = 427) and assessed the diagnostic accuracy of FCP measurement and FIT results in determining clinical severity, based on Mayo score, and endoscopic remission, based on Mayo endoscopic sub-score (MES) or UC endoscopic index of severity. We also followed 452 patients in clinical remission from UC (Cohort 2) for 12 months and evaluated the associations of FCP levels and FIT results with clinical recurrence.
RESULTS
The levels of FCP and FIT each correlated with the MES and UC endoscopic index of severity. There were no significant differences in the areas under the curve of FCP vs FIT in distinguishing patients with MES≤1 from those with MES≥2 (P = .394) or in distinguishing patients with MES=0 from those with MES≥1 (P = .178). Among 405 patients in clinical remission at baseline, 38 (9.4%) had UC recurrences within 3 months and 90 (22.2%) had recurrences within 12 months. FCP≥146 mg/kg (hazard ratio [HR], 4.83; 95% confidence interval [CI], 2.80-8.33) and FIT≥77 ng/mL (HR, 2.92; 95% CI, 1.76-4.83) were independently associated with clinical recurrence within 12 months. UC recurred within 12 months in 69% of patients with levels of FCP≥146 mg/kg and FIT ≥77 ng/mL; this value was significantly higher than the rate of recurrence in patients with levels of FCP≥146 mg/kg and FIT <77 ng/mL (31.5%, P < .001) or patients with levels of FCP<146 mg/kg and FIT ≥77 ng/mL (30.0%, P < .001).
CONCLUSION
In a nationwide study of patients with UC in Japan, we found that the level of FCP and FIT could each identify patients with endoscopic markers of disease severity (MES≥2). The combination of FCP and FIT results can identify patients in remission who are at risk for disease recurrence. Clinical Trials Registry no: UMIN000017650 (http://www.umin.ac.jp/ctr/).

Identifiants

pubmed: 31394288
pii: S1542-3565(19)30843-2
doi: 10.1016/j.cgh.2019.07.054
pii:
doi:

Substances chimiques

Biomarkers 0
Leukocyte L1 Antigen Complex 0

Types de publication

Clinical Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1102-1111.e5

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : ErratumIn

Informations de copyright

Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.

Auteurs

Makoto Naganuma (M)

Division of Gastroenterology and Hepatology, School of Medicine, Keio University, Tokyo, Japan. Electronic address: nagamakoto@keio.jp.

Taku Kobayashi (T)

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

Masanao Nasuno (M)

IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.

Satoshi Motoya (S)

IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.

Shingo Kato (S)

Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.

Katsuyoshi Matsuoka (K)

Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.

Ryota Hokari (R)

Department of Internal Medicine, National Defense Medical College, Tokorozawa, Japan.

Chikako Watanabe (C)

Department of Internal Medicine, National Defense Medical College, Tokorozawa, Japan.

Hirotsugu Sakamoto (H)

Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.

Hironori Yamamoto (H)

Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.

Makoto Sasaki (M)

Department of Gastroenterology, Aichi Medical University School of Medicine, Nagakute, Japan.

Kenji Watanabe (K)

Division of Gastroenterology, Osaka City General Hospital, Osaka, Japan; Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan.

Hideki Iijima (H)

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

Yutaka Endo (Y)

Center for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital, Kanagawa, Japan.

Hitoshi Ichikawa (H)

Department of Gastroenterology, Tokai University Hachioji Hospital, Hachioji, Japan.

Keiji Ozeki (K)

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Satoshi Tanida (S)

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Nobuhiro Ueno (N)

Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.

Mikihiro Fujiya (M)

Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.

Minako Sako (M)

Department of Internal Medicine, Division of IBD, Tokyo Yamate Medical Center, Tokyo, Japan.

Ken Takeuchi (K)

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

Shinya Sugimoto (S)

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

Takayuki Abe (T)

Department of Preventive Medicine and Public Health, Biostatistics Unit at Clinical and Translational Research Centre, Keio University School of Medicine, Tokyo, Japan; School of Data Science, Yokohama City University, Yokohama, Japan.

Toshifumi Hibi (T)

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

Yasuo Suzuki (Y)

IBD Center, Toho University Sakura Medical Center, Sakura, Japan.

Takanori Kanai (T)

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

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