TY - JOUR
T1 - Significance of Conducting 2 Types of Fecal Tests in Patients With Ulcerative Colitis
AU - Naganuma, Makoto
AU - Kobayashi, Taku
AU - Nasuno, Masanao
AU - Motoya, Satoshi
AU - Kato, Shingo
AU - Matsuoka, Katsuyoshi
AU - Hokari, Ryota
AU - Watanabe, Chikako
AU - Sakamoto, Hirotsugu
AU - Yamamoto, Hironori
AU - Sasaki, Makoto
AU - Watanabe, Kenji
AU - Iijima, Hideki
AU - Endo, Yutaka
AU - Ichikawa, Hitoshi
AU - Ozeki, Keiji
AU - Tanida, Satoshi
AU - Ueno, Nobuhiro
AU - Fujiya, Mikihiro
AU - Sako, Minako
AU - Takeuchi, Ken
AU - Sugimoto, Shinya
AU - Abe, Takayuki
AU - Hibi, Toshifumi
AU - Suzuki, Yasuo
AU - Kanai, Takanori
N1 - Funding Information:
Conflicts of interest These authors disclose the following: M. Naganuma received non-financial support (measuring fecal calprotectin) from Thermo Fisher Scientific during the conduct of the study and also received lecture fees from Thermo Fisher Scientific and Mochida Pharmaceutical Co Ltd outside the submitted work. T. Kobayashi received research grant, lecture fee, and advisory fee from Alfresa Pharma, lecture fee and advisory fee from Mochida Pharmaceutical Co Ltd, and research grant and lecture fee from Thermo Fisher Scientific outside the submitted work. K. Matsuoka received research grant, lecture fee, and advisory fee from Thermo Fisher Scientific and received research grant from Alfresa Pharma, Sekisui Medical, and Mochida Pharmaceutical Co Ltd outside the submitted work. K. Watanabe received non-financial support from Thermo Fisher Scientific outside the submitted work. M. Fujiya received non-financial support from Thermo Fisher Scientific and research grant and lecture fee from Mochida Pharmaceutical Co Ltd outside the submitted work. T. Hibi received advisory fee from Alfresa Pharma and received lecture fee from Thermo Fisher Scientific outside the submitted work. T. Kanai received research grant and lecture fee from Mochida Pharmaceutical Co Ltd outside the submitted work. The remaining authors disclose no conflicts.
Funding Information:
Funding Supported in part by Health and Labor Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labor and Welfare of Japan.
Funding Information:
Funding Supported in part by Health and Labor Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labor and Welfare of Japan. Conflicts of interest These authors disclose the following: M. Naganuma received non-financial support (measuring fecal calprotectin) from Thermo Fisher Scientific during the conduct of the study and also received lecture fees from Thermo Fisher Scientific and Mochida Pharmaceutical Co Ltd outside the submitted work. T. Kobayashi received research grant, lecture fee, and advisory fee from Alfresa Pharma, lecture fee and advisory fee from Mochida Pharmaceutical Co Ltd, and research grant and lecture fee from Thermo Fisher Scientific outside the submitted work. K. Matsuoka received research grant, lecture fee, and advisory fee from Thermo Fisher Scientific and received research grant from Alfresa Pharma, Sekisui Medical, and Mochida Pharmaceutical Co Ltd outside the submitted work. K. Watanabe received non-financial support from Thermo Fisher Scientific outside the submitted work. M. Fujiya received non-financial support from Thermo Fisher Scientific and research grant and lecture fee from Mochida Pharmaceutical Co Ltd outside the submitted work. T. Hibi received advisory fee from Alfresa Pharma and received lecture fee from Thermo Fisher Scientific outside the submitted work. T. Kanai received research grant and lecture fee from Mochida Pharmaceutical Co Ltd outside the submitted work. The remaining authors disclose no conflicts.
Publisher Copyright:
© 2020 AGA Institute
PY - 2020/5
Y1 - 2020/5
N2 - 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/)
AB - 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/)
KW - Biomarker
KW - Inflammatory Bowel Disease
KW - Prognostic Factor
KW - Response to Therapy
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U2 - 10.1016/j.cgh.2019.07.054
DO - 10.1016/j.cgh.2019.07.054
M3 - Article
C2 - 31394288
AN - SCOPUS:85083049598
SN - 1542-3565
VL - 18
SP - 1102-1111.e5
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 5
ER -