Makoto Naganuma1, Taku Kobayashi2, Masanao Nasuno3, Satoshi Motoya3, Shingo Kato4, Katsuyoshi Matsuoka5, Ryota Hokari6, Chikako Watanabe6, Hirotsugu Sakamoto7, Hironori Yamamoto7, Makoto Sasaki8, Kenji Watanabe9, Hideki Iijima10, Yutaka Endo11, Hitoshi Ichikawa12, Keiji Ozeki13, Satoshi Tanida13, Nobuhiro Ueno14, Mikihiro Fujiya14, Minako Sako15, Ken Takeuchi16, Shinya Sugimoto17, Takayuki Abe18, Toshifumi Hibi2, Yasuo Suzuki19, Takanori Kanai17. 1. Division of Gastroenterology and Hepatology, School of Medicine, Keio University, Tokyo, Japan. Electronic address: nagamakoto@keio.jp. 2. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan. 3. IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan. 4. Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. 5. 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. 6. Department of Internal Medicine, National Defense Medical College, Tokorozawa, Japan. 7. Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan. 8. Department of Gastroenterology, Aichi Medical University School of Medicine, Nagakute, Japan. 9. Division of Gastroenterology, Osaka City General Hospital, Osaka, Japan; Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan. 10. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. 11. Center for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital, Kanagawa, Japan. 12. Department of Gastroenterology, Tokai University Hachioji Hospital, Hachioji, Japan. 13. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 14. Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan. 15. Department of Internal Medicine, Division of IBD, Tokyo Yamate Medical Center, Tokyo, Japan. 16. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan. 17. Division of Gastroenterology and Hepatology, School of Medicine, Keio University, Tokyo, Japan. 18. 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. 19. IBD Center, Toho University Sakura Medical Center, Sakura, Japan.
Abstract
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/).
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/).