4.3 Article

Fecal calprotectin is a useful biomarker for predicting the clinical outcome of granulocyte and monocyte adsorptive apheresis in ulcerative colitis patients: a prospective observation study

Journal

BMC GASTROENTEROLOGY
Volume 21, Issue 1, Pages -

Publisher

BMC
DOI: 10.1186/s12876-021-01889-0

Keywords

Fecal calprotectin; Ulcerative colitis; Biomarker; Granulocyte; Monocyte Apheresis (GMA); Endoscopic remission; Clinical remission; Colonoscopy

Funding

  1. JIMRO Co. Ltd., a satellite institution of Otsuka Pharmaceutical

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This study investigated the utility of fecal calprotectin (FC) as a biomarker for predicting clinical outcomes during granulocyte and monocyte adsorptive apheresis (GMA) therapy in active ulcerative colitis (UC) patients. The results showed that changes in FC concentration were significantly associated with clinical remission and endoscopic remission, with a specific cutoff value providing high sensitivity and specificity for predicting these outcomes. Additionally, the reduction rate of FC at one week was found to be the most accurate predictor of clinical remission at the end of GMA therapy.
Background Granulocyte and monocyte adsorptive apheresis (GMA) is widely used as a remission induction therapy for active ulcerative colitis (UC) patients. However, there are no available biomarkers for predicting the clinical outcome of GMA. We investigated the utility of Fecal calprotectin (FC) as a biomarker for predicting the clinical outcome during GMA therapy in active UC patients. Methods In this multicenter prospective observation study, all patients received 10 sessions of GMA, twice a week, for 5 consecutive weeks. FC was measured at entry, one week, two weeks, and at the end of GMA. Colonoscopy was performed at entry and after GMA. The clinical activity was assessed based on the partial Mayo score when FC was measured. Clinical remission (CR) was defined as a partial Mayo score of <= 2 and endoscopic remission (ER) was defined as Mayo endoscopic subscore of either 0 or 1. We analyzed the relationships between the clinical outcome (CR and ER) and the change in FC concentration. Result Twenty-six patients were included in this study. The overall CR and ER rates were 50.0% and 19.2%, respectively. After GMA, the median FC concentration in patients with ER was significantly lower than that in patients without ER (469 mg/kg vs. 3107 mg/kg, p = 0.03). When the cut-off value of FC concentration was set at 1150 mg/kg for assessing ER after GMA, the sensitivity and specificity were 0.8 and 0.81, respectively. The FC concentration had significantly decreased by one week. An ROC analysis demonstrated that the reduction rate of FC (Delta FC) at 1 week was the most accurate predictor of CR at the end of GMA (AUC = 0.852, P = 0.002). When the cut-off value of Delta FC was set at <= 40% at 1 week for predicting CR at the end of GMA, the sensitivity and specificity were 76.9% and 84.6%, respectively. Conclusion We evaluated the utility of FC as a biomarker for assessing ER after GMA and predicting CR in the early phase during GMA in patients with active UC. Our findings will benefit patients with active UC by allowing them to avoid unnecessary invasive procedures and will help establish new strategies for GMA.

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