Abstract

BackgroundGranulocyte 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.MethodsIn 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.ResultTwenty-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 (ΔFC) 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 ΔFC 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.ConclusionWe 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.

Highlights

  • Ulcerative colitis (UC) is a chronic intestinal disorder of unknown etiology and characterized by a relapsing and remitting course [1, 2]

  • We evaluated the utility of Fecal calprotectin (FC) as a biomarker for assessing endoscopic remission (ER) after Granulocyte and monocyte adsorptive apheresis (GMA) and predicting Clinical remission (CR) in the early phase during GMA in patients with active ulcerative colitis (UC)

  • There was no significant difference in the ratio of concomitant medication, such as 5-aminosalicylic acid, corticosteroids, immunosuppressants and anti-TNF-α agents, or in the biomarkers of FC, White blood cell (WBC) count and C reactive protein (CRP) at the start of GMA between the CR and Non-clinical remission (non-CR) groups

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Summary

Introduction

Ulcerative colitis (UC) is a chronic intestinal disorder of unknown etiology and characterized by a relapsing and remitting course [1, 2]. Several studies have further explored its value as a biomarker for predicting and assessing the clinical response to induction therapy in patients with active UC [12,13,14,15,16]. The utility of the FC concentration as a biomarker for predicting the clinical outcome during remission induction therapy has not been established. Granulocyte and monocyte adsorptive apheresis (GMA) is widely used as a remission induction therapy for active ulcerative colitis (UC) patients. We investigated the utility of Fecal calprotectin (FC) as a biomarker for predicting the clinical outcome during GMA therapy in active UC patients

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