scholarly journals 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.

2021 ◽  
Author(s):  
Nobuhiro Ueno ◽  
Yuya Sugiyama ◽  
Yu Kobayashi ◽  
Yuki Murakami ◽  
Takuya Iwama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Sensitivity And Specificity ◽  
Reduction Rate ◽  
Fecal Calprotectin ◽  
Remission Induction ◽  
Clinical Activity ◽  
Observation Study ◽  
Mayo Score ◽  
Adsorptive Apheresis

Abstract 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 (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.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.

scholarly journals 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

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nobuhiro Ueno ◽  
Yuya Sugiyama ◽  
Yu Kobayashi ◽  
Yuki Murakami ◽  
Takuya Iwama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Sensitivity And Specificity ◽  
Reduction Rate ◽  
Fecal Calprotectin ◽  
Remission Induction ◽  
Clinical Activity ◽  
Observation Study ◽  
Mayo Score ◽  
Adsorptive Apheresis

Abstract 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 (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. 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.

scholarly journals Fecal Calprotectin and Clinical Disease Activity in Pediatric Ulcerative Colitis

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Kaija-Leena Kolho ◽  
Dan Turner
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Roc Curve ◽  
Clinical Remission ◽  
Activity Index ◽  
Fecal Calprotectin ◽  
Elisa Test ◽  
Clinical Activity ◽  
High Level ◽  
Active Disease

Objective. To explore fecal calprotectin levels in pediatric ulcerative colitis (UC) in relation with the validated clinical activity index PUCAI. Methods. This study included all 37 children (median age 14 years) with UC who had calprotectin measured (PhiCal ELISA Test) by the time of PUCAI assessment at the Children's Hospital of Helsinki in a total of 62 visits. Calprotectin values <100 μg/g of stool were considered as normal. The best cut-off value of each measure to predict 3-month clinical outcome was derived by maximizing sensitivity and specificity. Results. In clinically active disease (PUCAI ≥ 10), calprotectin was elevated in 29/32 patients (91% sensitivity). When in clinical remission, 26% (8/30) of the children had normal calprotectin but 7 (23%) had an exceedingly high level (>1000 μg/g). The best cut-off value for calprotectin for predicting poor outcome was 800 μg/g (sensitivity 73%, specificity 72%; area under the ROC curve being 0.71 (95%CI 0.57–0.85)) and for the PUCAI best cut-off values >10 (sensitivity 62%, specificity 64%; area under the ROC curve 0.714 (95%CI 0.58–0.85)). Conclusion. The clinical relevance of somewhat elevated calprotectin during clinical remission in pediatric UC is not known and, until further evidence accumulates, does not indicate therapy escalation.

scholarly journals Effectiveness of treatment of moderate ulcerative colitis with prolonged mesalazine in real clinical practice

2021 ◽  
pp. 144-151
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Topical Therapy ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Prolonged Release ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Oral Mesalazine ◽  
High Doses

Introduction. Ulcerative colitis (UC) is one of the severe therapeutic diseases. High doses of oral granular mesalazine are required to maintain clinical and endoscopic remission of UC, which may be sufficient and supposedly more acceptable for patients, as some studies showed that adherence to topical therapy is significantly lower than to oral 5-ASA drugs.Objective of the study. To evaluate the efficacy of therapy of patients with moderate left-sided ulcerative colitis (UC) and pancolitis receiving prolonged-release ethylcellulose-coated mesalazine.Materials and methods. The evaluation of the outcomes of treatment of UC patients who received prolonged-release mesalazine was carried out. We examined 87 patients with UC who received granular ethylcellulose-coated mesalazine, of those 38 (43.7%) men and 49 (56.3%) women. The average age of the enrolled patients was 38.3 ± 12.6 years.Results and discussion. After 2 weeks from the beginning of therapy with prolonged-release mesalazine, the majority of patients – 71 (81.6%) responded to the therapy. After 12 weeks, 71 (81.6%) of 87 UC patients, who responded to therapy with prolongedrelease mesalazine, remained in clinical remission. On average, the Mayo score in the group decreased from 7.6 ± 0.99 to 2.6 ± 0.25 points. There was a significant decrease in CRP, ESR, leukocytosis, and fecal calprotectin. After 26 weeks, Mayo score in the group of patients remained on average at the level of 2.2–2.3 points. The number of UC patients with colon mucosal healing was 32 (36.8%) patients. A year after the start of therapy with prolonged-release mesalazine, 69 (79.3%) UC patients who responded to therapy had a clinical remission, of those 32 (36.8%) patients had a clinical and endoscopic remission. During the year of observation, no case of surgical intervention or re-hospitalization due to exacerbation of the disease was recorded in patients with UC who achieved remission.Conclusions. Treatment of moderate active UC should begin with oral mesalazine ≥ 3 g per day in combination with topical mesalazine. The prolonged-release mesalazines are the most preferred

scholarly journals P476 Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S465-S466
Author(s):  
M Chaparro ◽  
A Garre ◽  
M Iborra ◽  
M Sierra ◽  
M Barreiro-de Acosta ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Practice ◽  
Elevated Serum ◽  
Real Life ◽  
Development Program ◽  
Lower Probability ◽  
Clinical Activity ◽  
Mayo Score

Abstract Background The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims Primary: to evaluate the durability of ustekinumab treatment in UC patients in clinical practice. Secondary: to assess the short-term response (at week 16) and the long-term effectiveness (at maximum follow-up) and to assess the safety of ustekinumab in clinical practice. Methods Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) &gt;2] were included. Clinical activity and effectiveness were defined based on PMS. Results 95 patients were included (table 1). At week 16, 53% of patients had clinical response (including 35% of patients in remission) (figure 1). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with clinical remission. Long-term remission is represented in figure 2. 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72 (figure 3); primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusion Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

scholarly journals 302 – Early Change in Fecal Calprotectin Predicts One Year Clinical Outcome in Children Newly Diagnosed with Ulcerative Colitis

2019 ◽  
Vol 156 (6) ◽  
pp. S-60
Author(s):  
Chenthan Krishnakumar ◽  
Ashwin Ananthakrishnan ◽  
Brendan M. Boyle ◽  
Anne M. Griffiths ◽  
Neal S. Leleiko ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Fecal Calprotectin ◽  
Newly Diagnosed ◽  
Early Change ◽  
One Year

scholarly journals P434 Effectiveness and safety of ustekinumab in ulcerative colitis: real-world evidence from Eneida Registry

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S394-S395
Author(s):  
M Chaparro ◽  
A Garre ◽  
M Iborra ◽  
M Barreiro-de Acosta ◽  
M J Casanova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real Life ◽  
Development Program ◽  
Analysis Data ◽  
Lower Probability ◽  
Clinical Activity ◽  
Short Term ◽  
Mayo Score ◽  
Patient Status ◽  
Probability Of Response

Abstract Background Ustekinumab has shown promising results in ulcerative colitis (UC) in the development program (UNIFI) that should be confirmed in clinical practice. Our aim was to evaluate the effectiveness and safety of ustekinumab in UC in real life. Methods Patients included in the prospectively maintained ENEIDA registry that received at least 1 dose of ustekinumab intravenously due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS). The short-term response was assessed at week 8 and 16. The last-observation-carried-forward method was used in patients that stopped ustekinumab treatment before week 8 or 16. Variables associated with short-term remission were identified by logistic regression analysis. Data quality was assessed by remote monitoring. Results Forty-seven patients were included (Table 1); all of them had been previously exposed to biologic agents (70% to &gt;2): 100% to anti-TNF and 83% to vedolizumab. A total of 26% had been exposed to tofacitinib. Seventeen patients (36%) had response at week 8 [3 of them (6%) had remission]; 16 patients (34%) had response at week 16 [5 of them (11%) had remission] (Figure 1). There was a statistically significant decrease in C-reactive protein (CRP) concentration during the induction only in patients with a response at week 16 (Figure 2). The proportion of patients with CRP elevated at baseline and at week 8 was higher among non-responders at week 16 (Table 2). In the multivariate analysis, higher PMS at week 8 [odds ratio (OR) = 0.5; 95% confidence interval (CI) = 0.3–0.9)] and CRP over the upper normal limit at week 8 (OR = 0.1; 95% CI = 0.01–0.8) were associated with lower probability of response at week 16; steroids during induction increased the probability of response at week 16 (OR = 8; 95% CI = 1–71). Of patients without response at week 8, only 7% achieved response at week 16. Seventeen out of 31 patients continued ustekinumab beyond week 16, despite being non-responders. Of these 17 patients, 4 reached remission after the third dose, 1 after the fifth and 1 after the seventh one. There were 2 infections, one of them with fatal consequences (in a patient under steroids and tacrolimus due to renal transplant). Conclusion Ustekinumab shows benefit in some UC patients in real practice, even in a very refractory cohort in which the drug was prescribed as last resort. Patient status at week 8 seems to be a good predictor of response after the induction. Safety was consistent with the known profile of ustekinumab.

scholarly journals Soluble human Suppression of Tumorigenicity 2 is associated with endoscopic activity in patients with moderate-to-severe ulcerative colitis treated with golimumab

2019 ◽  
Vol 12 ◽  
pp. 175628481986914
Author(s):  
Fernando Magro ◽  
Susana Lopes ◽  
Marco Silva ◽  
Rosa Coelho ◽  
Francisco Portela ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Therapeutic Response ◽  
Clinical Activity ◽  
Open Label ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Mayo Score ◽  
Histological Activity ◽  
Median Change ◽  
Multicentre Prospective Study

Background: Suppressor of Tumorigenicity 2 (ST2) is an IL33 receptor detected in the mucosa and serum of ulcerative colitis (UC) patients. We evaluated soluble ST2 (sST2) as a surrogate biomarker of disease outcome and therapeutic response, in moderate-to-severe UC patients treated with golimumab. Methods: We conducted an open-label single-arm multicentre prospective study. At screening/baseline, week 6 (W6) and week 16 (W16), clinical and endoscopic activity (total Mayo score), histologic activity (Geboes index) and biomarkers were evaluated. Results: From 38 patients, 34 (89.5%) completed W6 and 29 (76.3%) completed W16. Mean age (±SD) was 34.6 ± 12.6 years; 55.9% were female. At W16, 62.1% achieved clinical response. Patients with endoscopic activity at W6 ( n = 20) had higher baseline sST2 (median, 24.5 versus 18.7 ng/ml, p = 0.026) and no decrease from baseline (median change, 0.8 versus −2.7, p = 0.029). At W6, sST2 levels correlated with endoscopic activity ( rs = 0.45, p = 0.007) but not with histological activity ( rs = 0.25, p = 0.151). The best cut-offs for endoscopic activity were sST2 = 16.9 ng/ml (sensitivity = 85%; specificity = 71%) and faecal calprotectin (FC) = 353 μg/g (sensitivity = 90%, specificity = 67%). Patients with histological activity at W6 ( n = 27) had higher baseline ST2 levels (median, 23.0 versus 13.7 ng/ml, p = 0.035). sST2 did not correlate with FC or serum C-reactive protein. FC levels correlated with histological activity and baseline FC were higher when Geboes ⩾3.1 at W6. Conclusions: sST2 may be a surrogate biomarker of UC activity and therapeutic response as it correlates with endoscopic and clinical activity at W6 of golimumab treatment, and subjects with endoscopic and histological activity at W6 had higher baseline ST2 levels.

scholarly journals CLINICAL FORMS OF ULCERATIVE COLITIS AND THEIR FEATURES IN CHILDREN

2020 ◽  
Author(s):  
Денисова М. Ф. ◽  
Букулова Н. Ю.
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Process ◽  
Clinical Laboratory ◽  
Fecal Calprotectin ◽  
Clinical Activity ◽  
Clinical Forms ◽  
Γ Globulins ◽  
Endoscopic Characteristics ◽  
And Gender ◽  
The Relationship

This article presents frequency of occurrence of clinical forms of the disease depending on the localization and activity of the inflammatory process, their age and gender differences, risk factors and disease triggers, based on a retrospective analysis of 116 cases of children with ulcerative colitis at the age of 4-18 years. Comparative clinical, laboratory and endoscopic characteristics of total, segmental and distal colitis have been also analyzed. It was found that clinical activity of total colitis is characterized by more severe course of the disease, accompanied with systemic and local extraintestinal manifestations (OR = 4,504±0,506, p<0.05), more pronounced changes in hemo- and proteinogram parameters (p<0.05). Endoscopic criteria for differences in the clinical forms of ulcerative colitis are the presence of ulcers (OR = 9,667±0,645, p <0,05), erosions (OR = 3,569±0,429, p<0,05), contact bleeding (OR = 4,364± ,444, p< 0.05), changes in the vascular pattern (OR = 3,748±0,477, p<0.05). Correlation analysis of the relationship between clinical (PUCAI), endoscopic (Rachmilewitz index) and laboratory markers of the inflammatory process (leukocytes, platelets, erythrocyte sedimentation rate, γ-globulins, fecal calprotectin, hemoglobin) has been also performed, the criteria of which might be used to monitor the course of the disease and the effectiveness of therapy.

scholarly journals Correlation between Neutrophil Gelatinase-Associated Lipocalin and Endoscopic, Histopathologic and Clinical Activities of Ulcerative Colitis

2020 ◽  
pp. 136-144
Author(s):  
Mohammed G. Flefel ◽  
Heba A. Mourad ◽  
Eiman A. Hasby ◽  
Sherif E. Ezzat ◽  
Waleed S. Mohamed
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Complete Blood Count ◽  
Control Group ◽  
Clinical Activity ◽  
Neutrophil Gelatinase Associated Lipocalin ◽  
Mayo Score ◽  
Liver And Kidney ◽  
Noninvasive Biomarkers ◽  
Neutrophil Gelatinase

Introduction: Detection of activity of ulcerative colitis (UC) is vital for predicting treatment outcome. The assessment depends on clinical, serologic, and endoscopic findings. One of the noninvasive biomarkers for disease activity detection is serum Neutrophil Gelatinase-Associated Lipocalin (NGAL). Aim: To assess the relationship between NGAL and endoscopic, histopathologic and clinical activity of UC. Methods: This study was conducted on 50 cases with definitive diagnosis of UC and 15 cases with normal colonoscopy examination as controls. UC cases were considered active if Geobes score was ≥3.1. Complete blood count, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and liver and kidney function tests were done. Serum NGAL was estimated using ELISA technique. Results: UC cases were classified into active group (n = 36) and inactive group (n = 14). In active UC cases, median value (IQR) of serum NGAL was significantly increased (101.15 (67.53 – 156.40) ng/mL) compared to inactive cases (63.35 (60.98–65.20) ng/mL) and control group (24.80 (15.50 – 31.50) ng/mL). Serum NGAL was well correlated with Geobes score, Mayo score, CRP and ESR. Serum NGAL at cut-off ≥ 63 can predict activity with sensitivity 88.89%, specificity 85.71%, PPV 94.12% and NPV 75%. Conclusion: Serum NGAL is valuable noninvasive marker for assessment of UC disease activity.

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