Early Change in Fecal Calprotectin Predicts One-Year Outcome in Children Newly Diagnosed with Ulcerative Colitis

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

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Sustained normoglycemia in newly diagnosed type I diabetic subjects. Short-term effects and one-year follow-up

Diabetes ◽

10.2337/diabetes.33.10.995 ◽

1984 ◽

Vol 33 (10) ◽

pp. 995-1001 ◽

Cited By ~ 12

Author(s):

K. Perlman ◽

R. M. Ehrlich ◽

R. M. Filler ◽

A. M. Albisser

Keyword(s):

Type I ◽

Newly Diagnosed ◽

Short Term ◽

One Year ◽

Short Term Effects

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Faculty Opinions recommendation of Mucosal healing predicts late outcomes after the first course of corticosteroids for newly diagnosed ulcerative colitis.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.12847957.14136055 ◽

2011 ◽

Author(s):

Mario Cottone

Keyword(s):

Ulcerative Colitis ◽

Mucosal Healing ◽

Newly Diagnosed

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Predicting disease course in ulcerative colitis using stool proteins identified through an aptamer-based screen

Nature Communications ◽

10.1038/s41467-021-24235-0 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Sanam Soomro ◽

Suresh Venkateswaran ◽

Kamala Vanarsa ◽

Marwa Kharboutli ◽

Malavika Nidhi ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Fecal Calprotectin ◽

Disease Monitoring ◽

Disease Course ◽

Lipocalin 2 ◽

Time Points ◽

Inflammatory Bowel ◽

Stool Samples

AbstractIn the search for improved stool biomarkers for inflammatory bowel disease (IBD), an aptamer-based screen of 1129 stool proteins was conducted using stool samples from an IBD cohort. Here we report that of the 20 proteins subsequently validated by ELISA, stool Ferritin, Fibrinogen, Haptoglobin, Hemoglobin, Lipocalin-2, MMP-12, MMP-9, Myeloperoxidase, PGRP-S, Properdin, Resistin, Serpin A4, and TIMP-1 are significantly elevated in both ulcerative colitis (UC) and Crohn’s disease (CD) compared to controls. When tested in a longitudinal cohort of 50 UC patients at 4 time-points, fecal Fibrinogen, MMP-8, PGRP-S, and TIMP-2 show the strongest positive correlation with concurrent PUCAI and PGA scores and are superior to fecal calprotectin. Unlike fecal calprotectin, baseline stool Fibrinogen, MMP-12, PGRP-S, TIMP-1, and TIMP-2 can predict clinical remission at Week-4. Here we show that stool proteins identified using the comprehensive aptamer-based screen are superior to fecal calprotectin alone in disease monitoring and prediction in IBD.

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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

BMC Gastroenterology ◽

10.1186/s12876-021-01889-0 ◽

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.

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EVALUATION OF A DIET AND ANTIBIOTICS TARGETING THE MICROBIOTA FOR TREATMENT OF MILD TO MODETARE ACTIVE PEDIARTIC ULCERATIVE COLITIS: AN OPEN LABEL PILOT STUDY

Inflammatory Bowel Diseases ◽

10.1093/ibd/izaa347.094 ◽

2021 ◽

Vol 27 (Supplement_1) ◽

pp. S38-S38

Author(s):

Chen Sarbagili-Shabat ◽

Lindsey Albenberg ◽

Johan Van Limbergen ◽

Dror Weiner ◽

Michal Yaakov ◽

...

Keyword(s):

Ulcerative Colitis ◽

Pilot Study ◽

Dietary Intervention ◽

Activity Index ◽

Fecal Calprotectin ◽

Dietary Therapy ◽

The Novel ◽

Open Label ◽

Intention To Treat ◽

Stable Maintenance

Abstract Background Newer strategies that target the microbiome may offer an alternative therapeutic approach for Ulcerative Colitis (UC). We developed a novel diet that targets changes in the microbiome and barrier function that have been reported in UC. The goal of the current study was to evaluate the efficacy of two sequential induction of remission strategies that target the microbiota: the novel diet termed the ulcerative colitis diet (UCD) and an antibiotics cocktail combination in dietary non responders. Methods This was a prospective, single arm, open label, pilot study in patients aged 8–19, with a pediatric UC activity index (PUCAI) scores >10 and ≤45 on stable maintenance therapy (5ASA or thiopurines). PUCAI score was assessed at week 3 and 6. Patients failing to enter remission or intolerant to dietary therapy could receive an open label 14-day course of Amoxycillin, Metronidazole and Doxycycline (AMD), and had PUCAI scored at day 21. Response was defined a decline in PUCAI ≥ 10 points, remission as PUCAI< 10. The primary endpoint was intention to treat (ITT) remission at week 6 with diet as the sole intervention. Results Twenty-three children mean age of 15.1±2.9 years were enrolled. Two patients (1 responder, 1 remission) withdrew by 3 weeks, four required additional therapy by week 3, all were considered failures by ITT. Mean PUCAI decreased at week 3 and 6 from 34.5±9.8 to 21.7±14.9 and 17.6±17.2 respectively (P=0.005, P=0.001) at ITT analysis including all patients. Sixteen out of twenty-three patients (69.6%) responded by week 6. Ten of twenty-three (43.5%) achieved remission by week 6, and nine (39.1%) had clinical remission at week 6. The median fecal calprotectin (FC) level decreased in patients (n=5) who achieved remission from 630 (IQR, 332–1586) μg/g at week 0 to 230 (75–1298) μg/g at week 6. Eight patients received treatment with antibiotics after failing diet, 4/8 (50.0%) subsequently entered remission. Conclusion A dietary intervention called the UC Diet appears to be effective for induction of remission in children with mild to moderate UC. Sequential use of diet, followed by antibiotic therapy in dietary non responders, needs further evaluation as a microbiome directed steroid sparing therapy in patient’s refractory to 5ASA and thiopurines.

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19 Colectomy Rate for Moderate to Severe Ulcerative Colitis with Biologics

British Journal of Surgery ◽

10.1093/bjs/znab134.188 ◽

2021 ◽

Vol 108 (Supplement_2) ◽

Author(s):

J W H Koh ◽

C H Ng ◽

M H Lee ◽

Y H Chin ◽

Z H Ong ◽

...

Keyword(s):

Ulcerative Colitis ◽

Current Literature ◽

Biologic Therapy ◽

Meta Analysis ◽

Severe Ulcerative Colitis ◽

Before And After ◽

Arcsine Transformation ◽

One Year

Abstract Introduction Biologics are recommended by both the ACG and ECCO community for the treatment of ulcerative colitis. Yet, current literature has yet to estimate the rate of colectomies after biologic therapy, and thus a pooled meta-analysis was conducted the rate of colectomies in 1month, 6 months, 1 year, 2years and five years after biologics. Method Medline and Embase were searched for articles examining biologics use in moderate to severe UC or acute severe UC (ASUC) from inception to 21st May 2020. Analysis of proportions were undertaken after a freeman-tukey double arcsine transformation. Results The pooled overall colectomy rates of ASUC and moderate to severe UC were 9% (CI: 4% - 14%) at one month, 18% (CI: 13% - 25%) at six months, 21% (CI:16% - 27%) at one year, 29% (CI:24% - 34%) at two years and 38% (CI:30% - 45%) at five years. Additionally, colectomy rates were consistently lower comparing between articles before and after 2010. At one-year, overall colectomy rate following infliximab use was at 25%, golimumab at 15%, vedolizumab at 14%, and adalimumab at 3%. Conclusions Colectomy rates in the era of biologics ranged from 8% to 38% and lower post-2010 showing significant improvement in management and supporting the utility of biologics in Ulcerative colitis management.

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Fecal Calprotectin, CRP and Leucocytes in IBD Patients: Comparison of Biomarkers With Biopsy Results

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwaa009 ◽

2020 ◽

Author(s):

Barry D Kyle ◽

Terence A Agbor ◽

Shajib Sharif ◽

Usha Chauhan ◽

John Marshall ◽

...

Keyword(s):

Ulcerative Colitis ◽

Fecal Calprotectin ◽

Dependent Manner ◽

Ascending Colon ◽

C Reactive Protein ◽

Concentration Dependent Manner ◽

Reactive Protein ◽

Inflammatory Bowel ◽

Descending Colon ◽

Active Inflammation

Abstract Background This study aimed to compare fecal calprotectin (FC) levels with other commonly used parameters as part of patient care during evaluation for inflammatory bowel disease (IBD). Methods We recruited adult IBD patients with ulcerative colitis (UC) and Crohn’s disease (CD) and compared the results of the patient’s biopsy results (i.e., inflamed versus noninflamed) for six sites (i.e., ileum, ascending colon, transverse colon, descending colon, sigmoid colon, rectum) with concentrations of C-reactive protein (CRP), total leucocytes and fecal calprotectin (FC). Results We found that FC was significantly elevated in a concentration-dependent manner that correlated with the number of active inflammation sites reported in biopsy. Although CRP and leucocyte measurements trended upwards in line with inflammation reported from biopsy, the results were highly variable and highlighted poor reliability of these biomarkers for indicating IBD inflammation. Conclusions These results strongly suggest that FC correlates best with biopsy reports and is a superior marker than CRP and leucocytes.

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