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GRANULOCYTE BIOMARKERS IN STOOL AND SERUM AND THEIR ASSOCIATION WITH DISEASE ACTIVITY AND LOCALIZATION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Helena Ekoff 1,2, Niclas Rydell 1, Per Martin Hellström 2, Robert Movérare 1,2

Affiliations

1 Thermo Fisher Scientific, Uppsala, Sweden

2 Uppsala University, Uppsala, Sweden

Summary

AI Generated

A study of 97 IBD patients and 100 IBS controls found that faecal and serum levels of calprotectin, myeloperoxidase, NGAL, and eosinophil-derived neurotoxin were significantly elevated in IBD and associated with disease activity and extent in ulcerative colitis.

All four biomarkers (calprotectin, MPO, NGAL, EDN) were significantly elevated in both faecal (p<0.001) and serum (p<0.01) samples from IBD patients compared to IBS controls.
In active ulcerative colitis versus remission, faecal calprotectin (610.9 vs 45.5 mg/kg, p=0.0180), faecal MPO (6.84 vs 1.30 mg/kg, p=0.0479), serum calprotectin (4599 vs 3128 µg/L, p=0.0194), and serum NGAL (298.3 vs 189.3 µg/L, p=0.0012) were significantly higher.
Patients with extensive ulcerative colitis had significantly higher faecal calprotectin (851.6 vs 148.3 mg/kg, p=0.0135), faecal MPO (17.67 vs 2.84 mg/kg, p=0.0493), and faecal EDN (1.34 vs 0.36 mg/kg, p=0.0146) compared to left-sided disease.
Faecal EDN was significantly higher in Crohn's disease compared to both ulcerative colitis (p=0.016) and IBS, while no biomarkers showed association with disease activity or location in Crohn's disease.
The authors conclude that faecal MPO may serve as an alternative to faecal calprotectin for monitoring ulcerative colitis activity, and that serum calprotectin and serum NGAL are promising novel markers for disease activity.

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Abstract

Introduction

Both patients and clinicians would benefit from less invasive means than endoscopy for detection of gut inflammation in inflammatory bowel disease (IBD), such as faecal or serological biomarkers.

Aims & Methods

The aim of this study was to investigate the presence of the neutrophilic proteins: calprotectin (CP), myeloperoxidase (MPO), neutrophil gelatinase-associated lipocalin (NGAL) and the eosinophilic protein: eosinophil-derived neurotoxin (EDN) in faecal and serum samples from IBD patients with ulcerative colitis (UC) and Crohn’s disease (CD) in relation to disease activity and intestinal inflammation localization. Their diagnostic potential in IBD was studied using irritable bowel syndrome (IBS) patients as controls.
Faecal (f) and serum (s) samples from 97 IBD (median: 38y, range 18-79y) and 100 IBS (median: 36y, range 18-75y) patients from the outpatient Gastroenterology Clinic, Uppsala University Hospital were included in the study. Active disease was defined as having a Partial Mayo score ≥ 2 (UC) or Harvey-Bradshaw score ≥5 (CD). Disease localization was obtained from patient journals.
CP and EDN were measured by commercial EliA and ImmunoCAP assays, respectively. MPO and NGAL were measured with in-house research assays based on the ImmunoCAP technology. All analyses were done using the automated Phadia 250 instrument.

Results

All four biomarkers were elevated in IBD compared to IBS in faecal samples (p<0.001) and serum (p<0.01), and most biomarkers were also elevated in the separate UC and CD groups (Table 1). Faecal EDN were higher in CD compared to both UC (p=0.016) and IBS.
Table 1. Biomarker levels in UC and CD patients in comparison to IBS patients

	UC N=59	CD N=38	IBS N=100	p-value (UC vs. IBS)	p-value (CD vs. IBS)
fCP	305.8 mg/kg	165.8 mg/kg	16.51 mg/kg	<0.0001	<0.0001
fMPO	3.74 mg/kg	2.42 mg/kg	0.10 mg/kg	<0.0001	<0.0001
fNGAL	7.30 mg/kg	6.78 mg/kg	2.36 mg/kg	<0.0001	<0.0001
fEDN	0.50 mg/kg	1.79 mg/kg	0.29 mg/kg	0.049	<0.0001
sCP	4186 µg/L	4124 µg/L	3037 µg/L	0.0145	ns
sMPO	291.6 µg/L	291.2 µg/L	151.3 µg/L	0.0006	0.0038
sNGAL	240.2 µg/L	239.5 µg/L	162.2 µg/L	<0.0001	0.0004
sEDN	29.07 µg/L	24.54 µg/L	19.4 µ/L	0.0020	ns

Four biomarkers were elevated in active UC vs remission: fCP (610.9 mg/kg vs 45.5 mg/kg, p=0.0180), fMPO (6.84 mg/kg vs 1.30 mg/kg, p=0.0479), sCP (4599 µg/L vs 3128 µg/L, p=0.0194) and sNGAL (298.3 µg/L vs 189.3 µg/L p=0.0012). No association was observed between the biomarkers and disease activity in CD.
Patients with extensive UC had significantly higher levels, compared to patients with left-sided UC, of fCP (851.6 mg/kg vs 148.3 mg/kg, p=0.0135), fMPO (17.67mg/kg vs 2.84 mg/kg, p=0.0493) and fEDN (1.34 mg/kg vs 0.36 mg/kg, p=0.0146). None of the biomarkers were associated with disease localization in CD.

Conclusion

Faecal and serum CP, MPO, NGAL and EDN may be used as diagnostic biomarkers to differentiate patients with IBD from IBS. Our study indicates that fMPO may be used as an alternative to fCP as disease activity marker in UC, and that sCP and sNGAL are promising novel serum markers for disease activity. In addition to the neutrophil markers, fEDN could be of value for characterization of extensive disease in UC patients. The higher fEDN levels in CD compared to UC observed in the present study indicates an important role of activated eosinophils in the clinical manifestation of CD.
The biomarkers MPO, NGAL and EDN measured both in faecal and serum could, in addition to CP, potentially aid in the clinical decision-making in IBD.

Disclosure

H Ekoff, N Rydell and R Movérare are employed by Thermo Fisher Scientific.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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The role of nurses/technicians in performing endoscopic necrosectomy of peripancreatic collections

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The role of nurses/technicians in performing endoscopic necrosectomy of peripancreatic collections

Ana Bertic 1

Affiliations

1 Clinical Hospital Center „Sisters of Charity“, Zagreb, Croatia

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Abstract

Event

UEG Week Vienna 2024

Topics

Nurses

Session

Abstracts II: Patient care and endoscopic techniques

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Endoscopy nursing education impact: The portuguese experience

Filomena Maia 1

Affiliations

1 Prelada`s Hospital, Oporto, Portugal

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Abstract

Event

UEG Week Vienna 2024

Topics

Nurses

Session

Abstracts I: Management and education

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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LARGE SCALE CLINICAL TRANSCRIPTOMICS ELUCIDATES MOLECULAR PREDICTORS AND CELLULAR DYNAMICS OF VEDOLIZUMAB RESPONSE

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LARGE SCALE CLINICAL TRANSCRIPTOMICS ELUCIDATES MOLECULAR PREDICTORS AND CELLULAR DYNAMICS OF VEDOLIZUMAB RESPONSE

Maria Paraskevopoulou 1, Saman Farahmand 1, Ruixue Hou 1, Jie Cheng 1, Dmitry Ostanin 2, Guliang Xia 1, Rajesh Kamath 1

Affiliations

1 Takeda Development Center Americas, Inc., Cambridge, United States

2 Takeda Development Center Americas, Inc. (Affiliation at the Time Analysis was Conducted and Abstract Developed), Cambridge, United States

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Abstract

Introduction

Patients with ulcerative colitis (UC) often have unpredictable response over time. Using clinical parameters has proven useful, however, deeper understanding of the molecular and cellular mechanisms that influence therapeutic outcomes in head-to-head trials is lacking. Here we performed a large-scale transcriptomics analysis of tissue biopsies derived from moderate-to-severe UC patients treated with vedolizumab (VDZ) or adalimumab (ADA) in the VARSITY trial (Sands, 2019).

Aims & Methods

The aim of this study was to identify biomarkers of response to VDZ and ADA treatment. We performed bulk RNA sequencing of 954 biopsies collected using the flexible sigmoidoscopy from pre-treatment/baseline, week (w)14 and w52. Our dataset comprised complete longitudinal tissue sampling of n=151 non-responders, n=117 responders based on clinical remission at w52. We employed comparative analysis to pinpoint differentially expressed genes (DEG) and differential pathways for ADA and VDZ treated patients. We then employed systems network strategies to identify gene modules (Choobdar, 2019) associated with clinical parameters. Finally, we utilized multivariate trajectory model (Nagin, 2018) to characterise longitudinal patient trajectories based on study endpoints and integrated transcriptomics signatures to patient variable response (Schreiber, 2023).

Results

Variable baseline gene expression profile was associated with prior exposure to anti-TNFα, corticosteroid or immunomodulator treatment. DEG and gene-modules linked to VDZ response in tissue biopsies revealed inflammatory, fibrotic, epithelial, and neuronal pathways, including but not limited to JAK/STAT, G-Protein Coupled Receptor signalling, ECM interactions, oxidative phosphorylation, and neuroglial signatures. Importantly, these consistent gene and gene-module predictors of clinical remission were detected at pre- and post-treatment (w14 and w52) to VDZ. For ADA treated patients, no DEG and gene-modules were significantly associated with treatment-response at baseline after FDR correction. Upon relaxing stringency, we were able to find pathways such as neutrophil degranulation, MAPK signalling, and Fc-mediated immune regulation linked to ADA response.
Cell type contributions were in silico inferred with deconvolution analysis of bulk gene expression data. In agreement with the pathway analysis, we identified epithelial, plasma, stromal populations as baseline biomarkers of response to VDZ, while specific CD4+, CD8+ T cell subsets, follicular B cells and inflammation-associated fibroblasts were significantly elevated in non-responders compared to the responders to VDZ from baseline to post-treatment. In ADA non-responding patients, CD4+ T cells were significantly increased compared to responders at baseline and post-treatment. Gene-module predictors were linked to distinct patients' trajectories based on symptoms; the greatest correlations with transcriptomics findings were observed between our extreme responding groups from trajectory analyses.

Conclusion

We present first-of-a-kind analysis using large-scale clinical trial integrating longitudinal bulk RNA-seq analysis with clinical outcomes in response to two different therapies. For VDZ, as opposed to ADA, we were able to find strong baseline predictors also preserved after treatment. We hope that similar approaches could support clinical precision medicine applications to help patients achieve faster and lasting disease control.

References

Sands, BE, et al. N Engl J Med 2019;381(13):1215-1226.
Choobdar, S, et al. Nat Methods 2019;16(9):843-852.
Nagin DS, et al. Statistical Methods in Medical Research 2018;27(7):2015-2023
Schreiber, et al., United European Gastroenterology Journal 2023; 11 (Supplement 8)

Disclosure

All authors are employees and shareholders of Takeda.

Event

UEG Week Vienna 2024

Topics

IBD Immunology Mechanisms & Personalised Medicine

Submission format

Abstract

Session

IBD: Latest news on a personalised approach

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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UEG Poster

Standard Poster

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THE EFFICACY AND SAFETY OF COMPOUND GLUTAMINE ENTERSOLUBLE CAPSULE IN THE TREATMENT OF DIARRHEA PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS-D): A MULTICENTER RANDOMIZED, DOUBLE BLINDING, PLACEBO-CONTROLLED WITHDRAWAL TRIAL

Tao Bai 1, Xinghuang Liu 1, Unknown Unknown 2, Yuting Guo 2, Min Zheng 3, Wenfu Tang 4, Xiangming Fang 5, Chengxia Liu 6, Shasha Wang 7, Wu Yongdong 8, Jianrong Tang 9, Yunwang CHEN 10, Huisheng Yu 11, Jieqiong Wu 12, Ying Song 13, Qinghua Zhao 14, Qing Zhang 15, Yisheng Wei 16, QIAOYUN TONG 17, Huiqiu Deng 18, Yongsong Gu 19, Deliang Liu 20, Yan Li 21, Maoyuan Ma 22, Xiaohua Hou 1

Affiliations

1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

2 The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China

3 Central Hospital of Tongchuan Mining, Tongchuan, China

4 West China Hospital, Sichuan University, Chengdu, China

5 Wuhan Puren Hospital, Wuhan, China

6 Binzhou Medical University Hospital, Binzhou, China

7 Xian Yang Central Hospital, Xianyang, China

8 Beijing Friendship Hospital, Capital Medical University, Beijing, China

9 Zhumadian Central Hospital, Zhumadian, China

10 Lianyungang Hospital of TCM, Lianyungang, China

11 Luo Yang First People's Hospital, Luoyang, China

12 The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xian, China

13 The Second Norman Bethune Hospital Of Jilin University, Changchun, China

14 Kaifeng hospital of traditional Chinese medicine, Kaifeng, China

15 The First People‘s Hospital of Jingzhou, Jingzhou, China

16 The First People's Hospital of Xianyang, Xianyang, China

17 Yichang Central People's Hospital, Yichang, China

18 ShangRao People's Hospital, Shangrao, China

19 The People's Hospital of Chizhou, Chizhou, China

20 2nd Xiangya Hospital, Chang Sha, China

21 Shengjing Hospital Of China Medical University, Shenyang, China

22 The Second People's Hospital of Taizhou, Taizhou, China

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Abstract

Introduction

Irritable bowel syndrome is one of the most common Disorders of gut-brain interaction, with diarrhea being the predominant subtype. At present, there are limited drugs for effective management of irritable bowel syndrome.
Compound glutamine entersoluble capsules are composed of traditional chinese medicine formulas Sijunzi Tang and L-glutamine. The Sijunzi Tang, which has been used in traditional complementary and alternative integrated medicine, has been used for the treatment of irritable bowel syndrome for many years. However, there is a lack of evidence from modern evidence-based medicine, its clinical efficacy and safety need to be confirmed. L-glutamine has the function of repairing damaged intestinal mucosa.

Aims & Methods

This study performed a multicenter randomized double-blind placebo-controlled withdrawal trial to explore the effectiveness and safety of compound glutamine entersoluble capsules in the treatment of diarrhea predominant irritable bowel syndrome.
The selected participants received the investigational drug for four weeks during the first single arm stage. The responding participants were randomly assigned to the compound glutamine entersoluble capsules and placebo groups in a 1:1 ratio for another 4 weeks.
The primary efficacy endpoint of the study was the response rate of both the improvement in abdominal pain and bowel movements after treatment in randomized controlled trial subjects (50% of the treatment course met the requirement of at least 30% improvement in abdominal pain severity (NRS pain score) and a reduction of at least 50% in bowel movement days for Bristol 6 or 7 types).

Results

A total of 558 subjects in 22 centers, of which 493 subjects were successfully screened and entered the placebo introduction period. During the placebo introduction period, there were a total of 493 subjects, of which 481 subjects were successfully rescreened and entered the single arm period. 437 subjects entered the randomized controlled trial period and were randomly divided into a treatment group of 217 subjects and a placebo group of 220 subjects.
For the primary efficacy endpoint, the number of response cases in the experimental group and placebo group were 114 (54.55%) and 89 (41.20%), respectively (P=0.0059). For secondary efficacy endpoints: (1) The number of improvements in NRS pain scores in the experimental group and placebo group were 138 (66.03%) and 107 (49.54%), respectively (P=0.0006); (2) The number of improved bowel movements in the experimental group and placebo group were 157 (75.12%) and 118 (54.63%), respectively (P<0.0001); (3) The median (quartile) relative baseline change of IBS-SSS scale in the experimental group was -47.00 (-97.00, -14.00) points; The median (quartile) relative baseline change in the placebo group was -17.00 (-63.00, 16.00) points, and there was a statistically significant difference between the two groups (P<0.0001); (4) The median (quartile) relative baseline change of IBS-QOL in the experimental group was -11.46 (-43.01, 0.00) points; The median (quartile) relative baseline change in the placebo group was -3.57 (-39.43,0.00) points (P=0.0007).
During the randomized controlled trial period, the incidence of all adverse events in the 217 subjects in the trial group was 18.89%, the placebo group was 22.27%, the incidence of TEAEs related to the drug in the trial group was 2.30%, and the placebo group was 3.18%.

Conclusion

Compound glutamine entersoluble capsule can effectively improve the clinical symptoms of diarrhea predominant irritable bowel syndrome with a satisfactory safety.

Conference

UEG Week Vienna 2024

Topics

Colorectal

Submission format

Abstract

Session

Mechanisms and treatment of IBS (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Bacteriophages

Rafael Valdes 1

Affiliations

1 None, None, Israel

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Abstract

Event

UEG Week Vienna 2024

Topics

Gut Microbiota Mechanisms & Personalised Medicine

Session

Future microbiome therapeutics

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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The role of nurses/technicians in performing endoscopic necrosectomy of peripancreatic collections

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LARGE SCALE CLINICAL TRANSCRIPTOMICS ELUCIDATES MOLECULAR PREDICTORS AND CELLULAR DYNAMICS OF VEDOLIZUMAB RESPONSE

Dmitry Ostanin

THE EFFICACY AND SAFETY OF COMPOUND GLUTAMINE ENTERSOLUBLE CAPSULE IN THE TREATMENT OF DIARRHEA PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS-D): A MULTICENTER RANDOMIZED, DOUBLE BLINDING, PLACEBO-CONTROLLED WITHDRAWAL TRIAL

Yan Li

Bacteriophages

Rafael Valdes

Improving patient compliance to replacement or removal of a plastic biliary stent inserted by ERCP

Eisa Hag

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Improving patient compliance to replacement or removal of a plastic biliary stent inserted by ERCP

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Improving patient compliance to replacement or removal of a plastic biliary stent inserted by ERCP

Eisa Hag 1

Affiliations

1 Rambam Health Care Campus - Haifa, Haifa, Israel

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Abstract

Event

UEG Week Vienna 2024

Topics

Nurses

Session

Abstracts I: Management and education

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Yan Li

Bacteriophages

Rafael Valdes

Improving patient compliance to replacement or removal of a plastic biliary stent inserted by ERCP

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