bluuebunny/crossref_metadata_2025 huggingface dataset:
P310 Smoking is not an independent risk factor for surgery in patients with Crohn’s Disease on biologic therapy
Authors: Sharara A , Halablab S , Sadaka C , Slika H , Adra N , Ghusn W , Shmeis M , Al Razim A
Published: January 2023

Background

To examine the effect of smoking on need for surgery in patients with moderate to severe Crohn’s disease (CD) receiving biologic therapy.

Methods

Retrospective study of adult patients with CD at a University Medical Center over a 20-year period.

Results

A total of 251 patients were included (mean age 35.9 ± 15.0; 70.1% males; current, former, and non-smokers: 44.2%,11.6%, and 43.8%, respectively). Mean duration on biologics was 5.0 ± 3.1 years (>2/3 received anti-TNFs, followed by ustekinumab in 25.9%) and a third of patients (29.5%) received > one biologic. Disease-related surgeries (abdominal, perianal or both) occurred in 97 patients (38.6%): 57 before, and 41 after starting biologics. There was no significant difference in surgeries between ever-smokers (current or previous) vs. non-smokers in the overall study group. On logistic regression, the odds of having any CD surgery were higher in patients with longer disease duration (OR = 1.05, 95% CI = 1.01, 1.09) and in those receiving > one biologic (OR = 2.31, 95% CI = 1.16, 4.59). However, among patients who had surgery prior to biologic therapy, smokers were more likely to have perianal surgery compared to non-smokers (OR = 10.6, 95% CI = 2.0, 57.4; p=0.006).

Conclusion

In biologic-naive CD patients requiring surgery, smoking is an independent predictor of perianal surgery. Smoking, however, is not an independent risk factor for surgery in this cohort after starting biologics. The risk of surgery in those patients is primarily associated with disease duration and the use of more than one biologic.
P316 Inflammatory Bowel Disease and malignancy: What are the predictors of malignancy in Inflammatory Bowel Disease?
Authors: Istemihan Z , Çavuş B , Bardak A E , Kırkoğlu A M , Kızıltaş C , Silay R , Şenkal İ V , İmanov Z , Nuriyev K , Rüstemzade A , Genç S , Güllüoğlu M , Çifcibaşı Örmeci A , Demir K , Beşışık F , Kaymakoğlu S , Akyüz F
Published: January 2023

Background

The aim of this study is to investigate the incidence of malignancy in patients with inflammatory bowel disease (IBD) followed up in a tertiary reference center.

Methods

IBD patients who were with at least 6 months of follow-up between the 1991-2022 from the gastroenterology clinic were evaluated retrospectively. Descriptive statistics for continuous variables in the study; expressed as mean (mean), standard deviation (SD), minimum, maximum, number (n) and percent (%). “Independent T-test” was used to compare continuous measurement values according to categorical groups. Chi-square test was used to determine the relationships between categorical variables.

Results

There were 696 patients in the study totally. 319 (45.83%) of these patients were female. Mean age of the patients were 48.27±14.58 years. IBD type was changed as; 307 (44.1%) had ulcerative colitis, 377 (54.1%) had Crohn's disease, 12 (1.8%) had indeterminate colitis. Before the diagnosis of IBD, 8 patients (1.1%) had a history of malignancy. The prevalence of malignancy after the diagnosis of IBD was 13 (1.86%). The characteristic of these 13 patients are described in Table 1. When the relationship between malignancy and gender, age, body mass index (BMI), disease age, and disease type in patients who developed malignancy in inflammatory bowel disease was examined, a statistically significant relationship was found in the elderly and those with high BMI (p=0.0019, p=0.004, respectively). When we look at the relationship between the risk of developing malignancy in IBD and the age of the disease at 10 and 8 years period, it was seen that there was no statistically significant relationship (p=0.245, p=0.343). When the patients who developed malignancy in IBD were compared in terms of the immunomodulators and biological agents used by the patients who did not develop malignancy, there was no statistical difference between the two groups (p>0.05). (Fig.1 Graphical abstract).

Fig.1 Graphical abstract

Conclusion

Higher BMI and being older age found to be risk for the development of malignancy in IBD patients, although no relationship was found with the use of immunomodulator, biological agents, or disease type. The risk of malignancy, especially colorectal cancers, is increased in IBD. Therefore, close follow-up of these patients is important.
P320 Confocal Laser Endomicroscopy to predict the efficacy of vedolizumab as first-line biotherapy in ulcerative colitis
Authors: Quénéhervé L , Trang-Poisson C , Fantou A , Flamant M , Durand T , Bouguen G , Bregeon J , Oullier T , Amil M , Dewitte M , Bardot S , Braudeau C , Josien R , Neunlist M , Bourreille A
Published: January 2023

Background

There is no biomarker to guide first-line of biotherapy in ulcerative colitis (UC). The main objective of this multicenter pilot study was to demonstrate the feasibility of identifying a4b7 and/or TNF-a expressing cells by dual-band confocal endomicroscopy (CLE) into the mucosa to predict the response to vedolizumab as first-line biotherapy. NCT02878083.

Methods

Patients with moderate to severe UC, naïve of biotherapy were prospectively included and received vedolizumab. Patients were evaluated clinically, biologically, endoscopically and histologically at week 22. Nonresponding patients were subsequently treated by adalimumab and were evaluated at week 30. Prior to the initiation of vedolizumab, during endoscopy, 8 biopsies were taken for extemporaneous and ex vivo analysis by CLE, histology and confocal microscopy. Fresh biopsies were treated with vedolizumab coupled with FITC and adalimumab coupled with Alexa-Fluor to analyze their respective fluorescence (figure) in one step with the Dual-band CLE system (Mauna Kea Technologies, France). The number and the surface of positive stained areas visualized by CLE were counted and compared between responders and non-responders. Blood samples were collected before each infusion and were used to analyze the immune cells (LT, LB, NK, monocytes) by FACS and vedolizumab trough levels. Frozen biopsies were analyzed by confocal microscopy (Opal Akoya multiplexing; Tyramide signal amplification) after labeling by an anti-a4b7 antibody.

Results

19 patients out of the 20 initially planned were included. Clinical remission, endoscopic improvement (Mayo ≤ 1), endoscopic remission (Mayo 0) at W22 were respectively 58%, 58% and 45%. 18 out of 19 patients (95%) could be analyzed by CLE. The number and surface of vedolizumab-FITC stained areas were numerically superior in responder patients at week22; by contrast, no difference was found for the areas marked by adalimumab-Alexa-fluor. A threshold value of 6 areas marked in CLE by the vedolizumab-FITC at week 0 discriminated responders and non-responders at week 22 with a Se of 78% and a Sp of 85%. No difference of circulating cell population has been identified between responders and non-responders and the vedolizumab trough levels were not predictive of the response. In confocal microscopy, 15 patients have been analyzed; the percentage of a4b7-binding cells was not different between responders (n=9) and non-responders (n=6)

Conclusion

This study confirms the feasibility of extemporaneous identification by dual-band CLE of the mucosal cells expressing a4b7 and/or TNF-a. Results suggest that only the proportion of cells binding vedolizumab-FITC in the mucosa was indicative of the response to vedolizumab
P322 Mycobiome signature in pediatric patients with Inflammatory Bowel Disease
Authors: Murugesan S , Kumar M , Saadaoui M , Elhag D A , Hendaus M A , Ibrahim N , Al-Mudhaka F , AbuHazima K , Akobeng A , Elawad M , Al Khodor S
Published: January 2023

Background

Inflammatory bowel disease (IBD) encompasses dysregulation of mucosal immunity involving multiple factors including diet, medication, family history, and the gut microbiome. The symptoms of Pediatric IBD are different from an adult-onset disease. Based on the clinical conditions, IBD can be classified into three categories: Crohn’s disease (CD), Ulcerative colitis (UC), and IBD-unclassified (IBDU). The gut bacteriome alteration is widely reported in IBD. But the gut mycobiome link to the disease remains sparse. This study compared mycobiome profile changes in pediatric patients with IBD and healthy controls.

Methods

Stool samples were collected from patients with CD (n = 110), UC (n=64), IBDU (n=23), and healthy control subjects (n = 42). ITS-2 (Internal Transcribed Spacer) libraries were sequenced and analyzed using the QIIME pipeline to assess the gut mycobiome composition. Lefse analysis was performed to identify the signature members among the study groups.

Results

Ascomycota and Basidiomycota were the most common phyla among the study groups. Saccharomyces cerevisiae and Candida albicans were the most abundant species in the gut. Patients with IBDU and CD had significantly lower alpha and beta diversities compared to the controls.

Conclusion

Pediatric IBD is associated with reduced alpha and beta gut fungal microbiome diversity. Specific Candida taxa were found to be increased in abundance in the IBD samples. These results emphasize the potential importance of fungal microbiota signatures as biomarkers of pediatric IBD, supporting their possible role in disease pathogenesis.
P324 Long-term impact of the COVID-19 pandemic on Inflammatory Bowel Disease healthcare utilization: A two-year nationwide update
Authors: Derks Eduarda Wilhelmina M , van Lierop L , te Groen M , Kuijpers C , Nagtegaal I D , Hoentjen F
Published: January 2023

Background

The COVID-19 pandemic has profoundly impacted utilization of inflammatory bowel disease (IBD) healthcare, with a large reduction in scheduled procedures in the early phase of the pandemic, as shown in our previous study1. In this current nationwide study, we aimed to determine the impact of consecutive COVID-19 waves on IBD healthcare utilization including IBD-related diagnoses and procedures during the first two years of the COVID-19 pandemic.

Methods

We conducted a search in the Dutch nationwide pathology databank (PALGA) to identify IBD patients who underwent an IBD-related procedure between March 1, 2018 and February 28, 2022. We determined the incidence of IBD-related endoscopic and surgical procedures, new IBD diagnoses and neoplasia diagnoses (indefinite (IND), low-grade (LGD), high-grade dysplasia (HGD) and colorectal cancer (CRC)) during the first two years of the COVID-19 pandemic in the Netherlands (March 2020 – February 2022). The mean incidence of the previous two years (March 2018 – February 2020) served as a comparator.

Results

Our search yielded 89,401 (94.2%) endoscopic and 5,462 (5.8%) surgical procedures. We calculated a net reduction of 2.9% (1,391 IBD procedures) after the first two years of the COVID-19 pandemic compared to the two pre-pandemic years (endoscopic procedures: -3.1%, n=1,409; surgical procedures: +0.7%, n=18, figure 1). For both endoscopic and surgical procedures, an initial net decrease after the first pandemic year was followed by a net increase after the second year (-6.2% (n=1,413) versus +0.02% (n=4) and -1.3% (n=18) versus +2.7% (n=36), respectively). A net reduction of 0.9% (n=54) in new IBD diagnoses was observed over the first two years of the COVID-19 pandemic (first year: -0.8%, n=24; second year: -1.0%, n=30). A net reduction of 1.9% (n=74) in IND/LGD diagnoses was observed after the two-year pandemic period (first year: -10.9%, n=213: second year: +7.1%, n=139). No net decrease was seen for HGD and CRC diagnoses.

Conclusion

In this nationwide cohort study covering the first two pandemic years, we observed a mitigation of the initial reduction of IBD-related procedures after the first COVID-19 wave. This illustrates the rapid adaptation of the national IBD healthcare system during subsequent COVID-19 peaks.

References:

1 te Groen M, Derks MEW, Kuijpers CCHJ, Nagtegaal ID, Hoentjen F. Reduction in Inflammatory Bowel Disease Healthcare During the Coronavirus Disease 2019 Pandemic: A Nationwide Retrospective Cohort Study. Gastroenterology. 2021;160(3):935-7.e1
P325 Proton pump inhibitors are associated with a disabling course of Crohn’s disease
Authors: Barrau M , Duru G , Nancey S , Phelip J M , Cheifetz A , Papamichael K , Paul S , Xavier R
Published: January 2023

Background

The impact of proton pump inhibitors (PPIs) on the evolution of inflammatory bowel disease (IBD) remains debated with only sparse data available. The primary objective of this study was to analyze the impact of PPIs on the course of IBD.

Methods

This was a single-center, retrospective cohort study. We included consecutive adult patients diagnosed with Crohn disease (CD) or ulcerative colitis (UC) who were followed prospectively in our day hospital over a 4-month period (from May to August 2022). PPI exposure was defined as PPI use for a cumulative duration of more than seven days from the date of IBD diagnosis until the end of follow-up. We performed a time to event analysis to investigate the association of PPI exposure with treatment failure defined as an IBD-related surgery or hospitalization and/or failure for more than four biologic treatment (Anti TNF, Vedolizumab, Ustekinumab).

Results

Among the 281 patients identified, 244 patients were eligible for analysis of the primary objective (152 with CD, mean age 45 years, sex ratio 1:1). 113 (46%) patients had been previously exposed to a PPI. PPI-exposed patients were significantly older (p=0.013), more often women (p=0.029), with more frequent active smoking (p=0.001). A total of 152 patients (62%) had treatment failure. Using Cox regression analysis, (Table 1), PPI use identified as an independent factor associated with treatment failure (HR = 1.920; 95% CI [1.084-3.403]; p0.025). In a subgroup analysis by IBD type, this remained statistically significant only for CD (HR = 3.190; 95% CI (1.412-7.206); p 0.005) but not for UC (HR = 0.981; 95% CI (0.384-2.504); p0.968). Survival without treatment failure (Figure 1) was significantly higher in patients without PPI exposure compared to patients with PPI exposure, (325 months vs. 228 months, respectively, p=0.022 (Log-Rank). In a subgroup analysis of infliximab-treated patients, PPI use was not associated with risk of immunogenicity (HR = 1.071; 95% CI (0.515-2.226); p0.854).

Conclusion

This study demonstrates the negative impact of PPIs on the disease course in patients with CD. The use PPIs should better be discussed on a case-by-case basis.
P329 Stool multiplex molecular PCR assay in comparison to conventional stool tests for detecting gastrointestinal infections as cause of flares in Inflammatory Bowel Disease
Authors: Kutar M , Desai D , Abraham P , Gupta T
Published: January 2023

Background

Inflammatory bowel disease (IBD) is characterized by unpredictable flares. Other than natural history, flares can be caused by superadded gastrointestinal (GI) tract infections. Diagnosis of infection is conventionally made by microscopy and culture of stool specimens. These are limited by lengthy turnaround time, low sensitivity, inability to detect agents other than bacteria, and effect of pre-test antibiotic usage.Stool multiplex molecular PCR assay allows simultaneous detection of nucleic acids from 23 bacteria, viruses and parasites.

Methods

We aimed to:

1. Compare infectious organisms detected by stool multiplex PCR assay and conventional stool tests during flare in patients with IBD.

2. Determine impact of detection of infective agents in the management of flares, as measured by use of anti-infective agents.

In this single centre, prospective, cohort study, every patient underwent conventional stool tests (microscopy, culture and Clostridioides Difficile toxin assay) and multiplex PCR assay by Biofire® FilmArray test. Consenting patients above 18 years with IBD flare were included. Patients with colorectal cancer, toxic megacolon, intestinal perforation, previous IBD surgery were excluded.

Results

Of 60 patients, 53 patients were of Ulcerative colitis (UC) and 7 were of Crohn’s disease (CD). The mean age of patients with UC was 42.32 years and that of CD was 37.5 years. Of the patients with UC, 26 were male and 27 were female. In CD, 4 were male and 3 were female.

Stool Biofire® resulted in better organism detection rate (Table 1) and more frequent need for change in management (Table 2) as compared to conventional tests.

The cost per stool Biofire® was INR 12000 (€142) and that of conventional stool tests INR 4300 (€51). However, the cost to achieve one positive result on stool Biofire® that led to change in management was INR 65,454 (€773) as compared to INR 86,000 (€1015) for conventional stool tests.

Conclusion

Stool Biofire® resulted in significantly more organism detection (33 vs 6 pts). It also led to more frequent need for change in management as compared to conventional stools tests (11 vs 3 pts). It also proved more cost-effective than conventional stool tests in terms of change in management of flare in patients with IBD.
P330 Ultrasound remission after biologic induction predicts long-term endoscopic remission in Crohn’s disease
Authors: Allocca M , Dell’Avalle C , Furfaro F , Zilli A , Radice S , D’Amico F , Peyrin-Biroulet L , Fiorino G , Danese S
Published: January 2023

Background

Intestinal ultrasound (IUS) is accurate and non-invasive to detect and monitor disease activity in Crohn’s disease (CD). The Bowel Ultrasound Score (BUSS= 0.75 × bowel wall thickness + 1.65 × presence (1) or absence (0) of bowel wall flow) demonstrated high accuracy in detecting therapy-related changes, and good correlation with the Simple Endoscopic Score for CD (SES-CD). The most accurate cutoff value for BUSS was 3.52 for endoscopic remission (SES-CD ≤ 2).This study aimed to prospectively evaluate ultrasound remission as a relevant treatment target.

Methods

Consecutive patients with active CD (SES-CD > 2) starting biologic treatments were included. Patients underwent colonoscopy and IUS at baseline and after 1 year of treatment. Clinical, biochemical and ultrasound assessments were additionaly performed at week 12. Primary outcome was to evaluate whether ultrasound remission at week 12 could predict endoscopic remission at week 54. Endoscopic remission was defined as SES-CD ≤ 2, ultrasound remission was defined by BUSS ≤ 3.52, clinical remission was defined by HBI (Harvey-Bradshaw Index) < 5, and biochemical remission was defined by normalization of C-reactive protein (< 5 mg/L) and fecal calprotectin (three different thresholds were assessed: < 250 µg/g, < 100 µg/g, < 50 µg/g).

Results

Ninety-three patients were included (8 under infliximab, 40 under adalimumab, 5 under vedolizumab and 40 under ustekinumab). Eighteen patients (19%) and 36 patients (39%) achieved endoscopic remission and ultrasound remission at week 54, respectively. CD patients with ultrasound remission at week 12 were more likely to achieve endoscopic remission (odds ratio [OR] 6.88 [2.14–22.04]; p = 0.001) and ultrasound remission (OR 4.26 [1.61–11.24]; p = 0.003) at week 54. Calprotectin value < 50 µg/g at week 12 predicted endoscopic remission at univariable (OR 3.14 [1.04–9.45]; p = 0.041), but not at multivariable analysis. No other clinical or biochemical variables at week 12 predicted endoscopic and/or ultrasound remission at week 54.

Conclusion

Ultrasound remission achieved at week 12 may predict long-term endoscopic remission and may be a strategic treatment target, both in clinical practice and in clinical trials.
P339 Zonulin concentration in patients with ulcerative colitis with and without COVID-19 infection
Authors: Knyazev O , Kulakov D , Kagramanova A , Tishaeva I , Baranova T , Poletova A
Published: January 2023

Background

Zonulin is a protein, reversibly increasing the permeability of the intestinal wall by changing the structure of tight junctions of the lateral surfaces of intestinal epithelial cells. Fecal zonulin is used for noninvasive assessment of increased intestinal permeability. Normal values of zonulin in stool (≤ 110 ng/ml) indicate the absence of damage of the intestinal villous mucosal surface and normal density of intercellular contacts.

The aim of the study was to determine the level of fecal zonulin (FZ) in the feces of ulcerative colitis (UC) patients with exacerbation of the disease and the presence of COVID-19 in the acute period and without COVID-19 to assess the degree of intestinal permeability.

Methods

46 patients with IBD without COVID-19 (Me age — 36 years) and 31 patients with UC with the presence of COVID-19 infection in the acute period (Me age — 42 years) were examined. Untreated stool samples of patients were frozen and stored at a temperature of 80 °C. FZ was measured by ELISA (IDK ® Zonulin ELISA Kit, Immunodiagnostik AG, Germany) in ng/ml. Reference values: < 83.15 ng/ml - a variant of the norm, 83.15-110 ng/ml - an elevated level, 110 ng/ml - a high level

Results

In the stool samples of patients with UC exacerbation without COVID-19 FZ was detected from 172.6 to 460.8 ng/ml (Me - 316), the average value was 322.4±14.6 ng/ml. In the stool samples of patients with UC exacerbation and COVID-19 infection, FZ was detected from 354.8 to 628.3 ng/ml (Me – 489.9), the average value was 472.9±18.4 ng/ml (p=0.000001).

Conclusion

FZ concentration in the feces of UC patients is significantly higher in UC patients with the presence of COVID-19 infection in the acute period, which indicates a higher permeability of the intestinal wall.
P341 Fracture risk in middle-age and older patients with inflammatory bowel disease: A Korean nationwide population-based cohort study
Authors: Lee J , Lee K M , Han K D
Published: January 2023

Background

Fracture risks and associated factors in middle-age and older Asian populations with inflammatory bowel disease are poorly understood. We investigated fracture risk and the effects of comorbidities and lifestyle habits on the risk of developing fractures in middle-age and older Korean patients with inflammatory bowel disease.

Methods

We conducted a nationwide population-based cohort study using data from the National Health Insurance Corporation Database. We included patients aged over 40 years with inflammatory bowel disease who received the National Screening Program. We compared patients with age- and sex-matched controls. The incidence of fractures, including vertebral, hip, and other sites was determined using claims data.

Results

The risk of total fractures and vertebral fractures was significantly higher in the inflammatory bowel disease group [adjusted hazard ratio=1.31, 95% confidence interval=1.16–1.48; adjusted hazard ratio=1.59, 95% confidence interval=1.33–1.92, respectively]. Obesity, diabetes, hypertension, and lack of exercise were associated with an increased risk of fracture in patients with ulcerative colitis. In contrast, risk tended to increase regardless of comorbidities and lifestyle habits in patients with Crohn’s disease.

Conclusion

The risk of bone fracture, especially vertebral fracture, is high in middle-age and older Korean patients with inflammatory bowel disease. Obesity, diabetes, hypertension, and lack of exercise are risk factors for bone fracture in patients with ulcerative colitis. These findings may be helpful for clinicians to educate patients with inflammatory bowel disease on bone health and raise awareness of bone fractures in patients with ulcerative colitis who have specific risk factors.
P342 Treatment experience of perianal fistulising Crohn’s disease: a systematic literature review
Authors: McKay C , Pacis S , Bolzani A , Geransar P , Panés J
Published: January 2023

Background

The treatment of complex Crohn’s perianal fistulas (CPF) is challenging, requiring both medical and surgical approaches. The treatment goal is fistula closure, but long-term success rates are modest and recurrence is high after both medical and surgical interventions. This systematic literature review (SLR) aimed to better understand the treatment patterns and outcomes associated with complex CPF.

Methods

Electronic databases (MEDLINE, Embase, EBM Reviews, EconLit) were searched. PICOS-T (population, interventions, comparators, outcomes, study design, time) selection criteria were used to identify relevant studies, and two reviewers independently screened and extracted data. Articles included observational studies with >50 patients published in English from 1 Jan 2015 to 17 Feb 2022. The study was still included if complex CPF was not defined. The NIH Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies was used to assess therisk of bias/quality of studies (good, fair or poor). All interventions were of interest. Treatments were grouped into 16 intervention categories, and treatment responses into 4 healing and 7 failure categories. Data on five morbidity categories (faecal incontinence, abscess, anorectal stricture, proctitis and sepsis) were extracted and summarized using descriptive statistics.

Results

In total, 140 studies were included; of which most were of good (n=14) or fair (n=98) quality regarding risk of bias. Few studies (n=24) defined complex CPF; hence, outcomes included all types of CPF. Included studies reported on treatment patterns, failures and responses (n=63) and morbidity (n=30). Loose seton was the most commonly recorded first- and second-line intervention given in a study. Among drug therapies, immunomodulators and biologics were the most common first- and second-line interventions, respectively (Table 1). Across all categories, healing rates ranged from 10.5% to 80.2% and failure rates from 3.6 to 83.0% (Table 2). Of the top five most frequent intervention categories, fistulectomy/-otomy was associated with the highest rate of healing (fistula healing/closure), and loose seton placement was associated with the highest rate of failure (recurrence) (Table 3). Reporting of morbidity varied widely; of which, abscesses were the most common reported at CPF diagnosis, followed by proctitis (Table 4).

Conclusion

This SLR detailed a broad range of current therapies, healing and failure rates, and heterogeneity in timing and treatment sequencing in patients with CPF. These results reflect the challenging nature of treating CPF with current therapies and highlight an unmet need for reliable treatment options to improve outcomes for patients with CPF.

Funding: Takeda Pharmaceuticals USA, Inc.
P345 Capsule endoscopy in the diagnostic process of suspected Crohn's Disease
Authors: Hennlich B , Madl C , Pachofszky T
Published: January 2023

Background

Since more than 20 years, capsule endoscopy (CE) complements endoscopic and radiological examinations, to diagnose diseases of the small bowel (SB), for it allows the direct visualisation of the intestinal mucosa. Although nearly 30% of people suffering from Crohn’s Disease (CD) are affected by an inflammation solely in the SB, this minimally invasive approach is mostly used late in the diagnostic algorithm. Studies concerning indicators of quality of the CE system exist above all for the indication of obscure gastrointestinal bleeding (OGIB), therefore, the aim of this study is to analyse the detection, completion, and complication rate as well as visibility and passage times of the CE in a cohort with suspected CD. Additionally, the different CE models should be compared regarding these parameters and an assessment, which influence the intraobserver-variability exercises on the diagnostic accuracy should be conducted.

Methods

For this purpose, corresponding data out of written CE records from 430 patients in a tertiary hospital in the eastern part of Austria were retrospectively analysed. “Major Lesions” contained aphthoid, ulcerating and stenosing pathologies whereas “Minor Lesions” consisted of mucosal and villous abnormalities. In addition, the diagnose made after a follow-up period of six months was extracted from the individual medical records.

Results

52,8% of the examinations were performed using the CapsoCam system, altogether there was a detection rate of 35,1%, the most frequent detected lesions being aphthoid abnormalities (76,8%). There was a completion rate of 95,4% and an average passage time of 266,94 ± 121,11 minutes. In 1,2% of the cases, a capsule retention occurred with a 1696 times higher chance in the presence of a stenosis. The visibility was rated “good” in 72,6% and the comparison between CapsoCam, PillCam, MiroCam and EndoCapsule showed, that only the completion rate has been associated with the choice of the CE model. After six months, CD has been diagnosed within 26,5% of the patients, resulting in a sensitivity of 70,2%, a specificity of 81,5% and a negative predictive value (NPW) of 84,2%.

Conclusion

Bearing in mind the increasing global incidence of CD and the association between an isolated inflammation in the SB with a poorer prognosis, CE can be highly contributing to an early diagnosis. The method is minimally invasive, patient-friendly, with a low complication rate due to a selective patient evaluation for the indication of suspected CD and the technology is constantly developing. The lack of standardized diagnostic criteria may be an important limitation, especially regarding the diagnostic accuracy, but special endoscopic indices are coming more and more into effect.
P350 Endoscopic sedation in IBD patients: a propensity score-matched retrospective study
Authors: Levartovsky A , Cohen T , Klang E , Ben-Horin S , Kopylov U
Published: January 2023

Background

Colonoscopy plays an essential role in the prevention of colorectal cancer screening and the management of inflammatory bowel disease (IBD). For patients with IBD, colonoscopy is advocated for detection of complications, guiding clinical decisions, and cancer surveillance. In most cases, sedation is a fundamental constituent of the procedure, reducing peri-procedural discomfort and improving examination quality. We aimed to compare the dosing of sedative medications and the duration of procedure for IBD patients compared to non-IBD controls in a large-volume endoscopic center.

Methods

This was a propensity score–matched retrospective study that took place at a high-volume gastroenterology department between June 2020 and September 2021. Colonoscopy data of patients with established IBD including medications and duration of procedure was collected, compared to a 1:2 propensity-scored matched cohort of non-IBD patients. Patients with polyposis, past abdominal surgery, known or suspected malignancy, suspected IBD, incomplete colonoscopies and colonoscopies with inadequate preparation were excluded. The sedation protocol in our institution includes an induction of Midazolam 1-2 mg and Fentanyl of 0.025-0.05 mg administered five minutes prior to procedure. An initial dose of 10-30 mg Propofol is initiated as well, with subsequent increments of 10-20 mg every 1-2 minutes, depending on sedation depth.

Results

During the study period, 14502 patients including 996 patients with IBD underwent colonoscopy and 4933 patients were excluded in accordance with the exclusion criteria. Propensity score matching was conducted using four characteristics - patient age, gender, American Society of anaesthesiologists score determined by the endoscopist, and endoscopists’ experience. A total of 2289 patients were included in the final analysis (763 IBD patients, 1526 control patients). The groups were similar in administered Propofol sedation doses [IBD- median dose of 100 mg, interquartile ratio (IQR) 70-150 vs control, 100 mg, IQR 80-150, p=0.2). In addition, total procedure time (considered the time from procedure start and end as recorded by the endoscopy nurse) was significantly longer in the IBD group (23 median minutes, IQR 18-30 vs 20 median minutes, IQR 16-27, p<0.0001). There were no differences in terminal ileum intubation rates between the groups (51% in IBD vs 49.5% in control, p=0.5).

Conclusion

In a retrospective analysis from a large-scale tertiary center cohort, colonoscopies of patients with IBD were significantly longer despite comparable terminal intubation rates; IBD patients did not require more intensive sedation than controls.
P352 Occurrence of moderate to severe anaemia and utilization and efficacy of intravenous iron therapies in a nationwide cohort of Inflammatory Bowel Disease patients
Authors: Khan N , Patel M , Sundararajan R
Published: January 2023

Background

Anaemia is the most common extraintestinal manifestation of inflammatory bowel disease (IBD), and iron deficiency is the leading cause of IBD-associated anaemia. It is associated with impaired physical and cognitive functioning, increased hospitalization rates, and reduced quality of life. With the advent of newer formulations of intravenous (IV) iron the management of anaemia has undergone a transformation. Our aim was to evaluate the percentage of patients with IBD who developed moderate to severe anaemia over the course of their disease as they are the subset who would benefit most from IV iron. We also evaluated the utilization and efficacy of IV iron therapies among this group of patients in a real-world setting.

Methods

We conducted a retrospective cohort study utilizing the Veteran Affairs Healthcare System (VAHS) to identify patients who had IBD and were followed in the VAHS. IBD patients who had moderate to severe anaemia over the course of their disease based on WHO criteria (Hemoglobin level: <10g/dl) were included in this study. Among this group of patients with moderate to severe anaemia, we determined how many patients were treated with different IV iron formulations (ferric carboxymaltose, ferumoxytol, iron dextran, iron sucrose and sodium ferric gluconate). From this set of patients treated with IV iron formulations, improvement of Hb levels post therapy defined as achieving a Hb ≥12 g/dl, was ascertained.

Results

A total of 71,137 patients diagnosed with IBD were identified in the VAHS. Of this group 65, 599 (92.22%) were male. Over the course of their disease the majority were treated with mesalamine (92%) followed by biologics (35%) and thiopurines (25%). Among this group, 21,159 (29.74%) patients developed moderate to severe anaemia over the course of their follow up. Among patients with moderate to severe anaemia, 3,533 (16.7 %) patients received IV iron therapies for the management of their anaemia. 1,132 (32%) of these patients achieved a Hb level ≥12 g/dl post IV iron therapy.

Conclusion

Almost a third of IBD patients develop moderate to severe anaemia over the course of their disease. Less than a fifth of these patients were treated with IV iron, and among those treated, about a third achieved a Hb level ≥ 12g/dl. Our findings suggest that in the real-world setting, moderate to severe anaemia despite being prevalent is not managed aggressively and efforts should be made to rectify this situation as anaemia has a profound effect on multiple aspects of a patient’s life.
P353 Ulcerative Colitis in the IBSEN III study: Frequent use of biologics and low colectomy rates first year of disease.
Authors: Strande V , Lund C , Småstuen M C , Bengtson M B , Cetinkaya R B , Detlie T E , Frigstad S O , Medhus A W , Henriksen M , Holten K I A , Hovde Ø , Huppertz-Hauss G , Johansen I , Olsen B C , Pallenschat J , Perminow G , Ricanek P , Torp R , Tønnessen T , Vatn S , Aabrekk T B , Opheim R , Høivik M L , Kristensen V A
Published: January 2023

Background

Biological therapy of ulcerative colitis (UC) has become more common in recent years, and colectomy rates have declined during the same period. The aim of this study was to describe the use of first-line biologic therapy and to estimate the colectomy rate in a population-based inception cohort during first year of disease.

Methods

Inflammatory Bowel Disease in South-Eastern Norway III (IBSEN III) is a population-based inception cohort with a prospective follow-up of newly diagnosed patients with inflammatory bowel disease from the South-Eastern Health Region of Norway, including from 2017 to 2019. In this project, we studied patients≥ 18 years with a verified UC diagnosis at baseline and at one-year follow-up. Baseline characteristics, use of biological therapy, and need for surgery during the first year after diagnosis were analysed. Kaplan-Meier plot was used to estimate the time to first-line biologic therapy.

Results

A total of 889 UC patients (45.9% female, median age 36 years (range 18-84), 6.2% smokers) were included in the study and met for one-year follow-up. Totally 129 (14.5%) patients started on biological therapy due to UC, during the first year of disease. Time from diagnosis to start of first-line biologic therapy is depicted in Figure 1 (Kaplan-Meier plot). In addition, four patients received biologics due to other indications than UC (not depicted in Figure 1). The colectomy rate at one-year follow-up was 0.9% (8/889).

Figure 1: Cumulative incidence of biologic therapy.

Conclusion

In this population-based inception cohort, colectomy rates during first year of disease were low compared to a prior population-based study from the same geographic area in the pre-biologic era (the IBSEN study)1, while the proportion starting on biological therapy was higher than reported in comparable inception cohorts2.

References:

1. Moum B, Ekbom A, Vatn MH, et al. Clinical course during the 1st year after diagnosis in ulcerative colitis and Crohn's disease. Results of a large, prospective population-based study in southeastern Norway, 1990-93. Scand J Gastroenterol 1997; 32: 1005-1012.

2. Burisch J, Katsanos KH, Christodoulou DK, et al. Natural Disease Course of Ulcerative Colitis During the First Five Years of Follow-up in a European Population-based Inception Cohort-An Epi-IBD Study. Journal of Crohn's & colitis 2019; 13: 198-208. 2018/10/06. DOI: 10.1093/ecco-jcc/jjy154.
P358 Long-term clinical outcomes of intestinal Behçet’s disease: a 30-year cohort study at a tertiary hospital in South Korea
Authors: Park J , Park S J , Park J J , Kim T I , Kim W H , Cheon J H
Published: January 2023

Background

Long-term clinical data on intestinal Behçet’s disease (BD) are scarce because of the rarity of this disease, and many issues remain unresolved due to the difficulty in performing a well-designed clinical trial or epidemiologic study. We aimed to investigate the long-term clinical outcomes of patients with intestinal BD with a 30-year cohort study at a tertiary hospital in South Korea, a hospital with the largest number of patients with intestinal BD worldwide. Additionally, we aimed to identify factors that could predict various clinical outcomes, including anti-tumor necrosis factor-alpha (anti-TNF-α) agent use, intestinal surgery, hospitalization, and emergency room visits.

Methods

A cohort of 780 patients with intestinal BD between 1997 and 2021 was investigated to determine the long-term clinical outcomes and prognostic factors at the inflammatory bowel disease Clinic of Severance Hospital, Seoul, Korea.

Results

During the median follow-up period of 12.7 ± 7.2 years, 5-aminosalicylic acids, corticosteroids, immunomodulators, and anti-tumor necrosis factor-alpha (TNF-α) agents were required in 94.9%, 67.2%, 43.8%, and 14.6% of the patients, respectively. The cumulative rates of anti-TNF-α use were 3.7%, 7.5%, 8.5%, 12.1%, 17.6%, and 24.0%, and that of abdominal surgery were 5.7%, 10.9%, 12.6%, 16.5%, 21.6%, and 28.3%, at 1, 3, 5, 10, 20, and 30 years, respectively, after the initial diagnosis of intestinal BD. The cumulative rates of hospitalization were 11.8%, 21.9%, 27.9%, 38.8%, 54.4%, and 74.8% and that of emergency room visits were 10.0%, 19.8%, 22.7%, 31.6%, 50.0%, and 65.0% at 1, 3, 5, 10, 20, 30 years. Older age at primary diagnosis, previous appendectomy history, higher disease activity index for intestinal Behçet’s disease score, systemic BD, multiple intestinal ulcers, deep intestinal ulcers, higher C-reactive protein, lower hemoglobin, and lower albumin levels were associated with poor prognosis. Married status, higher body mass index, oral ulceration, and arthritis were negatively associated with a poor prognosis.

Conclusion

The data on the long-term clinical outcomes of intestinal BD and their prognostic factors could guide physicians for adequate patient monitoring and optimizing individualized treatments.
P359 Evaluation of usability and performance of home fecal sampling using a dedicated device
Authors: Solhaug H , Haukø I , Mørk E
Published: January 2023

Background

Monitoring faecal calprotectin (fCal) levels is important in treating patients with inflammatory bowel disease (IBD). Analysis of faecal samples can be divided into sample collection and sample extraction, of which the former is very time-consuming and tedious work for the lab personnel. This step can easily be improved by allowing the patient to perform the sample collection at home with required amount of sample directly into the extraction buffer. Any home faecal collection device needs to show conformity to the golden standard of weighing method. Home sampling presents a solution but requires clear instructions to the user. The collected sample is also required to maintain stability during transportation.

Methods

The present study aimed to determine the usability of EasyExtractTM and a quick guide for home sampling performed by lay users. The usability study was conducted according to FDA guidelines on usability engineering. Twenty-four participants without prior knowledge of the product or procedure received an EasyExtractTM, a simulated human faecal sample, and a quick-guide to perform the home sampling. Matched participant-observer questionnaires were assessed to determine the usability. Performance studies of EasyExtractTM included consistent sample uptake, agreement with the weighing method, and stability (at room temperature, after transportation, and after freeze-thaw cycles). All samples were analysed with CalproLab ELISA (CALP0170) to determine fCal concentration. Appropriate statistical methods were used to quantify and visualize the results.

Results

100% of the participants in the usability study completed sampling successfully. EasyExtractTM and the quick guide got an average rating of 4.8 on a scale of 1-5 (1=difficult, 5= easy). In-house performance studies show that the average sample weight collected 29.2 mg with a CV of 2.7%. It also showed that the extracts remained stable during transport at RT for 5 days, and no changes after repeated freeze-thaw cycles. The collection device also shows strong agreement with the established weighing method.

Conclusion

EasyExtractTM and the quick guide enabled participants to sample accurately without prior experience with the device. Additionally, EasyExtractTM allows for consistent weight and agrees with the golden standard of weighing method. Furthermore, fCal stability is maintained at RT for 5 days and repeated freeze-thawing cycles. EasyExtractTM is a useful tool for home-sampling of fCal.
P361 Risk of persistent gastrointestinal inflammation after treatment with immune checkpoint inhibitors
Authors: Jeay M , Carbonnel F , Robert C , Bellanger C , Meyer A
Published: January 2023

Background

Immune checkpoint inhibitors (ICI) can cause immune-mediated gastrointestinal toxicity, but the long-term persistence of this toxicity is unknown. We aimed to describe the characteristics of patients with gastrointestinal inflammation persisting more than six months after discontinuation of ICI.

Methods

We included consecutive patients treated between October 2010 and March 2022 for endoscopic or histological gastrointestinal inflammation persisting at least six months after the last administration of ICI.

Results

Among 178 patients treated for a gastrointestinal immune-mediated adverse event during ICI therapy, 14 (8%) patients had chronic lesions persisting more than 6 months after the last ICI administration. The median follow-up time was 13 months after discontinuation of ICI. The most common symptom was watery diarrhea (54%). Ten (77%) patients had colon involvement and three (21%) had ileal involvement. Ten patients (77%) had an inflammatory phenotype, while two (15%) had a penetrating and one had (8%) a stricturing phenotype. All patients had lymphoplasmacytic infiltrate and basal plasmacytosis, and s54%) had crypt distortion. Two (15%) patients underwent surgery and nine (69%) received specific treatment, including five treated with vedolizumab. Among the patients who were followed up for at least one year, endoscopic lesions persisted at 1 year after stopping ICI in 4/6 patients, and at 2 years in 3/4 patients.

Conclusion

Eight percent of patients who had gastrointestinal toxicity due to ICI develop chronic inflammatory bowel disease characterized by watery diarrhea, colitis and lymphoplasmacytic infiltrate.
P364 Presence of malnutrition adversely affects short-term clinical outcomes in a sample of patients with Crohn's disease (CD)
Authors: Karachaliou A , Lekakis V , Bletsa M , Mantzaris G J , Tzouvala M , Bamias G , Kontogianni M D
Published: January 2023

Background

Malnutrition in patients with CD has been suggested to affect the disease course, leading to more frequent flare-ups, disease-related complications and longer hospitalizations. The aim of the present study was to assess the effect of malnutrition on several clinical outcomes of patients with CD.

Methods

Data regarding medical history, disease classification and basic anthropometric characteristics were collected at baseline. Disease activity was assessed endoscopically and using the Harvey-Bradshaw Index (HBI<5 indicates remission). Malnutrition was assessed with the GLIM (Global Leadership Initiative on Malnutrition) criteria and SGA (Subjective Global Assessment). Patients were followed-up at 6 and 12 months and clinical outcomes (need for hospitalization, corticosteroids and antibiotics’ use, change of biologic agents, surgery) were recorded.

Results

At baseline 237 patients (54.8% males, 41.2±14.1 years, 37.2% with active disease) were evaluated. Prevalence of malnutrition at baseline was 13.5% and 22.9% based on GLIM and SGA, respectively, and was higher in active disease compared to remission (GLIM: 25% vs. 6.7%, p<0.001, SGA: 41.9% vs. 11.5%, p<0.001). Outcomes of 237 patients were recorded at 6 months and of 233 at 12 months. Presence of malnutrition at baseline, according to GLIM criteria, was associated with an increased likelihood of need for intensification or change of biologic agent (OR: 2.66, 95% CI: 1.14-6.24, p=0.02], surgery (OR: 3.73, 95% CI: 1.02-13.70, p=0.04) and overall adverse outcome (OR: 2.33, 95% CI: 0.99-5.49, p=0.05) after adjustment for age, sex, disease location and disease activity at baseline. Similar results were observed when malnutrition was diagnosed with SGA only for need for intensification or change of biologic agent (OR: 5,78 (1,52, 21,92), p=0,01] after adjustment for age, sex, disease location and disease activity at baseline. No statistically significant associations were observed between presence of malnutrition (either diagnosed with GLIM criteria or SGA) and disease-related outcomes at 12 months.

Conclusion

Presence of malnutrition was associated with short-term (within 6 months) adverse clinical outcomes, such as need to intensify the therapeutic regimen, need for surgical interventions due to disease complications and a worse overall disease outcome in CD patients. No effect of malnutrition diagnosis on the examined clinical outcomes was observed at 12 months of follow-up.