bluuebunny/crossref_metadata_2025_split huggingface dataset:
P306 Efficacy and tolerance of sodium picosulfate preparation in bowel Magnetic Resonance Imaging in Crohn’s disease
Authors: Juif L , Calame P , Chausset C , Koch S , Briot C , De Billy M , Vuitton L 
Published: January 2022

Abstract

Background
Polyethylene glycol (PEG) is one of the most commonly used bowel preparation for magnetic resonance imaging (MRI) in Crohn’s Disease (CD). Sodium picosulfate (Pico) is a low volume bowel preparation known for its efficacy and higher tolerability for colonoscopy. No study has to date evaluated tolerance and efficacy of Pico preparations for MRI in CD. Aim: To assess for the first time the efficacy and tolerance of Pico preparation compared to PEG preparation for bowel MRI in CD.

Methods
The study took place in a French university hospital. To assess the efficacy of low volume preparations compared to PEG, we selected consecutive bowel MRI from January to June, 2017 prepared with PEG formulas, and consecutive MRI from January, 2020 to June, 2020 prepared with low-volume Pico formula.The sample size was calculated to assess the non-inferiority of Pico preparation vs PEG. The efficacy endpoint was the quality of bowel distention on a, 5 points scale and by visual analog scale (VAS) by two independent readers. To study Pico preparation tolerability, we performed a prospective survey in CD patients undergoing MRI from October, 2020 to August, 2021. Patients completed a self-administered validated questionnaire on tolerability and a VAS.

Results
In the efficacy study,84 MRIs were analysed (42 in each PEG and Pico group). There was no significant difference between PEG and Pico preparation regarding jejunum and ileum distention on the, 5 points quality scale. Moreover, we did not find significant difference between PEG and Pico regarding overall quality in the VAS (8.1 ±, 1.4 in PEG group, vs, 8.7 ±, 1.2 in Pico group, by reader, 1 (p=, 0.125);, 6.35 ±, 1 in PEG group, 6.5 ±, 1 in Pico group by reader, 2 (p=0.298)) with a moderate but significant correlation rate between the two readers (r=, 0.45; p&lt;0.001). There was no significant difference regarding ileal diameter between the two preparations with a moderate correlation rate between the two readers (r=0.41; p&lt;0.01). In the prospective study, 38 patients participated in the survey. The bowel preparation intake was completefor, 94.7% of the patients. The mean tolerance was, 6.84/10. Overall, 81.6% of patients were willing to take the same preparation again.

Conclusion
The study assessed Pico preparation non-inferiority to PEG preparation for small bowel MRI and confirmed low volume bowel preparations good tolerability profile. This suggests that low-volume preparations could be more widely implemented in clinical practice for small bowel imaging in chronic inflammatory bowel disease and thus improve follow-up acceptance.
P307 The effect of COVID-19 infection and vaccination in patients with Inflammatory Bowel Disease and Irritable Bowel Syndrome
Authors: Sciberras N , Pisani A , Vassallo C , Zahra Bianco E , Ellul P 
Published: January 2022

Abstract

Background
Inflammatory Bowel Disease(IBD) and Irritable Bowel Syndrome(IBS) are gastrointestinal disorders which differ in pathophysiology and management. The use of immunomodulatory drugs brings concerns which increased during the pandemic. Similarly, patients with IBS may have concerns about the effect of infection and vaccine on their wellbeing. The aim of this study was to assess for any differences in swabbing, vaccine uptake, COVID-19 infection, hospitalisation rates and outcomes in patients with IBD on immunomodulatory treatment and patients with IBS.

Methods
Patients were recruited through the local database (March, 2020 – August, 2021). All IBD patients had a histological diagnosis while IBS patients were diagnosed according to ROME IV criteria. All patients were offered vaccination. Apart from demographic data the following was collected: number of COVID-19 swabs taken, vaccination rates, type of vaccine administered, infection secondary to COVID-19, hospitalization and outcomes.

Results
Overall, 250 IBD patients (43.6% female) and, 250 patients with IBS (78.4% female) were recruited. The mean patient age in the IBS cohort was, 40.6 years (SD ±, 11.99) whilst the mean patient age in the IBD cohort was, 40.7 years (SD±15.7).
Patients with IBD underwent significantly more COVID-19 swab tests (n=759) than patients with IBS (n=615) (p =0.02).
Patients with IBD were having the following biological therapy:, 62.8% Infliximab, 24.8% Adalimumab, 10% Vedolizumab and, 2.4% Ustekinumab.
There was no significant difference in COVID-19 infection rate between the IBS cohort (8.8%; n=22 patients;, 2 patients not vaccinated) and the IBD cohort (6.4%; n=16 patients;, 3 patients not vaccinated)(p=0.3). The vaccine uptake rate was similar (IBD:, 91.2%, IBS: 90%).
Table, 1 demonstrates the type of vaccine administered to both cohorts.
In the IBS cohort, 1 patient was admitted to hospital in view of symptomatic hypoxaemia. The patient was treated with oxygen and dexamethasone, but did not require ventilatory support. Within the IBD cohort, 3 patients requiring admission for IBD related treatment, tested positive asymptomatically on pre-admission COVID-19 screening. All had an uneventful outcome.

Conclusion
This study demonstrates that vaccine uptake, Covid-19 infection rates and outcomes were similar in patients with IBS and IBD patients on immunosuppressive therapy. However, IBD patients underwent significantly more swabbing than patients with IBS and this was generally due to patient concern of acquiring Covid-19 while being on immunosuppresive medications. This added psychological burden may further impact patients’ psychological state and thus their quality of life.
P322 Effectiveness of Tumor Necrosis Factor-alpha inhibitors and Thiopurines combination therapy according to, 6-thioguanine nucleotides plasma levels: A Systematic Review
Authors: Céspedes Martínez E , Robles V , Miarons M , Herrera-De Guise C , Mayorga-Ayala L , Perez Z , Oller E , Casellas F , Borruel N 
Published: January 2022

Abstract

Background
Inflammatory bowel diseases (IBD), Crohn’s disease (CD) and Ulcerative Colitis (CU), have a progressive course with a significant percentage of primary or secondary failure to anti- tumor necrosis factor (TNF). It is already known that the combination therapy with anti-TNF and thiopurines have shown more effectiveness than monotherapy, especially with Infliximab (IFX). Thiopurines activity optimization, by the, 6-thioguanine nucleotides (6-TGN) measurement, have been related to better clinical outcomes in monotherapy, but evidence is lacking regarding combination therapy. Our aim was assessing the clinical and pharmacokinetic outcomes of the combination therapy regarding (6-TGN) serum levels.

Methods
We performed a systematic review in electronic resources in three major databases (PUBMED, Cochrane and Web of Science) up to, 18 January, 2021 using MeSH terms, text terms and specific outcomes without restrictions for year or language. We searched for randomized clinical trials (RCT) and observational studies. Outcomes included clinical remission, clinical relapse, mucosal healing, anti-TNF serum levels, antibodies to anti-TNF and adverse events regarding, 6-TGN serum levels. Studies without, 6-TGN measurement were excluded.

Results
Our search identified, 14 studies (three RCT and, 11 observational studies). Eight (57.1%) studies in Crohn’s disease patients. Seven (50.0%) publications included patients with IFX, and, 5 (35.7%) with adalimumab (ADA). Most of the studies showed a positive association between, 6-TGN serum levels and clinical remission in patients with IFX treatment. Higher, 6-TGN serum levels improved the pharmacokinetic profile in patients with both anti-TNF. The target, 6-TGN serum levels proposed for the pharmacokinetic outcomes were lower (125–200 pmol/, 8 ×, 108 RBC) than those for clinical remission (230 -, 450 pmol/, 8 ×, 108 RBC).

Conclusion
This systematic review shows that adequate, 6-TGN serum levels are associated with clinical response and better pharmacokinetic outcomes in combination therapy with IFX, with a weaker association with ADA therapy. Lower, 6-TGN serum levels could be enough to avoid unfavorable pharmacokinetic evolution with anti-TNF, especially IFX. There is not enough data supporting lower thiopurines doses for clinical outcomes, nor even to avoid adverse events. Further, well-designed research is needed to confirm the importance of, 6-TGN monitoring to optimize the combination therapy with anti-TNF and to decrease thiopurine doses when possible.
P329 Which should come first? Surgery or biologic therapy for ileocaecal Crohn’s disease in biologic naïve patients
Authors: Witjes C , Patel A , Zocche D , van ‘t Hullenaar C , Cripps S , Travis S , George B 
Published: January 2022

Abstract

Background
The L!RIC trial confirmed that surgical treatment of limited ileocaecal Crohn’s disease (ICCD) has comparable outcomes to antiTNF therapy. However, strict exclusion criteria for a randomised controlled trial make it difficult to determine if results can be generalised to a wider population. We therefore compared clinical outcomes between surgical resection or antiTNF or other biologic therapy amongst biologic-naïve patients with ileocaecal Crohn’s disease to provide real world experience.

Methods
All patients with ICCD who were naïve both to biologic therapy and surgery, treated at our institution between January, 2011 and December, 2018 were identified from surgical and pharmacy databases. Electronic case records were used to obtain data on patient characteristics retrospectively and treatment-specific outcomes. The, 5-year cumulative recurrence rate was calculated after composite consideration of endoscopic recurrence, recurrence on imaging, switch to different therapy, or surgical re-intervention.

Results
Overall, 222 patients were identified.149 (67%) underwent surgical resection first, of whom, 54 patients (36%) subsequently required antiTNF or other biologic therapy., 73 patients were treated with antiTNF or other biologic therapy first, of whom, 29(40%) subsequently required surgical resection (p=0.60). There were, 95/149 patients (64%) who were successfully treated by a surgical resection first approach alone.
There was no difference in, 1- and, 5-year cumulative recurrence rates between the two treatment approaches (17%, 55% for surgery vs, 14%, 54% for biologics (p=0.53)), median follow-up was, 74 months (0–406) and, 71 months (13–235), respectively.
There was no significant difference in time to switch from surgery to biologic or vice versa (p=0.10). Patients who underwent surgery more likely need post-operative biologic therapy if female (p=0.010), obstructive symptoms (p=0.028), or smoker (p=0.030). Patients on biologic therapy more likely undergo surgery if the disease was limited to terminal ileum (p=0.001), was stricturing or penetrating rather than inflammatory and if the patient had obstructive symptoms (p=0.003). Only, 3/149 patients required endoscopic dilatation because of an anastomotic stricture. None of the patients needed a second surgical resection.In comparison, 26 patients (20%) reported side effects from biologic therapy and as result of these side-effects or due to loss of response (n=9), biologic agents was changed in, 28 patients (22%).

Conclusion
This real world experience confirms the findings of the L!RIC trial, demonstrating that surgical intervention can be considered at an early stage in the disease process, rather than restricting it to patients who develop complications of Crohn’s disease.
P354 Immunological response to vaccination against SARS-COV-2 infection in Inflammatory Bowel Disease patients under immunosuppressive therapy: should we prioritize an additional booster injection?
Authors: Macedo Silva V , Lima Capela T , Freitas M , Cúrdia Gonçalves T , Boal Carvalho P , Dias de Castro F , Moreira M J , Cotter J 
Published: January 2022

Abstract

Background
The severe acute respiratory syndrome coronavirus, 2 (SARS-COV-2) infection may lead to the development of the novel coronavirus disease, 2019 (COVID-19). Currently, little to no data is available regarding safety and efficacy of SARS-COV-2 vaccination in Inflammatory Bowel Disease (IBD) patients, which may present differences between subgroups, as these patients may exhibit impaired innate and adaptive immune system responses. Lower immunological response could, in this specific population, require an additional booster injection.

Methods
We conducted a prospective study including adult patients with Crohn’s disease (CD) and Ulcerative Colitis (UC) who have undergone complete vaccination against SARS-COV-2 infection with BioNTech® vaccine. Patients with previous SARS-COV-2 infection were excluded. Medical data regarding age, sex, IBD classification and current medication for IBD were collected.
A control group with healthy individuals matched for age and sex was also analyzed.
Blood samples were collected, 30 days after complete vaccination to quantify IgG antibody titers for SARS-COV-2 in both groups (IBD and non-IBD).

Results
Our final sample included, 81 IBD and, 32 non-IBD patients, 55 (48.7%) of them females, with a mean age of, 40.2±13.0 years. From the IBD patients, 58(71.6%) had CD and, 23(28.4%) had UC.
IBD patients had significantly lower anti-SARS-COV-2 IgG levels when compared to the control group (8950±9366 vs, 14834±11679 AU/mL; p=0.003).
Regarding IBD medication, significant lower levels of SARS-COV-2 IgG antibodies when compared to control patients were found in patients under thiopurines (9074±9779 AU/mL; p=0.011); methotrexate (1987±2568 AU/mL; p=0.002); infliximab (7208±7276 AU/mL; p=0.001); and corticosteroids (1065±933 AU/mL; p=0.001). Additionally, patients under combined therapy (infliximab plus thiopurines) presented with significantly lower antibodies titers when compared to patients treated with thiopurines in monotherapy (8130±11048 vs, 10563±5680 AU/mL; p=0.039).
No significant differences were found in IBD patients under salicylates (10195±7371 AU/mL; p=0.226); adalimumab (15644±21467 AU/mL; p=0.336); vedolizumab (10464±9087 AU/mL; p=0.286) and ustekinumab (11366±10016 AU/mL; p=0.390).

Conclusion
IBD patients presented with significantly lower anti-SARS-COV-2 IgG levels, 1 month after complete vaccination against SARS-COV-2 infection compared to healthy controls. Thiopurines, methotrexate, infliximab and corticosteroid treatment were associated with significantly lower antibodies levels. These findings may express the benefit of an additional booster injection in this population.
P359 Radiomics could predict surgery at, 10 years in Crohn’s disease
Authors: Laterza L , Boldrini L , Tran H E , Votta C , Larosa L , Minordi L M , Scaldaferri F , Papa A , Armuzzi A , Gasbarrini A 
Published: January 2022

Abstract

Background
Predicting clinical outcomes and defining the best time for elective surgery represents a major challenge in managing Crohn’s disease (CD) patients. Radiomics provides a method to extract quantitative features from medical images and may successfully predict clinical course. Although radiomics has been successfully used in oncology, its application in inflammatory bowel disease is still scarce. The aim of this pilot study is to evaluate the use of radiomics to predict the need for surgery in a cohort of CD patients with a long-term follow-up.

Methods
We retrospectively selected a cohort of, 30 CD patients undergone one or more CT scan enterographies between, 2009 and, 2011 for a total of, 44 CT scans. For each CT scan, typical lesions of CD were searched by an expert radiologist generating a region of interest (ROI) segmentation for each lesion., 93 lesions were lastly obtained for radiomic analysis., 217 radiomic features were extracted from each ROI using a dedicated institutional R library (Moddicom) validated within the Image Biomarker Standardization Initiative. Patients’ charts were reviewed to assess if patients underwent surgery in a, 10-year follow-up for a binary classification.
The feature selection process included a univariate analysis with the Wilcoxon-Mann-Whitney test, the application of Boruta algorithm and the exclusion of highly correlated features. A logistic regression model was built with the selected features and evaluated by computing the area under the curve (AUC) of the receiver operating characteristic (ROC) curve. Accuracy, sensitivity, specificity, positive and negative predictive values (PPV, NPV) of the model were calculated using the best cut-off according to the Youden index method. A 3-fold cross-validation repeated, 5 times was used for internal validation.

Results
Two radiomic features were obtained from the feature selection process and resulted statistically significant in the fitted logistic regression model (p &lt;, 0.0001) in predicting surgery: grey level histogram variance and grey level non-uniformity. This model presented an AUC (95% CI) of, 0.83 (0.73-0-91) in predicting surgery, confirmed by the cross-validation. Mean (standard deviation) values of the model performance metrics over the cross-validation iterations were: accuracy, 0.78 (0.02), sensitivity, 0.68 (0.14), specificity, 0.86 (0.07), PPV, 0.72 (0.12), NPV, 0.83 (0.09).

Conclusion
Radiomics could be a helpful tool to identify patients with high risk for surgery and needing a stricter monitoring or therapy intensification. Further studies are required to understand the possible corresponding histopathological features and to obtain larger and external validations of this model.
P376 Switching from intravenous to subcutaneous vedolizumab maintenance treatment; feasibility, safety and clinical outcome
Authors: Wiken T , Høivik M L , Buer L , Bolstad N , Moum B A , Medhus A W 
Published: January 2022

Abstract

Background
Vedolizumab (VDZ) has until recently been available only as intravenous (i.v.) formulation, but the drug is now available also as subcutaneous (s.c.) formulation. In the present study, we aimed to assess the feasibility, safety and clinical outcome when switching a real world cohort of patients with inflammatory bowel disease (IBD) from i.v. to s.c. VDZ treatment.

Methods
All IBD-patients receiving i.v. VDZ at the department were identified using the medical records. Patients in the induction period or with planned change of medical treatment or surgery within, 3 months were not routinely switched. The dosage of s.c. VDZ was calculated based on current i.v. dose and interval. Patients were assessed at first and fourth injection and after, 3 months. The primary endpoint was percentage of patients still on s.c. treatment after, 3 months. Secondary endpoints were adverse events, clinical disease activity scores (Harvey Bradshaw index and Partial Mayo Score), C-reactive protein (CRP), fecal calprotectin (FC), VDZ treatment interval, plasma-VDZ, and patients’ preferred route of administration.

Results
In total, 108 patients were switched, 51 with ulcerative colitis (UC) and, 57 with Crohn’s disease (CD). After, 3 months, 95.3% (103/108) remained on s.c. treatment. Four patients had switched back to i.v. and one changed treatment to ustekinumab. Nineteen patients (17.6%) experienced injection site reactions (ISR), and twelve of these (63.2%) had repeated reactions. In three cases, patients were switched back to i.v. treatment due to ISR. No serious adverse events related to the switch were observed. The median interval between injections was, 12 (IQR:, 7–18) days. The median p-VDZ at three months was, 44.4 (IQR:, 28.9–64.7) mg/L. In the UC and CD patients, 92% (47/51) and, 72% (41/57) were in clinical remission at first injection, whereas the corresponding numbers after three months were, 88% (p=0.18) and, 83% (p=0.11), respectively. No significant change in CRP and FC was observed. Before switching, 25% of the patients reported that they would prefer i.v. treatment, 28% s.c. treatment and, 47% were indifferent. Three months after switching, the corresponding numbers were, 18%, 53% and, 29%, respectively (p&lt;0.001).

Conclusion
Switching from i.v. to s.c. VDZ was feasible and safe. Approximately one out of six experienced an ISR but only, 3% were switched back to i.v. administration. At, 3 months follow-up there was no change in clinical remission rates, CRP and FC. Furthermore, patients’ attitude towards route of administration changed after switching. The present real world data demonstrate that s.c. maintenance VDZ treatment represents an attractive alternative to i.v. treatment.
P408 Faecal infliximab and disease activity in Acute Severe Ulcerative Colitis
Authors: Shields S , Dunlop A , Gerasimidis K , Nichols B , Galloway P , Macdonald J , Hansen R , Seenan J P 
Published: January 2022

Abstract

Background
Infliximab (IFX) is increasingly used in the management of moderate to severe ulcerative colitis (UC) and as a ‘rescue’ treatment for acute severe UC (ASUC) but primary non response (PNR) and colectomy rates remain significant. Reasons for IFX treatment failure in ASUC are multifactorial but immunogenicity and faecal loss of drug are thought to be important factors. Emerging evidence suggests accelerated ‘rescue’ IFX dosing may be more effective. The aim of this work was to establish if a relationship exists between faecal IFX levels, disease activity, and clinical outcomes early in IFX treatment.

Methods
Patients with UC were prospectively recruited following initiation of IFX and designated as ASUC or non-ASUC based on Truelove and Witt’s criteria. Stool and serum were collected on days, 0, 7, 14, 28 and, 42 after initiation of IFX. Additional samples on days, 1–5 after IFX were obtained from inpatients. Albumin and CRP results were extracted from electronic patient records. Faecal calprotectin (FC) was measured using ELISA (CALPROLAB). Faecal IFX within the first, 2 weeks of treatment was analysed using a Promonitor-IFX-1DV ELISA assay, performed on the Triturus ELISA instrument. R studio was used to calculate areas under the curves of the time series. Spearman’s rank correlation test was used for correlation analysis.

Results
20 patients were recruited, 12 with ASUC. Faecal IFX correlated strongly with FC (ρ=0.793;p&lt;0.001) (Fig., 1), and moderately with CRP (ρ=0.51;p=0.02), and serum albumin (ρ=-0.51;p=0.02). The correlation was strongest between faecal IFX and FC within in the first week (ρ=0.93;p&lt;0.001), and less strong for crp (ρ=0.481;p=0.037) and albumin (ρ=-0.474;p=0.04). Higher faecal IFX was associated with increased colectomy and PNR rates but this did not reach statistical significance (p=0.098). A rapid decline in median FC was seen after initiation of IFX with a rebound rise in FC observed at day, 3 of IFX treatment (Fig. 2).

Conclusion
In this small cohort, faecal loss of IFX was associated with increased markers of systemic and luminal inflammation. Its role as a biomarker for disease severity, treatment response and clinical outcomes warrants further investigation. The rapid fall but early rebound rise in FC may support the need for earlier accelerated dosing in ASUC. However, larger studies are needed to establish the optimal early IFX regime to improve clinical outcomes.
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