bluuebunny/crossref_metadata_2025_split huggingface dataset:
P218 Accuracy of Ultrasonography in Assessing Disease Activity in Pediatric Ulcerative Colitis: Preliminary Results of a two-center study
Authors: Marra A , Terracciano F , Bossa F , Pastore M R , Marseglia A , Di Rodi A , Valvano M R , Carparelli S , Ippolito M A , D’Altilia M , Ferrara D , Esposito F , Bucci C , Perri F 
Published: January 2022

Abstract

Background
Ulcerative colitis (UC) is an inflammatory bowel disease involving rectum and colon. Transabdominal bowel ultrasound (TBUS) is a non-invasive technique evaluating inflamed colonic segments. Previous studies showed optimal concordance between TBUS and endoscopy in the colon, but suboptimal in the rectum. Transperineal ultrasound (TPUS) of the rectum achieved high agreement with endoscopy in adult UC patients. Aim of this study was to assess the accuracy of ultrasound in evaluating disease activity in pediatric UC patients by means of TBUS and TPUS

Methods
Pediatric UC patients were enrolled in two IBD centers from March to November 2021. Disease activity was determined using PUCAI score and Mayo Endoscopic Subscore (MES). TBUS and TPUS were performed within a week from endoscopy. MES ≤ 1, bowel wall thickness ≤ 3mm in the colon and ≤ 4mm in the rectum were defined as remission. A concordance analysis comparing endoscopy and US was performed.

Results
Eighteen patients were enrolled with a mean age of 9.1 ± 4.0 years and a mean disease duration of 2 ± 2.9 years.10 patiens had pancolitis, 2 distal colitis, 4 proctitis. Fifteen patients had endoscopic active disease (2 mild, 12 moderate and 1 severe), and 3 were in remission. Good correlation at the Cohen κ-value between endoscopy and TPUS was observed (K= 0.68). In the evaluation of colon with TBUS the same concordance was found in right (K= 0.64), the transverse (K= 0.75) and in the left colon (K= 0.77), while moderate in the sigma (K= 0.55).

Conclusion
If these results will be confirmed in a larger study, the combination of TBUS and TPUS could represent a non-invasive technique to assess disease activity in UC children.
P233 Efficacy and safety of oral sulfate tablet for the bowel preparation in patients with inflammatory bowel disease: multicenter randomized controlled study
Authors: Kim K O , Jang B I , Lee Y J , Lee H S , Kim E S , Jung Y J , Kim E Y , Kim S K , Yang C H 
Published: January 2022

Abstract

Background
Although high and low volume polyethylene glycol(PEG) bowel preparations are recommended for patients with inflammatory bowel disease(IBD) before colonoscopy, sometime it is limited due to poor compliance. So, studies regarding novel low volume preparations in IBD are need, but, there is limited data. We aimed to evaluated the safety, tolerability and efficacy of oral sulfate tablet (OST) by comparison with 2L PEG and ascorbate (PEG/Asc) in patients with IBD.

Methods
One hundred ten patients with IBD were enrolled in this single-blind, multicenter, non-inferiority study. Patients were assigned either 2L PEG/Asc or OST to be administered in a split-dose regimen. OST patients were administered 14 tablets with more than 1L of free water in the evening, and the following morning. Colonoscopies were performed by blinded investigators. The primary efficacy endpoint was successful bowel cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded endoscopist in each hospital. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Flare up of IBD symptoms and mucosa change associated with preparation were also evaluated. Tolerability, in terms of taste and degree of resistance to drink was assessed with VAS score by interview before colnoscopy. Safety was assessed by spontaneously reported adverse events, solicited ratings of expected prep symptoms, and laboratory testing.

Results
The cleansing score at all the segment was significantly higher in OST group. A high rate of cleansing success was seen with OST (98.1%), which was noninferior to 2L PEG/Asc (98.1%). Proportion of patients with bubble score 0 was significantly higher in OST than 2L PEPG/Asc group (94.5% vs. 50.0%, p&lt;0.001). Satisfaction, in terms of easiness to drink (8.2 ± 1.6 vs. 6.0 ± 2.2, p&lt;0.001) and taste(7.0 ± 2.8 vs. 5.4 ± 2.4, p=0.002) was significantly higher in OST group. More patients in OST group (94.5%) wanted to repeat the same preparation next colonoscopy. There was no significant difference in the development of vomiting and bloating between group. Aphthous ulcers were noted in the same number of patients in both group and symptom flare up were noted in 2 cases of OST group (p=1.000). No clinically significant differences were seen between preps for renal function and serum electrolyte.

Conclusion
Oral sulfate tablets achieved a high level of cleansing comparable with 2L PEG/Asc in patients with IBD. The risk of mucosal change or symptom relapse were not higher, on the other hand the degree of satisfaction was higher than 2L PEG/Asc. OST split method could be considered as one of the preparation method for patients with inactive IBD.
P235 The natural history of COVID-19 in vaccinated Inflammatory Bowel Disease patients
Authors: Viazis N , Theodoropoulou A , Zampeli E , Karmiris K , Tzouvala M , Bamias G , Koutroubakis I , Liatsos C , Koustenis K , Veretanos C , Papathanasiou E , Zacharopoulou E , Tribonias G , Kitsou V , Drygiannakis I , Michopoulos S , Mantzaris G 
Published: January 2022

Abstract

Background
Patients with Inflammatory Bowel Disease (IBD), especially those on immunosuppressive (IMS) treatment should be vaccinated against SARS-CoV-2 to prevent hospitalization, mechanical ventilation, and death. However, IMS may adversely affect vaccination, raising concerns as to how vulnerable these patients are to break through COVID-19 infections. Thus, we aimed to assess the proportion of IBD patients who despite complete vaccination developed COVID-19, as well as the course of the infection.

Methods
This study was an initiative of the Hellenic Group for the study of IBD which involved seven IBD referral Centers. Patients attending these Centers who reported a COVID-19 infection at least 3 weeks after vaccination completion were asked to complete an on-line anonymous questionnaire which included patient demographics and IBD clinical and therapeutic data, a detailed vaccination history, and the course and outcome of COVID-19, especially the need for hospitalization, oxygen supply, and admission to ICU. In patients with grave outcome information was sought by family members

Results
On estimate, 2940 patients reported full vaccination (Pfizer vaccine) in the 7 centers. Between 1st May 2021 and 30th October 2021, 46 (1.5%) fully vaccinated IBD patients reported COVID-19 infection [25 male, 32 CD, 14 UC, mean (SD) age 40.8 (13.7) years, mean (SD) IBD duration mean, 11.2 (10.8) years]. Five patients were receiving 5-ASAs, 2 corticosteroids, 5 azathioprine/methotrexate, 23 anti-TNFs as monotherapy and 3 in combination with azathioprine/methotrexate, and 1 with corticosteroids, 3 vedolizumab and 1 each ustekinumab, tofacitinib and rizakinzumab at the time of COVID-19 diagnosis; one patient was receiving no treatment. IBD was in remission in 37/46 patients (80.4%). Comorbidities were seen in 21 patients (thyroid disease 11; diabetes mellitus 2; hypertension 2; psoriasis 1; prior breast cancer 1; spondyoartropathy 2; dyslipidemia 1; and PSC 1 patient). The mean (SD) time between last vaccination dose and infection was 3.2 (1.4) months. Overall, 40 (86.9%) patients reported mild constitutional and respiratory symptoms, 4 (8.7%) were asymptomatic and only 2 patients (4.3%) required hospitalization which was uneventful in both. None needed high flow oxygen supply or ICU admission, and none reported symptoms of long COVID. No deaths were reported by patient relatives. IBD medications were stopped in 21 patients (45.6%) during the COVID-19 infection.

Conclusion
A minority of fully vaccinated IBD vaccinated patients developed COVID-19 which was relatively mild and uneventful. These results reinforce the importance of vaccination especially in vulnerable populations.
P244 COVID-19 vaccine does not increase the likelihood of disease exacerbation in IBD: results from a population-based study
Authors: Lev Zion R , Focht G , Lujan R , Mendelovici A , Friss C , Greenfeld S , Kariv R , Ben-Tov A , Matz E , Nevo D , Barak-Corren Y , Dotan I , Turner D 
Published: January 2022

Abstract

Background
While short-term safety data of COVID-19 vaccination has been reassuring, it is theoretically possible that the vaccine-associated immune activation could trigger immune dysregulation and thus exacerbation of IBD. We used the epi-Israeli IBD Research Nucleus (IIRN) database to perform a population-based study exploring the effect of COVID-19 vaccination on disease course in IBD patients.

Methods
We included all IBD patients insured in two of the four Israeli HMOs, covering 35% of the population, by validated algorithms, and selected those who received two doses of Pfizer BNT162b2 vaccine. These were matched to unvaccinated IBD patients by demographics, parameters of disease severity at baseline generated by hierarchical clustering of laboratory data, and length of time from previous exacerbation to baseline. The primary outcome was rate of IBD exacerbation as defined by proxies of hospitalizations, treatment escalation, and commencement of corticosteroid or enema. The study period was December, 2020 to June, 2021

Results
707 pairs of vaccinated and unvaccinated IBD patients were compared. The pairs matched exactly for gender, district, IBD type and disease severity, and ±1 year for age at IBD diagnosis and at vaccination. Mean age was 38.5±13.5 years and median follow-up was 98 days (IQR 16–143). No difference in the outcome was found between the groups from the 2nd vaccination to the end of follow-up, with risk of exacerbation in vaccinated patients of 29% and risk in unvaccinated patients 26% (p=0.3).

Conclusion
COVID-19 vaccinated IBD patients demonstrated a rate of IBD exacerbation following vaccination that was no different from that of unvaccinated patients. The multifaceted immune activation induced by the vaccine did not result in worsening IBD disease course. These results provide further reassurance for IBD patients receiving the vaccine.
P263 Very early onset Inflammatory Bowel Diseases: Review of the Genoa-Messina joint clinical experience. Clinical history: Part I
Authors: Gramaglia S M C , Cucinotta U , Dipasquale V , Arrigo S , Gandullia P , Romano C 
Published: January 2022

Abstract

Background
Pediatric inflammatory bowel diseases (pIBD) have specific phenotypes compared to Inflammatory Bowel Diseases (IBD) in adults. The Very Early Onset-IBD (VEO-IBD) is considered a diagnosis of IBD in children before age 6 years old with 15% of prevalence.

Methods
The objective of this study was to compare the clinical and endoscopic features of VEO-IBD compared to pediatric IBD (diagnosis &gt; 6 years old) also in terms of natural history and response to treatment.
The VEO patients followed at the IBD-Centers of Messina and Gaslini were enrolled retrospectively. We compared the results of this population with what is reported in the literature in terms of clinical characteristics at onset (symptoms, age at onset, age at diagnosis), comorbidities, complications, associated immunodeficiencies, endoscopic models. Percentage comparison and chi-square test of data was performed.

Results
74 VEO-IBD patients were enrolled. The onset is around 3 years, a predominantly colonic localization, inflammatory pattern. Positive family history for IBD in 8.1%. Histology is very nonspecific and is characterized above all by basal plasmacytosis (CD 68,4%; CU 72,7%) and hypereosinophilia (CD 36,8%; CU 40%). At diagnosis, IBD-U (= Unclassified) is prevalent (47,2%), the frequency of which will decrease over the years (3 years after onset, 32.4%), differentiating into CU and CD (table 1). The main clinical manifestations at onset are chronic diarrhea (CD 89,5%; CU 91%), blood in the stool and / or hematochezia (CD 78,9%; CU 96,4%; table 2). Sensitive onset tests for IBD are ESR, fecal calprotectin and iron deficiency anemia (positive respectively in CD 75-60-71,4%%; CU 58,8-84,6-66,7%). The most frequent extraintestinal manifestations are arthritis (CD 22,2%) and sclerosing cholangitis (CU 7,3%). To highlight the significant statistical association (p &lt;0.05) between VEO-IBD and neuro / nephrological diseases (major renal malformations and nephropathies, autism and neuropsychiatric disorders; table 3). Among the most common complications are severe anemia (CD 31,6%; CU 42,6%), acute attack of severe colitis, malnutrition and fistulization. A monogenic form of VEO-IBD was found in 5.4% frequently linked to immunedeficiency, 2 cases required allogenic HSC transplantation (XIAP, WAS).

Conclusion
VEO-IBDs represent a challenge for the pediatric gastroenterologist. The clinical course is no more severe than pediatric inflammatory bowel diseases, with the exception of monogenic forms. A genetic association between nephro / neurological comorbidities and VEO-IBDs is likely, the genetics is still to be discovered. Further studies will be needed to define the best therapeutic and diagnostic approach for these diseases.
P270 Ultrasonography interobserver agreement in Crohn Disease between experienced and non expert operators
Authors: Marra A , Dell’Aquila P , Di Leo A , Principi M B 
Published: January 2022

Abstract

Background
Bowel ultrasound (US) is a safe, noninvasive, accessible, reproducible, and cost-effective resource technique for assessing bowel inflammation in CD. Despite the performance and advantages of bowel US, its incorporation into routine gastroenterology practice is internationally inconsistent. To date, this technique is often branded as ‘‘operator -dependent’’ and it has value only in expert hands. Nevertheless, some evidence showed that bowel US in CD could be standardized with a good reproducibility among expert operators. This result has been confirmed more recently. Interobserver agreement between operation with several degree of experience in bowel US and its learning curve need to be investigated further. The aim of this study is to assess the interobserver agreement between experienced and non-experts sonographers in the evaluation of established bowel US parameters used in CD.

Methods
Twenty-eight patients with an established diagnosis of CD underwent bowel US examination by an experienced sonographer. After baseline examination, a small intestine contrast-enhanced ultrasonography (SICUS) by use of polyethylene glycol (PEG) was also be performed. Every exam was recorded and for each segment of the bowel a videotape was registered at baseline and after PEG intake. Every video was showed to both 10 blinded expert and 10 blinded non- expert operators. Interobserver agreement was scored by kappa statistics and AC1.

Results
Agreement among 16 sonographers for the evaluation of bowel wall thickening was high (K = 0.70; AC1 = 0.82), comparable between expert operators (K = 0.72; AC1 = 0.81) and non-experts (K = 0.69; AC1 = 0.83). Agreement was moderate for stratification and vascularization according to Cohen’s analysis (k = 0.60), and excellent at AC1 with values ​​of 0.90 and 0.84, respectively. The presence of lymph nodes was reproducible in both groups with k values ​​of 0.41 and 0.51, whereas that on abdominal free fluid was poor (0.09- 0.16). For the evaluation of complications (stenosis, fistulas, abscesses), the agreement differs significantly, resulting poor with Cohen’s K (0.14–0.37) and excellent with AC1 analysis (0.98-0.94), in both groups.

Conclusion
In this study, most of the US parameters used in CD showed moderate/substantial agreement without any significant difference between experienced and non-expert operators. A different agreement based on the statistical analysis for some parameters was observed. Standardized training between operators would be useful to reduce the variability of the learning curve.
P292 Association of golimumab trough concentrations during maintenance with endoscopic and histologic remission in patients with ulcerative colitis
Authors: Taxonera Samso C , Fernández-Aceñero M J , Olivares D , Calvo M , Casis B , Bermejo F , López Serrano P , Iborra M , Mesonero F , Boscá Watts M , Díaz del Arco C , Vera I , Olivares S , Alba C 
Published: January 2022

Abstract

Background
The aim of this study was to investigate the association of serum golimumab concentrations (SGC) during maintenance therapy in UC with clinical outcomes including endoscopic and histologic healing.

Methods
This multicentre, cross-sectional cohort study included UC patients who had received at least 5 maintenance doses of golimumab. A colonoscopy was scheduled, and study-specific recto-colonic biopsies were taken for blind central histologic reading. Samples for trough SGC and anti-golimumab antibodies (AGA) were collected on the day of the scheduled golimumab administration closest to the colonoscopy. Definitions: clinical remission = partial Mayo score (PMS) ≤2 with no individual subscore &gt;1, combined clinical-biochemical remission = PMS ≤2 + faecal calprotectin &lt;300 μg/g, endoscopic healing = Mayo endoscopic subscore of 0, deep remission = clinical remission + endoscopic healing, histologic remission = Geboes index ≤2.0, and disease clearance = clinical remission + endoscopic healing + histologic remission.

Results
Fifty-two patients were included. The overall median SGC was 1.79 µg/ml (interquartile range [IQR] 0.87–2.79). Three patients (5.7%) had undetectable SGC together with positive AGA. With a median of 23 [IQR 15–32] months of golimumab therapy, 46 patients (88%) were in clinical remission, 26 (52%) had combined clinical-biochemical remission, 18 patients (35%) had both endoscopic healing and deep remission, 21 (40%) had histologic remission, and 14 (27%) had disease clearance. Median SGC were significantly higher in patients who were in clinical remission (2.01 versus 0.72 µg/mL, P=0.047) µg/mL, combined clinical-biochemical remission (2.21 versus 1.47 µg/mL, P=0.041), mucosal healing and deep remission (2.52 versus 1.47 µg/mL, P=0.003), histologic remission (2.33 versus 1.50 µg/mL, P=0.02), and disease clearance (2.52 versus 1.70 µg/mL, P=0.009), compared with those not meeting these criteria. (Figure 1) The higher SGC quartiles were associated with higher rates of mucosal healing (P=0.005), and histologic remission (P=0.006). (Figure 2) Receiver-operating characteristic analyses identified SGC thresholds [area under the curve] of 0.85 [0.76], 1.90 [0.65], 2.29 [0.75], and 2.29 [0.72] µg/mL be associated with clinical remission, combined remission, deep remission, and disease clearance, respectively. (Table 1) On multivariate analysis, body mass index (P=0.021) and CRP level (P=0.040) were linearly associated with lower SGC, and concomitant immunosuppressant with higher SGC (P=0.47). (Table 2)

Conclusion
We identified SGC thresholds during maintenance most closely associated with clinical outcomes including endoscopic and histologic healing. Higher SGC are needed to achieve increasingly stringent therapeutic targets.
P293 Insights from patients with Ulcerative Colitis on disease burden: Findings from a real-world survey in Europe
Authors: Burisch PhD J , Hart A , Oortwijn A , Khalid J M , Hennessy F , Knight H , Meadows R , Patel H , Armuzzi A 
Published: January 2022

Abstract

Background
Ulcerative colitis (UC) requires life-long management with symptom control and disease remission being the ultimate goals. Despite existing treatments (Tx), there are patients without fully controlled disease which impacts their health-related quality of life (HRQoL). We investigated the disease burden, including residual disease symptoms and quality of life impairment, among moderate-severe UC patients in remission and not in remission.

Methods
Data were drawn from Adelphi Inflammatory Bowel Disease (IBD) Disease Specific Programme, a point-in-time survey of gastroenterologists (GIs) and patients conducted in France, Germany, Italy, Spain and UK in Oct 2020-Mar 2021. Patient demographics, clinical characteristics (including mMayo components: stool frequency, rectal bleeding, endoscopic findings) and Tx history were reported by GIs while the patients reported symptoms, satisfaction with Tx, Short IBD questionnaire (SIBDQ), and EQ-5D at the time of consultation. Derived mMayo was used to define remission groups. Propensity score matching was used to compare outcomes among those with and without remission.

Results
Data for 502 UC patients were included (mean age 38.9 years, 46% males, 67% employed, mean disease duration 5.2 years, and 61% treated with advanced therapies). At time of consultation, 74% of patients reported presence of symptoms, most frequent being fatigue (27%), abdominal pain (26%) and bowel movement urgency (26%); they were also reported as most bothersome symptoms (25%, 23%, 31% respectively) alongside bloody diarrhoea (28%). Since Tx initiation, patients stated no improvement in sexual problems (54%), sleep disturbance (47%), fatigue (33%), night-time urgency (27%) and no steroid reduction (22%). 37% of the patients were dissatisfied or believed a better control was possible with their Tx; common reasons were overall lack of efficacy (30%) and uncontrolled symptoms (30%). Symptoms reported by patients satisfied with their Tx vs those dissatisfied or believed a better control was possible are reported in Fig 1. Out of 502 patients, 66% (n=332) were in remission and yet reported that symptoms such as urgency, pain and fatigue remained (Fig 2). Whilst patients in remission had significantly better HRQoL measured by SIBDQ and EQ-5D, their scores were not optimal (Fig. 3, Fig. 4).

Conclusion
We found that 66% of the UC patients have achieved remission, however 65% of those patients still reported residual symptoms. Quality of life aspects related to pain, discomfort, anxiety and depression still remained unaddressed among patients in remission. Our data highlights the need for a holistic approach to remission in the management of UC.
P303 Biologic Therapeutic Drug Monitoring in Patients with Inflammatory Bowel Disease: Are we aiming high?
Authors: Robertson A , Hawkins I , Wilkinson S , Patel R 
Published: January 2022

Abstract

Background
Infliximab and Adalimumab are the only funded biologic therapies for inflammatory bowel disease (IBD) in New Zealand. We hypothesised that clinicians are aiming for higher drug trough levels to mitigate for the absence of alternative therapies.

Methods
Retrospective study of IBD patients at Lakes DHB from, 2016 to, 2021. Data collected using the IBD patient register and electronic patient records. Change in management included dose escalation, de-escalation and switching biologic. Analyses were performed using chi-square and student t-test. Target trough levels are Infliximab &gt;5 mg/L and Adalimumab&gt;7.5 mg/L. We defined high trough levels as greater than double the suggested target levels (Infliximab &gt;10mg/L, Adalimumab&gt;15mg/L).

Results
197 patients in the IBD register., 79 (40.1%) receiving biologic therapy (Infliximab, 31 [39.2%], Adalimumab, 48 [60.8%]).Therapeutic drug monitoring (TDM) performed in, 61 (77.2%) biologic patients with a total of, 129 TDM results available. Mean trough levels: Infliximab, 7.7 (sd, 9.2) mg/L, Adalimumab, 5.7 (sd5.8) mg/L.

Conclusion
High trough levels were seen more with Infliximab use, reflecting its increased use as a, 2nd line agent and a final option to optimise medical management prior to considering surgery. Fewer changes to management were seen with high trough levels indicating improved clinical outcomes and acceptability of high levels within our practice.