bluuebunny/crossref_metadata_2025 huggingface dataset:
P203 The performance of the Rutgeerts’ score, SES-CD, and MM-SES-CD for prediction of post-operative clinical recurrence in Crohn’s disease
Authors: Narula N , Wong E , Dulai P , Marshall J , Jairath V , Reinisch W
Published: January 2022

Background

Prevention of post-operative recurrence in Crohn’s disease (CD) is important to avoid further complications requiring additional surgeries. The Rutgeerts’s score is currently the gold standard assessment in clinical trials of post-operative CD. However, the Simplified Endoscopic Score for CD (SES-CD) has not been validated or used clinically in post-operative CD patients. The Modified Multiplier of the SES-CD (MM-SES-CD) is a novel internally validated tool that was developed to account for differences in items of the SES-CD and has not yet been validated in the setting of post-operative CD. The purpose of this study was to compare the SES-CD and MM-SES-CD scores with the Rutgeerts’ score for predicting clinical recurrence (CR) of post-operative CD.

Methods

This was a post-hoc analysis of data from the phase 3 PREVENT trial (ClinicalTrials.gov identifier: NCT01190839) of 208 participants who received infliximab or placebo. Receiver operating characteristic curve analyses to compare the Rutgeerts’, ileum SES-CD, and ileum MM-SES-CD scores at week 76 with CR at week 104. Multivariate logistic regression models evaluated cut-offs for the odds of achieving week 104 CR, after adjustment for confounders, including treatment allocation, disease duration, prior anti-TNF use, and concomitant immunomodulator use. CR was defined as CDAI score ≥200 and ≥70 point increase from baseline (or development of fistulas, abscesses, or treatment failure) and endoscopic recurrence, defined as Rutgeerts’ score ≥i2.

Results

The Rutgeerts’ score predicted week 104 CR at with fair accuracy [AUC: 0.74 (95% CI: 0.65–0.83)], which was similar to the SES-CD ileum score [AUC: 0.72 (95% CI: 0.64–0.80)] and the MM-SES-CD ileum score [AUC: 0.72 (95% CI: 0.63–0.80)]. Compared to various cut-offs by the other scores, the MM-SES-CD ileum score ≥26 at week 76 had the best ability to predict week 104 CR. Patients with a week 76 MM-SES-CD ileum score ≥26 were 4.17 times (95% CI: 1.90–9.12, p <0.001) more likely to have CR compared to those with a MM-SES-CD ileum score <26.

Conclusion

The ileal SES-CD and ileal MM-SES-CD perform similarly to the Rutgeerts’ score for predicting CR of post-operative CD. The MM-SES-CD threshold of ≥26 best predicted post-operative CR. Clinicians and trialists should consider the use of the MM-SES-CD in the assessment of post-operative CD given its performance and ability to capture colonic disease recurrence.
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

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

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<0.001). Satisfaction, in terms of easiness to drink (8.2 ± 1.6 vs. 6.0 ± 2.2, p<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

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

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

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 > 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 <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

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

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 >1, combined clinical-biochemical remission = PMS ≤2 + faecal calprotectin <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

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

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 >5 mg/L and Adalimumab>7.5 mg/L. We defined high trough levels as greater than double the suggested target levels (Infliximab >10mg/L, Adalimumab>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.
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

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<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<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

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

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

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

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

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 <, 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

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<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.