bluuebunny/crossref_metadata_2025_split huggingface dataset:
P511 Efficacy of Crohn’s Disease exclusion diet in different clinical scenarios in paediatrics; at onset of the disease and after loss of response to biological therapy
Authors: Jijón M C , Pujol-Muncunill G , Lozano Ruf A , Vila Miravet V , Alvarez Carnero L , García Arenas D , Egea Castillo N , Martín de Carpi J 
Published: January 2022

Abstract

Background
Crohn’s disease (CD) exclusion diet (CDED) associated with partial enteral nutrition (PEN) has showed to induce remission in different clinical scenarios of the disease. Our aim is to evaluate its efficacy at onset and after loss of response to biological treatment in paediatric CD.

Methods
Retrospective observational cohort study of children with CD treated with CDED+PEN. Demographic (gender, age at diagnosis and at CDED initiation), clinical (Paediatric Crohn’s Disease Activity Index (PCDAI) and weight Z score), and analytical (faecal calprotectin (FC), haemoglobin, albumin, C reactive protein (CRP), iron, ferritin, and erythrocyte sedimentation rate (ESR)) variables were analysed at 0, 6, 12, and 24 weeks of treatment. Primary outcome was clinical remission, defined as PCDAI &lt;10 points.

Results
Fifteen patients were included (8 male); group A (n 9; mean age 15.8 years, [IQR:12.6–18.1]) received CDED+PEN at onset, while group B (n 6; mean age 12 years [IQR:10.7–15]) received it after loss of response to biologics. All patients in group A and 2 in B received azathioprine. In group B, 3 patients were on Adalimumab and 3 on Ustekinumab. Adherence at week 6 was 100% in both groups. Group A had a mean PCDAI of 15 [IQR: 11.25–17.5] at baseline and 100% of the patients achieved clinical remission by week 6 and maintained it through week 12; 87% (7/8) maintained clinical remission by week 24. One patient required step-up to Adalimumab due to sustained FC elevation. In group A PCDAI significantly improved at week 6 (p0.09), 12 (p0.002) and 24 (p0.006). FC and albumin also improved at week 6 (p0.02; p0.03), 12 (p0.016; p0.03) and 24 (p0.019; p0.016). ESR improved at weeks 12 (p0.021) and 24 (p0.027). Haemoglobin and iron only improved at week 24 (p0.048; p0.003). The weight Z score, CRP, and ferritin did not improve significantly in group A. In group B mean PCDAI at baseline was 20 [IQR: 3.75–39.38]; 100% achieved clinical remission at week 6 and maintained it at week 12. By week 24, 60% (3/5) maintained clinical remission (1 patient required steroids due to a relapse (moderate activity assessed by colonoscopy) and 1 patient presented with clinical relapse. PCDAI and FC decreased over time but did not reach statistical significance. The rest of variables did not show significant improvement in group B.

Conclusion
Treatment with CDED+PEN was well tolerated and patients had excellent adherence. Our cohort showed better results at disease onset than after loss of response to biologics. However, CDED+PEN is a new promising rescue strategy to treat CD after failure to previous biologics in a safe manner, and without needing to change the therapeutic target.
P527 Telemedicine in IBD patients: results of a national survey of the Italian IBD patients’ association (AMICI Onlus)
Authors: Costantino A , Caprioli F , Vecchi M , Stocco D , Aloi M , Armuzzi A , Ficari F , Manguso F , Mocci G , Orlando A , Pironi L , Radice S , Rizzello F , Tongiorgi A , Leone S , Bossa F 
Published: January 2022

Abstract

Background
Telemedicine is one of the major changes that clinicians have encountered over the past decade; in particular during the COVID-19 pandemic, televisits were rapidly implemented to guarantee patients’ assistance, with the intention of Health Care Providers (HCPs) to continue to use them beyond the pandemic.
The aim of our national survey was to evaluate the current usage of telemedicine for IBD patients from their perspective, investigating patients’ impressions about telemedicine and factors affecting them through a Machine Learning (ML) analysis.

Methods
In March 2021, the Italian IBD patients’ association (AMICI Onlus) distributed to their members - through its mailing list and on social media platforms - an anonymous online questionnaire investigating the use of telemedicine.
Socio-demographic and IBD characteristics were collected; the usage, patients’ satisfaction and trust of telemedicine were assessed through Likert scales.
ML tools - Decision Trees (DT) and Random Forest (RF) - were applied to identify the determinants of patient’s perceptions about telemedicine; the produced RF ranking displays two indicators: %IncMSE and IncNodePurity.

Results
Nine hundred and seventy-eight IBD patients (women 58.9%) from every Italian region completed the questionnaire.
Among the respondents, 87 (8.9%) personally had a telemedicine experience; 153 reported that their Centre performed a telemedicine service during the COVID-19 pandemic (24.2% televisits, 39.2% e-mails, 24.8% phone-calls, 3.9 % dedicated website, 7.9% others).
Overall, 707 (72.3%) would trust a telemedicine service, 760 (77.7%) would like to have it also with another HCP (e.g., nutritionist, psychologist) and 778/961 (81%) would like to use telemedicine in the future (17 did not answer to this specific question); 792 (81%) stated they thought useful to have the possibility to use telemedicine and 847 (86.6%) would like their Centre to offer them this facility.
Considering this last question as the output at the DT, the variable which have been found to influence the most this patients’ willingness is patient’s perception of the usefulness of telemedicine in treating their disease, since it represented the root of the tree explaining the results. The RF rankings confirmed that this variable influenced the most patients’ perception with the highest levels of %IncMSE and IncNodePurity(Figure 1).

Conclusion
The practice of telemedicine in the management of IBD patients has not been very relevant throughout Italy so far (less than 10%), but more than four every five respondents would like to use telemedicine.
Machine learning analysis shows that the perceived usefulness of telemedicine service is the key point for patients who would like it was a part of usual clinical practice.
P529 Evolution of COVID19 serology in a real-life population of IMID patients. Results of the BELCOMID study: BELgian Cohort study of COVID-19 in Immune Mediated Inflammatory Diseases (IMID)
Authors: Geldof J , Sabino J , Ferrante M , Lambert J , Lapeere H , Hillary T , Van Laethem A , De Vlam K , Verschueren P , Lobaton T , Vermeire S 
Published: January 2022

Abstract

Background
Immunomodulators (IMM) and Targeted Immune-Modulating Therapies (TIMT) such as anti-TNF, anti-interleukins and Janus Kinase inhibitors, for treatment of Immune Mediated Inflammatory diseases (IMID) could theoretically interfere with the cytokine storm and humoral immune response against COVID19 infection and vaccination. We investigate seroprevalence and evolution of SARS-CoV2 antibodies in relation to previous vaccination and/or exposure to COVID19 and ongoing IMID-treatment in a Belgian, real-life population of IMID patients.

Methods
A cross-disciplinary, prospective, observational cohort study was set up at two university hospitals. All patients with IMIDs of the gut (Crohn’s disease, ulcerative colitis), joints (rheumatoid, psoriatic or spondyloarthritis) and skin (psoriasis, hidradenitis suppurativa, atopic dermatitis) visiting the respective clinics were asked to participate. Patients had to fill out an electronic survey (REDCap®, based on WHO-ISARIC) and blood samples were drawn for serology testing (anti-Spike(S) and anti-viral Nucleocapsid(N) protein antibody IgG, Abbott). Results at baseline, prior to the national vaccination program and at 6 months follow-up are presented. R version 4.0.2 was used for statistical analyses.

Results
At baseline 2165 IMID patients consented to take part. In 3.2% SARS-CoV2 anti-N seroconversion was confirmed. Of the anti-N seroconverted patients 72.9% reported a positive PCR test prior to inclusion.
At 6-months follow-up, data of 1853 IMID patients was collected. Of these, 81.7% were fully and 14.4% partially vaccinated. Seroconversion for anti-N antibodies was confirmed in 2.5% of all participants and seroconversion for anti-S antibodies in 90.8%. In 5.1% (61/1483) of fully vaccinated IMID patients no seroconversion in anti-N nor anti-S antibodies was found.
Chi Square analyses show, at 6-months follow-up, no significant association between anti-S seroconversion rate and treatment with systemic steroids (RiskRatio 1.22, 95%CI 0.38–3.9, P=0.99), TIMT (RiskRatio 0.57, 95% CI 0.3–1.1, P=0.12), IMM (RiskRatio 1.65, 95% CI 0.85–3.19, P=0.19) or combination treatment IMM/TIMT (RiskRatio 1.60, 95% CI 0.75–3.4, P=0.32).
Appearance of COVID19 symptoms followed the epidemiological curve in Belgium (Fig1).

Conclusion
In this real-life IMID cohort, the number of COVID19 cases confirmed by PCR prior to vaccination was low. Seroconversion rate for anti-N antibodies was lower at 6-months follow-up, suggesting decrease in antibody titre over time. Full COVID19 vaccination led to a high anti-S antibody seroconversion rate. Nonetheless, 5.1% of fully vaccinated patients showed no antibody seroconversion. So far, no significant association between anti-S antibody seroconversion and IMID treatment was noted.
P538 Implementation of Kono-S anastomosis as a new standard of surgical care
Authors: Adamou A , Müller G , Iesalnieks I 
Published: January 2022

Abstract

Background
The Kono-S ileocolic anastomosis is thought to reduce the risk of clinical and surgical recurrence in Crohn’s disease patients. The Kono-S anastomosis was established as a new standard of care at our institution in 2018, however, it was not performed in all patients. The present study describes the learning curve and reasons for hesitation to use the new technique.

Methods
Consecutive patients undergoing bowel resection with formation of ileocolic anastomosis since starting to use Kono-S technique were included in the present retrospective analysis. Intraabdominal septic complications (IASC) were peritonitis, anastomotic leak, intraabdominal fistula and abscess.

Results
Since starting to use Kono-S anastomosis, 90 patients underwent ileocolic resection (45M, 45F). However, during this period, conventional side-to-side ileocolic anastomosis was still performed in 26 patients (29%). Kono-S anastomosis was performed in 46% of cases during the first 6 months, in 76% during the next 6 months and in 82% of cases after the first year since implementation (p=0.005). There was no difference in postoperative IASC rate between patients with or without Kono-S anastomosis (2% vs. 4%, p=0.5). Also, postoperative overall complication rate, incidence of postoperative small bowel obstruction and length of postoperative hospital stay did not differ between groups. There were no anastomotic leaks. By the multivariate analysis, the presence of intraabdominal abscess or fistula (Hazard ratio 0.25, p=0.037) was the main reason to perform the conventional hand S/S anastomosis instead of new technique.

Conclusion
Some hesitation to use Kono-S anastomosis could be observed after the implementation of the new standard of care, especially during the first six months and in patients presenting with more complex intraabdominal findings. However, the learning curve has no impact on postoperative morbidity.
P547 Early modification of inflammatory burden through treatment with vedolizumab or adalimumab is predictive of long-term treatment success in patients with Ulcerative Colitis from the VARSITY Study
Authors: Schreiber S , Galinsky K , Aubrecht J , Juarez J , Agboton C , Loftus E V , Danese S 
Published: January 2022

Abstract

Background
Use of inflammatory biomarkers is common practice in ulcerative colitis (UC) management1. This study examined the utility of faecal calprotectin (FCP), C-reactive protein (CRP), and albumin biomarkers and their combination, for predicting outcomes of clinical remission and disease control (composite of clinical, endoscopic and histologic disease activity measures2) in patients (pts) with UC under therapy with vedolizumab (VDZ) or adalimumab (ADA) in the VARSITY study.

Methods
VARSITY was a phase 3b, randomized, double-blind, double-dummy, active-control trial evaluating VDZ (anti-α 4β 7 integrin) vs ADA (anti-tumour necrosis factor-α) treatment in pts aged 18–85 years with moderate-to-severe UC (NCT02497469; EudraCT:2015-000939-33). Pts received either VDZ IV infusions (300 mg) on Day 1 and at Weeks (WKs) 2, 6, 14, 22, 30, 38, and 46 or ADA SC injections (40 mg), total dose 160 mg at WK1, 80 mg at WK2, and 40 mg every 2 weeks thereafter until WK50. In this post hoc analysis of data from 769 pts, the probability of clinical remission (total Mayo score ≤2, no subscore &gt;1) and disease control (pt-reported outcome-2 [PRO2, Mayo subscores of stool frequency and rectal bleeding]; Mayo endoscopic subscore ≤1 [endoscopic improvement], and Robarts Histopathology Index score &lt;5, [absence of histologic active disease]) were assessed at WK52 based on baseline and WK14 levels of dichotomized FCP (high-risk: ≥100 µg/g), CRP (high-risk: ≥5mg/L), and albumin (high-risk: &lt;45 g/L) including the composite of high-risk CRP and FCP termed ‘inflammatory burden’ (IB).

Results
In comparison with biomarkers measured at baseline, FCP at WK14 was the most predictive of WK52 clinical remission after VDZ or ADA treatment3; WK14 FCP was also predictive of disease control using a combined endpoint of PRO2, endoscopy and histologic remission/response. VDZ-treated pts with low-risk FCP (&lt;100 µg/g) at WK14 had a 76% chance of achieving WK52 clinical remission vs 35% for pts with high-risk FCP (70% vs 33% for ADA-treated pts with low and high-risk FCP, respectively). VDZ-treated pts with IB (high-risk levels of FCP and CRP) at WK14 had a 16% chance of clinical remission at WK52 vs a 57% probability for this endpoint in pts without IB at WK14; the risk difference for this composite biomarker was 42% (Table).

Conclusion
The addition of CRP to FCP as a composite biomarker of IB at WK14 after treatment initiation can be a useful negative predictor of pts who are likely to achieve significant long-term benefits, including remission and disease control, with VDZ or ADA treatment.
References
1. Turner D, et al. Gastroenterology 2021;160(5):1570-38.
2. Danese S, et al. J Crohn’s Colitis 2021;15(Suppl1):S305–S305.
3. Dulai PS, et al. Gastroenterology 2021;160(6):S-46–7.
P548 External validation and consistency in time of patient segmentation based on disease acceptance and perceived control in Inflammatory Bowel Disease
Authors: Van Erp L W , Thomas P W A , Groenen M J M , Bloem S , Russel M G V M , Römkens T E H , Wahab P J 
Published: January 2022

Abstract

Background
The patient segmentation model based on disease acceptance and perceived control may guide personalized inflammatory bowel disease (IBD) care. A first single-centre evaluation of the model showed its validity and found that disease acceptance and perceived control are important determinants of health-related quality (HRQoL) in IBD patients. We aimed to investigate the external validity of the segmentation model and its performance in course of time.

Methods
This is a longitudinal study of adult IBD patients guided at three secondary care centres with questionnaires on HRQoL (10-item Short IBDQ, range 10–70) and disease acceptance and control (3-items each, 7-point Likert scale). Two cohorts were created: 1) external validation cohort excluding participants of initial validation study and 2) follow-up cohort of patients with questionnaires after one year. Segments were formed based on mean acceptance and control (cut-off high score&gt;5).

Results
The external validation cohort included 921 patients that were divided in four segments (Figure 1). The acceptance and control scale were unidimensional (85% and 83% of variability explained by the first factor) and internally consistent (Crohnbach’s alpha 0.92 and 0.90). The segments differed significantly in gender, disease duration, IBD medication and clinical disease activity (p&lt;0.05). In multiple regression analysis, high acceptance and high control were significantly associated with a higher HRQoL compared with low acceptance and low control (Beta (95%CI) segment I=11.8 (10.5–13.2), segment II=9.4 (7.8–11.0) and segment III=3.8 (1.6–6.1), p&lt;0.01). The follow-up cohort included 783 patients: 58% remained in the same segment while 42% differed in segment over time (Figure 2). HRQoL differed significantly between patients with positive, negative or no change in segment (p&lt;0.001)(Figure 3). The change in HRQoL over time correlated positively with changes in segment (Spearman rho 0.38, p&lt;0.001) (Figure 4).

Conclusion
This study demonstrated the patient segmentation model based on disease acceptance and perceived control is externally valid and shows consistency over time. The independent association between the different segments and HRQoL was confirmed. In many patients disease acceptance and perceived control remained low after one year. Future research and interventions should aim at improving disease acceptance and perceived control of IBD patients.
P555 Ustekinumab tissue and serum levels in patients with Crohn’s disease are closely correlated though not consistently associated with objective response after induction
Authors: Proietti E , Bayoumy A , Pauwels R , van der Woude J , Doukas M , Oudijk L , Peppelenbosch M , Grohmann U , Crombag R , de Vries A , Fuhler G 
Published: January 2022

Abstract

Background
Ustekinumab (UST), which targets p40 of IL23/IL12, is an effective treatment for Crohn’s disease (CD). Therapeutic drug monitoring (TDM) may optimize UST posology. The aim of this study was to investigate UST and IL23 serum and tissue concentrations in relation to mucosal inflammation and treatment response.

Methods
A prospective cohort study was performed in adult CD patients who initiated UST at Erasmus MC, the Netherlands, between December 2016 and November 2018. Endoscopies were performed at baseline and week 16. UST and IL23 serum and tissue concentrations were measured at week 16. Clinical and biochemical response were defined as decline of ≥3 points in Harvey Bradshaw Index and reduction of ≥50% in fecal calprotectin levels. Endoscopic response was defined as a ≥50% decline in simple endoscopic score or a decline of ≥1 points in Rutgeerts’ score. Histological remission was defined as GHAS score ≤4.

Results
All 56 included patients were previously treated with anti-TNFα-inhibitors prior to UST. Upon treatment with UST, 17 (30%) showed clinical response, 16/53 (30%) biochemical response, and 20/56 (36%) endoscopic response. UST, but not IL23, concentration in biopsies was correlated to levels in corresponding sera (p &lt; 0.0001). No correlation was found between UST serum and tissue levels with clinical or endoscopic response, or histological remission. However, patients achieving biochemical response showed significantly higher UST serum levels as compared to those without biochemical response (3.12 µg/ml vs 1.41 µg/ml, p = 0.01). Furthermore, tissue IL23/UST ratio correlated with histologic mucosal inflammation (p = 0.01).

Conclusion

This is the first study to demonstrate a correlation between serum and tissue UST levels. We showed that the tissue IL23/UST ratio correlated with mucosal inflammation. UST tissue concentrations did not correlate with treatment response, while UST serum concentrations were associated with biochemical response at week 16. The role of UST levels for TDM in IBD warrants further research.
P576 Real-world effectiveness and safety of risankizumab in patients with moderate-to-severe multi-refractory Crohn’s disease: a Belgian multi-centric cohort study
Authors: Alsoud D , Franchimont D , D’Heygere F , Bossuyt P , Vijverman A , Van Hootegem P , Sabino J , Cremer A , Vermeire S , Ferrante M 
Published: January 2022

Abstract

Background
In recent phase 3 trials, risankizumab (RZB), a humanised monoclonal IgG1 antibody targeting the interleukin 23 p19 subunit, proved to be superior to placebo in inducing and maintaining clinical remission and endoscopic response in patients with moderate-to-severe Crohn’s disease. In this study, we aimed to evaluate the effectiveness and safety of RZB in a real-world cohort of multi-refractory CD patients.

Methods
Adult CD patients from six Belgian IBD centres who initiated RZB prior to May 2021 as part of a medical need program were prospectively followed. Patients with an ostomy were excluded for the main analyses. The primary endpoint was steroid-free clinical remission at week 24 (average daily liquid stool frequency [SF] ≤2.8 and average abdominal pain [AP] score ≤1, both not worse than baseline). Secondary endpoints included clinical response, endoscopic remission, endoscopic response, biological remission, biological response, need for CD-related hospitalisation or surgery, and serious adverse events (definitions in Figure 1). Given that a follow-up endoscopy has not yet been performed in some patients, results are shown for both “all patients” (with non-responder imputation) and “as observed”.

Results
A total of 27 patients started RZB of whom 19 patients were eligible for this study with a minimal follow-up of 24 weeks (Table 1). Eight patients were excluded as they had an ostomy at time of RZB initiation. Eighteen patients (95%) had been exposed to more than 3 biologicals and 13 (68%) previously underwent a CD-related intestinal resection. By week 24, 7/19 (37%) and 7/19 (37%) patients achieved steroid-free clinical remission and endoscopic response, respectively (Figure 1). In the “as observed” analyses, these rates were 7/18 (39%) and 7/9 (78%), respectively (Figure 2). Five patients used concomitant steroids at baseline and were all able to stop it after a median of 10 weeks. Eventually, three patients had to be hospitalized for bowel resection (2 with placement of an ostomy) after a median of 24 weeks, two of them required earlier an emergent hospitalization due to flares of abdominal pain and bloody diarrhea. None of the patients experienced serious infections or intolerance. Based on physician global assessment, three out of eight patients with an ostomy did achieve clinical remission, and two other achieved clinical response. Endoscopic follow-up data were available in six patients, and three of them experienced endoscopic response.

Conclusion
In this real-world, multi-refractory cohort, clinical remission and endoscopic response were both observed by week 24 in more than one third of CD patients initiating RZB. RZB was well tolerated with no safety issues.