bluuebunny/crossref_metadata_2025_split huggingface dataset:
P554 Assessment of corticosteroid prescribing trends and appropriateness for management of Inflammatory Bowel Disease in a secondary care centre in New Zealand
Authors: Hajelssedig O , Clark E , Edward P , Kenrick K , Inns S 
Published: January 2024

Abstract

Background
Corticosteroids are commonly used for inducing remission in Inflammatory Bowel Disease (IBD) but are considered ineffective for long-term maintenance1. Evaluating the appropriateness of corticosteroid usage is crucial in optimising IBD management given their common adverse effects.

Methods
This study aimed to assess the appropriateness of corticosteroid usage for patients with IBD in a secondary centre in New Zealand, using international standards2,3.
A retrospective records’ audit was conducted in 2020, encompassing all IBD patients encountered in Nelson Hospital from 2005 to 2020. Ethical approval was obtained beforehand. The primary outcome measure evaluated was the appropriateness of corticosteroid prescriptions, in accordance with established international standards (UK2 and ECCO3). Key criteria included dosage (strength and/or duration), patient counselling on side effects and alternatives.

Results
We studied a group of 613 IBD patients with an average age of 55, comprising 311 males and 302 females. Crohn's Disease was the predominant diagnosis (297 cases), followed by Ulcerative Colitis (252 cases) and Indeterminate Colitis (64 cases). Of the patients included in the audit, 51.4% (315 out of 613) were prescribed steroids during the 15-year study period. Of the 315 total prescriptions, 52.1% (163) were considered inappropriate. Among these, 28.6% (90) were excessively long courses, 23.5% (74) were due to under-dosing or multiple short courses, and 6.3% (20) were because of corticosteroid dependence. Out of a total of 315 prescriptions, Gastroenterologists issued 36.5% (115), while General Practitioners were responsible for 24.1% (76). The remaining prescriptions were divided among General Surgery (9%), General Medicine (6%), and the Emergency Department (5%).

Conclusion
Corticosteroid prescribing for IBD patients in this secondary centre in New Zealand deviated from international guidelines, primarily in terms of dose and duration. It’s vital to adopt accessible, customized guidelines and enhance quality measures to ensure IBD patients receive evidence-based corticosteroid treatment when needed.
References
1-Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2011;106:590-599; quiz 600.
2- Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011;60:571-607.
3-Gomollon F, Dignass A, Annese V, et al. 3rd European evidencebased consensus on the diagnosis and management of Crohn’s disease 2016: part 1: diagnosis and medical management. J CrohnsColitis. 2017;11:3-25
P558 Clinical Effectiveness and Safety of Vedolizumab vs. Infliximab in Biologic-Naïve Ulcerative Colitis Patients: A Brazilian Real-World Multicentric Observational Study
Authors: Ferreira S , Chebli J M F , Parra R , Yukie Sassaki L , de Mello M K , Luporini R L , Chebli L A , Firmino Nóbrega F J , da Silva B C , Dutra R D M , de Oliveira Vasconcelos J R , Moraes Sales M P , Féres O , Parente J M L , Troncon L E D A 
Published: January 2024

Abstract

Background
Vedolizumab (VDZ) and infliximab (IFX), are considered first-line agents in the treatment of moderate to severe Ulcerative Colitis (UC). However, there are no head-to-head studies comparing the relative effectiveness of the two agents, and Real-world data on the effectiveness and safety of VDZ and IFX in UC are lacking in the Brazilian population. We aimed to compare effectiveness and safety of VDZ to IFX in Biologic-naïve UC patients.

Methods
We conducted a multicenter retrospective cohort study, including patients with moderate to severe UC (Total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who treated with VDZ or IFX. The primary endpoints were: clinical remission, defined as a partial Mayo score (PMS) ≤2, endoscopic remission (endoscopic Mayo subscore of 1 or 0) and steroid-free clinical remission at week 52. Secondary endpoints included; clinical response at weeks 12 and 26, need for drug optimization, adverse events (AEs), need for hospitalization and colectomy, loss of response and biochemical remission (C-reactive protein [CRP] ≤ 0.5 mg/dl and/or fecal calprotectin [FC] ≤ 150 mcg/g) at week 52.

Results
A total of 174 UC (79 VDZ and 95 IFX) patients were included. Clinical remission and endoscopic remission at week 52 were achieved by 56 (70.8% vs 68.4%, p= 0.44) and 46 (58.2% vs 55.7%, p=0.18) of VDZ and IFX patients, respectively. Steroid-free clinical remission at week 52 was 84.2% and 54.1% in the VDZ and IFX group, respectively (p = 0.03). Clinical response at weeks 12 and 26 was reached in 80.0% vs 76.2%, p = 0.74 and in 71.4% vs 77.3%, p = 0.71 in the VDZ and IFX group, respectively. The need for drug optimization was higher for IFX than for VDZ (36.8% vs. 21.5%, p = 0.03). The incidence of AEs (26.3% vs 12.6%, p=0.03) and need for hospitalization (26.3% vs 11.4%, p=0.02) were higher for IFX than to VDZ patients. Secondary loss of response was similar in the two groups (16.4 % for VDZ and 16.8% for IFX, p = 1.00). Biochemical remission at week 52 was 75.0% for VDZ, and 63.9% for IFX, respectively (p=0,42).

Conclusion
In this real-world study VDZ and IFX had similar efficacy in inducing clinical remission, endoscopic remission, clinical response and biochemical remission at week 52. Compared to IFX, VDZ was superior in inducing steroid-free remission, in addition to having a better safety profile and less need for dose escalation. Both VDZ and IFX were effective treatment options in bio-naïve UC patients.
P559 Descriptive observational pilot study about the use of Virtual Reality (VR) in patients with Inflammatory Bowel Disease (IBD) and biological treatment
Authors: Díaz Molina R J , Comesaña Castellar C , Crespi Rigo J , Radu Tomsa C , Quesada Bauzá P , Porcel Corral I , Ginard Vicens D 
Published: January 2024

Abstract

Background
Virtual reality (VR) is a neurosensory experience in which simulated images and spaces are created where a person has the sensation of being and being able to function within them. A high percentage of patients with Inflammatory Bowel Disease (IBD) receive intravenous biological treatments in a day hospital (HDD) regime. VR has been used in some fields of medicine, such as Oncology, demonstrating its usefulness in reducing chronic symptoms such as pain or anxiety. However, we don’t have any literature demonstrating the applicability of VR in IBD.

Methods
Descriptive observational pilot study based on an initial cohort of 87 patients obtained from the HDD of the IBD Unit. Satisfaction and acceptance of VR through the use of 3D glasses and the reduction of negative symptoms during intravenous biological treatment in patients with IBD in HDD have been assessed.

Results
43 patients (52.4%) used VR and completed the study. The mean age was 45.3 years. The validated IBDQ-32 questionnaire on quality of life in IBD obtained a mean score of 169 points (range: 32-224). In the comparative analysis of the results of the questionnaires before and after the use of VR, a statistically significant improvement was observed in the patients' view of the ability of VR to achieve a reduction in stress (65% patients improve; p: 0.0021) and pain (VAS, 54% p. improve; p&lt;0.05) during treatment. Likewise, with the applicability of VR in other areas of medicine (53%; p: 0.05) and with the possibility of improving well-being during the stay in the HDD (56%; p: 0.0014). No side effects were reported with the use of the 3D glasses.

Conclusion
The use of VR could be a useful complementary tool to improve the stay of patients with IBD on HDD during treatment with intravenous biologic drugs. To this end, we believe it is appropriate to complete our research and obtain more data through other studies along the same lines.
P560 The impact of reactive point-of-care drug level measurement on the medium-term course of inflammatory bowel disease
Authors: Ivány E , Farkas B , Resál T , Bacsur P , Bálint A , Farkas K , Molnár T 
Published: January 2024

Abstract

Background
First generation of biologicals (infliximab (IFX) and adalimumab (ADA)) has revolutionised the treatment of patients with Crohn’s disease (CD) and ulcerative colitis (UC), however, primary resistance or loss of efficacy are serious clinical challenges. Although there is currently insufficient evidence to recommend for or against the use of therapeutic drug monitoring to improve clinical outcomes, the determination of IFX and ADA levels with point-of-care tests (POCT) is fast, simple and can be a helpful tool to guide the therapy. Our aim was to evaluate the impact and duration of IFX and ADA level measurement with POCT on the medium-term course of the disease.

Methods
In our retrospective study we enrolled patients with UC and CD who were treated at our department with IFX or ADA and underwent a reactive drug level (DL) measurement which was carried out with POCT method between October 2021 and May 2023. We examined the types of therapeutical decision (dose intensification, switch or swap) were performed knowing DL and how the changes have affected the half-yearly outcome. Laboratory findings such as C-reactive protein (CRP), iron, albumin, haemoglobin, platelet, stool calprotectin level and calculated disease activity indices, Crohn’s disease activity index (CDAI), Harvey-Bradshaw Index (HBI), partial Mayo score and Simple clinical colitis activity index (SCCAI) were analysed at baseline and after 6 months.

Results
99 patients were enrolled; median age was 37 years (IQR 29-51 years). Baseline characteristics are shown in table 1. In 46 cases the drug level was subtherapeutical while in 53 cases was in normal range. At baseline patients with low drug level had significantly higher CRP (22.09 vs 10.7 mg/l, p=0.026), platelet count (344.6 vs 272.8 G/l, p=0.004) and significantly lower iron level (12.28 vs 15.6 umol/l, p=0.033) compared to patients with normal drug level while there was no difference between the activity indices (CDAI p=0.091; HBI p=0.187; SCCAI p=0.830; pMayo p=0.662) within the two groups. 70% of the patients in the low DL group had a therapeutic change: in 52% dose increase, in 13% switch, and swap in 15%. Changes in the therapy were significantly more frequent in the low DL group (p&lt;0,0001). The difference in baseline CRP and iron level between the two groups was no longer detectable at month 6 (CRP 7.55 vs 8.7 mg/l, p=0.669, iron 14.1 vs 15.6 umol/l, p=0.325). All activity indices were significantly lower in low DL group at month 6 compared to baseline (CDAI p=0.022; HBI p=0.016; SCCAI p=0.047; pMayo p=0.046).

Conclusion
The drug level monitoring with POCT affected the decision-making process and presented beneficial effect for medium-term and helped to achieve stride therapy goals.
P563 Nutritional screening in patients with inflammatory bowel disease: a challenge in the timely diagnosis of malnutrition and sarcopenia
Authors: Parra Izquierdo L V , Orduz-Diaz G , Frías-Ordoñez J , Hoyos-Rondon S , Reatiga-Pedraza A , Sarmiento-Navarro J , Bohorquez L E , Cano D F , Pinto O , Duarte A , Florez-Sarmiento C , Cuadros C , Garces J , Acevedo J J , Barco A G , Flechas-Amaya S M 
Published: January 2024

Abstract

Background
Malnutrition is prevalent in inflammatory bowel disease (IBD) and has been reported in up to 70% in patients with active disease and 38% in patients in remission, being related to sarcopenia, so different tools have been proposed for the nutritional screening of these patients taking into account the importance of early intervention avoiding consequences related to altered body composition such as inadequate response to treatment and poor quality of life, but the evidence in IBD patients is still unclear and there are no studies in Colombian IBD patients. Therefore, the aim of this study is to describe the nutritional status of patients using multiple nutritional screening and assessment tools.

Methods
Descriptive observational cross-sectional study in patients diagnosed with IBD with clinical activity, by applying nutritional screening tools such as the Malnutrition Universal Screening Tool (MUST) and the Malnutrition Inflammation Risk Tool (MIRT) to determine their nutritional status and degree of sarcopenia.

Results
Nutritional screening was performed in 20 patients with Inflammatory Bowel Disease, with mild to moderate clinical activity of the disease; patients in clinical remission were excluded. Sixty percent were men and 40% women; with an average age of 44.5 years, 19 years as minimum age and 73 years as maximum age. Taking into account the Malnutrition Universal Screening Tool (MUST), 30% have a high risk of malnutrition, with a higher percentage in men. On the other hand, the MIRT (Malnutrition Inflammation Risk Tool), which evaluates BMI, showed that 25% have a score greater than or equal to 3, which indicates a risk. In addition, and 40% of the population underwent nutritional status assessment in order to rule out sarcopenia. Muscle strength, muscle mass and muscle function were assessed and 25% of this population were diagnosed with sarcopenia and another 25% with possible sarcopenia.

Conclusion
Patients with IBD are at increased risk of malnutrition, This is the first Colombian study to approach the nutritional assessment of IBD patients with mild to moderate disease activity using nutritional screening tools such as the Malnutrition Universal Screening Tool (MUST) and the Malnutrition Inflammation Risk Tool (MIRT), showing that up to one third of patients are at high risk of malnutrition and 50% have a diagnosis or possible diagnosis of sarcopenia, which is slightly lower than that described in the literature, However, it does raise awareness of the importance of nutritional screening in IBD patients as these alterations have been shown to be associated with increased hospitalisation requirements, number of disease flares and associated complications.
P566 Maintenance vedolizumab treatment in pediatric IBD: 54-week follow-up of the prospective multicenter VEDOKIDS study
Authors: Atia O , Shavit-Brunschwig Z , Focht G , Lev-Tzion R , Stein R , Broide E , Urlep D , Hyams J , Weiss B , Aloi M , Assa A , Russell R K , Turner D 
Published: January 2024

Abstract

Background
Prospective long-term data on vedolizumab (VDZ) in children with Crohn’s disease (CD) and ulcerative colitis (UC) are lacking. In this prospective, multicenter cohort study, we aimed to evaluate the effectiveness and safety of maintenance therapy with VDZ in pediatric CD and UC.

Methods
Children commenced on VDZ were followed at baseline and 2, 6, 14, 30 and 54 weeks thereafter. Serum for drug levels and stool for calprotectin were repeatedly obtained. The primary outcome was sustained steroid-free remission (SSFR), defined as clinical remission )PUCAI&lt;10 or wPCDAI&lt;12.5) without steroids/EEN at both 30 and 54 weeks, analyzed under the ITT principle.

Results
139 children were enrolled (77 [55%] UC, 62 [45%] CD; age 14.9 years (IQR 12.0-16.6). Of the 119 (86%) children &gt;30kg, 110 (92%) received a dose of 300mg; 20 (14%) weighed&lt;30 kg and received a dose of 8.3mg/kg (IQR 7–10.3). Week-54 remission rate was 52% in UC and 37% in CD; SSFR rates were 42% and 24%, respectively (OR 2.2 [95%CI 1.1-4.7] Figure). SSFR rate was numerically higher in isolated colonic CD than in ileal disease (5/11 [45%] vs 10/49 [20%], OR 3.3 [95%CI 0.8-12.9]; p=0.08). Infusion interval was shortened in 22 children (10 [13%] UC, 12 [19%] CD), of whom none achieved SSFR.
SSFR rate was higher in week-6 responders compared to non-responders in UC (51% vs 27%, OR 2.9 [1.1-7.7]) and CD (35% vs 14%, OR 3.4 [95%CI 0.95-12.4]), similar to the week-14 figures (UC: 50% vs 22%, OR 3.6 [1.2-11.1]; CD: 36% vs 8%, OR 6.2 [1.3-30.8]). SSFR was eventually achieved in 49% of UC children having mild disease at week-6 and 14% with moderate-severe disease (OR 5.8 [95%CI 1.2-28.2]); the corresponding rates in CD were 31% and 0% (p=0.02).
In multivariable models, the best predictors in CD were lower wPCDAI at baseline (AUROC 0.88 [95%CI 0.79-0.96]; optimal cutoff 25 (sens/spec 76%/80%)) and at week 6 (0.90 [0.82-0.98]; optimal cutoff 17.5 (80%/87%)). In UC, the best predictors were PUCAI at week 6 (0.70 [0.57-0.82]; optimal cutoff 10 (64%/57%)) and at week-14 (0.78 [0.67-0.89]; optimal cutoff 5 (76%/60%; Table).
In children &lt;30kg, SSFR was associated with week 6 drug levels &gt;30ug/mL, not reaching statistical significance (3/6 [50%] vs 1/8 [13%], OR 7.0 [95%CI 0.5-97]). By week 54, 197 adverse events were recorded, of which were VDZ-related in 8 (5.8%) children, and in 2 (1.4%) led to stopping VDZ; none were severe. There was 1 lymphoma case judged to be unrelated to VDZ.

Conclusion
VDZ was effective for maintaining remission, more so in UC and in colonic CD. The likelihood of eventually achieving SSFR was very low in children with moderate-severe disease or those not showing response at week-6, particularly in CD.
P583 Infliximab Monitoring in Crohn's Disease and Development of Neural Networks Using Clinical Variables to Predict Disease Activity and Immunogenicity
Authors: Gomes L E M , Genaro L M , Castro M M , Pascoal L B , Ricci R L , Silva F B C , Camargo M G , Bonfitto P H L , Ayrizono M L S , Azevedo A T , Leal R F 
Published: January 2024

Abstract

Background
Infliximab (IFX) is a biological drug that inhibits the action of tumor necrosis factor-alpha (TNFα), a pro-inflammatory cytokine enrolled in the pathogenesis of Crohn's disease (CD). Trough-level drug monitoring (TDM) has been increasingly used in clinical practice to optimize biological therapy and improve precision medicine. Therefore, this study aimed to analyze the serum level of IFX and antidrug antibodies (ADA) in active and in remission CD patients and develop prediction models via neural networks using a combination of clinical variables.

Methods
Seventy-five CD patients who underwent IFX therapy in the maintenance phase were included. Disease activity was defined by endoscopic and/or radiological criteria, comprising remission (CDR) and active (CDA) groups. Serum IFX levels were measured by ELISA (Promonitor ®) and rapid lateral flow test (Quantum-Blue®). ADA was measured using ELISA (Promonitor ®). For statistical analysis, a non-parametric test was used, with adopted p≤0.05. To create a prediction model, four sets of neural networks were constructed for the following output variables: remission/activity, presence or not of ADA, therapeutic level according to ELISA, and therapeutic level according to the lateral flow test. The neural networks and ROC curves were designed using the Keras package in Python software. The study was approved by the Research Ethics Committee.

Results
No differences were observed in the IFX level when comparing the CDA and CDR groups in both tests (p&gt; 0.05). There was no statistical difference in IFX levels according to the use of immunosuppressants (IMS) (p&gt;0.05). ADA levels &gt; 5AU/mL were detected in only 11 (14.6%) patients. All patients with positive ADA had infratherapeutic IFX levels in both tests, and 72.7% were on combination therapy with IMS. Of the 4 neural networks developed, two, whose output variables were “remission/activity” and “presence or not of ADA,” showed excellent performance, with AUC ranging from 82% to 92% and 100%, respectively.

Conclusion
The introduction of IFX monitoring may allow more individualized and precise therapeutic management. Regarding the performance characteristics of the neural networks, an AUC &gt;80% was evident in two of them. Through clinical and non-invasive laboratory variables, disease activity was determined. Furthermore, the finding of combinations of variables that determine the ADA level, and at the same time not having demonstrated good models for IFX serum level measurement, means that the latter continues to be necessary for clinical practice. Otherwise, ADA levels, which indicate immunogenicity, can be predicted by non-invasive clinical variables.
P584 Complication rates after two-stage vs three-stage restorative proctocolectomy with ileoanal pouch construction in the era of biologics
Authors: Doyon F , Saifi M , Doyon A , Kienle P 
Published: January 2024

Abstract

Background
Patients with proctocolectomy and ileoanal pouch construction typically undergo a two-stage or three-stage surgical procedure, depending on the general condition and recent immunosuppressive therapy. Our single center database prospectively records all surgeries performed since 2021 and retrospectively of patients before this year. Complications are registered by Clavien-Dindo classification.

Methods
All patients with two-stage or three-stage proctocolectomy and ileoanal pouch construction were identified from the database. The prevalence and severity of complications was analyzed according to Clavien-Dindo, with scores of 3 and above classified as severe complication. Patients were grouped by having either one or more severe complications or none at any surgical procedure.

Results
102 patients were identified from the database, of those 44 (43%) had a two-stage procedure and 58 (57%) a three-stage procedure.
In the three-stage group, 25 (43%) patients were on active systemic corticosteroid therapy at the time of the first surgery compared to 0 patients in the two-stage group (p&lt;0.001). Biological therapy within the last 3 months before the first surgery was received by 35 (60%) of the patients in the three-stage group versus 16 (36%, p=0.016 ) in the two-stage group.
The three-stage procedure resulted in 11 out or 58 patients (19%) having at least one major complication compared to 3 out of 44 patients (7%) of the group with two-stage approach (p=0.077).

Conclusion
There is a trend towards a higher major complication rate in patients operated by a three- versus a two-stage approach in restorative proctocolectomy. This may be due to a selection bias as patients undergoing a three-stage procedure had significantly more often steroids at the time of first surgery and significantly more often biological therapy three months before the first surgery. Further data collection and then multivariate analysis including further risk factors, need to be done in order to better define the preferable individual surgical strategy.