bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0256 Histologically-proven isolated cuffitis and quality of life among patients with ileoanal pouch
Authors: Fischman M , Codish M , Barkan R , White I , Wasserberg N , Rabinowitz K , Avni-Biron I , Banai H , Snir Y , Yanai H , Dotan I , Ollech J 
Published: January 2025

Abstract

Background
Patients with ulcerative colitis (UC) undergoing ileal pouch-anal anastomosis (IPAA) may develop inflammation of the ileal pouch (pouchitis), rectal cuff (cuffitis), or both. We aimed to evaluate how isolated cuffitis impacts patients' quality of life (QoL).

Methods
In a comprehensive pouch clinic at a tertiary referral center (Rabin Medical Center), consenting patients were followed prospectively, with routine clinical, laboratory, endoscopic, and QoL evaluations. Patients undergoing IPAA due to UC and having ≥1 cuff biopsy during follow-up were included. Patients with isolated cuffitis (cuff inflammation but no pouch inflammation) were compared to patients with isolated pouchitis (inflammation of the pouch with a normal cuff). Pouch endoscopy findings were defined based on the Pouchitis Disease Activity Index (PDAI) endoscopic and histologic subscores. Cuff endoscopy findings were defined based on Mayo endoscopic subscore and NANCY histological index. Cuffitis was defined as evidence of moderate-to-severe histologic inflammation (NANCY score 3-4).

Results
The cohort included 116 patients (median age 50 years, IQR 42-64; 60% females, n=68) who underwent 250 endoscopies (median 2, range 1-3). Isolated cuffitis (Mayo≥2) was diagnosed in 7 endoscopies, and isolated pouchitis (PDAI&gt;2) in 33. Histologically, isolated cuffitis was detected in 39 biopsies, and isolated pouchitis in 72 biopsies.
Patients with isolated cuffitis had higher body mass index (27 [23–29] vs. 23 [21–27], p=.03). Inflammatory markers, including C-reactive protein (0.61 [0.32–1.27] vs. 0.64 [0.31–1.03], p=.98) and fecal calprotectin (135.5 [53.25–347.5] vs. 276.0 [131.0–553.0], p=.21), were similar.
Both groups had comparable daily bowel movements (BMs); 39% of patients with isolated cuffitis vs. 42% of those with isolated pouchitis had &gt;10 BM/day (p=.79). Bristol stool scale scores 6-7 were reported in 94% of patients with isolated cuffitis compared to 76% with pouchitis (p=.04). Both groups had similar PDAI clinical sub-scores (p=.98).
Patients with isolated cuffitis were more likely to report overall (22% vs. 7%, p=.08) and current (31% vs. 16%, p=.13) poor well-being. QoL scores were comparable: median Short Inflammatory Bowel Disease Questionnaire (SIBDQ) 46.5 vs. 50.5, (p=.53) and IBD-Control score of 10.0 vs. 7.0, (p=.6).

Conclusion
Cuff histology reveals higher rates of inflammation than endoscopy alone. Patients with histologically-proven isolated cuffitis and a normal pouch experience a negative impact on QoL as those with an inflamed pouch only. These findings suggest that greater attention to identifying cuffitis and effective management are required.
P0257 Correlation of biochemical, endoscopic and histologic endpoints in vedolizumab-treated patients with ulcerative colitis: a post-hoc analysis from the VIEWS randomised controlled trial
Authors: Pudipeddi A , Dhanji P , Paramsothy S , Kariyawasam V , Paramsothy R , Ghaly S , Haifer C , An Y K , Begun J , Connor S , Corte C , Ward M , De Cruz P , Fung C , Redmond D , Chan W , Mourad F , Kermeen M , Leong R 
Published: January 2025

Abstract

Background
Biochemical, endoscopic and histologic endpoints are commonly used to objectively define remission status in ulcerative colitis (UC). Little data exists on the correlation of these endpoints from prospectively collected samples based on a well-defined protocol. Also, optimal faecal calprotectin (FC) values that predict histo-endoscopic remission are lacking.

Methods
The phase IV Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS) prospectively recruited 62 patients with UC on vedolizumab in steroid-free clinical remission. Treatment endpoints were assessed at week 0 and 48. Biopsies for histology were standardised using strict protocolised criteria. Definitions of remission using treatment endpoints were C-reactive protein (CRP)&lt;5mg/L, FC&lt;150µg/g, centrally-read Mayo endoscopic score (MES)=0, centrally-read Nancy Index (NI)=0, and histo-endoscopic remission (MES=0 and NI=0). Correlation was assessed using phi (ϕ) co-efficient analysis (value between -1 and 1 reflecting strength of correlation). Receiver operating characteristic (ROC) analysis was performed to determine optimal FC cutoffs to predict histo-endoscopic outcomes (IBM SPSS Statistics, version 30).

Results
A total of 124 datapoints were obtained from paired endpoints. From these, CRP remission was noted in 81%, FC remission 82%, endoscopic remission 66%, histologic remission 61% and histo-endoscopic remission in 54%. Strong correlations were found between endoscopy and histology (ϕ=0.447, P&lt;0.001), and between FC and endoscopy (ϕ=0.395, P&lt;0.001). FC had moderate correlation with histology (ϕ=0.204, P=0.03). CRP had weaker correlations with FC (ϕ=0.158, P=0.08), endoscopy (ϕ=0.111, P=0.24), and histology (ϕ=0.196, P=0.04) (Figure 1). A FC cut-off of 62.6 µg/g (sensitivity 78%, specificity 54%) predicted endoscopic remission (AUC 0.72 [95%CI: 0.61-0.84], P&lt;0.001). A FC cut-off of 34.2µg/g (sensitivity 65%, specificity 60%) predicted histologic remission (AUC 0.66 [95%CI: 0.55-0.77], P=0.006). A FC cut-off of 23.7µg/g (sensitivity 60%, specificity 63%) predicted histo-endoscopic remission (AUC 0.65 [95%CI: 0.54-0.76], P=0.006) (Figure 2).

Conclusion
Endoscopic and histologic endpoints correlate strongly when standardised in a trial setting. FC values below 34.2µg/g and 23.7µg/g best predicted for histologic and histo-endoscopic remission respectively.
P0259 Iron deficiency anemia patterns and outcomes in Romanian inflammatory bowel disease patients: results of a prospective cohort study
Authors: State R M , Marinica A , Mateescu R B 
Published: January 2025

Abstract

Background
Iron deficiency anemia (IDA) is the most frequent complication of inflammatory bowel disease (IBD), with several contributing mechanisms: iron loss from bleeding, decreased iron intake from enterocytes, impaired iron absorption. Our main objective is to study the prevalence and evolution patterns over time of IDA in Romanian patients with IBD.

Methods
We conducted a retrospective analysis of prospectively collected data of ulcerative colitis and Crohn’s disease patients included in the local IBD cohort. Clinical data about disease activity and laboratory data (including CBC, serum CRP levels and ferritin levels) was collected at baseline and follow-up visits. We defined anemia according to the ECCO guidelines as hemoglobin levels &lt; 13g/dL for male and 12g/dL for female patients, and iron deficiency using a serum ferritin level &lt; 100µg/ml [1].

Results
We included in the final analysis 168 patients, totaling 331 patient-visits. 27 female patients (50%) were anemic at their baseline visit and 67% of patients showed ferritin levels &lt; 100µg/ml at baseline. Overall criteria for anemia were fulfilled at 26.6% of patient-visits, while 71.8% of patient-visits showed ferritin levels &lt; 100ug/ml. Over time, the percentage of patients with anemia significantly improved (27.3% and 16.6% at first and second follow up visits respectively, p=0.048 Chi Square) but iron deficiency as reflected by ferritin levels &lt; 100 did not significantly improve over time (75.6% and 81.8% at first and second follow-up visits respectively, p=0.119) despite a significant decrease in the proportion of patients with clinical activity at follow up visits (52% at first visit vs 32% at second visit, p=0.001).

Conclusion
The prevalence of anemia among IBD patients shows a decreasing trend over time as disease control improves; iron deficiency however remains an unmet problem among a majority of IBD patients despite clinical improvement over time.

References
[1]Dignass AU, Gasche C, Bettenworth D, et al. European consensus on the diagnosis and management of iron deficiency and anaemia in inflammatory bowel diseases. J Crohns Colitis. 2015;9(3):211-222. doi:10.1093/ecco-jcc/jju009
P0261 The hidden impact of surgery for inflammatory bowel disease: a qualitative exploration of sexual function and intimacy
Authors: Joshi S , Pelly T , Alrubaiy L , Dames N , Dibley L , Fourie S , Rajeswaran K , White I , Hart A , Tozer P ,   Sex-PROM
Published: January 2025

Abstract

Background
Surgery for inflammatory bowel disease (IBD) often carries a hidden cost in terms of sexual function. Traditionally, when measuring outcomes, the focus has been on those easily measured, quantified, analysed and applied to health economics, such as mortality, morbidity and disease recurrence. Whilst research in this subject area is expanding, there are limited qualitative data specifically investigating patient experiences of sexual dysfunction post-surgery for IBD. This study aims to produce an in-depth exploration of patient perspectives of sexual dysfunction after surgery, and to assess the broader impact on relationships, intimacy and quality of life.

Methods
An exploratory qualitative study was performed following the ‘Standards for reporting qualitative research’ (SRQR) recommendations. Purposive sampling was employed to recruit a diverse group with differing ages, genders, ethnicities, sexual orientations, religions and relationship status. Participants were recruited from clinical settings, social media and national IBD charities. An interview guide was developed iteratively, with input from an expert patient, qualitative researchers, sexual function experts, gastroenterologists and colorectal surgeons. Semi-structured interviews were conducted via Microsoft Teams/Zoom and audio-recorded, transcribed and analysed. Thematic analysis was conducted using the Framework analysis method (open coding with an inductive approach).

Results
Qualitative interviews were conducted (n=10, 5 females, 5 males, median age 47, age range 24-69), including patients with Crohn’s disease (n=6) and ulcerative colitis (n=4). Participants were of varying sexualities: heterosexual (n=8), pansexual (n=1) and asexual (n=1). Surgeries included fistula surgery, stoma formation, proctectomy and ileo-anal pouch formation. Thematic analysis revealed physical dysfunction including loss of sensation, impaired pelvic muscle control, erectile and ejaculatory dysfunction, diminished orgasmic sensation and adjustments to sexual positions. Psychological impacts were prominent, including loss of desire, altered body image and a sense of shame/stigma. The impact on spontaneity, intimacy and the overall sexual experience was substantial. Crucially, this often led to relationship strain and breakdown, resulting in further isolation and frustration.

Conclusion
Patients who retain ‘normal’ sexual function after surgery can still experience psychological challenges that significantly impact their sexual desire, spontaneity, relationships, intimacy, and sexual experience. These interviews have revealed the often unspoken effects of surgery for inflammatory bowel disease, emphasising the need for healthcare professionals to address these issues in clinical practice.
P0269 Examination of the safety and effectiveness of budesonide rectal foam for patients with Ulcerative Colitis: Final report of post-marketing surveillance in Japan
Authors: Omori T , Saruta M , Nagaki A , Kuramoto K , Suzuki Y 
Published: January 2025

Abstract

Background
Budesonide rectal foam (BF) was approved in Japan in September 2017 for the treatment of mild to moderate active ulcerative colitis (UC).
Post-marketing surveillance was conducted from February 2018 to evaluate the safety and effectiveness in clinical practice.

Methods
We conducted this as a prospective, multicenter, open-label, observational study of subjects with mild to moderate active UC who received BF between February 2018 and April 2019.
Patient background, BF dosing status, adverse drug reaction (ADR), effectiveness using Partial Mayo score (PMS), and current health condition using the Visual Analogue Scale (VAS) were evaluated.

Results
Of the 633 patients included in the safety analysis, 53.7% were men, the mean age was 45.6 years, and the mean duration of BF treatment was 55.0 days.
Prior to BF administration, 92.9% used other UC medications, and the use of topical preparations was 22.1%.
The concomitant use of other UC medications was 96.7%, of which 91.5% was concomitant use of oral 5-ASA preparations.
ADRs occurred in 27 patients (4.27%). Serious ADRs were cytomegalovirus enteritis and enteritis infectious in one case each, but both cases recovered.
Glucocorticoid-related ADRs were observed in 7 patients (1.11%), but all ADRs were non-serious and the outcome was reversible or remitted.
In the 503 patients included in the effectiveness analysis, PMS and subscores significantly decreased from baseline to week 2 (Wilcoxon test, p&lt;0.0001 for all).
Clinical response and remission at week 6 were 72.8% and 72.1%, respectively.
The changes in VAS scores were significantly improved from baseline to week 2 (all p&lt;0.0001 by t-test).

Conclusion
No new safety concerns were identified for the BF in Japanese patients with mild to moderate acute UC, and its effectiveness and improvements in health condition were confirmed in actual clinical practice.
P0270 Standardisation of Rapid TDM Assay with WHO International Reference Material for Anti-Infliximab Antibodies
Authors: Dähn O , Johnson J , Ricken B , Anchling L , Gerhold C B 
Published: January 2025

Abstract

Background
Point-of-care (POC) tests play a crucial role in therapeutic drug monitoring (TDM) for Inflammatory bowel disease (IBD) patients undergoing anti-TNF therapy. Infliximab (IFX), the first biologic used in IBD treatment, is a chimeric anti-TNF-alpha blocker. However, its composition can trigger an immune response in patients, leading to the production of anti-drug antibodies (ADAs). Consequently, regular monitoring for ADAs is essential during IFX therapy. Various assays are available to measure anti-IFX antibody levels, mainly based on ELISA technology. The recent introduction of an international reference material (IRM) for infliximab ADAs allows enhanced measurement traceability and enables harmonised standardisation and improved comparability across different assays. Furthermore, it is mandatory to standardise with an existing IRM for compliance with the in vitro diagnostic regulation (IVDR). This study focused on standardising the lateral flow based Quantum Blue® Anti-Infliximab assay (LF-ADIF) using the IRM and comparing its performance with the current standardisation material. Additionally, a method comparison to established ELISA assays was carried out.

Methods
The lateral flow assay was calibrated with both the currently used standardisation material and the new IRM. Blant-Altman analysis was performed to evaluate the comparability of both standardisation materials. To establish the cut-off, 105 healthy donor samples were measured. This cut-off will be used for discrimination of positive and negative results of the rapid test. Furthermore, a set of 30 patient samples was analysed for method comparison with established ELISA assays.

Results
The Blant-Altman analysis revealed that a IRM based calibration is feasible and IRM concentrations &lt;100 IU/mL can be detected. A technical cut-off was established allowing the discrimination of positive and negative patient samples. Total agreement between the lateral flow assay and the ELISA assays was demonstrated in the method comparison.

Conclusion
To the best of our knowledge the here presented assay is the first IRM based and IVDR ready lateral flow assay for anti-infliximab. The total agreement of patient sample results between the Quantum Blue® Anti-Infliximab assay and commercially available ELISA assays revealed good comparability. IRM standardisation across all anti-IFX assays would further improve comparability between them.
P0272 Evaluation of Rectal Wall Thickness Measurement Sensitivity via Transabdominal Ultrasound to Assess Mucosal Activity in Ulcerative Colitis: Could This Be a Useful Non-Invasive Tool? A Preliminary Analysis.
Authors: Calabrese F , Pasta A , Marabotto E , Furnari M , Santamorena G , Giannini E , Bodini G 
Published: January 2025

Abstract

Background
Ulcerative colitis (UC) is a chronic inflammatory bowel disease where accurate assessment of disease activity is essential for patient management. Endoscopy is the gold standard for evaluating mucosal inflammation, but non-invasive alternatives, such as transabdominal ultrasound (TAUS), are garnering interest. This study aimed to evaluate the sensitivity of rectal wall thickness measurement using TAUS to assess UC activity, comparing to endoscopic and histological findings.

Methods
In a prospective, observational study, we enrolled consecutive adult patients with UC who were referred to our tertiary center from May to October 2024. Eligibility required a scheduled TAUS before 30 days of a staging colonoscopy, without intervening therapy adjustments. Exclusion criteria included technically inadequate TAUS readings (e.g., due to anatomical variations or excessive gas interposition). In all patients we evaluated rectal wall thickness and laboratory parameters such as C-Reactive Protein and fecal calprotectin. Disease activity was assessed by endoscopist (MAYO score). Histological status (active/inactive) and additional clinical data, including disease duration, extent, and UC treatment, were recorded.

Results
We studied 29 patients (51.7% females, median age 55 years). The median UC duration was 10 years, and most patients had proctitis or left-sided colitis (37.9% each). Patients with an endoscopic MAYO score of 0 or 1 had a median rectal wall thickness of 4.7 mm (IQR 4.5-5.5), while those with a score of 2 or 3 had a median of 7.0 (IQR 5.3-7.4 mm, p=0.005). ROC analysis of TAUS rectal wall thickness revealed significant discriminatory capability for endoscopic activity (AUC: 0.833, CI 95%, 0.678-0.989), while the same figures for fecal calprotectin and C-Reactive Protein were 0.890 (CI 95%, 0.671-1.000) and 0.774 (CI 95%, 0.604-0.944), respectively. For histological activity, accuracy of rectal wall thickness, fecal calprotectin, and C-Reactive Protein were 0.796 (CI 95%, 0.620-0.972), 0.790 (CI 95%, 0.605-0.975), and 0.645 (CI 95%, 0.429-0.861), respectively.

Conclusion
This preliminary analysis showed that rectal wall thickness measured by TAUS has a high accuracy in identifying both endoscopic and histologic activities in patients with UC, positioning it as a promising tool to avoid endoscopy. Future studies with larger cohorts are needed to confirm these findings and further optimize the use of TAUS in this setting.
P0277 Skin tag excision in Crohn’s disease: first, do no harm?
Authors: Unal E , Lavryk O , Kanters A , Spivak A , Lipman J , Fulmer C , Falloon K , Qazi T , Cohen B , Holubar S 
Published: January 2025

Abstract

Background
Traditionally, perianal skin tag excision has been contraindicated in patients with Crohn’s disease (CD) owing to risk of non-healing wounds. However, little data exists on this topic. We aimed to review our institutional experience with outcomes after perianal skin tag excision in patients with CD. We hypothesized that perianal skin tag excision in CD would be associated with non-healing wounds.

Methods
We retrospectively reviewed adults with CD who underwent skin tag excision with or without limited excisional hemorrhoidectomy at our center between 2012 and 2024. Demographics, CD characteristics, medications, operative data, pathology, and postoperative outcomes were reviewed.

Results
Forty-five patients with CD underwent excision of skin tags (28, 62%) and/or limited excisional hemorrhoidectomy (20, 44%). Demographics, CD characteristics, and medications are detailed in Table 1. Short -term complications occurred in 2 (4.4%); 1 fistula and 1 wound dehiscence. Pathology results were available for 42 (93%) patients; the majority were benign (33, 78.5%) but a small subset (2, 5%) had anal intraepithelial neoplasms (Table 2). Long-term complications occurred in 11 (24.4%) patients (Table 2), of which 9 (81.8%) were managed [conservatively or with non-operative therapy. Complications included perianal fistula (4, 8.8%), anal stenosis (4, 8.8%), nonhealing wounds (2, 4.4%) and anal fissure (1, 2.2%). Of these patients, seven (63.6%) later had complete wound healing. Almost half of these patients had penetrating disease with perianal involvement (5, 45.5%).
At most recent follow-up, 41 (91.1%) patients had complete wound healing, and only one (2%) patient required proctectomy. Four patients (9%) had persistent non-healing wounds; 2 with history of perianal fistulae requiring surgery (one requiring diversion), 1 with fistula 4 years after skin tag excision, and 1 later diagnosed with perianal hidradenitis suppurativa. Three (75%) of these patients had prior surgery for perianal disease (one each: fissure, abscess, and stricture), and all were on biologic therapy (infliximab, 3; adalimumab, 1).

Conclusion
Perianal skin tag excision in carefully selected CD patients resulted in wound healing in the majority (91%) of patients and can be considered for lifestyle limiting symptoms. Pathology was typically benign but occasionally revealed actionable results, including neoplasia, and should encourage routine pathologic evaluation of specimens. The risk of long-term complications was low, but higher in the CD population compared to average, and the sequelae were mostly managed with non-operative therapy. Our data suggests that previous surgery for perianal Crohn’s may be a risk factor for non-healing wounds after perianal skin tag excision.