bluuebunny/crossref_metadata_2025_split huggingface dataset:
P491 Clinical application of ICCE criteria for suspected Crohn’s disease undergoing small bowel capsule endoscopy
Authors: Roig Ramos C , Giordano A , Asensio Porti J , Gordillo Ávalos J , Bertoletti F , González Muñoza C , Garcia Planella E , Guarner Argente C , Romero Mascarell C 
Published: January 2024

Abstract

Background
Small-bowel capsule endoscopy (SBCE) is the primary diagnostic modality for exploring the small bowel (SB) in patients with suspected Crohn’s disease (CD) and inconclusive ileocolonoscopy findings, provided there are no obstructive symptoms or known bowel strictures. In 2005, the International Conference on Capsule Endoscopy (ICCE) established preselection criteria for these patients (Figure 1). SBCE is indicated if one criterion from group A is met, along with any other from the remaining groups (B/C/D). The aim of this study is to evaluate the diagnostic accuracy of ICCE criteria in unselected cases of suspected small bowel CD (SBCD) explored with SBCE.

Methods
An observational, single-center, retrospective study was conducted, including all SBCE performed in patients with suspected CD between January 2020 and August 2023. Demographic and clinical data, inflammatory markers, SBCE findings, confirmed CD diagnosis and indication to therapy were analyzed.

Results
A total of 46 patients were included (67.4% females, median age 43 years, IQR 32-60). SBCE identified lesions suggestive of CD based on Mow's criteria in 23.9% of patients (n=11). These findings led to a CD diagnosis in all cases, with subsequent initiation of immunomodulators or biologic therapy. In the study population, 35 (71.4%) patients had 2 ICCE criteria (A+B/C/D). The percentage of patients with ≥2 criteria did not differ significantly between those with and without CD (90.9% vs. 71.4%, p=0.18). However, overall ungrouped ICCE criteria showed a significant correlation with confirmed CD (OR 1.56, 95%CI 1.03-2.36). The creation of a model using 4 ungrouped ICCE criteria significantly improved CD prediction accuracy (area under the ROC curve 0.77, sensitivity 91%, specificity 51.4%). Patients with 4 ungrouped ICCE criteria had a higher likelihood of having confirmed CD (90 vs 48%, p=0.02).

Conclusion
In our patient cohort, the existing ICCE criteria seem insufficient for effectively identifying patients with a higher probability of SBCD. Our findings suggest that adopting a cut-off of 4 ungrouped ICCE criteria would increase the diagnostic accuracy of SBCE for SBCD.
P492 All intestinal ultrasound scores for ulcerative colitis (and IBUS-SAS) strongly correlate with endoscopic activity: a prospective study
Authors: Innocenti T , Rocco C , Lynch E N , Bagnoli S , Macrì G , Rogai F , Orlandini B , Bonanomi A G , Milla M , Milani S , Galli A , Biagini M R , Dragoni G 
Published: January 2024

Abstract

Background
Intestinal ultrasound (IUS) is gaining increasing acceptance as a reliable tool for tight monitoring of ulcerative colitis (UC). Although several IUS scores have been proposed, none has been formally implemented into official recommendations of international scientific societies. This study aims to compare the available IUS score for UC, in terms of correlation with endoscopic activity.

Methods
Patients with UC ≥ 18 years old undergoing partial or full colonoscopy between April and October 2023 were prospectively included. Endoscopic evaluation of at least the sigmoid colon was mandatory for inclusion, and patients with proctitis (Montreal E1) were excluded. Endoscopic activity was scored with both the Mayo Endoscopic Subscore (MES) and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and defined by MES ≥ 1 and UCEIS ≥ 2. IUS was performed within 4 weeks of endoscopy. The Milan Ultrasound Criteria (MUC, Allocca et al.), the UC-IUS score (Bots et al.), the US Score from Parente et al., and the score from Hata et al. were included in the analysis. Applicability of the US Score from Civitelli et al, an IUS score developed for paediatric patients, and the IBUS-SAS, an IUS score validated for Crohn’s disease, was also evaluated. The Spearman’s rank coefficient (rho = ρ) was used to perform correlations, while receiver operating characteristic (ROC) curves were compared with the Hanley & McNeil method.

Results
Fifty-nine patients were included, of which 59.3% and 50.8% showed any endoscopic activity using the MES and the UCEIS, respectively. Detailed information about the population is reported in Table.
All the evaluated IUS scores showed a significant positive correlation with endoscopic activity (p &lt; 0.001), with the UC-IUS score and the US Score from Civitelli et al. outperforming the others both with MES (ρ = 0.745, ρ = 0.762) and UCEIS (ρ = 0.751, ρ = 0.769). The same scores showed the highest Areas Under the Curve (AUC) for detecting a MES ≥ 2 (UC-IUS: 0.841, 95%CI 0.722-0.923, p &lt; 0.001; Civitelli et al.: 0.842, 95%CI 0.724-0.924, p &lt; 0.001) [Figure].
The optimal cut-offs for detecting a MES ≥ 2 with both the MUC and the Civitelli score were similar to that proposed by the Authors (&gt; 5.04 vs &gt; 6.20 and &gt; 2 vs &gt; 1, respectively).

Conclusion
All the included IUS scores showed good correlation with endoscopic activity. The UC-IUS and the US Score from Civitelli et al. performed better than the others in detecting a MES ≥ 2 and might be suggested to monitor disease activity of UC and intervene early during disease relapse.
P500 Systematic review of sexual function measurement instruments in the context of pelvic and perineal surgery for Inflammatory Bowel Disease
Authors: Joshi S , Anand E , Renshaw S , Alrubaiy L , Dibley L , Dames N , White I , Fourie S , Rajeswaran K , Hart A , Tozer P 
Published: January 2024

Abstract

Background
Sexual dysfunction after Inflammatory Bowel Disease (IBD), pelvic and perineal surgery is common but poorly discussed, investigated and treated in the peri-operative period. There remains no standardised measurement tool to assess sexual function in routine use for patients undergoing benign pelvic colorectal surgery.
The necessity for open dialogue regarding sexual dysfunction was evidenced in a patient-led study conducted by Dames et al. Our primary objective was to undertake a systematic review of sexual function measurement instruments, to identify the need for a novel sexual function patient-reported outcome measure (sex-PROM) that may be used in the context of pelvic and perineal surgery for IBD e.g. fistula surgery, defunctioning ostomy formation, ileo-anal pouch formation and proctectomy.

Methods
We performed a systematic review according to Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria (Prospero registration: CRD42023403396). Embase, Medline and PubMed Databases were searched for previously validated patient-reported outcome measures that could be used in the assessment of sexual function. These instruments were evaluated for their psychometric properties, in addition to their overall quality, utility and suitability in the context of IBD and other benign surgery. A global rating was attained according to COSMIN criteria. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) checklist was applied to evaluate the quality of evidence. In addition, patient involvement in instrument development was assessed.

Results
Some 2331 articles were screened, 305 full-text studies were assessed for eligibility and 56 measurement instruments were identified and evaluated. All studies showed limited psychometric validation. The Female Sexual Function Index and the International Index of Erectile Function were among the highest-scoring instruments, however conveyed significant limitations, including an anatomical focus, limited exploration of quality of life and relationship satisfaction, and a lack of significant patient involvement in their development. All identified measurement instruments carried limited specific clinical utility for patients after IBD surgery.

Conclusion
Sexual dysfunction after pelvic surgery for inflammatory bowel pathology is multi-factorial. It can result from anatomical nerve damage but can also occur secondary to the psychological impact of altered body image, sexual self-esteem, and relationships and intimacy. We recommend the development of a novel patient-centred sexual function measurement instrument that may be used after benign pelvic/perineal colorectal surgery to be used in the clinical and research settings.
P506 Prevalance of the osteoporosis/osteopenia and related factors in patients with inflammatory bowel disease : An observational single-center study
Authors: Celebi G , Ekici R , Buyukturan G , Gul Aydın E , Uygun A 
Published: January 2024

Abstract

Background
Inflammatory bowel disease is characterized by chronic progressive inflammation of the gastrointestinal tract which is mainly includes Crohn’s disease and ulcerative colitis. Patients with inflammatory bowel disease are at risk for osteopenia and osteoporosis. However,this topic is not well investigated and results of the studies are contradictory. The objective of this study was to investigate of the osteopenia/osteoporosis prevalance and related risk factors in patients with inflammatory bowel disease.

Methods
Patients with inflammatory bowel disease were consecutively recruited between September 2022 to September 2023 in our single-center, cross-sectional observational study. Bone mineral density was measured by dual energy X-ray absorption scans at the femur total, femur neck, femur ward’s and spine total. Relevant patients’ and disease-spesific parameters such as clinical (MAYO score or Harwey-Bradshaw index), biochemical, endoscopic and treatment history were recorded.

Results
A total of 177 inflammatory bowel disease patients, encompassing 60 with Crohn’s disease (33.9 %) and 117 (66.1%) ulcerative colitis, were enrolled. The median age was 42.3 years (range,18-75), the mean body mass index (BMI) was 23.87 kg/m2 (range,12.4 - 42.24) and the mean disease duration was 6.9 years (range,1.8 - 32.4). Prevalance of the femoral osteoporosis and osteopenia were 7.9% (n=14) and 16.4 % (n=29) in our study population respectively. Lumbar osteoporosis and osteopenia were more prevalent in our study cohort, 16.9% and 28.2% respectively. According to our study results,female patients were significantly more effected from osteoporosis than male patients and BMI was negatively correlated with femoral osteoporosis in inflammatory bowel disease (p=0.019 and r= -0.210, respectively). The disease activity (total MAYO score) was significantly associated with femur total T score in patients with ulcerative colitis (p=0.007). Similar association was documented with high sensitivity C-reactive protein (hsCRP) and femur total T score, spine total T score (P=0.014 and p= 0.027, respectivey).

Conclusion
Based on our study results, inflammation is the most important risk factor for osteoporosis in patients with inflammatory bowel disease. Effective anti-inflammatory treatments may reduce prevalance of the osteoporosis in patients with inflammatory bowel disease.
P535 Effectiveness of upadacitinib in patients with Ulcerative Colitis: a real-life, multicenter, Italian report
Authors: Teani I , Bevilacqua N , Gabbiadini R , Bezzio C , Ferronato A , Saibeni S , Armuzzi A , Comberlato M , Desideri F 
Published: January 2024

Abstract

Background
Upadacitinib (UPA) is an oral, selective JAK inhibitor, that has recently received approval in Italy for the treatment of Ulcerative colitis (UC). To our knowledge, only few data of real-life studies are available. The aim of our observational data collection is to report the first real-life experiences with UPA in UC in terms of effectiveness and safety.

Methods
These data come from four Italian IBD centers. Adult patients with a diagnosis of UC, who have been prescribed UPA for active disease, after failure of at least one anti-TNF therapy, were enrolled. After an induction period of 8 weeks with a 45 mg daily dosage, treatment efficacy were assessed using the partial Mayo score (pMS) and the fecal calprotectin levels (CP). Treatment-related adverse events were also recorded.

Results
Among 20 patients who started UPA, 12 have completed the induction and were therefore enrolled and evaluated before starting UPA and at the end of the 8 weeks induction period. 83% (10 patients) had previously failed two or more biological therapies, including tofacitinib (3 patients, 25%). 3 patients (25%) were tapering systemic corticosteroids and 3 patients (25%) were receiving topical steroids when they started UPA. In the pre-treatment evaluation, the mean pMs was 5,25 (SD 2,26) and the median CP was 1270 ug/g (411- 3152). At the end of induction (week 8), 10 patients (83%) achieved clinical remission and one patient showed clinical response with a decrease of 6 points of pMS. One patient underwent colectomy after 4 weeks of ineffective therapy. The mean pMS at week 8 was 0 (SD 0,92) (Fig. 1), with a median CP of 88 ug/g (5-4639). Reported adverse events, that however did not cause drug discontinuation, were one case of leukopenia and one case of acne. To the date of the last evaluation, all patients maintained the achieved results, with a mean follow-up period of 92 days. A further analysis excluding the physician global assessment from pMS has been performed, to obtain a sort of patient-reported outcome 2 (PRO-2): the results, in terms of percentage reduction of the scores, were in line with the presented data. Despite the limited number of patients who completed the induction (11), we observed statistical significance in the difference between pretreatment and post-induction values of all the measured variables (Tab. 1, Fig. 1).

Conclusion
With this first Italian report in a real-life setting, UPA showed promising effects in rapidly inducing clinical remission and in normalizing a sensitive marker of intestinal inflammation. Moreover, it seems to be well tolerated. Long-term real-life studies, including endoscopic and histologic evaluations, are needed to confirm efficacy and safety of UPA in maintaining stable remission in UC patients.
P539 Assessment of VEdolizumab aNd Ustekinumab in Elderly patients with Crohn’s disease (CD): the IG-IBD AVENUE study
Authors: Viola A , Ventimiglia M , Sparacino A , Orlando A , D'Antono E , De Vivo S , Scaldaferri F , Pugliese D , Varca S , Ribaldone D G , Armandi A , Balestrieri P , Castiglione F , Savarino E V , Cappello M , Viganò C , Mocci G , Allocca M , Principi M B , Soriano A , Onali S , Bodini G , Riguccio G , Festa S , Bertani L , Checchin D , Caprioli F A , Fries W ,   AVENUE Study Group: Michele Francesco Chiappetta Giulio Calabrese Piera Melatti Giorgia Orrù Francesca Maria Onidi Giorgia Orrù Maria Napolitano Francesca Onnis
Published: January 2024

Abstract

Background
Comparative data regarding ustekinumab (UST) and vedolizumab (VDZ) effectiveness and safety in elderly inflammatory bowel disease (IBD) patients are limited. The aim of the present nationwide multicenter cohort study was to compare persistence and safety of these drugs in elderly versus non-elderly Italian IBD patients.

Methods
Data from 20 Italian centers were retrospectively collected. Based upon age and treatment, IBD patients aged ≥65 years were allocated to group 1 (G1) and group 3 (G3) (cases) if treated with UST or VDZ, respectively, and to group 2 (G2) and 4 (G4) (controls) if they were aged &lt; 65 years and treated with UST or VDZ, respectively. The primary outcome was drug persistence at week 52. Propensity score analysis was performed for primary outcome using the inverse probability of treatment weighting method. Secondary outcomes included: steroid free remission (SFR) at week 52 and frequency of adverse events (AEs) at the end of follow-up.

Results
A total of 439 patients (176 elderly and 260 non-elderly) were included in the study. Among elderly patients, 93 and 83 were included in the group G1 and G3, respectively. Among non-elderly patients, 147 and 116 were included in the group G2 and G4, respectively. Baseline characteristics are represented in Table 1. No differences were found in terms of persistence between G1 vs G3, G1 vs G2 and G3 vs G4 (Figure 1). Higher baseline Harvey-Bradshaw Index (HBI) (OR=2.09, 1.15 – 3.78; 0.015) and baseline steroid therapy (OR=1.10, 1.04 – 1.15; p&lt;0.001) were identified as predictors of a lower drug persistence at Cox model. Steroid free remission at week 52 was achieved by 80% and 77% of elderly patients in G1 and in G3 (p=0.63), respectively. Similarly, no differences for SFR were found between G1 and G2 (p=0.73) and between G3 and G4 (p=0.68). Incidence rate for AEs were G1 and G2 were 7.85 and 7.90 respectively; for G3 and G4 IR were 5.81 and 12.50 respectively. No differences were found in the UST groups (IRR=0.99; p=0.98) while in VDZ-treated patients, non-elderly had a higher rate of AEs (IRR=0.46; p=0.006).

Conclusion
These data confirm that ustekinumab and vedolizumab are highly effective drugs in patients with IBD, associated with a good safety profile in both elderly and in non-elderly IBD patients.
P544 Ustekinumab safety and effectiveness in ulcerative colitis patients: results from a large real-life study
Authors: Mocci G , Scaldaferri F , Pugliese D , Savarino E , Bodini G , Cuomo A , Donnarumma L , Maconi G , Cataletti G , Rodino S , Sebkova L , Ferronato A , Gaiani F , Marzo M , Luppino I , Paese P , Elisei W , Monterubbianesi R , Faggiani R , Napolitano D , Grossi L , Serio M , Scarcelli A , Lorenzetti R , Allegretta L , Rocco G , Zampaletta C , Bolognini L , Meucci C , Colucci R , Tonti P , Della Valle N , Piga R , Forti G , Onidi F M , Usai Satta P , Picchio M , Papa A , Tursi A 
Published: January 2024

Abstract

Background
Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC), but with limited real-world data. We assessed therefore the effectiveness and safety of UST in UC patients in a real-world setting

Methods
This is a multicentre, retrospective, observational cohort study. The primary endpoint was the clinical remission rate (partial Mayo score, PMS, ≤1). Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and faecal calprotectin (FC) reduction at week 24.

Results
We included 256 consecutive UC patients (M/F 139/117, median age 52). The clinical remission and clinical response rates at 8 weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p=0.0004) and 24 (p=0.038). At 8 weeks, patients naïve or with one previous biologic treatment, showed higher remission (p=0.002) and clinical response rates (p=0.018) than patients previously treated with ≥2 biologics (finding not confirmed at week 24). Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy.

Conclusion
This large real-world study shows that UST effectively and safely treats UC patients.
P546 Endoscopic findings related to the long-term response to anti-TNF-α antibody treatment in patients with Crohn's disease
Authors: Toyokawa T , Horii J , Fujita I 
Published: January 2024

Abstract

Background
Anti-TNF-α antibody treatment in Crohn's disease patients has been established, but loss of treatment response has become a problem in recent years. No studies have investigated the endoscopic findings related to loss of response particularly in the long-term treatment. In this study, we investigated the endoscopic findings associated with diminished efficacy of anti-TNF-α antibodies in Crohn's disease patients treated over a long period of time.

Methods
A total of 79 patients with Crohn's disease who were observed for at least 1 year after the anti-TNF-α antibody treatment was initiated at our hospital were included in this study. These patients were stratified into cases with and without loss of response to the anti-TNF-α antibody treatment, and the endoscopic findings were compared between the two groups. A case with loss of response was defined as one in which the dose was increased or the duration of treatment was shortened during the anti-TNF-α antibody treatment or the anti-TNF-α antibody preparation was changed to another due to lack of response to the initial preparation. The findings examined were aphtha, erosion, cobblestone-like mucosa, fistula, multiple ulcer, longitudinal ulcer, and anal lesion. Mann-Whitney's U test, χ2 test, and logistic regression analysis were used for statistical analysis, and differences with p &lt; 0.05 were considered significant.

Results
The mean observation period for all patients was 85.5 months, and the longest period was 188 months. Of the 79 patients included, 29 met the criteria with loss of response, and 50 did not (loss of response rate 37%). Comparisons between the loss of response group and the no loss of response group by univariate analysis showed that anal lesions (66% vs 42%, p = 0.028), stenosis (75% vs 48%, p = 0.021), and multiple ulcers (82% vs 53%, p = 0.011) were significantly more frequent in the loss of response group. The multivariate analysis on these items identified anal lesions (OR: 3.06, 95% CI 1.04-9.04, p = 0.042) and multiple ulcers (OR: 5.33, 95% CI 1.59-17.9, p = 0.0068) as independent risk factors for loss of response.

Conclusion
In this study, Crohn's disease patients with endoscopic findings of anal lesions and multiple ulcers were prone to loss of response to the anti-TNF-alpha antibody treatment after long-term administration. This result is considered to be very useful for developing a treatment strategy for patients requiring long-term anti-TNF-α antibody treatment.
P574 Clinical outcomes in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with Crohn’s disease (CD-EXTEND Study)
Authors: Kato S , Tagawa K , Yamaga N , Yakabi K , Nagoshi S 
Published: January 2024

Abstract

Background
De-escalation was a useful strategy for improving patient’s QOL and reduction of medical expenses. However, de-escalation of ustekinumab (UST) for the patients with Crohn’s disease (CD) has not been reported. The aim of this study was to elucidate clinical outcomes of de-escalation of UST.

Methods
This was a single-centre prospective observational study approved by the institutional review board of our hospital. CD patients who selected de-escalate UST treatment after administration of intravenous UST 6 mg/kg and subcutaneous UST 90mg every 8 weeks until 54 weeks were enrolled in this cohort. Primary endpoint was clinical remission rate at one year, including patients treated with re-escalation. Secondary endpoints were persistency of de-escalation of every 12 weeks and re-escalation effects of every 8 weeks. We also compared backgrounds and biomarkers including CRP, fecal calprotectin (FC) for persistent and non-persistent groups. Cut-off values of prediction for non-persistent was calculated by receiver operating characteristic (ROC) curve. Definition of clinical remission was CDAI&lt;150 for CD.

Results
In total, 30 participants were included in the final analysis. Clinical remission rate at one year was 96.7% (29/30). Persistency of de-escalation at one year was 76.7% (23/30). Persistency after re-escalation was 85.7% (6/7). There was no difference between the backgrounds of persistent (n=23) and non-persistent groups (n=7). CRP titer at week 12 was significantly higher in non-persistent group than persistent group (Median 0.59 vs 0.17 mg/dL, p=0.021). FC titer at week 0, 12 and amount of change at week 24 was significantly higher in non-persistent group than persistent group (Median 660 vs 120 μg/g, p=0.021;1341 vs 61 μg/g, p=0.001; 528 vs 4 μg/g, p=0.04). Cut-off values of prediction for non-persistent from CRP at week 12, FC at week 0, 12 were 0.33 mg/dL, 314 μg/g, 581.5 μg/g, respectively.

Conclusion
De-escalation was feasible strategy for CD patients treated with UST. CRP and FC were good prediction biomarker for non-persistence