bluuebunny/crossref_metadata_2025 huggingface dataset:
P326 Impact of disease flares on resource use, health-related quality of life and productivity in untreated Crohn’s Disease patients in US: an analysis of national health and wellness survey data
Authors: Dubon-Garcia A , Naessens D , Pollack P , Sikirica M , Sanon M
Published: January 2024

Background

Patients with Crohn’s Disease (CD) alternate periods of exacerbation, flares, and periods of remission. The periods of flares can be debilitating to patients causing significant discomfort impacting the patient’s health-related quality of life (HRQoL). Despite symptoms, many patients do not receive treatments for their condition thus our objective was to describe the burden related to healthcare resource utilization (HRU), HRQoL and work productivity among a real-world cohort of patients who are not receiving any prescribed medications for CD.

Methods

The 2019 National Health and Wellness US Survey (NHWS) data was analyzed. NHWS is a self-administered Institutional review board (IRB) approved, internet-based annual survey that assesses numerous health conditions, demographic characteristics, medical history, healthcare utilization, attitudes, and outcomes. Respondents currently not taking prescription treatment for CD were categorized by flare frequency as infrequent (0-2 flares/year), intermediate (3-6/year), and frequent (>1/month to <7/week). HRU included HCP visits, gastroenterologist visits, emergency room (ER) visits and hospitalizations. HRQoL was assessed using the 5-dimension EuroQoL questionnaire (EQ5D), and work activity impairment using the Work Productivity and Activity Impairment questionnaire.

Results

A total of 74,994 respondents participated in the survey, of whom 577 reported being diagnosed with CD and 231 (40.0%) of whom were not taking prescription treatment for CD. Fifty-six percent of the untreated sample reported having mild disease. Among the untreated patients, 37% reported infrequent, 21% intermediate and 42% frequent flares. The mean age of patients with frequent flares was lower than those with infrequent or intermediate flares (infrequent: 51 years; intermediate: 45 years; frequent: 41 years). The mean EQ5D summary score decreased as the frequency of flares increased (infrequent: 0.77, intermediate: 0.66 and frequent: 0.63). Patients with frequent flares had higher gastroenterologists, ER and hospitalization rates compared to patient with infrequent of intermediate flares (Table 1). Overall work impairment was reported by 40%, 52% and 63% of patients with infrequent, intermediate, and frequent flares respectively (Figure 1).

Conclusion

This real-world analysis shows up to two-thirds of untreated CD patients present intermediate or frequent flares. In addition, those with frequent flares experienced poorer HRQoL, lower work productivity, and had higher healthcare resource use. This study reveals a high level of disease burden in patients who are not receiving treatment, the majority of whom reported to have ‘mild’ disease.
P340 The association between colon pseudopolyps presence and clinical adverse events in UC patients treated with biologics
Authors: Tomasic V , Biscanin A , Cacic P , Babic F , Burcul I , Siranovic Pongrac I , Kralj D , Dorosulic Z , Ogresta Kordej D , Hrabar D
Published: January 2024

Background

Colon pseudopolyps (aka post-inflammatory polyps) are potential marks of previous severe ulcerative colitis (UC) activity. The association between outcomes of patients treated for UC with biologics and presence (or lack of presence) of pseudopolyps, are unclear.

Methods

A single center, noninterventional retrospective cohort review study was performed on real-life data of adult patients with moderate-to-severe UC who were treated with biologics (infliximab, vedolizumab, ustekinumab) for a minimum of 6 months. The difference in first occurence of treatment failure defined as a negative composite outcome (need for steroid rescue therapy, biologic switch, IBD-related hospitalization and/or surgery) between two groups (with or without pseudopolyps) was investigated. Participants’ characteristics were assessed using descriptive statistics. Normal distribution was assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Categorical variables were analyzed using Chi-square test and continuous variables using Mann-Whitney test. Kaplan-Meier analysis and log-rank test were used in order to assess difference in therapy duration between two groups.

Results

Total of 92 patients (51% females; smokers 17%; 24% with pseudopolyps) were included. There were no differences in key baseline characteristics such as age, sex, smoking status, extraintestinal manifestations, serum albumin and CRP as well as fecal calprotectin levels between groups of patients with or without pseudopolyps. Median duration of follow up was 18.5 months (IQR 8-37). Presence of pseudopolyps was not associated with a higher risk for treatment failure; there was no statisticaly significant difference in the occurrence (χ2(1, N =91)=1.38, p=0.31) of negative composite outcomes or time to develop negative composite factor (χ2(1, N =91)=1.57, p=0.21).

Conclusion

In our cohort we have failed to detect any association between presence of colon pseudopolyps and rates of first occurence of treatment failure in UC patients treated with biologics.
P362 Mesenteric fat proliferation and fat edema in magnetic resonance enterography as predictor of long-term disease complications in Crohn’s disease
Authors: Spector Cohen I , Lopez-Alonso R , Ben Hur D , Ron S , Ilivitzki A , Waterman M
Published: January 2024

Background

Fibrofatty proliferation of the mesenteric fat is a common finding in magnetic resonance enterography (MRE) in patients with Crohn’s disease (CD). Mesenteric fat is thought to play an active role in inflammation, fibrosis and stricture formation in CD. However, it is unclear whether these findings have a prognostic value in prediction of bowel damage and complications. We aimed to examine the association between mesenteric fat proliferation and inflammation on MRE and risk for hospital admissions and bowel surgery.

Methods

Patients with established CD diagnosis with at least 1 available MRE imaging data were followed for hospital admissions for CD exacerbation or abdominal surgery. MRE were reviewed by an expert radiologist for various characteristics (intestinal wall thickening and enhancement, stricture, or abscess formation, fibrofatty proliferation and fat edema reflecting fat inflammation).

The association between mesenteric fat and outcomes was assessed using the Kaplan Meier method and log rank test. Crude and adjusted Hazard ratios (HR) with 95% confidence interval (CI) adjusting for baseline MRE characteristics (wall thickness and stricture and pre-stenotic dilatation) were estimated from the Cox proportional hazards regression model (R version 4.2.1).

Results

159 CD patient charts and MRE imaging data were analyzed. Patients’ characteristics and medication exposure at described in table 1. On initial MRE the frequency of mesenteric fat proliferation was noted in 43 (27.0%) and fat edema in 79 (49.7%). Other MRE features noted were: mild, moderate and severe wall thickening in 72 (45.5%), 47 (29.9%) and 11 (7.0%) patients, respectively. Contrast intestinal wall enhancement was present in 122 (76.7%) patients. Intestinal stricture with pre-stenotic dilatation was noted in 17 (10.7%) patients and abscess and fistula formation was seen in 10 (6.3%) and 11 (6.9%) patients, respectively. During a mean (SD) follow up of 95.7 (39.5) months, 100 (62.9%) and 40 (25.2%) patients underwent hospitalization or surgery, respectively. On survival analysis, fat proliferation was associated with hospitalizations (Fig 1A, p=0.0005) and surgery (fig 1B, p<0.0001), while fat edema was associated with abdominal surgery (Fig 1D p=0.0003) but not with hospitalization (Fig 1C p=0.28). On multivariable analysis of the associations between fat proliferation and surgery and hospitalization remained highly significant (adjusted HR (95%CI) =3.15 (1.57-6.33) and adjusted HR (95%CI) =1.77 (1.06-2.97), respectively.

Conclusion

in this analysis of baseline MRE features, mesenteric fat proliferation was independently associated with increased risk for abdominal surgery and hospital admission for disease flares.
P376 A prospective multi-model study on diagnostic performance of 18F-FAPI PET/CT in comparison with 18F-FDG PET/CT or magnetization transfer MR imaging to detect intestinal fibrosis in Crohn’s disease
Authors: Li Z , Wang Y , Zhang R , Huang S , Feng S T , Li X
Published: January 2024

Background

Accurate and early detection of Crohn's disease (CD) induced intestinal fibrosis is crucial for effective clinical management, yet it remains an unmet requirement. The magnetization transfer MR Imaging (MTI) was reported to offer high accurancy for detection of intestinal fibrosis. Recently, the utilization of fibroblast activating protein inhibitor (FAPI) PET/CT has emerged as a promising tool for assessing fibrosis. The diagnostic efficacy of 18F-FAPI PET/CT in detecting intestinal fibrosis was compared with that of 18F-FDG PET/CT and MTI.

Methods

Twenty-two rats were treated with TNBS for 2-4 weeks to simulate fibrosis development, and multi-model quantitative imaging was performed during a week. The mean and maximum standardized uptake values (SUVmean and SUVmax) were calculated on 18F-FAPI and 18F-FDG PET/CT, as well as the normalized magnetization transfer ratio on MTI (normalized MTR). Pathological evaluation of intestinal fibrosis was performed, and MTI was used as the imaging standard for fibrotic analysis. Imaging and pathological criteria were used to compare the diagnostic effects of fibrosis imaging parameters. Ten patients with 34 cases of intestinal stenosis were prospectively recruited to validate their diagnostic performance using the same imaging protocol.

Results

In patients, the accuracy of MTI (AUCs=0.90-0.91, P≤0.05) was comparable to FAPI uptake (AUCs=0.80-0.87, both P≤0.01) but higher than that of FDG uptake in distinguishing between non-to-mild and moderate-to-severe fibrosis (AUCs=0.53-0.82, P=0.01-0.36). In rats, FAPI uptake showed a rapid response to intestinal fibrosis at an early disease phase (week 0-2) and demonstrated a significant increasing trend with prolonged treatment duration (week 0-4;). In contrast, normalized MTR and FDG uptake presented only a minimal response at week 2 and did not correlate so clearly with treatment duration. Consistently, in early disease phase (rats treated till week 2), the correlations of FAPI uptake (SUVmean: R=0.69) with fibrotic scores were stronger than those of FDG uptake (SUVmean: R=0.17) and normalized MTR (R=0.52). In late disease phase (rats treated till week 3 or 4), normalized MTR (R=0.93) showed stronger correlations with fibrotic scores than FAPI uptake (SUVmean: R=0.55) or FDG uptake (SUVmean: R=0.19).

Conclusion

In accurately identifying early-stage intestinal fibrosis, 18F-FAPI PET/CT demonstrates vast potential and outperforms the performance of the other two imaging modalities, warranting further research. However, 18F-FAPI PET/CT offer an equal performance for characterization of intestinal fibrosis with MTI and has significant advantages compared to 18F-FDG PET/CT in the whole disease course from Crohn's disease.
P378 The link between periodontitis and disease activity in inflammatory bowel disease
Authors: Madsen G R , Bertl K , Pandis N , Stavropoulos A , Burisch J
Published: January 2024

Background

Periodontitis and inflammatory bowel disease (IBD) share similarities in their aetiopathogenesis and patients with IBD are reported to have more often severe periodontitis. Conversely, recent studies have suggested that periodontitis also impacts IBD activity. In this study we used two distinct IBD-populations to assess whether the presence of periodontitis is associated with increased IBD activity, disability, and severity.

Methods

Identical questionnaire-based surveys were conducted in Sweden and Denmark, distributed by the respective patient-organisations. The survey included self-reported oral health as well as IBD-related characteristics. Oral health was assessed by the Periodontal Screening Score (PESS), which is a validated instrument to screen for severe periodontitis (indicated by a score ≥5), and by the number of remaining teeth, as tooth loss is the ultimate outcome of untreated periodontitis. Disease activity in patients with ulcerative colitis (UC) was assessed by the Simple Clinical Colitis Index (SCCAI), and in Crohn’s disease (CD) by the Harvey & Bradshaw’s Activity Index (HBI). Disease related disability was assessed by the Inflammatory bowel disease disability index (IBD-DI).

Results

In total, 1,879 IBD patients, encompassing 898 patients (47.8%) with UC and 981 patients with CD (52.2%), completed the questionnaire. In both UC and CD, severe periodontitis was significantly associated with a higher level of current disease activity [OR 1.51 (1.18;1.93); p=0.001] based on SCCAI/HBI, increased IBD disability score [Coef. 3.62 (1.46;5.79); p=0.001], and increased disease activity in the last 12 months (defined as number of episodes of disease activity in the last 12 months) [OR 1.50 (1.20;1.87); p=<0.001]. Tooth loss (<20 remaining teeth) was associated with both an increased disease activity in the last 12 months [OR 1.36 (1.05;1.76); p=0.018] as well as IBD disability score [Coef. 4.15 (1.66; 6.65); p=0.001]. Tooth loss also showed a tendency to be associated with current disease activity (SCCAI/HBI), although this was not significant [OR 1.31 (0.99;1.75); p=0.062]. IBD severity (a composite parameter of history of IBD-related surgery and/or treatment with biological therapy) was neither associated with severe periodontitis [OR 1.17 (0.90;1.54); p=0.241], nor tooth loss [OR 1.30 (0.95;1.78); p=0.100].

Conclusion

In this questionnaire-based study with responses from 1,879 IBD patients from two countries, we found the presence of periodontitis and tooth loss to be closely associated with both increased disease activity and disability in IBD patients. These findings emphasize the need for an increased focus on the oral health of patients with IBD.
P388 Eliakim score performance among patients with active Crohn’s disease
Authors: Ukashi O , Lahat A , Ungar B , Levy H , Eidler P , Ben-Horin S , Eliakim R , Kopylov U
Published: January 2024

Background

Pan-enteric capsule endoscopy [PEC] (PillCam Crohn’s, Medtronic, USA) is a useful tool for disease assessment and monitoring in Crohn’s disease (CD). We have previously demonstrated the reliability and accuracy of Eliakim score (ES) in the assessment of CD-activity among patients with quiescent disease. We aimed to examine the performance of ES among patients who experienced clinical flare, as well as its responsiveness and sensitivity to change during follow-up (≤52weeks).

Methods

Patients with CD who have been started on biologics were included. They were prospectively followed with clinical visits, biomarkers and PEC at baseline, and after 14 and 52 weeks. At each time-point Crohn’s disease activity index (CDAI), C-reactive protein (CRP) and fecal-calprotectin (FC) levels were collected, and Lewis score (LS) and ES were calculated (independently reviewed by two experienced readers). Inter-class classification (ICC) was used to asses for agreement between readers. Baseline correlations were obtained using the Spearman's correlation. Repeated-measures correlation (RMC) was calculated using the rmcorr package in R (version 3.3-1). William's test was used to assess difference between correlations.

Results

Seventy-four patients were included (median age of 31.0 [22.5-46.5] years, male–50%). 142 PEC procedures were performed (Baseline– 62, week 14– 58, week 52– 22). Inter-rater agreement between both readers was high for both the LS and ES (ICC of 0.872 [p<0.001] and 0.925 [<0.001], respectively). At baseline, the correlations between FC and ES (r=0.509 [p<0.001]) and FC and LS (r=0.467 [p<0.001]) were comparable (p=0.68). RMC between biomarkers and ES were higher than between biomarkers and LS (CRP: r=0.376 [p=0.005] vs. r=0.204 [p=0.138], FC: r=0.549 [p<0.001] vs. r=0.412 [p=0.003], for ES and LS, [p=0.034/0.021], respectively), while no difference was observed (p=0.77) with regard to CDAI score (r=0.381 [p=0.007] vs. r=0.346 [p=0.015]). Performing sub-group analysis restricted to procedures which were confined to the small bowel (n=88), RMC was numerically higher (p=0.12) between FC and ES (r=0.590 [p=0.001]) than between FC and LS (r=0.470 [p=0.010]).

Conclusion

ES is a reliable and accurate scoring system in assessing mucosal inflammation in patients with active CD, and might have a higher sensitivity to clinical/inflammatory biomarker changes over time compared to LS.
P402 Early diagnosis of Crohn’s disease with perianal lesions as first clinical symptom: Development and validation of a new MR imaging-based model disease
Authors: Xiang Y , Yang F , Yuan F , Zhang J , Qiao L , Zhu Z , Chen Q , Gong Y , Yang B
Published: January 2024

Background

Early diagnosis is crucial for the treatment and prognosis of Crohn's disease. Perianal fistulae or abscesses may present as the initial manifestation of Crohn's disease (CD) in patients. Despite magnetic resonance imaging (MRI) is the gold standard for the clinical assessment of perianal fistulae, there is shortage of MRI properties for clinical use in early perianal fistula diagnosis in CD.

Methods

Data from patients with a definitive diagnosis of PFCD and cryptoglandular disease (CGD) between September 2013 and December 2020 were examined retrospectively. The data was splited into training and test sets at a 7:3 ratio. The MRI characteristics were reviewed by two gastroenterology radiologists in consensus. The characteristics were then used to train a random forest classification model to predict a diagnosis of PFCD. The validity of the model was assessed using the area under the receiver operating characteristic curve (AUROC) and confusion matrix. Predictor importance was determined using the Shapley additive explanation (SHAP) framework.

Results

A total of 144 patients diagnosed with PFCD and 406 patients diagnosed with CGD were included. Utilizing the Boruta algorithm, 12 significant features which confirmed important for the diagnosis of PFCD, and a random forest classification model was developed. The model demonstrated an area under the receiver operating characteristic curve (AUROC) of 0.9294 (95% CI: 0.8706-0.9882), an accuracy of 0.9515 (95% CI: 0.9067-0.9788) and a kappa of 0.8779. SHAP values was utilized to estimate the variable importance, and the top five features were ulceration in rectal wall, thickened rectal wall, T2 hyperintensity, submucosal fistula and age. The model for predicting PFCD diagnosis based on MRI was dynamically visualised using a web display approach (https://doctoryang1971.shinyapps.io/forceplot/).

Conclusion

We have developed a multi-modal visual dynamic prediction model that can be effectively used to guide the early diagnosis of patients with Crohn's disease who present with perianal fistula at their first clinical visit. PFCD is likely to originate as transmural ulcers leading to submucosal inflammation or fistulae before penetrating the anal sphincter and developing into complex perianal fistulae.
P409 Optimal endoscopic healing thresholds defined by MM-SES-CD < 22.5 and SES-CD < 4 are associated with low risk of disease progression in Crohn’s disease
Authors: Narula N , Wong E C , Dulai P S , Patel J , Marshall J K , Yzet C , Jairath V , Ungaro R C , Colombel J F , Reinisch W ,   CALM LTE
Published: January 2024

Background

After initiation of therapy in Crohn's disease (CD), it remains unclear what the optimal endoscopic healing (EH) threshold to target is using the SES-CD and the MM-SES-CD (Modified Multiplier Simple Endoscopic Score for Crohn’s disease). We assessed MM-SES-CD and SES-CD thresholds that are best associated with low likelihood of long-term disease progression.

Methods

Week 48 endoscopy videos from patients with CD who participated in the CALM long-term extension LTE study were obtained and re-read by central readers to obtain a SES-CD and MM-SES-CD score, which was used for the derivation cohort. A real-world validation was performed with data from 99 patients that had clinical response using a mixed cohort of biologic therapies from the McMaster IBD database. The primary outcome was disease progression, defined as a new internal fistula/abscess, stricture, perianal fistula or abscess, CD-related hospitalization or surgery since the end of the CALM trial for the derivation cohort, and over the observed period of follow-up for the validation cohort. The maximum Youden index was calculated to determine the optimal MM-SES-CD and SES-CD thresholds. Receiver operating characteristic curve analyses compared threshold scores of various remission definitions on disease progression. Kaplan-Meier survival curve analyses were performed to compare the time to disease progression from the end of study endoscopy in the derivation cohort.

Results

In the derivation cohort, the optimal thresholds associated with a low likelihood of disease progression were MM-SES-CD <22.5 and SES-CD <4. A significantly greater proportion of patients with a MM-SES-CD ≥22.5 had disease progression as compared to patients with MM-SES-CD <22.5 [10/17 (58.8%) vs. 3/44 (6.8%), p<0.001]. Similarly, a significantly greater number of patients with a SES-CD ≥ 4 had disease progression compared to those with a SES-CD <4 [11/25 (44.0%) vs. 2/36 (5.6%), p<0.001]. Compared to other clinical or endoscopic remission definitions, obtaining a MM-SES-CD <22.5 at the end of the CALM study performed the best for predicting disease progression [AUC: 0.81 (95% CI: 0.68-0.94), p<0.001](sensitivity 76.9% (95% CI: 46.2-95.0), specificity 85.4% (95% CI: 72.2-93.9)). Compared to those with lower scores, patients with MM-SES-CD ≥ 22.5 (log-rank p<0.0001) and SES-CD ≥ 4 (log-rank p=0.0002) had a significantly greater probability of disease progression (Figure 1A/B). These findings were confirmed in the validation cohort (Figure 1C/D).

Conclusion

Achievement of MM-SES-CD <22.5 and SES-CD <4 was associated with low risk of CD progression and may be a suitable target for EH in clinical trials and practice. Our findings support that targeting EH may modify the natural course of CD.
P426 Hematological Composite Scores in Patients with Inflammatory Bowel Disease
Authors: Morant-Domínguez A , Vera-Santana B , Hernández-Camba A , Ramos L , Alonso-Abreu I , Hernández Álvarez-Buylla N , Vela M , Hernández-Guerra M , Laura A , Ferraz-Amaro I , Carrillo Palau M
Published: January 2024

Background

Ulcerative colitis (CU) and Crohn’s disease (CD) are described as inflammatory bowel diseases (IBD). Emerging as potential blood-based inflammatory biomarkers in various chronic diseases are the neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammatory index (SIRI, calculated as neutrophils × monocytes/lymphocytes). In this work we aim to analyze if these hematological composite scores differ between IBD patients and healthy controls, and whether they are related to disease activity.

Methods

A total of 197 IBD patients, 130 with CD and 67 with CU, and 208 age- and sex-matched healthy controls were recruited. NLR, MLR, PLR, and SIRI were calculated. Multivariable linear regression analysis was performed to study whether these scores differ between patients and controls and how they related to IBD activity scores.

Results

After multivariable analysis adjustment, NLR and PLR, but not SIRI and MLR, were significantly higher in IBD patients compared to controls (table 1). C-reactive protein and SIRI and NLR correlated in patients with IBD. Nevertheless, fecal calprotectin was not related to none of these blood scores. Besides, disease activity parameters were not associated with any of the composite blood-based scores in both patients with CD and CU.

Conclusion

NLR and PLR, independently, are heightened in IBD patients in contrast to controls. However, SIRI and MLR do not share this distinction. Surprisingly, none of the four hematological scores displayed correlations with disease activity in either CD or UC patients.

Table 1. Multivariable analysis of the differences between patients and controls in hematological count cells and scores
P437 Feasibility study of a Point-of-Care assay for rapid determination of anti-TNFα biologics in capillary blood
Authors: Ricken B , Brosi L , Reinhard C , Anchling L , Neu S , Afonso J , Schuster T , Wütherich E , Burri E , Paul S , Berger A E , Guirao W , Barrau M , Bastide L , Roblin X , Pflimlin-Fritschy V , Rutscher U , Hrúz P , Gerhold C B
Published: January 2024

Background

Inflammatory bowel disease (IBD) patients benefit from therapeutic drug monitoring and personalized adjustment of anti-TNFα drugs such as adalimumab (ADL) and infliximab (IFX). Commercially available rapid assays allow the fast and easy measurement of ADL and IFX. Unfortunately, most ADL and IFX in-vitro diagnostic assays rely on serum as analyte matrix. This is a critical hurdle in point-of-care (POC) analysis, as it requires laboratory professionals, additional laboratory instruments and is time consuming. Therefore, two recently developed rapid tests for the determination of ADL and IFX that only require capillary blood (CB) or EDTA whole blood (WB) without further treatment are tested in a POC setup at three different study sites. The primary aim of this study is to demonstrate matrix equivalency of CB and EDTA WB compared to serum as reference.

Methods

This observational study was performed at three sites. Two sites in Switzerland, Clarunis Basel and Kantonsspital Baselland, and one site in France, Centre Hospitalier Universitaire de Saint-Étienne. Sample analysis was performed by healthcare professionals at the study sites with the established Quantum Blue® serum rapid tests and the newly developed capillary blood applications. Blood samples from patients under infliximab therapy were collected directly before infusion (trough level of drug). Samples from adalimumab-treated patients were collected irrespective of the injection schedule. In total, up to 100 IBD patients are anticipated in the study, 50 under infliximab therapy and 50 treated with adalimumab. This work evaluated the interim outcome after the analysis of 29 ADL and 18 IFX patients.

Results

Bland-Altmann analysis revealed a good agreement of CB and EDTA WB compared to serum for both IFX and ADL sample sets. The mean bias for the biologic’s trough level analysed in CB and compared to serum was 5.2% for IFX and -11.7% for ADL. Passing-Bablok analysis for CB versus serum resulted in a slope of 0.92 and an intercept at 0.08 for IFX and a slope of 0.86 and an intercept at -0.063 for ADL. A comparison of EDTA WB compared to serum revealed a mean bias of 7.8% for IFX and 7.4% for ADL. Passing-Bablok analysis for EDTA WB versus serum resulted in a slope of 1.00 and an intercept at 0.00 for IFX and a slope of 1.00 and an intercept at 0.30 for ADL.

Conclusion

The newly developed rapid Quantum Blue® assays for the determination of infliximab and adalimumab in capillary blood and EDTA whole blood are very well comparable to the analysis of either biologic in serum. This study furthermore demonstrated the assays are well suited to be used in a POC setting, such as infusion centres, rather than in a laboratory. Both assays are standardized to WHO reference material.
P453 Surveillance for colorectal dysplasia and neoplasia in Latin American patients with Ulcerative Colitis
Authors: Parra Izquierdo L V , Frías-Ordoñez J , Gil F L , Puentes-Manosalva F , Suarez K E , Villa-Ovalles K , Paredes J , Jara M L , Andrade D , Ibañez E , Florez-Sarmiento C
Published: January 2024

Background

colorectal cancer (CRC) in patients with inflammatory bowel disease (IBD) has worse prognostic features and a higher mortality rate compared to sporadic CRC. Screening colonoscopy is therefore an important tool to consider in this population. The aim of this study is to describe the findings of endoscopic surveillance of CRC in patients with IBD using the technology available in Latin American countries.

Methods

Descriptive, multicentre, cross-sectional, descriptive study conducted in multiple Latin American countries in patients with ulcerative colitis (UC) more than 8 years after diagnosis and ulcerative colitis with primary sclerosing cholangitis regardless of the time of diagnosis of colitis. Surveillance colonoscopies were performed according to the availability of technology in each country.

Results

78 subjects, 50% women, from 5 countries (Colombia, Costa Rica, Peru, Ecuador, and Dominican Republic), with mean age 47.9 (range 20.01-89.71; SD 151.4) years, mean age at disease diagnosis of 34.7 (range 8.52-80.9; SD 14.08) years, and mean time of disease of 12.8 (range 4.6-56.8; SD 8.9) years. 57.7% (45/78) with extensive colitis, 8.9% (7/78) with a family history of colorectal cancer. 52.6% (41/78) on biologic therapy. 24.4% (19/78) current use of Azathioprine. 9% (7/78) of corticosteroids. 70.5% (55/78) oral mesalazine. In 5.1% it was used white light, 1.3% high resolution white light, 76.9% digital chromoendoscopy and 16.7% chromoendoscopy with staining. In those with digital chromoendoscopy, NBI was used in 38.3% (28/73), 37% (27/73) LCI/BLI, and 24.6% (14/73) I-Scan. It was found pseudopolyps in 50% (39/78), and 11.5% (9/78) stenosis. 7.7% (6/78) had a history of previous dysplasia. Regarding the Paris classification modified by SCENIC consensus, 28.2% (22/78) found 0-I lesions, 16 subjects were 0-I s, and 6 subjects 0-Ip. 5 subjects had 0-II lesions, of which 4 subjects in 0-IIa, and 1 in 0-IIc. 1 subject had lesion type 0-III. 1 subject had mixed lesions (0-IIa+0-IIc), 6.4% (5/78) lesion with ulceration, 10.2% (8/78) with disruption of lesion borders, with KUDO classification, Kudo III, 5.1 (4/78) Kudo IV and 3.8% (3/78) Kudo V. Endoscopic resectability was possible in all lesions. Histological findings were: (11/78) low grade dysplasia, (1/78) high grade dysplasia and (3/78) adenocarcinoma. As for the presence of dysplasia not visible in white light in random biopsies, it was only detected in (2/78).

Conclusion

in this first Latin American study, endoscopic techniques with digital chromoendoscopy with targeted biopsies were preferred, most were endoscopically visible and resectable lesions suggesting that the yield of targeted biopsies is superior to random biopsies.
P460 The POCER index: application of a novel endoscopic score in a real-life cohort of patients with Crohn's disease after surgery
Authors: Parisio L , Del Gaudio A , Privitera G , Cuccia G , Lopetuso L R , Laterza L , Rumi G , De Biasio F , Mignini I , Calvez V , Coppola G , Gasbarrini A , Scaldaferri F , Pugliese D
Published: January 2024

Background

The Rutgeerts score (Rs) is the most widely used score that offers essential prognostic information in the field of postoperative management of patients (pts) with Crohn's disease (CD). A recent study has introduced the POCER postoperative index (Pi), which includes the circumferential extent and depth of anastomotic ulcers, which can be an additional tool to better define the prognosis of this category of pts

Methods

Our study aims to evaluate the Pi in a real-life cohort, its correlation with Rs, and its prognostic value. We conducted a single center retrospective study, evaluating different outcomes of pts with CD who underwent ileocolonic resection. All pts underwent the first endoscopic evaluation within 6-12 months to assess postoperative recurrence (POR). We applied both the Rs and the Pi. POR was defined as Rs≥2 or Pi≥2. A clinical and objective assessment was performed at 18-24 months. Clinical Recurrence (CR), evaluated in all pts, was defined with a Harvey-Bradshaw Index (HBI)≥5. Objective Recurrence (OR), evaluated in a subgroup, was defined by the presence of endoscopic activity and/or radiological activity (assessed by ultrasound (US) when a wall thickness≥4 mm was present)

Results

We included 103 pts who underwent ileocolonic resection, with a median age at surgery of 38 years old. The main indication for surgery was a stenotic disease. 63% of pts had ≥1 risk factor for POR. All pts underwent prophylactic biologic therapy. At 6 month, POR was observed in 50 (48.3%) and 17 (16.5%) pts, according to Rs and Pi, respectively. Mean Rs and Pi were 1.39 (± 1.31) and 0.70 (± 1.08); a moderate correlation (r=0.523) between the two was observed. We assessed the ability of Rs and Pi at 6-12 months to predict CR and OR at 18-24 months. A Rs≥2 predicted CR with an AUROC of 0.8345 (sensitivity 93.3% and specificity 59.3%). A Pi≥2 predicted CR with an AUROC of 0.693 (sensitivity 33.33% and specificity 84.88%). When evaluating the performance of the mean of the two scores, we observed that a mean score≥1.75 could predict CR with an AUROC of 0.807 (sensitivity 80.00% and specificity 68.6%). A mean score≥1.75 could also predict OR with an AUROC of 0.662 (sensitivity 45.45% and specificity 74.29%). We also evaluated the subgroup of pts with Rs 1-2 at 6 months and the significance of the addition of the Pi: although no statistical significance was observed, a Pi<1 had a specificity of 100% in predicting the absence of CR

Conclusion

Rs and Pi can be used to assess POR and predict CR and OR. The combination of the two might outperform each of them with a good compromise between sensitivity and specificity. The addition of the Pi in pts with Rs 1-2, might be helpful in clarifying the prognostic significance of this result
P475 Potential of molecular remission: tissue neutrophil elastase is better than histological activity for predicting long-term relapse in patients with Ulcerative Colitis in endoscopic remission
Authors: Jun Y K , Lee J A , Choi Y , Shin C M , Park Y S , Kim N , Lee D H , Oh H J , Yoon H
Published: January 2024

Background

Growing interest exists in deep remission, beyond clinical and endoscopic remission, to enhance long-term prognosis in patients with ulcerative colitis (UC). Our study aimed to evaluate the risk of relapse according to tissue expression levels of calprotectin and neutrophil elastase (NE) in patients with quiescent UC.

Methods

Rectal biopsies were performed on 218 patients with UC in clinical and endoscopic remission. Histological activity was prospectively scored using the Robarts Histological Index. Tissue calprotectin and NE levels were evaluated using immunohistochemistry. Clinical relapse was defined as the requirement for medical therapy escalation, systemic steroid administration, UC-related emergency room visits, hospitalization, or surgery. Optimal tissue calprotectin and NE cutoffs for relapse were determined using log-rank analysis. A Kaplan–Meier analysis was performed to assess the cumulative incidence of clinical relapse, and a Cox proportional hazard analysis was conducted to identify the risk factors for clinical relapse.

Results

Tissue calprotectin and NE levels were significantly higher in patients with histological activity than in those in histological remission (P < 0.001, respectively). The optimal cutoffs of tissue calprotectin and NE for relapse were 10.61 /mm2 and 22.08 /mm2, respectively. The 3-year clinical relapse risk was significantly lower in the low tissue NE group than in the high tissue NE group (P = 0.009); however, it did not differ between the low- and high-tissue calprotectin group (P = 0.094) (Figure). In multivariate analyses, a low level of tissue NE expression (adjusted hazard ratio [aHR] = 0.453, 95% confidence interval [CI] = 0.225–0.911, P = 0.026) and maintenance treatment using biologics (aHR = 0.368, 95% CI = 0.141–0.962) were independently associated with a lower risk of 3-year clinical relapse, but previous steroid exposure was independently related to increase the risk of 3-year clinical relapse (aHR = 2.824, 95% CI = 1.298–6.141) (Table). The histological index and tissue calprotectin did not have influence on the 3-year clinical relapse.

Conclusion

In patients with UC who have achieved clinical and endoscopic remission, tissue expression of NE is a better predictor of long-term relapse than histological activity.
P488 Development and validation of a risk prediction tool for inflammatory bowel disease (IBD) diagnosis in patients presenting in primary care with abdominal symptoms, a UK based study
Authors: Umar N , Wambua S , Harvey P , Haroon S , Adderley N J , Trudgill N
Published: January 2024

Background

There are no prediction models for a diagnosis of inflammatory bowel disease (IBD) in primary care. An IBD risk prediction tool has the potential to reduce the length of time patients have undiagnosed IBD symptoms and improve IBD clinical outcomes. Therefore, our aim was to develop and validate a risk prediction model for the diagnosis of IBD, ulcerative colitis (UC) and Crohn’s disease (CD) in men and women separately.

Methods

A population-based retrospective open cohort study using Clinical Practice Research Datalink (CPRD) Aurum database was undertaken between 1st January 2010 and 31st December 2019, including patients aged 18 years or older. Patients were followed from first presentation with lower gastrointestinal (GI) symptoms potentially related to IBD to the earliest of IBD diagnosis, loss to follow-up, death or study end. 2,054,530 patients were in the model derivation cohort and 673,320 patients in the validation cohort. Cox proportional hazards models were used to derive separate risk equations in men and women for IBD, UC and CD. Candidate predictors included demographic factors (age, sex, smoking, body mass index, Charlson comorbidity score, loperamide use), family history of IBD, co-existing conditions (anxiety, depression, irritable bowel syndrome (IBS), haemorrhoids), extraintestinal manifestations (EIM) (mouth ulcers, ophthalmic, primary sclerosing cholangitis, dermatological), investigations (hemoglobin, mean corpuscular volume, platelets, albumin, vitamin B12, ferritin, C-reactive protein, erythrocyte sedimentation rate, calprotectin level). Measures of calibration and discrimination (C-statistic and D-statistic, higher values indicate better discrimination) were determined in men and women separately in the validation cohort at 1,2,3 and 5 years after symptom presentation.

Results

In the derivation cohort, 15,105 (0.7%) patients had an IBD diagnosis (10.014 UC (66.3%) and 5,088 CD (33.7%)). The IBD prediction model included 41 and 40 predictors, and the UC model 37 and 36 predictors, in women and men respectively; the CD model included 37 predictors in both men and women. C-statistics and D-statistics in men were as follows: IBD model 0.77 and 1.74; UC model: 0.81 and 1.95; and CD model: 0.77 and 1.95, respectively. Similar values were observed in women.The measures of discrimination showed that the prediction models reliably differentiated patients with and without IBD, UC and CD in both sexes. Model calibration was good, tending to overestimate at higher risk thresholds in validation cohort.

Conclusion

A risk model of patient demographics, symptoms and investigations performs well for IBD, UC and CD and may help in prioritising suspected IBD referrals in symptomatic subjects in primary care.
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

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

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 < 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 < 0.001; Civitelli et al.: 0.842, 95%CI 0.724-0.924, p < 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 (> 5.04 vs > 6.20 and > 2 vs > 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

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.