bluuebunny/crossref_metadata_2025_split huggingface dataset:
P609 Artificial intelligence in the image recognition of pouchoscopies in patients who have undergone restorative proctocolectomy with ileal pouch anal-anastomosis (IPAA)
Authors: Saifi M , Schmitz D , Ringwald F , Eisenmann U , Rudi J , Kienle P 
Published: January 2024

Abstract

Background
Restorative proctocolectomy with ileal pouch anastomosis (IPAA) has become the gold standard in the surgical treatment of ulcerative colitis, with pouchitis being the most common late complication of IPAA. Pouchoscopy is the diagnostic tool of choice to examine the pouch in cases of pouchitis. Artificial intelligence (AI)-based image recognition programmes can assist the examiner in making a diagnosis, support in the education of physicians in training and potentially improve patient outcomes. The use of artificial intelligence has not yet been demonstrated in patients with IBD. The aim of this study is the development of an image recognition algorithm based on Convolutional Neural Networks (CNN) that reliably detects the endoscopic findings of pouchitis analogue to the PDAI score in endoscopic images.

Methods
The dataset consisted of 10 pouchoscopy videos, which were split into individual frames and assessed using a specially developed labelling tool. In the training process, the labelled images were divided into training, validation and test datasets (ratio 60:20:20). Pre-trained networks and hyperparameters were selected by cross-validation. The defined networks were then fine-tuned through tenfold cross-validation and evaluated for accuracy, specificity, precision F1 score and AUC.

Results
Our dataset consisted of 7130 images, with 1961 images in the „Inflammation“ group, 2326 images in the „Not assessable“ group and 2843 images in the „Healthy“ group. The final model has been cross-validated 10 times and has been shown to be able to correctly assess the endoscopic features of pouchitis to a certain extent. However, its performance is not yet sufficient for clinical use.

Conclusion
The work has shown that it is possible to develop an image recognition programme using artificial intelligence that is capable of detecting endoscopic features of pouchitis to a certain extent. Our model is not yet able to make a reliable classification, so it is not yet ready for practical use. However, it should be noted that this project was a feasibility study with a small number of cases and a limited patient population. Further research and more data are needed to sufficiently train the model. Once this is done, the model could be further developed to make reliable classifications and be used in clinical practice.
P611 Relation between AntiTNF levels during the induction and clinical and radiological outcomes in perianal Crohn´s disease
Authors: Amiama Roig C , Suarez Ferrer C , Martin Arranz E , Rueda Garcia J L , Sánchez Azofra M , Poza Cordón J , Gonzalez Diaz I , Amor Costa C , Martín-Arranz M D 
Published: January 2024

Abstract

Background
Perianal Crohn's disease(PCD) significantly impacts quality of life with poor long-term prognosis. Anti-tumor necrosis factor(anti-TNF) therapy improves fistula closure rates. However, achieving permanent closure remains challenging. Our aim is to evaluate the relation between antiTNF(infliximab (IFX) and adalimumab(ADA) serum concentrations at induction(w2 and 6), and clinical and radiological outcomes at w24 and w52

Methods
We conducted a single tertiary center, retrospective, cohort study including patients with an established diagnosis of PCD treated with antiTNF because of perianal activity. Variables related to their PCD(phenotype, location, fistulas type) were collected. Regarding treatment, we collected serum levels at week 2,6,24 and 52, concomitant treatment and setons presence. We defined clinical response as the absence of drainage on physical examination and clinical remission as the absence of external fistula openings. Radiological response was defined as the absence of T2 hypersignal, gadolinium enhancement, abscess and proctitis in pelvic MRI

Results
65 patients were included, baseline characteristics are in Table1. None of the demographic characteristics collected were statistically significant related to clinical or radiological response although non smokers(p=0.01), ileal(p=0.02) and non-stricturing disease(p=0.01) had statistically significant higher drug levels. Taking into account the clinical response at w52, IFX mean levels at w2 were 25.8µg/mL(SD 4.1) in non responders and 30.9µg/mL(SD 14) in responders(p=0.39). At w6 they were 17.2µg/mL(SD 12.2) and 19.4µg/mL(SD 13.8) respectively(p=0.7). ADA mean levels at w2 were 13.3µg/mL(SD 7.7) in non responders and 14µg/mL(SD 6.3) in responders(p=0.87). At w6 they were 10.1µg/mL(SD 3.3) and 12µg/mL(SD 6.1) respectively(p= 0.59). For radiological response at w52 IFX mean levels at w2 were 27µg/mL(SD 15.3) in non responders and 32.7µg/mL(SD 14.5) in responders(p=0.45). At w6 the mean levels were 15.9µg/mL(SD 6.7) and 23.7µg/mL(SD 14.8) respectively(p=0.27). In ADA group the mean levels at w2 were 14.8µg/mL(SD 7.6) in responders and only one patient did not respond. At w6 ADA mean levels were 12.3µg/mL(SD 5.9) in non responders and 12.7µg/mL(SD 6.2) in responders(p=0.94). Early response at w24 was related with a long-term response at w52, 89.9% of the patients who responded at w52, had already responded at w24.

Conclusion
In our study we observed that almost 90% of the patients who had an early response also responded at w52, so trying to achieve an early response should be an aim in clinical practice. Despite the limited number of patients, our study shows a trend in the relationship between higher antiTNF levels and clinical and radiological response rates
P646 Clinical decision support in the prevention of adverse effects associated with immunosuppressive drugs in patients with Inflammatory Bowel Disease
Authors: Lobato Matilla M E , Marin Jimenez I , Menchén Viso L A , Miranda Bautista J , Chamorro de Vega E , Romero Jiménez R , Ferris Villanueva M , Herranz Alonso A , Sanjurjo Sáez M 
Published: January 2024

Abstract

Background
With the goal of effective and early prevention and detection of medication-related adverse effects, an explosion of technological advances is taking place. However, none of these systems are currently intelligent enough to ensure safe prescribing of treatments on their own.

Purpose
To design and integrate clinical decision rules (CDR) to increase the safety of immunosuppressive treatments in patients with inflammatory bowel disease (IBD) into an electronic prescribing assistance software (HIGEA).

Methods
This is a descriptive study conducted in a tertiary university hospital in Madrid (Spain).
1. We reviewed the technical product information sheet of the immunomodulatory drugs used in the treatment of patients with IBD and the current recommendations and clinical practice guidelines on the management of IBD.
2. The CDR were developed within a multidisciplinary team of physicians and pharmacists by integrating data from pharmacogenetics, microbiology, biochemistry, immunology and haematology laboratories, the electronic medical record and the electronic prescribing programme.
3. Integration was performed using a standard language (HL7).

Results
The technical product information sheet of 33 immunomodulatory drugs (19 biological therapies, 6 small molecules and 8 traditional disease-modifying drugs) and the clinical practice guidelines for the treatment of IBD of the European Crohn's and Colitis organisation (ECCO) and the Spanish working group on Crohn's disease and ulcerative colitis (GETECCU) were reviewed.
A total of 169 CDR were developed: 2 related to pharmacogenetics laboratory values, 26 to microbiology, 38 to biochemistry, 24 to immunology, 42 to haematology, 28 to clinical history and 9 related to concomitant use of other drugs.
Of the 169 CDR, 50 (29.58 %) were related to screening prior to initiation of immunosuppressive treatment, 10 (5.92%) to drug interactions and 109 (64.5%) related to clinical conditions requiring adjustment or discontinuation of immunosuppressive treatment.

Conclusion
The incorporation of personalised clinical rules into the medical prescription and pharmaceutical validation process will allow the selection of patients in whom there could be a safety problem with immunosuppressive treatment, increasing the percentage of early detected and avoided adverse events.
Future steps will be to evaluate the impact of the implementation of the CDR tool on increasing safety, reducing healthcare costs and improving patient health outcomes.
P665 Statins use and the risk of colorectal cancer in patients with inflammatory bowel disease: A Systematic review and meta-analysis
Authors: Jung B W , Lee W M , Choi S , Lee H S , Park Assistant professor J J 
Published: January 2024

Abstract

Background
Statin use has been linked to a reduced risk of advanced colorectal adenomas; however, its association with colitis-associated dysplasia and cancer is not well-defined. We aimed to perform a systematic review and meta-analysis to assess the pooled association of statin exposure with dysplasia and colorectal cancer in patients with inflammatory bowel disease (IBD).

Methods
We searched MEDLINE, EMBASE, and the COCHRANE library to identify full text articles analyzing the risk of CRC or dysplasia development based on statin use in patients with IBD. A meta-analysis was performed using a random-effects model to pool estimates and report hazard ratios [HRs] or odds ratios [ORs], following the data format specified in the individual studies.

Results
A total of 4 studies were identified as eligible for the meta-analysis. In the analysis of studies presented with time-to-event outcomes, statin use was associated with a statistically significant reduction in risk of colorectal cancer (HR 0.76, 95% confidence interval [CI] 0.61-0.95, P=0.016). Meanwhile, in the analysis of non-time-to-event study results, statin use was associated with a trend towards lower colorectal cancer risk (OR 0.28, 95% CI 0.07-1.10, P=0.068).

Conclusion
Statin use appears to be associated with a reduced risk of colorectal cancer in patients with inflammatory bowel disease. Statins may serve as potential chemopreventive agents for long-standing IBD patients, and further large-scale prospective studies will be needed to confirm its potential benefit.
P710 Prevalence, Characteristics and Management of Patients with Difficult-To-Treat Inflammatory Bowel Disease: A Cross-Sectional Study From a Tertiary Referral Center
Authors: Parigi T L , Massimino L , Carini A , Allocca M , D'Amico F , Furfaro F , Zilli A , Peyrin-Biroulet L , Ungaro F , Danese S 
Published: January 2024

Abstract

Background
Difficult-to-treat (D2T) inflammatory bowel disease (IBD) is defined by lack or loss of response to advanced treatments with 2 or more mechanisms of action (MoA), Crohn’s (CD) recurrence after 2 resections, chronic antibiotic refractory pouchitis, complex perianal CD or by the presence of psychiatric comorbidities impairing IBD management.1 We aimed to assess the prevalence, characteristics, management, and outcomes of D2T-IBD.

Methods
We retrospectively searched the electronic medical records of patients with IBD followed at San Raffaele Hospital (Milan, Italy) as of October 1st, 2023. Patients enrolled in clinical trials altering disease management were excluded.

Results
In total 679 patients with moderate-to-severe IBD were included (350 CD, 326 UC, 3 IBD-U). 163 patients (24%) met at least one criterion of D2T (25% CD, 23% UC). Of these, 75% did not respond or lost response to 2 or more biologics/small molecules with different MoA, 18% had complex perianal CD, 17% had CD recurrence after 2 or more resections for active CD, the remaining had antibiotic refractory pouchitis or psychiatric comorbidities impairing IBD management. Multiple criteria can coexist. Figure 1.
Drug-wise, 54% of patients with D2T-IBD failed 2 MoA, 26% 3 MoA, and 3% 4 MoA, the remaining had other causes of D2T-IBD.
Prevalence of D2T varied across phenotypes of CD. The presence of perianal disease doubled the probability of D2T-CD (48 vs 24%); stricturing (B2), fistulizing (B3), and upper gastrointestinal involvement (L4) also increased risk. In UC, 22% of left-sided colitis (E2) and 27% of pancolitis (E3) were D2T, no proctitis was D2T.
Patients with D2T-CD had a longer mean disease duration (14 vs 8.7 years; p&lt;0.05) and time on advanced treatments (78 vs 63 months; p&lt;0.05). The same two analyses showed no significant difference for UC (11.6 vs 11.2 years; and 41 vs 50 months; both p&gt;0.05).
Differently from bio-naive patients (Figure 2A), patients with D2T-IBD were mostly on ustekinumab, followed by infliximab and adalimumab in CD, and by upadacitinib, infliximab and tofacitinib in UC. Notably, 11 patients with D2T-CD received a combination of advanced therapies. Figure 2B
Overall, 61% of patients with D2T-IBD were in clinical remission, 43% in biochemical remission (calprotectin &lt;150 μg/g), and 13% in endoscopic remission (Mayo≤1; or SES-CD≤3 or Rutgeerts i0-i1).

Conclusion
D2T-IBD is heterogeneous but most commonly due to multidrug failure and associated with certain phenotypes of IBD. Ustekinumab was the most common treatment choice for D2T-IBD. The majority of patients with D2T-IBD achieved clinical remission but failed to achieve biochemical or endoscopic remission.
1. Parigi et al. Lancet Gastroenterol. & Hep. 2023
P712 Effectiveness of switching from intravenous to subcutaneous infliximab in Inflammatory Bowel Disease patients: A combined analysis of real-world evidence
Authors: Cummings F , Buisson A , Smith P J , Rahmany S , Subramanian S , Kwon B , Park S , Lee Y N , Fumery M 
Published: January 2024

Abstract

Background
Since approval, numerous inflammatory bowel disease (IBD) patients have been treated with subcutaneous (SC) infliximab (IFX), but real-life data based on a large multi-national population of patients switching from intravenous (IV) to SC IFX is lacking.

Methods
The ASSEMBLE project is an initiative to combine multi-national real-world cohort datasets and analyse the effectiveness and safety of SC IFX therapy. In the ASSEMBLE-1 analysis, three studies from France and the United Kingdom1-3 were integrated to assess the clinical outcomes up to 6 months (6M) after switching from IV to SC IFX. Clinical remission was defined as Harvey-Bradshaw Index (HBI) or modified HBI (mHBI) &lt;5 for Crohn’s disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) &lt;3 for ulcerative colitis (UC). Treatment persistence was assessed by Kaplan-Meier survival analysis.

Results
The data of 428 patients were pooled from the three datasets (70.6% CD, 29.4% UC). 85.4% of patients were in clinical remission before switching with median HBI or mHBI of 1 (IQR 0,2) for CD and median SCCAI of 2 (IQR 1,3) or PMS of 0 (IQR 0,0) for UC. 59.6% of patients were treated with the standard dose of IV IFX (5 mg/kg Q8W) before switching and 54.0% of patients were on concomitant immunomodulator therapy. Patients were switched to SC IFX 120 mg Q2W (94.4%) or 120 mg QW (5.6%) regimen. After switching, the overall clinical remission rates were 83.4% and 84.7% at 3M and 6M, respectively. CD patients were associated with higher remission rate (89.8%) than UC patients (71.9%) at 6M (p&lt;0.001). The disease activity scores and the levels of fecal calprotectin and C-reactive protein of the overall population were maintained stable after switching (Table 1). High persistence was observed in both CD (97.3% at 3M, 94.8% at 6M) and UC patients (96% at 3M, 94.1% at 6M), with no significant difference between indications (p=0.47 at 3M and p=0.78 at 6M). Perianal CD patients (n=89) did not have a significantly worse treatment persistence rate than non-perianal CD patients (p=0.30). The most common reasons leading to drug discontinuation were lost to follow-up, consent withdrawal, worsening of disease activity, and worsening of perianal disease (3 cases for each). Two patients discontinued due to injection-site pain.

Conclusion
This pooled analysis of ASSEMBLE-1 confirms that switching from IV to SC IFX is effective and safe for CD and UC patients in clinical practice and that the clinical remission is well maintained up to 6M after switching, with no new concerns in safety profiles. [1] Smith et al. J Crohns Colitis 2022 [2] Buisson et al. Clin Gastroenterol Hepatol 2023 [3] Rahmany et al. Gastroenterology 2023.
P722 The steep ramp test is a valid practical test to assess cardiorespiratory fitness in patients with inflammatory bowel disease
Authors: Demers K , Bongers B C , Jonkers D M A E , Pierik M J , Stassen L P S 
Published: January 2024

Abstract

Background
Comprehensive disease management of inflammatory bowel disease (IBD) requires a holistic approach that extends beyond achieving endoscopic healing. Monitoring health-related physical fitness (HRPF) parameters (i.e. body composition, cardiorespiratory fitness, muscular strength, muscular endurance, and flexibility) may lead to a more proactive approach to managing IBD, as IBD may affect HRPF due to e.g. chronic inflammation, malnutrition, corticosteroid use, and reduced physical activity. Yet, knowledge regarding HRPF in patients with IBD is limited. Assessment of cardiorespiratory fitness (CRF), a key component of HRPF in other chronic diseases, could offer valuable insights into physical capacity and overall health. However, the gold standard, measuring oxygen uptake at peak exercise (VO2peak) achieved during cardiopulmonary exercise testing (CPET) is impractical for widespread implementation in clinical practice. The steep ramp test (SRT), a short-term maximal exercise test on a cycle ergometer, might serve as a less demanding assessment method to facilitate routine assessment of CRF in clinical practice and deliver more practical endpoints for intervention studies. This study aimed to examine the criterion validity of the SRT as compared with CPET in evaluating CRF in patients with IBD.

Methods
From August 2022 to October 2023, adult patients with IBD in remission or with mild-to-moderate clinical disease activity were consecutively enrolled. Each participant performed a SRT and a CPET within 14 days to examine CRF. The main outcome measures were the achieved work rate at peak exercise (WRpeak) for the SRT (SRT-WRpeak) and VO2peak as well as WRpeak for CPET (CPET-VO2peak and CPET-WRpeak). Validity of the SRT was evaluated with Pearson’s correlation coefficients between SRT-WRpeak and CPET-VO2peak and SRT-WRpeak and CPET-WRpeak.

Results
A total of 50 participants, with a mean age of 42.9 years and 56% diagnosed with CD, were included (Table 1). One participant was excluded from the analysis due to the inability to achieve a maximal effort during CPET. Mean (±SD) WRpeak attained at the SRT was 4.32 (±1.06) W·kg-1, and mean (±SD) VO2peak and WRpeak achieved during CPET were 33.47 (±9.85) mL·kg-1·min-1 and 2.90 (±0.95) W·kg-1, respectively. Figure 1 illustrates robust linear relationships with very strong correlations between SRT-WRpeak and CPET- VO2peak (r=0.945, p&lt;0.001) and SRT-WRpeak and CPET-WRpeak (r=0.960, p&lt;0.001).

Conclusion
Results of this study suggest that the SRT is a valid alternative test for examining CRF in patients with IBD, indicating its potential application in both clinical practice and intervention studies. Further research should explore the criterion validity of practical tests for other components of HRPF.
P751 Off-label dose escalation of Ustekinumab in Inflammatory Bowel Disease patients. Safety profil of different patterns
Authors: García-Morales N , Agra-Blanco I , Gayoso-Rey M , Carmona A , Ayude M , De Castro Parga M L , Rodriguez-Prada I 
Published: January 2024

Abstract

Background
Approved maintenance regimens for UST in patients with inflammatory bowel disease (IBD) are 90 mg subcutaneously every 8 (Q8) or 12 weeks (Q12). In the real world, off-label dose escalation is frequently performed after inadequate response or loss of response, and has been shown to be effective. However, different dosing regimens are used and the best strategy is still unknown. Our aim is to evaluate the safety profile of UST dose escalation in IBD patients.

Methods
We performed an observational cohort study in 2 hospitals in Vigo-Spain. All patients who started UST between 1 June 2017 and 31 December 2022 to control their active IBD were enrolled. The primary endpoints were the rate of serious adverse events (AE) and the need to discontinue UST treatment in off-label dose escalation patients.

Results
173 IBD patients received UST: females 53,8% (93), mean age 49.7(15.5) years, Crohn´s disease 82% (142), previous anti-TNF 93,6% (162) and vedolizumab 22,5% (39) (Table 1). At 16 weeks, subcutaneous UST was maintained Q8 in 110 (63.6%) and Q12 in 60 (34.7%). Dose escalation was performed in 56 patients (32,4%) with different patterns: 30 Q4 (54,5%), 12 intravenous reinduction plus Q4 (21,8%), 7 Q6 (12.7%) and 6 only intravenous reinduction (10,9). In 11 patients (6,4%) a second dose escalation was performed.
196 adverse events were reported in 95 patients (54,9%), mostly infections 63 (32,1%) and musculoskeletal disorders 46 (23,5%) (Figure 1). More than one AE was reported in 67 patients (38.7%), showing 2 AE in 41 (23.7%), 3 AE in 12 (6.9%) and 4 AE in 14 (8.1%). Twelve adverse events were considered serious (12,5%) as they lead to hospitalization and in 4 cases to discontinuation of treatment (0.02%). Infections were the most frequent cause of serious AE (50%). With a fmedian ollow-up time of 13,5 (11) months, IBD patients scheduled to off-label UST dose escalation regimens showed no higher incidence of AE or severe AE than standard regimens.

Conclusion
In IBD patients, off-label UST dose escalation showed a good safety profile. Most of the reported adverse events were mild infections that did not change the UST treatment regimen. The schemes of dose-escalation were very heterogeneous between the participants.