bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0776 EVOKE - Evaluation of the long-term outcomes of Crohn’s disease complicating intra-abdominal abscess - retrospective, multicentre cohort study
Authors: Bacsur P , Nemeczek S , Filip R , Fotios F , Mpakogiannis K , Pastras P , Blesl A , Vieujean S , Gatt Y , Brinar M , Kagramanova A , Iliás Á , Gönczi L , Miheller P , Resál T , Ivány E , Farkas B , Bálint A , Fábián A , Bor R , Rutka M , Bősze Z , Szepes Z , Farkas K , Molnár T ,   Collaborators: Katsanos Konstantinos, Christos Triantos, Pierre Ellul, Zeljko Krznaric, Magdalena Gawron-Kiszka
Published: January 2025

Abstract

Background
Crohn’s disease (CD) complicated with intra-abdominal abscess often requires surgical intervention. Image guided percutaneous drainage (PD) can help to avoid surgical interventions, however there is limited evidence on the optimal management after PD. Our study aimed to analyze the long-term outcomes of CD complicated with intra-abdominal abscess after intervention.

Methods
In this multicenter, multinational retrospective trial penetrating CD patients with simplex intra-abdominal abscess were enrolled and followed. Baseline was defined as the day of the first detection of simplex abdominal abscess, while follow-up period of 12-24 months was set. Patients with urgent resection were excluded. Patients were grouped based on elective surgical need during follow-up after a successful PD, while a control group of patients after resection without PD is created. Primary outcome was the abscess recurrence, while stoma rate, post procedural complications rate (&lt;30 days), and postoperative luminal recurrence were analyzed as secondary outcomes. Logistic regression and Cox-regression models were created, while descriptive statistics, Welch’s test, and Fisher’s exact test were used to compare groups, with p-values &lt;0.05 considered significant.

Results
A total of 131 CD patients from 7 countries were recruited (Table 1., 58% were male, the median age at inclusion was 31.4 [IQR25-40] years) and 74/131 patients had PD due to simplex abdominal abscess during a median follow-up of 104 (74-104) weeks. Abscess recurrence rates did not differ between groups (p=0.155, Figure 1.); however baseline SES-CD score was coupled with increased risk of recurrence (HR=1,17, 95% CI 0.993-1.389). Need for re-drainage was more common amongst PD patients (OR=0.092, 95% CI=0.012-0.732), while new stoma was created more frequently in patients without prior PD (OR=2.50, 95% CI=1.034-6.034). Postoperative luminal recurrence was similar between groups based on PD. Surgical complications were coupled with increased odds in patients without prior PD (OR=8.609, 95% CI=1.825-40.616), septic complications, perforation and new fistula formation were reported the most, while PD associated complication did not occur.

Conclusion
However, abscess recurrence did not differ between groups, PD prior to surgery strongly correlated with less stoma creature. Furthermore, surgical treatment of intra-abdominal abscess alone may be coupled with post procedural complications.
P0778 Exploring the impact of personalised and curated educational videos delivered via an online platform to paediatric IBD patients
Authors: Tucknott S , Rose J , Sivananthan A , Glemas C , Heuschkel R , Zilbauer M 
Published: January 2025

Abstract

Background
Paediatric IBD patients and families want reliable, easily accessible information from sources they trust. Appointment time is limited and teams spend much of that time repeating basic information. Families often struggle to remember/process information imparted in appointments, and have no way to check details/ask further questions, resulting in misunderstanding, anxiety and information being sought from unregulated sources. Patients and families feel isolated and unsupported between appointments.
In this study we looked at 12 months use of IBDmate, an online platform for patient education and present initial results of a high-level survey.

Methods
IBDmate is an online education platform (figure 1) featuring over 150 videos filmed with healthcare professionals and patients. It offers ‘prescribable information about all aspects of IBD, including patient and family members’ stories.
During a 12 month period, 104 paediatric IBD patients under the care of Addenbrooke’s Hospital in Cambridge were signed up to IBDmate. They were prescribed educational video modules at diagnosis and at appropriate times during following appointments. Over the 12 months, a total of 1,116 videos were watched by these patients (average &gt;10 per patient) for a total of 64 hours (average &gt;36mins per patient). At the end of this period we conducted a survey to gather feedback from patients and families using IBDmate. We asked the following questions assessed on a 5-point scale (table 1).

Results
43 patients of 104 asked (41%) and family members responded to the survey over a period of 72 hrs.
• 83.72% (n=36) of respondents strongly agreed or agreed that IBDmate helped them understand their/their child’s disease better.
• 86.05% (n=37) of respondents strongly agreed or agreed that IBDmate helped them understand treatments available to them/their child and make better informed decisions about their care.
• 88.37% (n=38) of respondents strongly agreed or agreed that having access to patient/family stories in IBDmate helped them feel less alone.
• 88.37% (n=38) of respondents strongly agreed or agreed that having access to IBDmate had been beneficial to them/their family.

Conclusion
Paediatric patients and families who use IBDmate are better informed and better equipped to manage their disease. They feel more confident making decisions about their care, and feelings of isolation are significantly reduced. Anecdotally IBDmate reduced the need for in-person consultations, especially for routine education about treatments and disease management. This represents a key next step for the impact assessment of IBDmate.
P0784 Independent association between baseline simple endoscopic score for Crohn’s disease and C-reactive protein with Crohn’s disease-related complications: An analysis of the Randomized Evaluation of an Algorithm for Crohn’s Treatment – Study 2 (REACT2)
Authors: Jairath V , Joshi N , Clark R , Kristina K , Xuan S , Zou G , Peng Y , Dubcenco E , Feagan B , Dulai P S , Sedano R , Ma C 
Published: January 2025

Abstract

Background
Endoscopic improvement in the validated Simple Endoscopic Score for Crohn’s disease (SES-CD) is associated with better long-term outcomes in CD; however, a relationship with CD-related complications is not clear. Elevated biomarkers, such as C-reactive protein (CRP) also are associated with adverse long-term outcomes. We assessed the relationship between baseline (BL) SES-CD score, elevated CRP, and CD-related complications and identified the threshold for SES-CD score associated with an increased risk of complications.

Methods
Pooled data from REACT2 (NCT01698307) was analysed. SES-CD at BL was categorized as inactive disease (0–2), mild (3–6), moderate (7–16) and severe disease (&gt;16). Elevated BL CRP was defined as &gt;5mg/L. CD-related complications (ie, hospitalisation, surgery, medications-related, and non-surgical CD events) were assessed from BL through 24 months. Exposure-adjusted incidence (EAI) of CD-related complications was analysed as incidence rates. Adjusted analyses compared time to the first occurrence of CD-related complication, with Cox proportional hazard regression used to adjust for clustering effects and key patient characteristics. The BL SES-CD threshold that was associated with complications was determined using receiver operating curve (ROC) approach.

Results
Of 502 patients (pts) reporting BL SES-CD, 21.9% had inactive disease, 32.7% had mild disease and 45.4% had moderate-to-severe disease. A greater proportion of pts in the moderate-to-severe group (50.0%) had ≥1 CD-related complication vs those with inactive disease (32.0%; P=.0004). More pts with moderate-to-severe disease (20.6%) had CD-related hospitalizations vs those with inactive disease (5.8%; P=.0002). The EAI rate of CD-related complications was higher with moderate-to-severe vs inactive disease (0.4347 vs 0.2239; P=.0003). The adjusted risk of CD-related complications was higher in moderate-to-severe SES-CD vs inactive disease (HR=1.72; P=.0058). The ROC approach suggested SES-CD ≥7 was associated with CD-related complications.
The proportion of pts with ≥1 CD-related complication was higher in those with elevated CRP at BL (48.6%) vs not (34.6%; P&lt;.0001). Similar trends were observed for CD-related hospitalization. The adjusted risk of CD -related complications was higher among pts with elevated CRP vs not (HR=1.48; P=.0016); results were similar for CD-related hospitalizations (HR=1.75; P=.0013).

Conclusion
Elevated SES-CD and CRP are independently associated with a higher risk of complications in pts with CD. These findings point to the importance of controlling mucosal healing and inflammation to reduce risk of complications.
P0789 Combined inhibition of TL1A and integrin β7 is superior to either monotherapy in mouse models of colitis and coadministration of SPY001 and SPY002 demonstrates no drug-drug effects on exposure in non-human primates
Authors: Siegel M , Friedman J , Nguyen D , McNally J , Kennedy M , Ballew O , Rose M , Spencer A 
Published: January 2025

Abstract

Background
Advanced treatments for IBD typically have placebo-adjusted clinical remission rates of only 10 to 25%. The combined use of targeted biologic agents could break through this efficacy ceiling while avoiding the risks associated with broad immunosuppression. Spyre Therapeutics is developing fully human half-life extended IgG1 antibody drug candidates that can be used in combination against clinically validated IBD targets, including α4β7 integrin (SPY001) and TL1A (SPY002). The efficacy of combined inhibition of integrin β7 and TL1A was tested in proof-of-concept mouse colitis models. In advance of clinical assessment, it is essential to assess potential drug-drug effects on pharmacokinetics (PK). Accordingly, the clinical-stage antibodies SPY001 and SPY002 were evaluated in non-human primate (NHP) PK studies independently and in combination.

Methods
The efficacy of mouse surrogate anti-β7 or anti-TL1A antibodies used alone or in combination was assessed in the TNBS and anti-CD40 mouse models of colitis. Mice were treated with the antibodies or isotype control on Day -1 and Day 2. Body weight, stool consistency, blood in stool, and disease activity scores were recorded daily until the end of the study on Day 6. Colon weight and length were measured at the conclusion of the study. In separate experiments, SPY001 and SPY002 PK were measured in NHP following individual or combination dosing.

Results
In the murine TNBS model, combination therapy with anti-β7 and anti-TL1A antibodies significantly reduced body weight loss, improved body weight gain, and reduced disease activity to a greater extent than either monotherapy alone. In the anti-CD40 model, anti-β7 and anti-TL1A monotherapy increased weight gain and improved disease scores. Combination therapy reduced weight loss through Day 3, improved weight gain, improved disease activity, and reduced the colon weight-to-length ratio, all to a greater extent than either monotherapy. In NHPs, PK profiles of SPY001 and SPY002 were similar whether they were dosed individually or in combination.

Conclusion
Combined anti-β7 integrin and anti-TL1A therapy showed additive or greater than additive in vivo biological activity relative to either monotherapy in the TNBS and anti-CD40 mouse colitis models. Coadministration of SPY001 and SPY002 in NHPs demonstrated no drug-drug effects on PK. These preclinical results support the advancement of the combination of SPY001 and SPY002 into clinical trials.
P0793 Correlation between patient centred disease control versus biochemical parameters in IBD
Authors: Aliu A , Mujagic Z , Jeuring S , Pierik M 
Published: January 2025

Abstract

Background
Subjective patient experiences related to treatment are frequently underreported by healthcare providers, leading to potential discrepancies between patients and physicians in defining remission. This can influence patient expectations, engagement behaviours, and ultimately clinical outcomes. Based on these findings, the treatment approach for IBD has evolved, with the STRIDE-II consortium incorporating disease control from the patient perspective into the long-term treatment goals established in STRIDE-I. This study aims to compare subjective disease control assessed with patient reported outcome measures (PROMs) to objective biochemical parameters after starting Vedolizumab or Ustekinumab for the treatment of active disease.

Methods
Patients with IBD starting Vedolizumab or Ustekinumab included in the remote monitoring care-path with myIBDcoach were eligible for inclusion. Follow-up was 48 weeks and patients completed questionnaires at least once every 16 weeks. The IBD-control questionnaire and Monitor IBD At Home (MIAH) questionnaire were used as PROMs for disease control and clinical disease activity. The cut-off value of disease activity assessed with the MIAH questionnaire was &gt;3.5 for ulcerative colitis and &gt;3.6 for Crohn’s disease. Biochemical parameters C-reactive protein (CRP) and faecal calprotectin (FCP) were also measured every 16 weeks. The correlation per follow-up moment between IBD control and clinical remission measured with MIAH questionnaire, CRP and FCP was analysed with bivariate correlation tests. The longitudinal correlation between IBD control and clinical remission was assessed with linear mixed models (LMM).

Results
70 patients were included in the analyses. 25 and 46 patients started Vedolizumab or Ustekinumab, respectively (Table 1). At baseline, the mean IBD-control score was 8.5 (SD 4.7). 38% of the patients had active disease based on the MIAH questionnaire and median FCP and CRP at baseline were 369 (929) and 4 (15), respectively. IBD-control showed a moderate correlation of -0.50 with MIAH score at baseline (P=0.001). There was a weak and non-significant correlation of 0.10 and -0.09 between IBD-control with both FCP (P=0.459) and CRP (P=0.508), respectively. The LMM showed a fixed longitudinal effect between IBD-control and MIAH (P=0.006), whereas there was no fixed effect between FCP (P=0.221) and CRP (P=0.222).

Conclusion
In this explorative study, a significant correlation between IBD-control and a PROM for clinical disease activity was seen, whereas the correlation between IBD-control and objective biochemical parameters was low and not statistically significant. Treating physicians should be aware of the discrepancy between clinical and biochemical indicators of disease activity in IBD.
P0798 Forty-eight months outcomes of Teduglutide in adult stable patients with short bowel syndrome and home parental nutrition dependence: a real-world italian single center observational cohort study
Authors: Guglielmi F W , Regano N , Lamacchia S , Silvestri A , Mazzuoli S 
Published: January 2025

Abstract

Background
This real-life study is designed to investigate the short and long-term efficacy and safety of teduglutide (TED) and its effects on quality of life (QoL) in a cohort of adult, stable patients with short bowel syndrome and chronic intestinal failure (SBS-CIF) receiving a long term parenteral support (PS).

Methods
A prospective, single-center study was conducted for individuals who began using TED between March 2017 and August 2023.

Results
Ten patients were included in the analysis, among which the median duration of teduglutide administration was 48 (range, 12-
71) months. Data relative to short-term clinical outcomes demonstrate that 4 of 10 (40%) patients were early responders to teduglutide therapy, defined as a ≥20% reduction in PS requirement at 3 months. Six of 10 (60%) were no-responders. Data relative to 48 months long-term clinical outcomes demonstrated the absence of late responder patients and underline that all of 4 early TED responder patients continued to mantein a sustained reductions in PS. Two of the 4 patients (50%) responding to TED discontinued PS while the other 2 patients (50%) reduced the number of weekly PS infusions by approximately 50%. The physical and mental components of QoL improved significantly (p&lt;0.05) in responsive patients while they did not change in non-responsive ones. Predictibility of response to TED therapy in this study seems to be linked to: i) SBS type 3 that is completely absent in the no-responder patients (p&lt;0.0001), ii the residual small bowel length significantly (p&lt;0.02) higher in the responder (102=18 cm) compared to no-responder patients (67=27 cm), and i11) SBS type 1 and 2, enterostomy, surgical complications are significantly predictive of no response. Crohn's disease is equally present in both responder and non-responder patients. The number of side effects observed in our experience is extremely rare both at the 3th (0.01 n°/day/patients) and at the 48th months (0.001 I°/day/patients). No endoscopic neoplastic lesions were observed up to the 48th month of TED therapy.

Conclusion
This real-world experience allows us to state that, after 48 months of treatment, TED: a) is a safe therapy with minimal side effects: b) produces a rapid reduction in PS volumes in 40% of treated patients; c) consents to weaned off PS in 20% of enrolled patients; d) maintains a stable nutritional state and, finally, e) significantly improves Qol.
P0806 Monitoring of vedolizumab therapy using fecal calprotectin, abdominal ultrasound, and drug levels in ulcerative colitis: a predictive algorithm
Authors: Helwig PD U , Sobotzk C , Plachta- Danielzik S , Schreiber S 
Published: January 2025

Abstract

Background
Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a relapsing course. Vedolizumab, an anti-integrin, induces clinical remission in UC, but response is typically evaluated after 14 weeks. Earlier predictive markers could optimize treatment. This study aimed to develop an algorithm using baseline and week 6 data (especially abdominal ultrasound, fecal calprotectin, and drug levels) to predict clinical response and remission at week 14.

Methods
In this prospective study, 37 UC patients were recruited from 2018 to 2024, and 17 were included in the final analysis. The primary endpoint was clinical response or remission at week 14, based on significant changes from baseline to week 6 in at least two markers (vedolizumab ≥ 24 µg/ml, ≥ 25% reduction in colon wall thickness, or ≥ 50% reduction in fecal calprotectin). Secondary endpoints included outcomes at week 22. Statistical methods included among others Mann-Whitney U-tests, Fisher’s exact tests, and logistic regression.

Results
Vedolizumab levels at week 6 were the most reliable individual marker for predicting clinical response at week 14, with 0.67 sensitivity and 0.62 specificity. In addition, leukocytes and pancreatic elastase were negatively associated with clinical response, while zonulin showed a positive association (p &lt; 0.001). For clinical remission, colon wall thickness reduction and the combined predictive marker demonstrated perfect sensitivity (1.00) and negative predictive value (1.00). A significant association was found between reduced colon wall thickness and clinical remission (OR = 13.91, 95% CI: 1.13–1986.85).

Conclusion
Early changes in vedolizumab levels, fecal calprotectin, and colon wall thickness can predict clinical response and remission in UC. Colon wall thickness proved the strongest predictor of remission. Larger studies are needed to validate and refine this algorithm for personalized vedolizumab therapy.
P0807 Impact of Risankizumab on Patient-reported Outcomes and Biomarkers Over Time: Post-Hoc Analysis of Phase 3 INSPIRE and COMMAND Studies
Authors: Lindsay J , Ferrante M , Armuzzi A , Peyrin-Biroulet L , Dubinsky M C , Danese S , Garrison A , Yafei Z , Kalabic J , Remple V , Vladea R , Sharma D , Panaccione R 
Published: January 2025

Abstract

Background
Patients with ulcerative colitis (UC) may experience debilitating symptoms that impact their quality of life. This post hoc analysis evaluates changes in patient-reported outcomes (PROs) and biomarkers over time during maintenance treatment with risankizumab (RZB), a specific inhibitor of IL-23, among patients who responded to RZB induction treatment.

Methods
Patients with a clinical response to 12 weeks of intravenous (IV) RZB treatment from the Phase 2b and Phase 3 INSPIRE induction studies were randomised 1:1:1 to subcutaneous (SC) placebo (PBO) withdrawal, 180 mg RZB SC, or 360 mg RZB SC every 8 weeks during maintenance (COMMAND). Individual PROs were examined as no bowel urgency, no abdominal pain, no nocturnal bowel movements, no tenesmus, no faecal incontinence, no UC-related sleep interruption, and no fatigue (Functional Assessment of Chronic Illness-Fatigue [FACIT-F] ≥ 40). Biomarkers examined were faecal calprotectin (FCP) and high-sensitivity C-reactive protein (hs-CRP). Results were reported as the percentage of patients achieving each outcome for all PROs and median values for biomarkers at Week (wk) 0 of induction and every 8 wks from wk 0–52 of maintenance, unless otherwise stated for FACIT-F ≥ 40.1, hs-CRP and FCP. Non-responder imputation with no special data handling for missing data due to logistic restrictions (COVID-19 or the geo-political conflict in Ukraine and surrounding impacted regions) was used for missing data.

Results
In total, 548 patients (PBO SC, n=183; RZB 180 mg SC, n=179; RZB 360 mg SC, n=186) were randomised into the maintenance study. A higher proportion of patients achieved PROs at maintenance wk 0 compared to the induction baseline (Figures 1 and 2). Throughout maintenance, achievement of PROs persisted in patients receiving RZB, regardless of dosage, except for no nocturnal bowel movements, no fecal incontinence, and no UC-related sleep interruption, which showed a slight decrease in response for all treatment groups. A decline in achievement of all PROs in the PBO withdrawal arm was seen from wk 32 onwards. Both biomarkers showed a decrease in median levels from induction wk 0 to maintenance wk 0. During maintenance, median FCP levels were lower for both RZB doses compared to PBO. Lower median hs-CRP levels persisted during maintenance but were similar among all treatment groups.

Conclusion
Improvements in most PROs and biomarkers were sustained throughout maintenance, with declines seen in the PBO maintenance group likely due to the withdrawal of RZB from RZB induction treatment. These findings show that RZB may decrease common UC-related symptoms and may improve patients’ quality of life and inflammatory burden.