bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0744 Observational Real-World Study of Switching from Intravenous to Subcutaneous Vedolizumab in IBD Patients: Clinical and Pharmacokinetic Analysis
Authors: Diz Lois Palomares M T , Barreiro de-Acosta M , Baz López A , Porta Sánchez Á , Elberdin Pazos L 
Published: January 2025

Abstract

Background
Following the introduction of subcutaneous vedolizumab (VDZ-sc), which demonstrated efficacy in maintaining remission after two intravenous (iv) induction doses, a real-world approach was proposed to switch stable patients undergoing intravenous vedolizumab (VDZ-iv) treatment to the subcutaneous formulation.

Aims
To prospectively evaluate the switch from VDZ-iv to VDZ-sc in stable IBD patients receiving maintenance therapy with VDZ-iv.

Methods
A prospective study was conducted across three centers, including stable patients on maintenance VDZ-iv who opted to switch to VDZ-sc and consented to participate. Demographic data, IBD characteristics, and details of VDZ treatment were collected. Three evaluation points were established: baseline (at the time of switching), 6 months, and 12 months. During each visit patients completed two PRO questionnaires (IBD-Control and WPAI); also clinical data (Harvey-Bradshaw Index (HBI) for Crohn's Disease, partial Mayo score (pMS) for Ulcerative Colitis), biological data (fecal calprotectin (FC), CRP), and VDZ trough levels were collected.

Results
A total of 17 IBD patients were included, 70% had Ulcerative Colitis, with a median duration of 9,7 years. VDZ-iv was the second line of therapy in 58% of patients. Six patients (35.3%) had intensified VDZ-iv dosing. Upon switching, VDZ-sc dosage was intensified in 5 patients (Table 1).
At baseline, 10 patients were in remission (HBI ≤4, pMS ≤1) with CF &lt;250. 12 patients (70,6%) had a score on the IBD-control ≥13, and it remained stable. Among the 12 patients able to work, 6 were actively employed. In these patients, the impact of IBD on work was low across all visits.
VDZ Trough levels were significantly higher at 6 and 12 months compared to baseline. No other variables showed differences.
At baseline, 4 patients (23.5%) doubted whether their IBD was controlled and/or if VDZ treatment was useful (questions 1 and 2 of the IBD-Control questionnaire). All of these patients had mild clinical and biological activity. By month 6, two of them were switched (one to intensified VDZ-iv and the changed to ustekinumab). Additionally, another patient lost response during the switch to biweekly VDZ-sc dosing, and was reverted to intensified VDZ-iv, subsequently regaining response.
The persistence of VDZ-sc at one year was 82.3%, while the overall persistence of VDZ (both iv and sc) was 94.1%.

Conclusion
VDZ-sc is effective in maintaining the response achieved with VDZ-iv, with high persistence at one year. Patients’ perception of the treatment's utility and IBD control was positive and remained consistent during the switch. Patients with a perception of poor control and lack of deep remission at baseline are at higher risk of losing response when switching to VDZ-sc.
P0746 Impact of timing of prophylaxis therapy on post-operative endoscopic recurrence in a real-life cohort of patients whit Crohn’s disease
Authors: Del Gaudio A , Cuccia G , Di Vincenzo F , Coppola G , Parisio L , Laterza L , Pugliese D , Sacchetti F , Sofo L , Papa A , Cammarota G , Gasbarrini A , Scaldaferri F , Lopetuso L R 
Published: January 2025

Abstract

Background
The optimal timing for initiating biologic therapy after resection surgery (SR) in Crohn's disease (CD) has not been established, and the impact of a delayed start remains unclear, particularly outside the context of clinical trials.

Methods
Our study aims to assess the impact of the timing of prophylactic biologic therapy initiation on endoscopic recurrence after resection surgery in CD, and to compare prophylactic treatment strategies used in patients already on biological therapy before SR. We conducted a retrospective study evaluating endoscopic outcomes of CD patients who underwent ileo-colonic resection. All patients underwent their first endoscopic evaluation within 6-12 months after surgery to assess POR, using the Rutgeerts score (POR defined as Rutgeerts ≥ 2). All patients received biological therapy for recurrence prevention within 16 weeks after surgery.

Results
We included 173 patients. Prophylactic biologic therapy was administered to all patients, with initiation within 8 weeks, 8-12 weeks, and 12-16 weeks in 45%, 19%, and 36% of patients, respectively. POR was observed in 50% of the entire cohort. Comparing the timing of prophylaxis therapy initiation in univariate analysis (&lt;8, 8-12, &gt;12 weeks), both initiation &lt;8 and initiation between 8-12 weeks had a significantly lower recurrence rate than initiation &gt;12 weeks (p= 0.004, OR 0.37, 0.18, 0.73, 95% CI and p=0.039, OR 0.40, 0.16, 0.95, 95% CI respectively. Furthermore, for patients already on biologic therapy prior to SR (103), therapy was either maintained unchanged, switched, or swapped in 54%, 18%, and 28% of patients, respectively. We noted that the therapeutic swap was significantly worse (p=0.0009, OR 3.65, 1.42, 10. 1 95%CI) compared with continuation of the same therapy. There was no difference between continuation of the same therapy and treatment switch. In the cohort of patients who were already on biologic therapy prior to SR, when considering treatment strategy, timing of therapy in the multivariate analysis, the swap showed significantly higher POR than maintaining the same therapy and the switch. (OR 3.42, 1.20, 10.5 95% CI, p=0.025) while therapy timing was not significant. All the groups were homogeneous in characteristics and post-operative complications.

Conclusion
Prophylaxis administered within 12 weeks after resection correlates with a reduced risk of post-operative recurrence. For patients already on biological therapy before the SR, the prophylaxis strategy had a significant impact on POR.
P0753 Early surgery in pediatric-onset ileocecal Crohn’s disease is associated with less unfavourable disease course: a retrospective population-based study
Authors: d’Alès C , Sarter H , Fumery M , Dupont-Lucas C , Turck D , Bertrand V , Wils P , Richard N , Gower-Rousseau C , Coevoet H , Paupard T , Guillon N , Savoye G , Ley D , Leroyer A 
Published: January 2025

Abstract

Background
Early surgery in Crohn’s disease (CD) seems to be efficient and safe in recently diagnosed adult ileocecal CD as compared to anti-tumor necrosis factor (anti-TNF) therapy. However, its role in the first-line treatment of paediatric-onset CD remains unknown. We aimed to compare long-term disease course in paediatric-onset CD treated within one year of diagnosis with ileocecal resection (ICR) or anti-TNF therapy.

Methods
We conducted a retrospective study using a population-based cohort of patients aged of less than 17 years old at the diagnosis of ileocecal CD and treated with ICR or anti-TNF therapy within one year of diagnosis.
The primary outcome was unfavourable disease course defined as CD-related hospitalization, major CD-related surgery, systemic corticosteroids or perineal CD. We collected ICR characteristics, post-operative complications and clinical remission (Harvey Bradshaw score &lt; 4 without biologic therapy or new surgery). Cumulative incidence was calculated at 1, 3 and 5 years. We performed a Cox regression model with a propensity score. Results are expressed with 95% confidence intervals.

Results
From January 1988 and December 2011, 1007 patients were identified. 134 patients with ileocecal involvement at diagnosis were included, 67 patients in the ICR group and 67 in the anti-TNF group. The median follow-up was 6.0 years, IQR (3.2-11.1). Only 19% patients in the anti-TNF group had complicated behaviour as compared to 94% in the ICR group (p&lt;0.001) at diagnosis. The mean length of the surgical specimen was 33.5 cm (IQR: (4-95)) and surgeries were performed in emergency in 20% of the patients.The incidence rate of unfavourable disease course was 80 per 1000 person-years [54-113] in the ICR group, and 270 per 1000 person-years [196-363] in the anti-TNF group with a cumulative incidence of 17%, [7-26], 26% [14-37] and 30% [17-41] respectively at 1, 3 and 5 years in the ICR group, versus 24% [13-33], 54% [40-65] and 71% [55-81] in the anti-TNF group (p &lt;0.0001). When including the propensity score, patients in the ICR group had better disease course than patients in the anti-TNF group with a hazard ratio (HR) of 0.16 [0.08-0.35] over time.
Clinical remission was achieved in 83% of patients in the ICR group and 41% in the anti-TNF group (p &lt;0.001) at 5 years. Sixteen patients (23%) experienced an early postoperative complication, including 6 (9%) severe complications (Clavien-Dindo ≥ 3). Only emergency surgery was associated with late complications (HR = 6.9 [2.3-20.6]).

Conclusion
Early surgery in paediatric-onset ileocecal CD was significantly associated with less unfavourable outcome and seemed safe. These data support the role of early elective surgery in the first-line treatment of paediatric-onset ileocecal CD.
P0755 Long-term safety of subcutaneous vedolizumab in Ulcerative Colitis and Crohn’s disease: Findings from the VISIBLE OLE study
Authors: Vermeire S , Jones S , Velazco N , Agboton C , Wojtowicz A M , Young L , Phillips R , Loftus- Jr. E V , Danese S , D’Haens G 
Published: January 2025

Abstract

Background
Vedolizumab (VDZ) is a gut selective, monoclonal anti-α4β7 integrin antibody approved for the treatment of moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) and is available in subcutaneous (SC) formulation. This analysis assessed the long-term safety outcomes of specific interest to the SC formulation of VDZ.

Methods
Patients (pts) who participated in VISIBLE 1 or VISIBLE 2 were eligible to enrol in VISIBLE OLE (NCT02620046). In VISIBLE 1, pts with UC were treated with placebo, VDZ SC or VDZ intravenous (IV). In VISIBLE 2, pts with CD were treated with placebo or VDZ SC. In VISIBLE OLE, pts received VDZ SC 108mg every 2 weeks (Q2W) or weekly. Pts received training on SC administration, and most injections were conducted at home by pt or caregiver. Safety of VDZ SC included assessing anti-VDZ antibody (AVA) status and injection site reaction (ISR) adverse events. Blood specimens for AVA assessment were collected 30 minutes before dosing every 16 weeks, at the final dose and the final safety visit 18 weeks after last dose. Data were assessed by treatment pts received during VISIBLE 1 and 2.

Results
Overall, 288 pts with UC and 458 pts with CD enrolled in VISIBLE OLE. A mean of 91.1 and 74.2 SC injections were completed by pts with UC and CD, respectively, during the OLE. Among pts with UC, the positive AVA rate was higher in pts previously treated with placebo (17.3%) than those treated with VDZ SC (3.4%) or IV (2.6%) (Table 1). The positive AVA rate was also higher among pts with CD previously treated with placebo (11.4%) than with VDZ SC (1.8%). A total of 14/288 pts (4.9%) with UC reported ISRs (Table 2), most of which were mild and none were serious. Two pts developed moderate ISRs; neither required dose modification and both were resolved. Overall, 19/458 pts (4.1%) with CD reported ISRs (Table 2). The majority of ISRs were mild, 2 were moderate and none were severe, and none required dose modification. No direct correlation between AVA status and ISRs was identified, with 11/14 pts (78.6%) with UC and 17/19 pts (89.5%) with CD who reported ISRs being AVA negative. All 5 pts who were AVA positive and reported an ISR had previously received placebo. The highest rate of ISRs were in pts who received placebo in VISIBLE 1 (13.5%).

Conclusion
No new long-term safety events were identified with the VDZ SC route of administration compared to IV, except for ISRs. A higher proportion of patients who had previously been treated with placebo than those treated with VDZ during VISIBLE 1 and 2 were AVA positive during VISIBLE OLE, supporting a benefit of continued therapy with VDZ SC after IV induction, rather than cessation of treatment for a period of time.
P0760 Long-term Efficacy and Persistence of Subcutaneous Infliximab after Switching from Intravenous Infliximab in patients with Crohn's disease: A Real-World Multicenter Prospective Cohort Study in Korea
Authors: Kim K , Hong S N , Kang S B , Lee K M , Koo J S , Jung Y , Yoon H , Lee B J , Lee H S , Lee Y J , Lim Y J , Lee J , Lee C K , Shin S Y , Moon J M , Seo J , Lim H , Choi C H 
Published: January 2025

Abstract

Background
Subcutaneous infliximab (IFX-SC) has shown comparable efficacy and safety to IV infliximab (IFX-IV) in Crohn's disease (CD), since its launch in 2021. We aimed to evaluate the real-world efficacy and durability of IFX-SC within two years of follow-up in a Korean patient cohort.

Methods
This multicenter, prospective cohort study, conducted from September 2021 to June 2024, included patients with CD receiving IFX maintenance therapy. Patients received IFX-SC 120 mg at 8 weeks after the last IFX-IV administration (Week [W] 0), and every 2 weeks thereafter. Clinical relapse (CREL) at W26, W50, W74, and W98 and drug survival within W98 were assessed. Among CD patients with W0 clinical remission, CREL was defined as Crohn’s disease activity index ≥150 points. Drug survival was evaluated based on the time of drug persistence from W0 to the last date of IFX-SC administration among drug-off cases.

Results
A total of 372 patients with CD were finally included. Enrolled patients included young adults with a male predominance (Table 1). Most of the patients had ileocolonic disease, and about half had non-stricturing/non-penetrating disease phenotype. At W0, 283 patients with CD showed clinical remission., and the proportion of CREL showed incremental trend (W26 CREL 6.8%, W50 CREL 12.2%, W74 CREL 17.7%, and W98 CREL at 25.3%, Ptrend 0.004) (Figure 1A). On the other hands, drug durability was also investigated as shown on Figure 1B. Drug survival rate at W50 and W98 were 93.4% (95% confidence interval [CI], 0.908–0.961) and 91.3% (95% CI, 0.882–0.945), respectively. During the study, drug re-switch rate was 8.6% (32/372), mainly due to injection site discomfort, and also less than 5% of serious adverse events were reported.

Conclusion
In real-world settings, IFX-SC administration presents a viable strategy for maintenance therapy subsequent to IFX-IV treatment. Given the favorable drug durability, low relapse rate, and tolerable safety profile, IFX-SC may facilitate more tailored and individualized therapeutic approaches.
P0765 Insights into personalized biologic therapy with infliximab and ustekinumab: The predictive role of IL12P40 levels for mucosal healing outcomes
Authors: Chen L , Li X , Wu X , Mao R , Hu S , Feng R 
Published: January 2025

Abstract

Background
Current consensus guidelines recommend the early initiation of biologic therapies for managing Crohn’s disease (CD). Among the first-line options, infliximab (IFX) and ustekinumab (UST) have shown significant efficacy. However, therapeutic responses vary, necessitating reliable biomarkers for personalized treatment strategies.

Methods
This retrospective study included bio-naive CD patients treated with IFX or UST at the First Affiliated Hospital of Sun Yat-sen University between May 2019 and July 2023. Clinical characteristics and endoscopic outcomes, assessed as mucosal healing (MH), were evaluated 24–32 weeks post-treatment initiation. Serum levels of 19 cytokines at both baseline and evaluation timepoint were measured. Univariate and multivariate analyses identified predictors of MH in IFX and UST cohorts. Furthermore, patients were stratified based on cytokine levels linked to treatment efficacy for IFX and UST. Comparative efficacy analysis was conducted within stratified groups.

Results
A total of 91 patients were included (IFX: 49; UST: 42). MH rates were 40.82% and 54.76% for IFX and UST, respectively, with no significant difference (P = 0.2637). In the IFX cohort, age at administration, body mass index (BMI), age at diagnosis, disease duration, CD14, and IL2 were determined to be independent predictors of MH, with the corresponding predictive model achieving an area under the curve (AUC) of 0.914 (95% confidence interval (CI): 0.876-0.953). In the UST cohort, independent predictors included gender, disease behavior, upper gastrointestinal involvement, and IL7 (AUC = 0.880, 95% CI: 0.830–0.930). Univariate analysis showed IL12P40 and IL13 were significantly associated with MH after UST treatment, though these did not persist in multivariate analysis. Post-treatment, it was observed that IL12P40 levels significantly increased in IFX responders (P = 0.0408) but decreased in UST responders (P &lt; 0.0001). Additionally, the patients achieving MH with UST exhibited a higher baseline IL12P40 compared to those with IFX (P = 0.0052). Subsequently, Stratification by baseline IL12P40 levels (cut-off: 25.00 pg/ml) revealed higher MH rates for UST in the IL12P40-Higher group (P &lt; 0.0001) and for IFX in the IL12P40-Lower group (P = 0.0521).

Conclusion
Baseline IL12P40 levels and treatment-associated cytokine changes are predictive of mucosal healing in CD patients treated with IFX or UST. Higher IL12P40 levels favor UST, while lower levels favor IFX, supporting cytokine profiling as a tool for personalized treatment selection in CD. These findings highlight the value of integrating biomarkers into clinical decision-making to optimize outcomes.
P0771 Early Infliximab Rescue therapy is associated with reduced length of stay in patients with acute severe ulcerative colitis
Authors: Mohamedrashed M , Yogakanthi S , Xu C , Bartlett R , Chew M , Nedumannil L , Lucas S , Chauhan A , Lewis D , Kashkooli S , Garg M 
Published: January 2025

Abstract

Background
Acute severe ulcerative colitis (ASUC) represents a medical emergency necessitating admission and prompt commencement of intravenous steroids. Up to 40% of patients may require rescue therapy with infliximab, traditionally administered on day 3 of admission based on the Modified Oxford Criteria. This study aimed to evaluate the impact of early (≤ 72 hours) versus standard (&gt; 72 hours) infliximab administration on clinical outcomes.

Methods
A single centre retrospective cohort study was conducted for patients admitted with ASUC as defined by the Truelove and Witt’s criteria who received infliximab therapy between January 2016 and October 2024. Patients were divided into 2 groups: early infliximab therapy (≤ 72 hours of admission) and standard infliximab therapy (&gt;72hrs of admission). Patient demographics and disease characteristics were accessed from the electronic medical records (EMR). Outcomes assessed included length of stay, 12-month readmission and colectomy rates.

Results
84 patients (53% male, 37% female) were included in this study. Of these 31/84, (37%) received early infliximab therapy (median 52 [IQR 45-56] hours) and 53/84 (63%) had standard (median 105 [IQR 94-149] hours) infliximab therapy. Disease characteristics are shown in table 1. Mean albumin on admission was higher in the early infliximab group (36g/L vs 32.5g/L, p= 0.01). No other significant differences were noted.
The median length of stay was shorter in patients who received early vs standard infliximab therapy at 6 vs 7 days (p= 0.048). No significant difference was seen in requirement for colectomy between the early and standard groups at index admission (3.2% vs 3.8%, (p = 1.0) or at 12-months follow up (6.6% vs 6.9%, (p = 1.0). Similarly, there was no significant difference in readmission rates at 6-months (33.3% vs 26%, p= 0.67) and at 12-months (40% vs 28.8% p= 0.63) for both ulcerative colitis-related and non-ulcerative colitis causes across the two groups. There was no difference in rate of infective complications in the first 30 days (6.4% vs 7.5%, p = 0.85).
A propensity matched cohort of 30 patients (matched 1:1 for age, HR, albumin on admission, Hb on admission, and dose of first infliximab dose) further confirmed shorter length of stay in the early vs standard group at a median of 6 vs 7 days (p= 0.039).

Conclusion
In patients admitted with ASUC, early infliximab therapy as defined by administration ≤ 72 hours from presentation was associated with shorter hospitalisation, with no difference in rates of colectomy, re-admission or infective complications. An early treatment strategy may reduce the burden of this condition upon health care utilisation.
P0774 Key elements of high quality and sustainable IBD care: the common eye from an inter-, and intra stakeholder perspective
Authors: Thomassen B , Hendrix E , Mujagic Z , Smeets F , De Jong M , Gevers T , Veldhuijzen G , Van der Horst D , Scherpenzeel M , Dijkstra G , Kimman M , Ament S , Pierik M 
Published: January 2025

Abstract

Background
In the Netherlands, the growing burden of IBD, driven by a rising prevalence, a shift to new expensive treatments, and lifelong tight monitoring of mucosal inflammation, necessitates redesigning care processes to ensure accessible and high quality care in the future. Successful innovation requires engagement from all stakeholders within the healthcare system. In this study, we aimed to identify key elements of IBD care from an inter-, and intra-stakeholder perspective in the Dutch setting, exploring shared and unique elements to inform future healthcare improvements.

Methods
This study included all stakeholders involved in Dutch IBD care: 1) patients, 2) informal caregivers (ICs), 3) healthcare professionals (HCPs), 4) managers of gastroenterology departments, and 5) national stakeholders, e.g. pharmaceutical companies, healthcare insurers, eHealth providers, and the IBD patient organization. Participants were recruited from outpatient clinics and through networks, using purposive, convenience, and snowball sampling. In Phase 1, key elements of IBD care were identified through semi-structured interviews. These elements were prioritized within each group in Phase 2 and Phase 3 convened all stakeholders to discuss shared values, differences, and future implications (Figure 1).

Results
A total of 78 participants contributed to the study; 21 patients, 10 ICs, 27 HCPs, 8 managers and 12 national stakeholders. Key elements for each stakeholder group (Phase 1) and their rankings (Phase 2) are shown in Figure 2. Patients and ICs mainly identified micro-level elements of IBD care, while managers and national stakeholders focused on meso- and macro-level elements. HCPs addressed elements across all levels. Key elements prioritized across groups for the group discussion (Phase 3) included: accessible and affordable IBD care, adequate information and support, regular follow-up, holistic care with sufficient time and attention, achieving remission, patient autonomy and self-management, shared decision-making, remote monitoring, IBD care at home, easy access to HCPs, HCP’s expertise, scientific research, and a trustful relationship between HCPs, patients and ICs. In Phase 3, stakeholders acknowledged the importance of the identified elements, but revealed differing interpretations of shared concepts, like remote monitoring. Preserving personalized care and a trusting relationship between patients and HCPs were emphasized as key priorities in this.

Conclusion
Our study shows shared values but also significant differences between stakeholders in IBD care. Shared values can be priorities in redesigning care processes, but innovators should be aware of the elements valued by specific stakeholders based on their unique perspectives.