bluuebunny/crossref_metadata_2025 huggingface dataset:
P0718 Ulcerative Proctitis: Adherence to Guidelines and confirmation of clinical, biochemical and endoscopic remission in phenotypically E1 patients.
Authors: Malkopoulos A , Gluch A , Kakkadasam Ramaswamy P , Mohsen W
Published: January 2025

Background

Ulcerative proctitis is a subtype of Ulcerative colitis in which only the rectum is affected. Despite the length of inflammation and ulceration being significantly less than that observed in other ulcerative colitis phenotypes, the clinical impact on patients can be considerable.

Our aim was to review clinician adherence to British Society of Gastroenterology (BSG) guidelines in the management of phenotypically E1 patients with active proctitis in a tertiary hospital outpatient setting. The secondary objective was to evaluate rates of biochemical, clinical and endoscopic remission at 6-18 months post endoscopy.

Methods

Retrospective data was collected from endoscopy reports from a single Australian tertiary centre over a 2-year period between 2022 to 2024. Patients included in this cohort were all above the age of 18 with active proctitis identified on endoscopy. Those who were not phenotypically E1 were excluded. Review of the electronic integrated medical system was then conducted to determine if management was in line with BSG guidelines. Evidence of biochemical, clinical and/or endoscopic remission status at 6-18 months post endoscopy finding were also reviewed. Clinical remission was defined as SCCAI score <2 , endoscopic remission was defined as UCEIS score of ≤ 1 and biochemical remission was defined as CRP ≤ 5 +/- faecal calprotectin ≤ 50.

Results

A total of 875 colonoscopies and/or sigmoidoscopies were identified with the impression of ulcerative colitis in the report. Of these 172 scopes showed proctitis. Among these, 74 of these patients were phenotypically E1 with no prior evidence of more extensive disease. Exclusion of 6 inpatients and 12 repeat procedures resulted in a total analysis of 56 patients (Figure 1).

Fifty percent of patients (n=28) were treated in line with current BSG Guidelines (initial and maintenance).

Eighty percent (43 of 56) of the patients reported clinical remission within 1 year. Biochemical remission was confirmed in 73.2% (41) of patients. Of the 56 patients, thirty were assessed for endoscopic remission within 18 months. Thirteen (43%) of these had proven endoscopic remission within 18 months of diagnosis.

Conclusion

Adherence to BSG guidelines was observed in 50% of cases, highlighting significant variability in the management of proctitis in an outpatient setting. A substantial proportion of patients reported complete clinical and biochemical remission within the 18 months. A relatively lower rate of confirmed endoscopic remission, suggests that this group of patients may be undertreated.
P0719 The SAPHIR study: Assessment of Fresenius Kabi adalimumab biosimilar persistence in patients with inflammatory chronic diseases: Descriptive analysis of patients baseline characteristics
Authors: Peyrin-Biroulet L , Bouguen G , Becheur H , Cambon A , Bouhnik Y
Published: January 2025

Background

Biosimilar treatment initiation is based on a shared decision-making process, in which the patient’s acceptability to the treatment plays a major role. Indeed, negative perception of the biosimilar by the patient can generate a nocebo effect, which interferes with treatment results, leading to subjective worsening of the disease or poor tolerability. The SAPHIR study aimed to evaluate baseline patients’ characteristics predictive of biosimilar treatment persistence.

Methods

The SAPHIR study is a prospective, multicentre, observational cohort study. All patients with inflammatory rheumatic diseases and inflammatory bowel diseases were included after initiating treatment with Idacio® (adalimumab biosimilar) and were to be followed over a period of one year with assessments at 1, 6 and 12 months.

We present here the patients baseline characteristics and their acceptability to treatment.

Results

Of the 582 patients enrolled, 18 presented a protocol deviation and were not analysed. The 564 patients analysed were divided into two groups based on the circumstances of the Adalimumab biosimilar prescription: the "initiation" group (n=318) not previously treated with biotherapy and the "switch" group (n=246) previously treated with originator adalimumab. Disease severity was assessed globally on a Likert scale. According to this evaluation, 61% (n=185) of patients in the "initiation" group versus 10% (n=25) in the "switch" group were considered markedly or severely ill.

Baseline data from these patients are summarised in Table 1.

Patients were questioned about chronic treatment in general: 38% (n=61) of patients in the "initiation" group and 13.5% (n=25) in the "switch" group do not know if their medications are effective or even doubt their benefit. The perception of the biosimilar was assessed by a serie of affirmations (self-completion questionnaire on the acceptability of switching to a biosimilar), summarised in Table 2.

Conclusion

Biosimilars still meet with reluctance from patients. This situation seems linked to a lack of information on the concept of biosimilarity. Numerous guidelines have been published to promote and facilitate the transition from biotherapy to its biosimilar. These preliminary results show that difficulties with treatment acceptability also exist and seem more pronounced in patients initiating biological treatment with a biosimilar.

Table 1: Baseline data: BMI, Body Mass Index; SF-12, 12-Items Short Form Survey; HAD Scale, Hospital Anxiety and Depression Scale.

Table 2: Perception of the biosimilar by the patient
P0726 The Moderating Role of Adverse Childhood Experiences in the Relationship between Crohn's Disease Activity and the Development of PTSD Symptoms
Authors: Di Vincenzo F , Spagnolo G , Vecchione M , D'Onofrio A M , Camardese G , Sani G , Gasbarrini A , Cammarota G , Chieffo D P R , Ferrarese D , Scaldaferri F
Published: January 2025

Background

Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) characterized by transmural granulomatous inflammation, skip lesions, and a relapsing-remitting course, potentially affecting the entire gastrointestinal tract. Patients with chronic illness are at an increased risk for traumatic stress because of the medical trauma. Previous evidence suggests that many patients perceive the chronic nature of the disease and related diagnostics and therapeutic procedures as traumatic events. Initial studies on post-traumatic stress (PTS) in patients with IBD have found that approximately one-third of patients may experience significant PTS symptoms, including flashbacks, nightmares, hypervigilance, disrupted sleep, and low mood, potentially leading to the development of post-traumatic stress disorder (PTSD).

This study aims to explore the moderating role of adverse childhood experiences (ACEs) in the link between CD activity and PTSD symptoms.

Methods

In a cross-sectional design, the revised Impact of Event Scale (IES-R) and the ACEs Questionnaire were administered to consecutive CD outpatients at Policlinico A. Gemelli in Rome. Disease activity was assessed with the Harvey-Bradshaw Index (HBI). Data were analyzed using Pearson correlation coefficients and moderated regression models in SPSS (version 27).

Results

A total of 172 CD patients were included in the study, of whom 152 completed the IES and 148 also completed the ACEs questionnaire. Forty-eight patients (31.2%) exhibited a score of 33 or more on the IES-R, suggestive of PTSD. Correlation analyses revealed that ACEs scores correlated significantly with all subscales of the IES-R: intrusion (r=.405, p< .001), avoidance (r=.348, p< .001), and hyperarousal (r= .363, p< .001). Moreover, patients with higher ACEs had significantly more severe disease activity (r= .272, p< .001). Notably, the highest scores of ACEs were observed for the items related to feeling undervalued and ignored by one’s family. Further results from a hierarchical regression analysis demonstrated that the relationship between CD activity and the overall IES- R score was significantly stronger among patients with high ACEs scores (b= .21, p < .001) compared to those with medium (b= .12, p= .005) or low scores (b=.06, p =.291).

Conclusion

Our study revealed that ACEs play a moderating role in the relationship between CD disease activity and the development of PTS symptoms. Patients with higher PTS symptoms and more ACEs are less likely to achieve remission and may require increased use of gastroenterology services. These findings underscore the importance of a psychological assessment to enhance the management of these patients. Intervention trials to mitigate PTS symptoms in patients with IBD are warranted.
P0727 Effectiveness and Safety of ustekinumab in the Treatment of Penetrating Crohn’s Disease: A Prospective Real-World Study
Authors: Wu Y , Huang Z , Deng X , Chao K ,   Yan-Hui WU Zhao-Peng HUANG Xiao-Xia DENG Min-Zhi LIN Zi-Cheng HUANG Xiang GAO Kang CHAO
Published: January 2025

Background

Ustekinumab (UST) has been proved to be effective in the treatment of Crohn's disease (CD). However, data on the efficacy of UST in treating CD patients with penetrating complications are limited. The objective of this study was to evaluate the efficacy and safety of UST in the treatment of penetrating CD.

Methods

In this single-center, prospective, observational real-world study, we enrolled patients with penetrating CD who were undergoing UST treatment. The primary endpoint was the rate of transmural healing at week 26 and 52 evaluated by computerized tomography enterography or magnetic resonance enterography. Secondary endpoints included radiologic response rates and surgery-free survival rates at week 26 and 52, as well as surgery-free survival duration and safety. Statistical analysis was conducted using the Kaplan-Meier method.

Results

The study included 134 patients, among whom 26.8% had complex intestinal fistula. Transmural healing rates at week 26 and 52 were 11.9% and 17.8%, respectively. Radiologic response rates were 60% and 50.6% at week 26 and 52. Surgery-free survival rates were 90.5% and 87.1% at week 26 and 52, respectively. After a median follow-up period of 55.57 weeks, 17 patients required abdominal surgery. The median surgery-free survival duration was 164.5 weeks (95% CI 145.6-183.5 weeks). During the follow-up period, only one patient developed erythema, with no serious adverse events reported.

Conclusion

UST demonstrates promising efficacy and safety profiles for treating penetrating CD.
P0728 Interventions for ocular extraintestinal manifestations in inflammatory bowel disease: an umbrella review of systematic reviews
Authors: Estevinho M M , Solitano V , Magro F , Yuan Y , Jairath V
Published: January 2025

Background

A significant proportion of patients with inflammatory bowel disease (IBD) develop extraintestinal manifestations (EIM). Ocular involvement occurs in an estimated 12–25% of ulcerative colitis cases and 25–50% of Crohn’s disease cases, making it the third most common EIM after rheumatological and dermatological manifestations. There is limited information on treatment options for ocular EIM. To address this gap, we reviewed all systematic reviews (SRs) evaluating drug interventions for ocular EIM.

Methods

We searched three databases (MEDLINE, Embase, and the Cochrane Database of Systematic Reviews) from inception to May 2024 to identify SRs addressing therapeutic interventions for ocular EIM. The exclusion criteria ruled out studies that were not systematic reviews, did not focus on patients with IBD, or were unrelated to ocular interventions. Screening, selection, and data extraction were performed independently by two authors, with a third author consulted when necessary. The quality of SRs was assessed using the AMSTAR-2 tool.

Results

Of 1,436 studies, six met the inclusion criteria. The ocular EIMs most commonly reported included uveitis, iritis, scleritis, and episcleritis. The number of studies reporting ocular EIM within each SR varied from two (Guillo, 2021) to 22 (Peyrin-Biroulet, 2017). Therapeutic interventions differed: two SRs evaluated vedolizumab (Zheng, 2024; Chateau, 2019), one focused on ustekinumab (Guillo, 2021), while the others assessed different advanced therapies. Quality assessment using AMSTAR-2 rated the reviews from high to low confidence, with most achieving moderate confidence due to some non-critical weaknesses.

The incidence of new ocular EIM after treatment was 1% for both vedolizumab and ustekinumab in two SRs. For existing EIM, ocular symptoms improved in 55–59% of cases with ustekinumab (data from two SRs). However, there was no consistent evidence supporting vedolizumab for treating established ocular EIM. Anti-tumor necrosis factor (TNF) drugs were evaluated in two SRs, showing benefits for most patients with ocular manifestations without notable differences in the effectiveness among the different anti-TNF agents. No SRs focused on the risk of new ocular EIM after starting anti-TNF therapy.

Conclusion

Infliximab, adalimumab, certolizumab and ustekinumab appear effective for ocular EIM. There is no strong evidence that vedolizumab is effective for treating existing ocular EIM, though it may reduce the occurrence of new EIM. Further research with clear definitions and systematic assessments of ocular manifestations is needed. A multidisciplinary approach remains crucial.

References

Licona Vera E, Betancur Vasquez C, Peinado Acevedo JS, Rivera Bustamante T, Martinez Redondo JM. Ocular Manifestations of Inflammatory Bowel Disease. Cureus. 2023;15(6):e40299
P0730 Inflammatory Bowel Disease Lifestyle Food and Exercise (IBDLiFE) study: a randomized controlled trial to investigate the effectiveness of a personalised diet and physical activity intervention for adults with inactive IBD in Aotearoa, New Zealand
Authors: Yap J , Wall C L , Meredith-Jones K , Iosua E , Osborne H , Schultz M
Published: January 2025

Background

People with inflammatory bowel disease (IBD) are at higher risk of metabolic diseases that may respond to changes in diet and physical activity. Whether these lifestyle changes are possible and effective in IBD is unclear. This study aims to investigate the effectiveness of personalised diet and physical activity advice on metabolic disease risk factors in adults with inactive IBD.

Methods

A randomised controlled trial was conducted at three hospitals in New Zealand (NZ) from May 23 to August 24. Eligible participants (aged >18 years, body mass index (BMI) ≥ 25 kg/m2, low fibre intake (<25g/day), stable medical therapy, and could exercise) were randomised to one of two 6-month interventions: dietitian-delivered generic or personalised physical activity and heart-healthy diet advice. The primary outcome was body fat change and secondary outcomes included disease activity, faecal calprotectin, self-reported physical activity, and dietary intake (3-day food diaries). Multivariable regression models investigated between group differences adjusted for age, sex, and baseline values (significance p<0.05). Dietary intake and physical activity were adjusted for seasonality and disease activity. The study was approved by the NZ Health and Disability Ethics Committee (ref 2022 EXP 13602).

Results

A total of 64 participants were randomised and 51 (80%) completed the 6-month intervention and had complete datasets. Participants were median age 47 (LQ, UQ 37, 55), 59% female, 91% NZ European ethnicity, 61% had Crohn’s disease, 75% had faecal calprotectin < 100µg/g, 80% were non-smokers, and 81% on maintenance medical therapy including 44% on biologics. The intervention group had a non-significant decrease in fat mass (-188g; 95%CI: -1606, 1230) compared to the control group and statistically significant changes in dietary intake: increased fruit (0.5 serves/day; 95%CI: 0.1, 1.0) and dietary fibre (3.1 g/1000kcal/day; 95%CI: 1.1, 5.1), and reduced discretionary food and drink (-1.7 serves/day; 95%CI: -3.0, -0.3) and sodium (-911 mg/day; 95%CI: -1783, -40). Physical activity increased non-significantly by 188 total MET-mins/week (95%CI: -3336, 3711). Disease activity indices and faecal calprotectin did not significantly alter.

Conclusion

Dietitian-delivered personalised compared to generic advice, led to significant changes in dietary intake associated with reduced metabolic disease risk in patients with inactive IBD. However, the lack of significant changes in fat mass between groups is likely due to the absence of increased physical activity or reduced energy intake. Nonetheless, this study shows that adults with inactive IBD can make lifestyle changes without worsening disease activity.
P0731 Analysis of the short-term efficacy and risk factors of ustekinumab combined with surgical intervention in the management of perianal fistulizing Crohn's Disease: a single center real-world result
Authors: Ma K , Li Y , Weng F , Yao Y , Wang C
Published: January 2025

Background

The aim of this study was to evaluate the short-term clinical efficacy and identify potential risk factors for Ustekinumab (UST) in conjunction with surgical intervention among patients diagnosed with perianal fistulizing Crohn's Disease (pfCD), utilizing MRI healing as the gold standard.

Methods

The study was conducted retrospectively from July 2021 to July 2024, including all patients diagnosed with pfCD who underwent surgical intervention combined with UST treatment and completed a 24-week follow-up. The clinical data of patients and perianal fistula characteristics, were collected. The primary efficacy evaluation indicator is the clinical healing rate and MRI healing rate after treatment. The secondary efficacy indicators included the CDAI, PDAI, CRP, ESR, and FC. Additionally, the SES-CD and Van Assche score were utilized, along with Wexner incontinent score, to evaluate effectiveness prior to treatment and at 24 weeks post-treatment. The independent risk factors induced MRI healing after treatment were determined through multivariate analysis using binary logistic regression analysis.

Results

A total of 66 patients were included in this study. According to the Montreal classification, group A1, A2 and A3 consisted of 3 patients (4.5%), 59 patients (89.4%), and 4 patients (6.1%) respectively. In terms of disease location, 26 patients (39.4%) were classified as L1, 9 patients (13.6%) as L2, and 31 patients (47.0%) as L3. Additionally, 50 patients (75.8%) presented with B1 while the remaining 16 patients (24.2%) had B2. Four patients (6.1%) presented with simple anal fistulas, while complex anal fistulas were observed in 62 cases (93.9%). At 24-week follow-up, the clinical healing rate was 95.5% (63/66) with an average healing time of 8.58 ± 4.27 weeks. The MRI healing rate demonstrated a significant outcome of 68.2% (45/66). Additionally, there was a notable reduction in patients' CDAI and PDAI scores, as well as CRP, ESR, FC concentrations, Van Assche scores, SES-CD and Wexner scores at 24-week compared to baseline levels (p < 0.001). The multivariate logistic regression analysis revealed that the presence of perianal abscess (OR = 0.05, 95%CI: 0.004~0.052, p = 0.014) and a high baseline Van Assche score (OR = 0.48, 95%CI: 0.252~0.901, p = 0.023) were identified as independent risk factors for MRI healing in patients with pfCD. Meanwhile, no instances of anal function problems were reported during the follow-up period.

Conclusion

The combination of UST and surgical intervention demonstrates favorable short-term clinical efficacy and safety in the management of patients with pfCD. Notably, the presence of perianal abscess and a high Van Assche score independently contribute to the risk of incomplete MRI healing.
P0738 Apulian Network for Inflammatory Bowel Disease (AN-IBD) safety profile: Pilot data
Authors: Ditonno I , Contaldo A , Dell'Aquila P , Suriano V , Bossa F , Annese M , Perri F , Mazzuoli S , Guglielmi F W , Bringiotti R , Palmisano C M , Pranzo G , Albano F , Neve V , Tonti P , Stasi E , Facciorusso A , Marzo M , Paiano P , Gatti F , Di Lorenzo M P , Fanigliulo L , Panarese A , Allegretta L , Bucci A , Hadad Y , Pisani A , Sacco R , Tursi A , Principi M
Published: January 2025

Background

The Apulian Network for Inflammatory Bowel Disease (AN-IBD) is a prospective observational regional database recently approved by the Ethics Committee in Apulia (Italy), enrolling all IBD patients with an established diagnosis and focusing on the safety and effectiveness of all licensed therapies. We aimed to evaluate the safety profile of IBD therapies registered in patients enrolled in the participating centres and to record the occurring adverse events.

Methods

The AN-IBD involves 19 centres across Apulia, selected based on their capacity to prescribe advanced IBD therapies. In the six months following the ethical approval, we recorded unselected patients in the database and stratified them by disease type, age, sex and type of treatment. The occurrence of infusion reactions (local and systemic), infections, IBD-related hospitalization, need for colectomy, malignancies, thromboembolic events, and laboratory alterations were recorded. Their severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Results

A total of 420 patients were enrolled, consisting of 251 males (59,76%) and 169 females (40,24%), with a median age of 44 years. Among them, 243 (57,86%) were diagnosed with ulcerative colitis, 156 (37,14%) with Crohn’s disease and 21 (5%) with unclassified colitis. Overall, 341 patients (81,19%) were treated with advanced therapy, including biologic therapy and small molecules. A total of 33 (7,85%) adverse events were recorded comprehensively, and most of them were graded as moderate according to the CTCAE. Twenty-three patients were treated with biologic therapy (70%), seven with small molecules (21%), one with immunomodulators (3%) and two with conventional therapy (6%). The most common adverse events were infusion reactions, with fourteen cases recorded (42%), followed by eight cases of infective complications (24%), predominantly due to cytomegalovirus reactivation. Other recorded adverse events included IBD-related surgery (15%), malignancies (9%) and altered liver enzymes (9%).

Conclusion

These preliminary findings evaluate the real-world prevalence and nature of adverse events among the population enrolled in our newly developed multicentre regional cohort. The establishment of this new database, given the absence of a national registry, will allow for closer monitoring of IBD patients undergoing conventional and advanced therapies and will increase awareness of the safety of these treatments.
P0742 Real-world efficacy and safety of Upadacitinib in IBD patients. Preliminary data from the Apulian Network for Inflammatory Bowel Disease (AN-IBD)
Authors: Bossa F , Principi M B , Marzo M , Stasi E , Mazzuoli S , Pranzo G , Sacco R , Fanigliulo L , Neve V , Tursi A , Rizzi M , Bringiotti R , Bucci A , Allegretta L , Contaldo A , Mastronardi M , De Tullio N , Hadad Y , Annese M , Delll'Aquila P , Palmisano C M , Paiano P , Facciorusso A , Rima R , Guglielmi F W , Sgarro C , Perri F
Published: January 2025

Background

Upadacitinib is a selective Jak-1 inhibitor approved for treating Inflammatory Bowel disease (IBD). Its efficacy and safety have been assessed in pivotal trials. Few real-world experiences of Upadacitinib in IBD patients have been published so far. We aimed to investigate the effectiveness and safety of Upadacitinib in a cohort of IBD patients in clinical practice.

Methods

This multicenter, observational study was performed among the Apulian Network for Inflammatory Bowel Disease (AN-IBD). All consecutive patients with IBD starting Upadacitinib from its introduction were included.

Results

We enrolled 68 patients with Ulcerative Colitis (UC) and 9 with Crohn’s Disease (CD. The mean age of the patients was 40.2 ± 14.2 (range 19 - 74) and 45.3 ± 11.8 (range 26 - 62) for UC and CD, respectively. Regarding gender, 51 patients were male (66.2%). The mean disease duration was 11.8 ± 8.4 (range 3 - 31) for UC patients and 11.4 ± 8.6 (range 2 - 26) for CD patients. As for disease extension, patients with UC were divided into three groups: pancolitis (n=31, 45.5%), distal colitis (n=33, 48.5%), and proctitis (n=4, 6%). In CD patients, 5 had ileitis (55.6%), 2 colitis (22%), 1 ileocolitis (11.2%) and 1 jejunoileitis (11.2%). The response and remission rates after 8 weeks were 39% and 52% in UC patients. The response and remission rates after 12 weeks were 66% and 16% in CD patients. The primary non-response rate was 9.5% and 16% in UC and CD, respectively. Regarding safety, two cases of herpes reactivation were observed (1 herpes zoster in a non-vaccinated patient, and 1 herpes simplex infection, both managed with antiviral therapy). One patient experienced mild anemia, rapidly corrected after switching to 15 mg/day. One non-responder underwent an urgent colectomy.

Conclusion

These preliminary data confirm the efficacy of upatacitinib in inducing responses in IBD patients (both UC and CD) with a very low rate of primary failure. No new safety issues were identified.
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

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 <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

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 (<8, 8-12, >12 weeks), both initiation <8 and initiation between 8-12 weeks had a significantly lower recurrence rate than initiation >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

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 < 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<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 <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 <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

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

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

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 < 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 < 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

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 (> 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 (>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.