IBD Center Research Articles

P0909 Efficacy of biologic therapy according to Crohn’s Disease location: a real-life observational study

Abstract Background The location of Crohn’s disease (CD) can affect evolution, disease monitoring, and management of patients. In daily practice, clinicians perceive a lower efficacy of therapies in ileal-dominant CD compared to other CD locations, but recent evidence is controversial. The primary aim of our study was to explore the efficacy of available biologic agents according to the main CD location in a real-life cohort of patients. Methods We retrospectively included all CD patients starting a biologic therapy at our IBD Centre from 2021 to 2023. In case of switch of therapy, the patient was reinserted and the endpoints re-evaluated. The efficacy was evaluated in terms of clinical remission (Harvey Bradshaw Index [HBI] <5) and clinical response (≥3 point decrease of HBI), endoscopic remission (Simple Endoscopic Score [SES-CD] <4), and response (≥2 point reduction of SES-CD), and ultrasound (US) response (resolution or improvement >25% of bowel wall thickening). Results We enrolled 127 consecutive CD patients under biologic therapy (75 males, mean age 49±15 years); 40 patients were treated with multiple lines of biologic therapy leading to a total of 181 cases analysed: 35 on Infliximab (IFX), 76 on Adalimumab (ADA), 19 on Vedolizumab (VDZ), 47 on Ustekinumab (USK) and 3 in dual therapy (VDZ+USK). Of these, 70 cases (39%) had an ileal-dominant CD (L1), while 111 (61%) had a colonic or ileocolic involvement (L2, L3). According to disease location, patients with an ileal-dominant CD showed a higher rate of clinical remission after the induction (59/68 [86.8%] ileal CD patients versus 77/106 [72.6%], p=0.028). Still, this difference was not maintained at W52 (53/62 [85.5%] versus 64/78 [82.1%], p=0.586). No difference was observed in clinical response. The clinical efficacy of different biologic therapies is shown in Table 1. USK was more effective in ileal patients, both after induction and at W52 (p=0.060). Moreover, a significantly higher clinical response was observed at W52 in ileal patients treated with ADA. No difference was observed in terms of endoscopic or US efficacy by CD location. During the observation period, ileal CD patients showed a higher rate of clinical flare-up (27/42 [38.6%] versus 21/105 [20.0%], p=0.007). However, the hospitalization and surgery rate was similar. Globally, the discontinuation rate was 71/181 (39%) after a mean time of 14 months, in 54 cases for inefficacy (18 in ileal CD versus 36, p=0.33). Conclusion The ileal-dominant location of CD does not seem to significantly affect the efficacy of biologic agents in a real-life cohort of CD patients. Among the available therapies, USK and ADA seem to show a slight clinical advantage in managing the ileal forms compared to other biologics.

N40 Efficacy and safety of Risankizumab in moderate to severe paediatric Crohn’s disease in a tertiary Paediatric IBD (PIBD) centre – A case series

Abstract Background Risankizumab (Risa) is a humanized monoclonal antibody designed to target interleukin 23A (IL-23A). In UK approved in 2023 for moderate to severe Crohn’s disease (CD). There is limited data on its use in PIBD patients. The aim of the study was to assess efficacy and safety of Risa in pIBD after treatment failure on previous biologic agents. Methods All children initiated on Risa between March and November 2023 were identified in our database in a retrospective review, including patients’ characteristics, treatment response and safety. All patients received 3 intravenous doses at 4 weekly intervals then went on to subcut doses. Clinical activity at initiation was assessed by the 4 point ‘Improve Care Now’ Physician Global Assessment (PGA) based on severity of symptoms (1=asymptomatic; 2=mild; 3=moderate, and 4=severe). Primary outcome was clinical reduction of PGA between week 12-16. Clinical remission was defined as a PGA of 1.Data on faecal calprotectin (FC), radiologic and endoscopic response between week 12-16 were collected. Adverse events were recorded to date Results 13 patients were identified (11 male) 6 had perianal Crohn’s. 11/13 have had follow up for at least 12 weeks. 2 were excluded for not meeting follow up at the time of the study. Age range from 13 years to 17 years old, median age 16 years. Prior to commencing Risa, 81% (9/11) had moderate to severe disease activity on PGA. Although the remaining 2 patients had mild or asymptomatic PGA for the GI tract, switched for metastatic penile Crohn’s disease and severe joint issues. At re-assessment between week 12 and 16 weeks, 92% (10/11) had a PGA of 1 indicating clinical remission. 1/11 patient had a PGA of 4. Faecal calprotectin available in 63.6% (7/11) showed a dramatic drop in 86% (6/7). Radiological assessment either MRI or SBUS at week 12 or 16 was performed in 37% (4/11) with 2 showing improvement of small bowel disease when compared to radiology assessment prior to Risa, 1 showed no response and 1 showed worsening of disease. 1 patient who had Risa for joint issues showed improvement in inflammatory joint symptoms and the other for penile CD awaits assessment. Endoscopy assessment performed in 1/11 showing persistent disease resulting in a laparotomy and resection of proximal ileal segment and anastomosis. No serious adverse events were reported Conclusion Risankizumab induces sustained clinical response in this heterogenous, refractory group of pIBD patients with no significant side effects reported. However, mucosal healing reflected by FC, radiologic and endoscopic findings remains challenging. Further longer term follow up studies and the use as a 1st or 2nd line bilogic treatment on effectiveness and safety of Risankizumab in pIBD patients are required

P0481 Real-World Analysis of Disease Progression in Ulcerative Colitis: A Comparative Study Across Diagnostic Eras at a Tertiary IBD Center

Abstract Background Ulcerative colitis (UC) is a chronic condition characterized by a relapsing-remitting course, leading to cumulative systemic damage and disease progression. This progression may include extension of colitis, new extraintestinal manifestations (EIMs), dysplasia/colorectal cancer (CRC), and the need for colectomy. This study aimed to compare disease progression based on the time of diagnosis, to assess the impact of new therapeutic options. Methods Retrospective study at Reina Sofía University Hospital, analyzing all UC patients diagnosed within the past 10 years (2014-2023, cohort B) and a matched cohort diagnosed prior to 2014 (cohort A). Disease progression was defined as the first occurrence of new EIMs, new dysplasia/CRC, need for colectomy, or progression of UC extension. Kaplan-Meier analysis was used to calculate time to progression events. Results Of 643 patients identified, 72 were excluded, leaving 571 for analysis. Among them, 194 (34%) were diagnosed before 2014 and 377(66%) within the last decade (2014-2023). Median age at diagnosis was 39.5 years (IQR 27.3–54.2), and 304 (53.2%) were male. Initial disease extent was: proctitis 147(25.7%), left-sided colitis 203 (35.6%) and pancolitis 191 (33.5%). At diagnosis, 40 (7%) had EIMs. During a median follow-up of 7.1 years (3.7–13.3), 223(39.1%) patients experienced disease progression, including extension of colitis in 57(10%) cases, new EIMs in 114 (20%), colectomy in 46 (8.1%), and dysplasia/CRC in 56(9.8%). Patients diagnosed within the last decade showed a shorter time to progression compared to those diagnosed prior to 2014 (log-rank test, p<0.0001). This trend was also observed for new EIMs (p=0.01), dysplasia/CRC (p<0.0001), and disease extension (p=0.014) (Figure 1B-E). However, no significant difference was found in time to colectomy between groups (p=0.31) (Figure 1F). First maintenance therapy was mesalazine in 366(97.9%) of patients diagnosed within the last decade compared to those diagnosed previously 178(96.7%). Corticosteroids were used at some point in 379(69.4%), median number of corticosteroid courses of 2(1-4). Advanced therapy during follow-up was prescribed in 94(24.9%) of patients diagnosed in the last decade compared to 66(34%) of those diagnosed previously, p=0.022. However, time to advanced therapy prescription was significantly shorter in patients with recent diagnosis (log-rank test p=0.014) (Figure 1A) Conclusion A substantial proportion of patients with UC experienced disease progression within a follow-up period of less than 10 years. Despite the availability and earlier use of advanced therapeutic options, disease progression was observed to occur sooner in patients diagnosed within the last decade, compared to those diagnosed before 2014.

P0855 Rise in admissions for Acute Severe Ulcerative Colitis at an Australian tertiary IBD centre with a culturally and linguistically diverse population: Implications for health resource planning

Abstract Background Epidemiological data suggests greater risk of inflammatory bowel disease in first- and second-generation migrants from a low to high prevalence country, with risk of ulcerative colitis (UC) preceding Crohn’s disease. Little is known about the effect of this on hospitalisations for UC, including acute severe ulcerative colitis (ASUC). This study evaluated demographic trends of ASUC admissions in a metropolitan healthcare setting with an expanding culturally and linguistically diverse (CALD) population, with admission outcomes compared. Methods Demographic and disease characteristics of patients admitted with ASUC at a single tertiary metropolitan centre from January 2016 to October 2024 were recorded. Trends in presentation and outcomes in ASUC patients of European Caucasian and non-European background were compared. Results During this 9-year period, 210 patients (88 [41.9%] female, median age 34.5 [16-90] years) had a total of 261 admissions. The ethnicity of patients for UC admissions was 50.9% European Caucasian, 16.2% South Asian, and 13.8% Middle Eastern; ethnicity information was not available for 11% of patients. Of index admissions, 150 (71.4%) met Truelove and Witts criteria for ASUC (62 [41.3%] female, median age 33.5 [16-87] years); 51.3% European Caucasian, 16% South Asian, and 12% Middle Eastern; ethnicity information was not available for 12% of patients. For patients with recorded ethnicity, when comparing all UC admissions in 2016-2019 to 2020-2024, there was a significant increase in the proportion of non-European background patients, increasing from 32.1% to 47.3% (p=0.05), and an increasing trend in ASUC admissions from 29.0% to 46.8% (p=0.08). Median length of stay was 6 days (IQR 5-11) in European Caucasian patients and 6 days (IQR 4-7) in non-European background patients (p=0.11). 12-month steroid dosage was similar in both European Caucasian (median 1685mg) and non-European (median 1612.5mg) patients (p=0.45). 12-month readmission rate was significantly less in the non-European background ASUC population (10.0%) when compared with the European Caucasian population (30.1%), p = 0.02. 7.1% patients of European Caucasian background required inpatient colectomy, compared with 7.5% of non- European background (p=0.94). Conclusion There was an increase in proportion of patients of non-European background hospitalised with UC, including ASUC. In ASUC patients, 12 month-steroid usage, colectomy rates, and length of stay of index admission were similar across ethnicities, but patients of non-European background had lower readmission rates. Further studies are required for improved planning of healthcare resources and assessment of ASUC in CALD populations.

P0683 Is it time to move away from malnutrition screening as a gateway to a dietitian referral in patients with Inflammatory Bowel Disease? An investigation into nutritional Issues in Crohn’s Disease Remission

Abstract Background Conventional methods of triaging patients with Crohn’s Disease (CD) to see a dietitian mainly focus on generic risk scores for identifying overt malnutrition and do not consider dietary-impact factors more specific to CD, such as food-related gastrointestinal (GI) symptoms, bowel strictures or food avoidance. The INTICO-2 study characterised the nutritional state of adults in CD remission and included a novel patient-completed questionnaire of nutritional risk factors and symptoms, which would warrant a referral to a dietitian. Methods The INTICO2 study recruited adults with CD in confirmed clinical (HBI <5) and biochemical remission (faecal calprotectin <250 mg/g) from a single UK outpatient IBD Centre for nutritional assessment. Participants completed a dietetic-developed questionnaire that addressed signs and symptoms likely to limit dietary intake or indicate nutritional risk, including weight, weight loss, appetite (SNAQ)1, food restriction, CD phenotype (strictures, previous surgery), GI symptoms and physical symptoms associated with nutritional deficiencies. Results The median BMI in the cohort was 26.1 kg/m2 (18.0-48.9), and only one reported recent weight loss. Only one patient was assessed as at risk of malnutrition by MUST criteria. Nevertheless, most patients (92%; 180/196) reported at least one sign or symptom with a mean of 4 (SD 3) signs or symptoms for the cohort. About a third (34%, 67/196) reported food restriction; dairy, wheat, red meat, pulses, garlic, and onion were the most avoided. On average, patients avoided two foods, with 47 different foods reported across the cohort. About a third of patients (30%, 57/192) reported impaired appetite (SNAQ≤14); the mean SNAQ score was 15.5 (SD 2.3). Gastrointestinal symptoms after eating and signs and symptoms that suggest micronutrient deficiencies were evident (Table 1). Participants who answered ‘yes’ to the presence of strictures or previous CD surgery had significantly more signs and symptoms than those who did not: Mean(SD) strictures 6.32 (2.9) versus no strictures 3.66 (2.7) P<0.001 and surgery 5.4(2.8) versus no surgery 3.8 (2.9) P<0.05). Conclusion Patients with CD in remission may experience significant symptoms impacting their nutritional intake. Patients in remission do not routinely see a dietitian. Triage based on low BMI or weight loss may be insufficient to identify those who might benefit from further dietetic assessment and advice. A move towards dietetic triage that also considers GI signs, symptoms, and prior surgery might improve the identification of those who would benefit from dietetic advice by improving nutritional intake and tailoring advice to relieve symptoms (e.g. texture modification advice for those with strictures).

P0994 Effectiveness of Risankizumab in an Emirati Crohn’s Disease Cohort: Real-World Insights on Induction, Maintenance, and Dose Intensification Outcomes

Abstract Background Risankizumab, an IL-23 inhibitor, has shown efficacy in RCTs and real-world studies for inducing and maintaining clinical remission in Crohn’s disease (CD) patients. We report the largest real-world evidence from the Middle East evaluating risankizumab’s effectiveness and safety in advanced therapy (AT) naive and exposed patients along with outcomes following dose intensification. Methods A prospective observational study in an Emirati cohort at tertiary IBD center in UAE evaluated clinical outcomes at induction (3-5 months) and maintenance (12-14 months), assessing clinical remission (CDAI <150), clinical response (CDAI improvement by 100 points) and endoscopic response (≥50% SES-CD improvement). Long-term outcomes following dose intensification were recorded for patients with inadequate or loss of response after 12 months. Continuous variables were reported using descriptive statistics, and predictors of clinical remission were identified using logistic regression. Results A total of 37 patients treated with risankizumab were included in the analysis of which 35.1% were AT naive, and 64.9% had prior AT exposure. The median age was 33 years (IQR 26-42) and the median follow-up was 7.5 months (IQR 4.5-16.5). AT-naive patients initiated risankizumab at a median of 31 days from diagnosis (IQR 31-61). Post-induction clinical remission was achieved in 43.2% (16/37), with higher remission observed in AT-naive patients (53.8%) compared to AT-exposed patients (37.5%). Clinical response during induction was observed in 89.2% of the total cohort, with 92.3% response in the AT-naive group and 87.5% in the AT-exposed group. Of the patients with a follow up period of >12 months, clinical remission and response was achieved in 60% (9/15) and 93.3% (14/15) of the total cohort respectively. Endoscopic response was achieved in 81.8% (9/11) of patients undergoing colonoscopy between 8 and 12 months. Prior AT exposure significantly reduced the odds of achieving clinical remission (p<0.05). Age, perianal disease, baseline Hb, albumin, CRP, CDAI, SES-CD, and prior ustekinumab exposure did not affect odds of remission. Response was re-captured in 4/6 patients with secondary loss of response following 4-weekly dose intensification. No adverse events were observed during the follow-up period. Conclusion Risankizumab was highly effective for Crohn’s disease in an Emirati cohort, especially in AT-naive patients with a short time from diagnosis to treatment. High endoscopic response was noted, and dose intensification frequently restored response in patients with a secondary loss. Prior advanced therapy exposure correlated with lower remission rates, highlighting the importance of early targeted intervention.

P1311 Mucosal Microbiome Signatures Associated with Postoperative Endoscopic Recurrence in Paediatric Crohn’s Disease

Abstract Background Following ileocecal resection (ICR) for Crohn’s disease (CD), recurrence is frequent even in the biologic era. Gut microbiota is involved in this setting and a few adult studies have suggested that bacterial recolonization after surgery may predict recurrence. Given the inherent risk of postoperative recurrence associated with age and disease duration, studies investigating the role of the gut microbiota in predicting relapse in children undergoing ICR appears critical. We aimed to identify changes in the mucosal microbiome associated with, and predictive of, endoscopic CD recurrence within the first year post-ICR in a paediatric population. Methods Microbiota composition (16S rDNA sequencing) was assessed from ileal and colonic mucosa at the time of ICR and later during endoscopic evaluation from above and below the surgical anastomosis in 33 patients (26 with paired samples) prospectively recruited at a tertiary care paediatric IBD center. Results The study included 33 children (mean age 16±2.7 years) undergoing ICR. At the time of ileo-colonoscopy, 9 (35%) patients had endoscopic recurrence (Rutgeerts’ score≥ i2). ICR strongly modified the gut mucosal microbiota composition with significant changes in β-diversity (R2= 0.03, PERMANOVA test, p=0.01). Bacterial recolonization post-ICR differed according to recurrence status (Figure 1). Post-operatively, recurrence was associated with an increase in Fusobacterium, Dialister genera and in members of the Lachnospiraceae family, and a decrease in Faecalibacterium, Lactobacillus genera and members of the Streptococcaceae family. Microbiota colonizing the neoterminal ileum and subanastomotic colon differed in children with recurrence and showed, compared to remission, elevated and reduced bacterial abundance of the Enterobacter (q=0.1) and Ruminococcaceae (q=0.05) families in colonic samples respectively while the ileal mucosa exhibited profound depletion in Faecalibacterium (q=0.01). Postoperative colonic mucosal relative abundance of Enterobacteriaceae (q=0.06) and Ruminococcaceae (q=0.06) correlated positively and negatively with length of intestinal resection. At the time of surgery, several bacterial taxa able to predict relapse were identified (Figure 2). Conclusion Predicting postoperative CD relapse remains challenging, although several clinical risk factors of recurrence have been identified. Our study demonstrates that bacterial recolonization following ICR might pave the way towards remission or recurrence. Our results highlight, for the first time in a paediatric population, target species that may help clinicians to better define patients at risk of relapse and allow precise modulations of the overall microbial ecosystem towards remission pattern.

P1124 Disease Clearence after Acute Severe Ulcerative Colitis episode: is it possible ?

Abstract Background Acute severe ulcerative colitis (ASUC) is a critical and potentially life-threatening condition necessitating prompt and effective intervention. Long-term follow-up of these patients is vital for understanding the disease trajectory, therapeutic outcomes, and overall patient management. The concept of disease clearance has been proposed as a potential target in ulcerative colitis (UC). This study aims to report one-year follow up data after patients experienced ASUC. Methods We performed a retrospective analysis of patients diagnosed with ASUC at our Referral IBD center from 2014 to 2024. Inclusion criteria were based on established clinical parameters in accordance with ASUC. Data collected included patient demographics, disease severity, treatment modalities, surgical interventions, and one-year outcome (disease clearance, mucosal healing, colectomy). Treatment comprised intravenous corticosteroids, followed by immunomodulator (Cyclosporine and biologics) in non-responders. Results The study included 109 patients diagnosed with ASUC. The average age at the time of initial presentation with ASUC was 42.1 years, and 47% of the participants (44 out of 109) were male. The mean C-reactive protein (CRP) level recorded was 77.65 mg/L. Among the patients, 36.7% (40 out of 109) were treated with Infliximab, while 14.6% (16 out of 109) received Cyclosporine as rescue therapy. Colectomy was necessary for 12% (14 out of 109) of the patients due to either refractory disease or complications within the first year. The rest of the patients, 44.9 % (49 out of 109) achieved remission on intravenous steroids, and consecutively received either Infliximab (33/49), Vedolizumab (11/49) or Tofacitinib (5/49). Additionally, 7.3% (8 out of 109) achieved clinical remission using intravenous steroids in combination with aminosalycilates. After one year of follow-up, 55% (57 out of 109) of the patients achieved mucosal healing, and disease clearance was observed in 27.5% (30 out of 109) of the cases. 67.5% (27 out of 40) achieving mucosal healing and 45% (18 out of 40) experiencing disease clearance. Conclusion Definition of disease clearance was proposed to provide practical recommendations for its implementation as a therapeutic target in UC. Almost one third of our patients achieved DC after ASUC, majority in Infliximab group with colectomy rate of 12 % in first year.

P1163 Treatment-based risk stratification of serious and opportunistic infections in IBD patients from an tertiary center in brazil: a comparison between advanced therapies and non-biologic exposure in real world setting

Abstract Background The risks of serious and opportunistic (OIs) infections associated with advanced therapies for IBD is one of the main concerns of both physicians and advanced practice clinicians in IBD care. We assessed the incidence and stratify the risk of serious infections or OIs in patients with IBD treated with advanced therapy. Methods We performed an ambispective observational study of adults patients with a diagnosis of IBD in a tertiary IBD center located in Brazil. We retrospectively analyzed the IBD patients from 2014 to 2017 and prospectively those from 2018 to 2022. Serious infections were defined as those requiring intravenous antibiotic therapy or hospitalization. The incidence (per 100 patient-years) and risks of serious and OIs associated with exposure to combination therapy (anti-TNF and thiopurines), monotherapies with anti-TNF, vedolizumab, ustekinumab or tofacitinib were compared with exposure to aminosalicylates using marginal structural Cox proportional hazard models adjusted for baseline characteristics and medications. Results Among the 504 patients, 75 serious infections and 35 OIs were observed, resulting in overall incidence rates of serious infections and OIs of 3.1 and 1.1 per 100 PY, respectively. Overall incidence rates of serious infections ranged from 0.1, 0.15, 0.13, 0.16, 1.2., and 3.1 per 100 PY in those exposed to aminosalicylates, ustekinumab, vedolizumab, tofacitinib, anti-TNF monotherapy, and combination therapy, respectively. Conversely, the overall incidence rates of OIs ranged from 0, 0.1, 0.1, 0.3, 0.9, and 2.1 per 100 PY in those exposed to aminosalicylates, ustekinumab, vedolizumab, tofacitinib, anti-TNF monotherapy, and combination therapy, respectively. OIs were mostly due to Mycobacterium tuberculosis (n=21) and herpes zoster (n=11). Compared with aminosalicylates, vedolizumab and ustekinumab therapy did not increase the risk of serious infections and OIs (HR, 0.93; 95% CI, 0.42-1.81). Conversely, tofacitinib, anti-TNF monotherapy and combination therapy were associated with increased risks of OIs (HR, 1.13; 95% CI, 1.05-2.01), HR, 2.13; 95% CI, 1.92-5.81 and HR, 32.3; 95% CI, 19.21-40.53, respectively). Conclusion Anti-TNF therapy and combotherapy were associated with an increased risk of serious infections and OIs, while vedolizumab and ustekinumab presented a insignificant risk of these infections. Tofacitinib was associated with a small increased risk of OIs. Tuberculosis was the main OI, and was associated exclusively with the use of anti-TNF monotherapy or combotherapy. In choosing advanced therapy for IBD, clinicians should consider, among other factors, the risk of serious infections and OIs and weighed against potential benefits of the various targeted therapies for IBD.

P1091 Trends in length of stay and steroid use in patients admitted with Acute Severe Ulcerative Colitis: Impact of intensified or accelerated infliximab dosing

Abstract Background The role of intensified (>5mg/kg), accelerated (>1 dose within first 14 days) infliximab (IFX) as rescue therapy in patients with acute severe ulcerative colitis (ASUC) remains controversial. This project evaluated the association between evolving strategies with length of stay, 12-month cumulative steroid burden, colectomy and readmission rates. Methods Patients admitted with ASUC between January 2016 and October 2024 to a single tertiary IBD centre were identified and reviewed. IFX rescue therapy was defined as standard dose if up to 5mg/kg or intensified/accelerated if ≥10mg/kg (further categorised as 10mg/kg or ≥20mg/kg) was administered within 14 days of admission. Outcomes assessed included length of stay, 12-month cumulative steroid exposure (in prednisolone mg equivalent), 12-month readmission and colectomy rates. Results 147 patients (61 [41.5%] female, median age 33 [range 16-87] years) met Truelove and Witts criteria for ASUC. 83 (56.5%) patients required IFX therapy, of whom 29 (34.9%) patients received 5mg/kg IFX dose, 35 (30.1%) patients received 10mg/kg and 19 (22.9%) patients ≥20mg/kg. Disease severity as defined by CRP:albumin ratio was similar between patients receiving 5mg/kg vs 10mg/kg (p=0.880), but higher in those receiving 20mg/kg vs 5mg/kg (p=0.012); vs 10mg/kg (p=0.008). There was an increasing trend in the proportion of patients receiving intensified/accelerated IFX (≥10mg/kg) from 2016-2019 (26.3%) to 2020-2024 (76.5%) (p<0.001). Length of stay was less in patients who received 5mg/kg and 10mg/kg compared to ≥20mg/kg (median 6 vs 6 vs 11 days p=0.001). 12-month cumulative steroid usage was similar in 5mg/kg (median 1850 mg), 10mg/kg (1642.5 [1297.5-1935]mg) and ≥20mg/kg (1600 [1452.5-1715]mg), p=0.135. Readmission (19.2% (5mg/kg), 28.6% (10 mg/kg) and 11.1% (≥20mg/kg), p=0.527) and colectomy (8.7% (5mg/kg), 10.5% (10 mg/kg), 12.5% ≥20mg/kg, p = 0.958) rates were similar across IFX groups. Median length of stay was similar (p=0.193) between 2016-2019 (6 days) and 2020-2024 (6 days). 12-month cumulative steroid exposure (median 1705mg vs 1617.5mg, p=0.282) and readmission rates (15.8% vs 21.2%, p=0.488) remained stable when comparing 2016-2019 and 2020-2024. 12-month colectomy rates[MG1] declined across all ASUC patients (15.8% in 2016-2019 to 1.5% in 2020-2024, p = 0.004), and ASUC patients receiving IFX (21.1% 2016-2019 to 2.8% in 2020-2024, p = 0.025). Conclusion Despite higher disease severity, intensified and accelerated dosing for IFX at ≥20mg/kg resulted in similar length of hospital stay, 12-month steroid exposure, readmission and colectomy rates to lower doses. Intensified and accelerated IFX dosing has increased over time, associated with reduction in colectomy rate.

Prevalence, Risk Factors and Association with Clinical Outcomes of Malnutrition and Sarcopenia in Inflammatory Bowel Disease: A Prospective Study.

The prevalences of malnutrition and sarcopenia in patients with IBD are not precisely known, and nutritional assessment is not standardized. We assessed the prevalence and risk factors of these conditions in outpatients and their impact on clinical outcomes. This prospective longitudinal study considered patients who had IBD for at least one year, were attending a tertiary IBD center, and were followed for the subsequent year. In a sample of 158 consecutive patients (96 with Crohn's disease and 62 with ulcerative colitis), the prevalence of malnutrition, according to GLIM criteria, was 13.3%. For identifying patients at risk of malnutrition, the Malnutrition Universal Screening Tool demonstrated better accuracy, (sensitivity 88.9 (65.3-98.6) and specificity 90.2 (83.8-93.4)) than the SaskIBD-NR questionnaire (sensitivity 69.3 (41.1-86.7) and specificity 60.9 (60.9-76.8)). The prevalence of sarcopenia was 34.2%. Considering clinical outcomes, sarcopenia at baseline was significantly associated with hospital admission within a year (p = 45.2% vs. 20.3%, 0.026). Malnutrition and sarcopenia were present in about one-third of IBD patients. Awareness should be raised among physicians caring for IBD patients about the need to evaluate patients' nutritional statuses to help patients achieve a better quality of life.

Effectiveness and safety of upadacitinib in acute severe ulcerative colitis patients from single Chinese IBD Center: a monocentric study

Upadacitinib is an oral new selective JAK1 inhibitor that has been approved for treating adult patients with moderately to severely active ulcerative colitis. However, a growing number of studies are needed on the effectiveness of upadacitinib in the treatment of acute severe ulcerative colitis. This study was mainly aimed to describe the clinical and endoscopic effectiveness of upadacitinib 45 mg in Chinese acute severe ulcerative colitis patients following eight weeks of treatment. In this study, we examined all patients with acute severe ulcerative colitis from Xijing IBD Center, Xi’an, China, with acute severe ulcerative colitis. All patients were initially given oral upadacitinib 45 mg. Clinical indicators, C-reactive protein, and erythrocyte sedimentation rates were collected. Clinical response and clinical remission were assessed using modified Mayo. Endoscopic evaluation was performed carried out using the Mayo Endoscopic Score and Ulcerative colitis endoscopic index of severity score. A total of 14 patients who received upadacitinib were included in the study period. All patients exhibited a clinical response to 45 mg upadacitinib initially. All patients completed the 8-week induction. The clinical remission rate was 28.6% after eight weeks. Two patients revealed endoscopic remission at 14.3%. The pathology improved in 50.0% of patients. The 8-week surgical resection rate was 7.1%, with the 16-week surgical resection rate being 14.3%. Adverse events included herpes simplex virus infection and increased thrombin time. The results of our study support the short-term effectiveness and safety of upadacitinib in acute severe ulcerative colitis, providing new choices for patients’ treatment. However, more extended investigation needs to be performed on the long-term effectiveness and safety.

Utility of the Endoscopic Healing Index in Identifying Active Inflammation in Patients with Crohn's Disease: Real World Data from a Tertiary Center.

The Endoscopic Healing Index (EHI) analyzes biomarkers in a patient's peripheral blood to assess mucosal healing. We aimed to characterize the effectiveness of the EHI as a predictor of disease activity in a real world clinical setting. This retrospective study looked at patients treated and followed up at the University of Chicago Medicine IBD center who had EHI tests done as part of routine clinical care. The results of the EHI were compared with radiological imaging or endoscopy performed within 3 months of the EHI in order to determine accuracy at diagnosing active inflammation. Fifty-five patients with CD and with an available EHI were included in this study. Four (50%) patients with an EHI of < 20 (n = 8) had evidence of objective inflammation. A cutoff of ≤ 20 had a sensitivity of 89% and specificity of 23.5% for predicting no evidence of any objective inflammation with an AUROC of 0.69. This score had a negative predictive value (NPV) of 50% and positive predictive value (PPV) of 72.3%. A cutoff EHI of 30 tended to classify patients as either having objective evidence of inflammation or not more often than FCAL (Correctly classifying inflammation: 89% vs 64%, respectively; p = 0.32). In this real world analysis, the EHI showed poor predictive value for the absence of active inflammation as assessed by imaging or endoscopy, has limited utility in confirming deep remission and should be used with another objective modality.

Oral Budesonide and low serum albumin levels at surgery are associated with a higher risk of postoperative intra-abdominal septic complications after primary ileocaecal resection for Crohn's disease: A retrospective analysis of 853 consecutive patients

The terminal ileum is the most frequent site of Crohn's Disease (CD) that necessitates surgery. Of the postoperative complications (POCs) associated with ileocaecal resection for CD, intra-abdominal septic complications (IASCs) include anastomotic leak, abscesses, and entero-cutaneous fistula. We aimed to identify predictors of IASCs and severe POCs (Clavien-Dindo ≥3) after primary ileocaecal resection for CD. This is a retrospective single-centre cohort study including all consecutive primary ileocaecal resection for CD in a tertiary IBD centre between 2004 and 2021. A total of 853 patients underwent primary ileocaecal resection for CD. 307 (36.6 %) patients were receiving antibiotics, 253 (29.8 %), systemic steroids, and 178 (21.0 %) oral budesonide at surgery. At 90 days, 260 (30.8 %) patients developed POCs, 62 (7.3 %) severe POCs, and 56 (6.6 %) IASCs. At multivariate analysis, severe POCs were associated with lower preoperative albumin levels (OR1.58, 95 %CI 1.02-2.50, p = 0.040) and a history of cardiovascular diseases (OR2.36, 95 %CI 1.08-7.84, p = 0.030). IASCs were associated with lower preoperative albumin levels (OR1.81, 95 %CI 1.15-2.94, p = 0.011) and oral budesonide (OR2.07, 95 %CI 1.12-3.83, p = 0.021) with a dose-dependent effect. The independent association, dose-dependent effect, and biological plausibility of budesonide and IASCs suggest a robust causal effect. Oral budesonide should be carefully assessed before primary ileocaecal resection for CD.

Real-World Outcomes of Dual Advanced Therapy in Children and Young Adults with Inflammatory Bowel Disease.

Data are limited on the safety and efficacy of combining advanced therapies for refractory patients with IBD. To evaluate the real-world efficacy and safety of dual advanced therapy (DAT), combining 2 biologics or a biologic with a small molecule, in children and young adults with refractory IBD. Primary outcome of this single IBD center cohort was DAT remission (clinical and biomarker remission) at first assessment (T1). Secondary outcomes included remission at T2, if DAT de-intensification (De-I) occurred and T3, if T2 DAT re-intensification (Re-I) occurred. Efficacy and safety outcomes were described. Of the 30 patients [43% female, 30% CD, median age of 18.3 [15.1-19.8] years], all 11 UST + TOFA achieved T1 remission; 6/10 De-I failed at T2; and 4/4 Re-I achieved T3 remission. Of 9 VDZ + TOFA, 6 achieved T1 remission; 5/6 De-I failed at T2; and 1/1 failed T3 Re-I. Of 4 UST + VDZ, 3 achieved T1 remission; 2/3 De-I failed at T2; and 0 had Re-I. Of 5 UST + UPA, 4 achieved T1 remission; 1/5 De-I failed at T2 but recaptured T3 remission post-Re-I. One VDZ + OZA achieved T1 remission and maintained T2 remission post-De-I to OZA monotherapy. At last follow-up, 43% were on original DAT, 17% on one of original DAT, and 40% neither. One UST + TOFA patient developed mild leukopenia and another developed septic arthritis and venous thromboembolism on VDZ + TOFA and prednisone. Most children and young adults treated with DAT achieved remission with minimal safety events; however, de-intensification had limited success.

Redo IPAA for long rectal cuff syndrome after ileoanal pouch for inflammatory bowel disease.

BACKGROUND: When constructing an ileal pouch-anal anastomosis (IPAA), the rectal cuff should ideally be 1-2cm long to avoid subsequent complications. We identified patients from our IBD center who underwent redo IPAA for a long rectal cuff. Long rectal cuff syndrome (LRCS) was defined as a symptomatic rectal cuff ≥ 4cm. Forty patients met the inclusion criteria: 42.5% female, median age at redo surgery 42.5years. The presentation was ulcerative proctitis in 77.5% of the cases and outlet obstruction in 22.5%. The index pouch was laparoscopically performed in 18 patients (45%). The median rectal cuff length was 6cm. The pouch was repaired in 16 (40%) cases, whereas 24 (60%) required the creation of a neo-pouch. At the final pathology, the rectal cuff showed chronic active colitis in 38 (90%) cases. After a median follow-up of 34.5 (IQR 12-109) months, pouch failure occurred in 9 (22.5%) cases. The pouch survival rate was 78% at 3years. Data on the quality of life were available for 11 (27.5%) patients at a median of 75months after redo surgery. The median QoL score (0-1) was 0.7 (0.4-0.9). LRCS, a potentially avoidable complication, presents uniformly with symptoms of ulcerative proctitis or stricture. Redo IPAA was restorative for the majority.

P233 Cytomegalovirus colitis in patients with moderate-to-severe Ulcerative Colitis: diagnosis, clinical impact and treatment efficacy

Abstract Background Cytomegalovirus (CMV) colitis is a serious concern worsening the prognosis of patients with ulcerative colitis (UC), involving mainly those who are not responding to immunosuppressive therapy. CMV colitis is an independent predictor of hospitalisation and surgery. Diagnosis of CMV colitis can be obtained either via immunohistochemistry (ICH) or tissue polymerase chain reaction (PCR), possibly both. We aimed to assess the prognostic impact of CMV colitis in patients with UC and the clinical utility of testing for CMV plasma-DNA reactivation. Methods We conducted a retrospective, observational, monocentric study in our IBD center in Bologna. Consecutive patients hospitalized for moderate-to-severe ulcerative colitis from January 2020 to June 2023 were included. Patients were tested for CMV colitis at hospitalization, along with other concomitant infections. Diagnosis of CMV-colitis was made either by ICH on colonic mucosa histological samples or on resected colon specimens. Need of surgery was evaluated at 28, 180 and 365 days. Basal characteristics of patients according to the presence or absence of CMV organ disease were compared with Mann-Whitney, X2 or Fischer tests, as appropriate. A Kaplan-Meier survival analysis was calculated to verify whether antiviral treatment for CMV organ disease had an impact on avoiding surgery. Results A total of 135 patients were included. CMV organ disease was present in 37 (27.4%). Around half (51.4%) were diagnosed endoscopically, and 62.2% had evidence of plasma reactivation with a median of 1008 cp/mL CMV-DNA viral load (IQR 318-2980). Differences between the two groups (CMV colitis vs non CMV) included age (p = 0.004), Charlson Comorbidity Index (CCI) (p = 0.003), refractory disease (p = 0.007), and median CMV-DNA viral load (p &amp;lt; 0.001). Patients with CMV colitis needed surgery in 24/37 cases within 1 year from the diagnosis, compared to 41/98 in the non-CMV group. Interestingly, among the first group, 54% of cases underwent colectomy within 28 days, whereas only 34.1% underwent colectomy in the non-CMV group (p = 0.049). At multivariable analysis, steroid refractory disease, CCI and serum CMV-DNA reactivation were associated with CMV colitis. The latter had the highest OR (17.7 p &amp;lt; 0.001). Kaplan-Meier showed that patients who were treated with anti-viral therapy had a significant reduction of the risk of receive surgical treatment (p&amp;lt;0.001) [Table 1]. Conclusion CMV-DNA plasma reactivation is independently associated to CMV colitis. The use of anti-viral treatment is able to reduce the risk to underwent surgery, suggesting that screening of CMV colitis is mandatory in patients with moderate-to-severe UC.

P703 Comparison of infliximab and adalimumab therapies Persistence in patients with Ulcerative Colitis: Results from a Single Tertiary Turkish IBD Center Cohort

Abstract Background In the last 25 years, the introduction of biological therapies has been a significant milestone in the management of inflammatory bowel diseases. Despite the recent emergence of new biological therapies and small molecules, Anti-TNF agents still play a crucial role in treatment. In a number of countries, anti-TNF agents are still reimbursed as a first line treatment following either a failure or intolerance to conventional therapies such as thiopurines and aminosalycilates. Many studies have been conducted previously to compare the efficacy of these drugs, but a clear conclusion could not be reached. In this study, we aimed to compare the persistence of infliximab (IFX) to adalimumab (ADA) in the treatment of ulcerative colitis at a tertiary IBD center in Turkey. Methods This was a retrospective cohort analysis of patients with ulcerative colitis either received adalimumab or infliximab as a first line biologic treatment. A total of 234 patients were included to this analysis. Demographic information such as gender, age, montreal classification, smoking and prior medications were noted from patients electronic medical records. Weighted Kaplan-Meier and Cox models were used to assess the outcomes. Results Out of the 234 patients included in the study, 116 had used infliximab, and 118 had used adalimumab as a first-line treatment. Age and gender of the patients in both groups did not differ from each other statistically. 88% of the patients treated with adalimumab and 84% of the patients treated with infliximab were thiopurine experienced. Montreal classification did not differ between two groups (in IFX group, 73% of the patients had Montreal E3 involvement where as in ADA group, 66% of the patients had Montreal E3 involvement, p&amp;gt;0.05). Primary non-response rates were not different between IFX and ADA group, 13.6% vs 13.4% respectively. In addition, clinical response rates after first year were 60% and 53% respectively. Drug persistency rates of adalimumab and infliximab in moderate to severe ulcerative colitis patients were not statistically different from each other (Figure 1). Conclusion Neither clinical efficacy rates nor drug persistency rates of adalimumab and infliximab in ulcerative colitis treatment were not different from each other. Factors such as age, gender, location of involvement, concomitant therapies, and smoking did not alter the outcome.

N10 Evaluation of the impact of an IBD nurse in an Inflammatory Bowel Disease Center

Abstract Background In some European countries, IBD nurse is not a recognized status. IBD nurses are general care nurses who wants to improve their knowledges and get involved in the « Care and Support » of IBD patients. An increasing number of IBD centers are using the services of IBD nurse. The aim of this study was to evaluate prospectively the activity and impact of IBD nurse on the management of IBD patients in an IBD center. Methods From March 13th to June 13th, 2023, all patients having interacted with IBD nurse in an expert center, were prospectively recorded. The main points were, the number and characteristics of patients, means and reasons of contact, actions implemented, follow-up and, finally, patient satisfaction assessed using a standardized questionnaire (visual analog scale from 0 to 10). Results During three months, 132 patients, 69 women and 63 men (47% Ulcerative Colitis, 52% Crohn's disease and 1% indeterminate colitis), with a median age of 40 years (16 to 87), had contacted the IBD nurse. The means of contact were phone call: n =131 (42%), text messages: n = 25 (8%), e-mail: n = 69 (22%), face-to-face consult: n = 86 (27.5%) and teleconsulting: n = 1 (0.5%). The reasons for contact were: Three hundred and twelve contacts had led to 315 actions divided into seven groups: Over this period, IBD nurse was contacted 22 times by 19 patients for a real or perceived emergency. These situations were managed by a multidisciplinary team, and resulted in reinsurance (68%), referral to others medical specialist (18%) or hospitalization (14%). Overall satisfaction with the IBD nurse intervention was 10/10 for 78% of patients and 9/10 for 11%. To the question: “do you think that the intervention of the IBD nurse improves disease management?”: 78.5% agreed at 10/10 and 7% at 9/10. To the question: “do you think contact with the IBD nurse improves access to care: 67.5% agreed at 10/10 and 3.5% at 9/10. The main patients’ advice / reviews to improve care were: to adjust levels of follow-up according to the patient and his/her needs, to strengthen the IBD Nurse coordination team to limited days off, to have explanation sheets and reports of IBD Nurse intervention, to develop more workshops for patients in the Education program. Conclusion This pilot study showed the importance of the IBD Nurse activity in an expert center. The patients who benefited from this care were very enthusiastic about it.

P548 Ustekinumab shows favourable safety profile and drug persistence rates in patients with Crohn’s Disease – results from a tertiary IBD centre

Abstract Background Patients with Crohn’s disease (CD) often require multiple biological therapies due to loss of response. Anti-TNF drugs are generally used as first-line biologic followed by a switch of class when patients lose response. Ustekinumab (UST), an IL12/23p40 antagonist is used in CD, often after anti-TNF failure. The aim of the study was to report on outcomes of UST therapy with a median follow-up period of nearly 24 months. Methods All CD patients who commenced UST therapy were identified from EMR at two tertiary referral centers between January 2017 and December 2021. All relevant demographic and clinical data were collected. Data on clinical response (defined as a downgrade in disease activity based on clinician assessment &amp; biochemical parameters), steroid-free duration, and long-term response to UST at 52 and 104 weeks were recorded. The response was assessed clinically and supported by biomarkers, cross-sectional imaging, endoscopic data, and sustained maintenance of UST. Statistical analysis was carried out using the IBM® SPSS® Statistics software package Version: 28.0.0.0. Results A total of 249 CD patients (M=133 (53%); median age 41 years) were included, with a median follow-up period of nearly 24 months (5-79 months). 94 (38%) patients had stricturing (B2), penetrating (B3) and perianal phenotype at baseline and 104 (42%) had undergone previous resection/s. 207 (83%) had documented moderate to severe disease activity and 211 (85%) patients were exposed to at least one biologic prior to treatment with UST. 66 (27%) patients were on concomitant thiopurines at the start of treatment. 224 (90%) patients in our cohort showed clinical response to UST and all remained on treatment at the end of follow-up period. The distribution of patients as per disease activity at baseline, 52 and 104 weeks is illustrated in Figure 1. An improvement in haemoglobin levels was observed post-therapy with UST, which was statistically significant at 104 weeks (p&amp;lt;0.001), with corresponding significant reduction in faecal calprotectin levels (median reduction: 506 mcg/g to 335 mcg at 104w; p&amp;lt;0.001). Only 10 (4%) patients had side-effects which were directly attributed to UST therapy. Conclusion UST is an effective therapeutic option in CD for both bio-naïve and previous biologic failure patients. Although our cohort had a large proportion of patients with complicated and refractory disease, clinical response was observed, regardless of their previous exposure status to biologics, and disease phenotype. UST appears to be well tolerated with a reasonable safety profile. UST has good drug-persistence rates making it economically feasible in the long term. Clinicians could safely continue UST for longer durations to manage CD.