Left-sided Colitis Research Articles

Fecal Calprotectin Correlates with Disease Extent but Remains a Reliable Marker of Mucosal Healing in Ulcerative Colitis.

Fecal calprotectin (FC) is a marker of mucosal inflammatory activity in ulcerative colitis (UC). FC levels may also be influenced by the extent of disease. We aimed to examine the relationships between FC, mucosal activity, and disease extent, and to assess how disease extent affects the diagnostic accuracy of FC. We conducted a single-center observational study of patients with UC. Mucosal inflammatory activity was rated by the Mayo Endoscopic Score (MES) and Nancy Histological Index (NHI). The endoscopic and histological extents of disease were categorized by the Montreal classification and colorectal distribution of histologically active inflammation (NHI ≥ 2), respectively. FC was measured by EliA Calprotectin Enzyme fluoroimmunoassay (Phadia). A total of 518 visits by 254 patients were analyzed. In endoscopically active UC (MES ≥ 2), FC levels were significantly lower in proctitis (440 [IQR: 175-1350] mg/kg) as compared to left-sided colitis (840 [IQR: 298-2011] mg/kg, p = 0.048) or pancolitis (1690 [IQR: 723-2582] mg/kg, p = 0.00005). In MES ≤ 1, FC levels were significantly higher in pancolitis (85 [IQR: 43-350] mg/kg) as compared to proctitis (24 [IQR: 15-116] mg/kg, p = 0.00032) or left-sided colitis (40 [IQR: 15-160] mg/kg, p = 0.012). However, FC remained a reliable marker of mucosal healing across all disease extents, with AUC ranging from 0.878 to 0.915, and no significant differences between the extent categories (DeLong´s test, p ≥ 0.2919). FC showed a significant association with disease extent yet remained a reliable surrogate marker for mucosal healing across all disease extents.

P0244 Serum IgLC Levels in Ulcerative Colitis: Limited Utility as Biomarkers for Disease Activity

Abstract Background Immunoglobulin free light chains (IgLC), which are surplus light chains produced by plasma cells that fail to bind to heavy chains, have been reported to be elevated in Crohn's disease. However, the presence and clinical significance of serum IgLC levels in ulcerative colitis (UC) remains unclear. We investigated serum IgLC levels and their association with disease activity in UC patients. Methods In this prospective study, we enrolled consecutive UC patients (n=25) and assessed disease activity using the partial Mayo score. Serum IgLC kappa and lambda levels were measured using immunoturbidimetric assay. Inflammatory markers including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were also evaluated. Disease extent was classified as proctitis, left-sided colitis, or pancolitis. Results Mean serum IgLC lambda levels were significantly higher in active UC compared to remission (29.8 ± 20.2 mg/L vs. 14.4 ± 3.0 mg/L, P = 0.044). However, IgLC kappa levels showed no significant difference between the two groups (36.0 ± 37.6 mg/L vs. 22.5 ± 7.4 mg/L, P = 0.330). In correlation analysis, CRP and ESR demonstrated strong correlations with disease activity (r = 0.573 and r = 0.517, respectively), while IgLC lambda showed only weak correlation (r = 0.315, P = 0.125). Subgroup analysis by disease extent revealed different patterns: while no biomarkers correlated with disease activity in proctitis, CRP alone showed significant correlation in left-sided colitis (r = 0.718) and pancolitis (r = 0.693), with ESR and IgLC lambda showing no significant associations. Conclusion Despite elevated serum IgLC lambda levels in active UC, its correlation with clinical disease activity was limited. These findings suggest that B-cell activity markers may not serve as reliable biomarkers for UC disease activity assessment.

P1222 The macroscopic and microscopic distribution of IBD in patients with PSC: a polytomous latent class analysis on 3177 endoscopies

Abstract Background Inflammatory bowel disease (IBD) in patients with primary sclerosing cholangitis (PSC) is a distinct disease entity requiring specific management1. Data on characterisation of the phenotype of PSC-IBD are limited and subclassification is lacking. Therefore, this study aims to describe the macroscopic and microscopic distribution of IBD in patients with PSC. Methods A retrospective analysis was conducted on data from PSC-IBD patients included in the EpiPSC2 registry, comprising patients from 46 hospitals across the Netherlands. Data on inflammation at macro- and microscopic level in the ileum and 6 colonic segments were collected on every available endoscopy. Data after (hemi)colectomy were excluded. Polytomous latent class analysis was used to identify subgroups of IBD distribution2. First, latent class models (LCM) were fitted on all endoscopic and histologic data and Akaike and Bayesian information criteria were used to determine the optimal number of classes. After random sampling with replacement the LCM with the ideal number of groups was fitted on 20 samples of one endoscopy with inflammation per subject, and the pooled class probability was calculated per subgroup. Results A total of 3177 endoscopies from 522 PSC-IBD patients (median of 5 [IQR 2-9] endoscopies per patient) were included. The maximum depth of insertion was the terminal ileum in 62% and caecum in 27% of endoscopies. Macroscopic inflammation was observed in 1521 (48%) endoscopies from 428 patients. Segmental colon biopsies were obtained during 650 (20%) endoscopies in 237 subjects, and ileum biopsies in 144 (22%) endoscopies in 100 subjects. Microscopic inflammation in any segment was observed in 265 (41%) endoscopies. An LCM with four classes was the best fit to the macro- and microscopic data: no inflammation, right-sided colitis (pooled class probability 36%), left-sided colitis (30%), and pancolitis (34%). In right-sided colitis and pancolitis the probability of ileal involvement was 16% and 22%, whereas left-sided colitis most often displayed an absence of ileal involvement (probability of 4%) [fig.1]. For microscopic inflammation no pooled class probabilities could be calculated due to low sample size. In 139 (21%) endoscopies, LCM showed more extensive inflammation at microscopic assessment as compared to macroscopic assessment. Conclusion Macroscopic and microscopic inflammation in PSC-IBD may be classified into right sided colitis, left sided colitis, and pancolitis. The microscopic extent exceeds macroscopic inflammation in over 20% of endoscopies with segmental biopsies. Future research into the prognostic implication of this subclassification on PSC- and IBD-related outcomes is required.

P0295 Histological healing reduces the risk of relapse in ulcerative colitis: results of a prospective study

Abstract Background The STRIDE II guidelines recognize endoscopic mucosal healing (MH), defined by a UCEIS score ≤1 or a Mayo endoscopic subscore = 0 (MES), as one of the main therapeutic goals in ulcerative colitis (UC). Nevertheless, histological healing (HH) could reduce the risk of long-term complications in UC. The aim of this study was to assess the risk of relapse in UC depending on the degree of remission achieved. Methods We conducted a prospective study including all consecutive UC patients in clinical remission and endoscopic MH (MES 0 or 1) between January 2021 and January 2024. The primary endpoint was UC relapse, defined as the need for treatment intensification and/or corticosteroids initiation and/or UC-related hospitalization and/or colectomy. Patients were followed up every 6 months for two years. HH was defined as a Nancy index ≤ 1 (blinded double reading). Results A total of 75 patients were included. The median disease duration was 12 years (IQR [7.5-19.0]) and 66 (82%) patients had a left side colitis (E2) or pancolitis (E3). Patients were treated for a median of 3 years (IQR [1.2 - 6.9]) prior to colonoscopy. Mayo=0 and HH were observed in 49 (65%) and 55 (79%) patients, respectively. After a median follow-up of 21.0 months (IQR [12.0 - 26.5]), relapse was observed in 13 patients (17%) after a median delay of 11 months (IQR [6.0 - 18.0]). There was no significant difference in the risk of relapse between MES 1 and MES 0 patients (13.6% vs. 30.7% respectively p = 0.27). The risk of relapse in patient with MES 1 was significantly higher among patient with absence of HH (39.7% versus 20.1% respectively p = 0.04). Similarly, in patients with MES 0, the risk of relapse was significantly higher among patients without HH (70.0% versus 27.4% respectively, p = 0.023). No UC-related hospitalizations or colectomy were reported during follow-up. In multivariate analysis, only absence of HH was associated with disease relapse (HR = 6.1, 95% CI = [1.6 - 23.1], p = 0.01). The degree of correlation between rectal biopsies and whole-colon biopsies was almost perfect (к 0.84 (%-agree 93.1, p < 0.001)) for HH assessment. Conclusion In this prospective study, histological healing was associated with improved long-term outcome in UC patients whatever the degree of endoscopic mucosal healing. Rectal biopsies were effective in identifying HH.

P0378 Normalization or reduction of at least 50% in faecal calprotectin levels after 3 months of treatment predicts clinical and endoscopic remission at 1 year in patients with ulcerative colitis: results of the prospective MIROIR study

Abstract Background The STRIDE-2 consensus considers the improvement of faecal calprotectin (Fcal) (biochemical response) as an intermediate goal in ulcerative colitis (UC). However, no consensual definition of biochemical response is currently available. MIROIR study evaluated the performance of Fcal levels three months after initiating treatment to predict clinical and endoscopic remission at 12 months in UC. Methods In this prospective longitudinal prediction study, any adult UC patient with partial Mayo score (>2) and endoscopic Mayo score (MES) ≥2, requiring starting therapy for UC was included. Patients with acute severe colitis or prior colectomy were excluded. Clinical and biological data, including Fcal levels, were collected, at baseline, month 3 (M3), M6, M9, and M12. Endoscopic and histological (Nancy index) evaluations were performed at inclusion, 3 months, and 12 months. Physicians were blinded from Fcal levels. The primary endpoint was Fcal level at 3 months, while the primary dependent variable was therapeutic success defined as clinical remission (total Mayo score ≤ 2 with endoscopic Mayo score (MES) = 0 or 1) at M12, without dose escalation or treatment discontinuation due to failure. Results Among 62 included patients, the mean age at inclusion was 43.9 ± 14.4 years, with 55.5% being male. UC extent was proctitis (E1) in 13.7%, left-sided colitis (E2) in 39.2%, and pancolitis (E3) in 47.1%. At baseline, endoscopic activity was Mayo 2 and Mayo 3 in 46.3% and 53.7%, respectively. and median ffcal level was 665 µg/g [296-1800]. Initiated therapies were 5-ASA (13.0%), corticosteroids (13.0%), immunosuppressants (5.5%), anti-TNF agents (26.4%), vedolizumab (22.6%), ustekinumab (35.8%), and tofacitinib (3.7%). At M3, 10 patients (18.5%) achieved endoscopic remission (MES 0), 23 (42.6%) showed endoscopic improvement (MES 0 or 1), while 10 (18.5%) and 13 (24.1%) still had endoscopic activity, MES 2 or 3, respectively. The median Fcal level at M3 correlated with MES at M3: 27 [14-142], 115 [20-460], 665 [135-1830], 755 [472-1340] (p = 0.0006) for MES 0, 1, 2 and 3, respectively, and with endoscopic activity (MES ≥2) at M3 (90 [18-192] vs. 679 [428-1830], p = 0.0001) with a substantial effect size (1.32 [0.72-1.91]). Fcal level <150 µg/g at M3 was the best threshold to predict therapeutic success at M12. A decrease of at least 50% in Fcal level at M3 was the best threshold for predicting therapeutic success at M12, with high negative predictive value: 92.3%[74.9% - 99.1%]. Conclusion Our study demonstrates that normalization or reduction of at least 50% in Fcal level after 3 months of treatment predicts therapeutic success at 1 year in ulcerative colitis. This could therefore be proposed as a definition of biochemical response.

P0881 Effectiveness and Safety of Tofacitinib in Biologic-Naïve Elderly Patients with Ulcerative Colitis

Abstract Background The prevalence of ulcerative colitis (UC) is increasing in elderly populations, yet real-world data on the efficacy and safety of tofacitinib in this demographic remains limited. This study aimed to evaluate the real-world effectiveness and safety of tofacitinib in elderly patients (≥60 years) with moderate-to-severe UC treated at a tertiary care center in North India. Methods This cohort study was conducted at Dayanand Medical College and Hospital, Ludhiana, from July 2022 to June 2024. Elderly patients (aged ≥60 years) with moderate-to-severe UC refractory to conventional therapies were included. Patients received tofacitinib at a dose of 10 mg twice daily for induction, followed by 5 mg twice daily for maintenance, and were assessed at weeks 8 and 52. The primary outcome was steroid-free remission at both weeks 8 and 52. Secondary outcomes included clinical remission (partial Mayo score ≤1), clinical response (≥3-point reduction in partial Mayo score), and steroid-free remission at individual time points. Adverse events were systematically recorded. Results A total of 35 patients (median age: 64 years, 40% male) were analyzed. Most patients (80%, n=28) had left-sided colitis. The primary outcome of steroid-free clinical remission at both weeks 8 and 52 was achieved in 9 patients (25.71%). At week 8, clinical remission, steroid-free remission, and clinical response were observed in 18 (51.42%), 15 (42.85%), and 22 (62.85%) patients, respectively. At week 52, clinical remission and steroid-free remission were each achieved in 22 (62.85%) patients, while 27 (77.14%) patients demonstrated a clinical response. The most common adverse events included hair loss (17.14%, n=6), sadness of mood (11.42%, n=4), and dyslipidemia (8.57%, n=3). Three patients developed self-limiting herpes zoster infection, and one patient reported bilateral retinal vein occlusion. Conclusion Tofacitinib demonstrated favorable efficacy and safety in biologic-naïve elderly patients with moderate-to-severe UC. These findings highlight its potential as a viable treatment option for this growing and often underrepresented patient population.

P0394 Sex- and phenotype-specific patient-reported outcomes and symptoms in newly diagnosed-inflammatory bowel diseases – a prospective population-based study

Abstract Background Sex and disease phenotype contribute to heterogeneity in inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). We aimed to investigate the relationship between sex, phenotype, patient-reported outcomes (PROs), and symptoms in newly diagnosed IBD. Methods Between May 1, 2021, and April 30, 2023, all adult and pediatric patients with incident IBD within a catchment area covering 20% of Denmark were enrolled in the prospective, population-based Copenhagen IBD Inception Cohort.1 Adult patients completed multiple PROs and symptom indices at the time of IBD diagnosis. Logistical regression analyses were adjusted for sex, age, and disease phenotype. Results A total of 203 patients with UC and 116 patients with CD completed PRO questionnaires within a median of 1.2 months (IQR 0.3–3.0 months) post-diagnosis. Sex- and phenotype-specific analyses revealed significant PRO impairments at IBD diagnosis (Figure 1). Female patients with UC reported worse health-related quality of life (HRQoL; Short Inflammatory bowel Questionnaire) (adjusted odds ratio [aOR]=3.73; 95% CI 1.69-8.22), disability (IBD Disability Index; aOR=7.85; 95% CI 2.86-21.58), and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; aOR=3.36; 95% CI 1.60-7.05) compared to males. Females with CD reported more disability (aOR=5.37; 95% CI 1.95-14.77) but not severe fatigue (aOR=1.90; 95% CI 0.85-4.25) compared to males. Phenotype-specific analyses showed that females with proctitis reported significantly worse HRQoL and fatigue than males, while females with extensive colitis experienced higher rates of disability and fatigue (Figure 1). Among CD patients, sex differences were observed only in moderate-to-severe disability, primarily in ileal and colonic disease (Figure 1). Table 1 reports the association between gastrointestinal symptoms, and moderate to severe PROs, along with sex- and phenotype-specific interactions. In UC, the relationship between abdominal pain and moderate to severe impairment of HRQoL was modified by sex, with females experiencing a stronger association than males. In addition, the relationship between stool urgency and moderate to severe impairment of HRQoL was modified by disease extent, with proctitis cases experiencing a stronger association than cases with left-sided colitis. No significant interactions were observed in CD. Conclusion This prospective, population-based cohort revealed substantial PRO impairments at the time of IBD diagnosis, with more pronounced impairments in females compared to males. These findings highlight the need for sex- and phenotype-specific approaches to optimize IBD management and improve patient outcomes.

P0272 Evaluation of Rectal Wall Thickness Measurement Sensitivity via Transabdominal Ultrasound to Assess Mucosal Activity in Ulcerative Colitis: Could This Be a Useful Non-Invasive Tool? A Preliminary Analysis.

Abstract Background Ulcerative colitis (UC) is a chronic inflammatory bowel disease where accurate assessment of disease activity is essential for patient management. Endoscopy is the gold standard for evaluating mucosal inflammation, but non-invasive alternatives, such as transabdominal ultrasound (TAUS), are garnering interest. This study aimed to evaluate the sensitivity of rectal wall thickness measurement using TAUS to assess UC activity, comparing to endoscopic and histological findings. Methods In a prospective, observational study, we enrolled consecutive adult patients with UC who were referred to our tertiary center from May to October 2024. Eligibility required a scheduled TAUS before 30 days of a staging colonoscopy, without intervening therapy adjustments. Exclusion criteria included technically inadequate TAUS readings (e.g., due to anatomical variations or excessive gas interposition). In all patients we evaluated rectal wall thickness and laboratory parameters such as C-Reactive Protein and fecal calprotectin. Disease activity was assessed by endoscopist (MAYO score). Histological status (active/inactive) and additional clinical data, including disease duration, extent, and UC treatment, were recorded. Results We studied 29 patients (51.7% females, median age 55 years). The median UC duration was 10 years, and most patients had proctitis or left-sided colitis (37.9% each). Patients with an endoscopic MAYO score of 0 or 1 had a median rectal wall thickness of 4.7 mm (IQR 4.5-5.5), while those with a score of 2 or 3 had a median of 7.0 (IQR 5.3-7.4 mm, p=0.005). ROC analysis of TAUS rectal wall thickness revealed significant discriminatory capability for endoscopic activity (AUC: 0.833, CI 95%, 0.678-0.989), while the same figures for fecal calprotectin and C-Reactive Protein were 0.890 (CI 95%, 0.671-1.000) and 0.774 (CI 95%, 0.604-0.944), respectively. For histological activity, accuracy of rectal wall thickness, fecal calprotectin, and C-Reactive Protein were 0.796 (CI 95%, 0.620-0.972), 0.790 (CI 95%, 0.605-0.975), and 0.645 (CI 95%, 0.429-0.861), respectively. Conclusion This preliminary analysis showed that rectal wall thickness measured by TAUS has a high accuracy in identifying both endoscopic and histologic activities in patients with UC, positioning it as a promising tool to avoid endoscopy. Future studies with larger cohorts are needed to confirm these findings and further optimize the use of TAUS in this setting.

P1098 The Clinical Spectrum of Acute Severe Ulcerative Colitis in the Biologic Era

Abstract Background Acute severe ulcerative colitis (ASUC) is a time critical situation requiring urgent intervention. Limited data exist on the evolving clinical spectrum of ASUC in the era of advanced therapies. Methods This prospective cohort study included 145 adult patients hospitalized with ASUC between January 2020 and June 2024. ASUC was defined by the modified Truelove and Witts (TW) criteria. Demographics, disease characteristics, including disease severity, probable precipitating factors, and corticosteroid failure rates were recorded. Results The median age of patients was 36 (26-48.5) years with 63 (43.4%) females. Most patients had left-sided colitis (53.1%). The median disease duration was 2 (IQR 1-4) years, with 91 (62.7%) patients presenting with ASUC within the first year of diagnosis of UC. One-third of the patients had previous exposures to biologics and small molecules. The most commonly reported probable precipitants of ASUC were poor compliance with treatment (n=43, 29.6%), antibiotic use (n=35, 24.1%), high perceived stress (n=32, 22.1%), and Clostridioides difficile infection (n=19, 13.1%). Forty (27.5%) patients were non-responders to intravenous corticosteroids. Twenty-nine (20%) patients received medical rescue therapy (infliximab, n=14[48.27%], cyclosporine A, n=6[20.68%], and tofacitinib, n=9 [31.03%]). Four (2.75%) patients underwent colectomy. Conclusion In this cohort of ASUC patients, poor treatment compliance, antibiotic use, stress, and C. difficile infection were common precipitants of flare-ups. Nearly one-third of patients required medical rescue therapy, and a small proportion underwent colectomy.

P0800 Efficacy of filgotinib in patients with ulcerative colitis refractory to prior biologics

Abstract Background Filgotinib has shown promise for patients with moderate-to-severe Ulcerative Colitis (UC) who are refractory to prior biologics. Given the need for effective alternatives in this challenging patients, this study examines the efficacy of filgotinib in biologic-refractory patients. Methods An observational, descriptive, ambispective, single-center study of 29 patients with active UC who were started on filgotinib 200mg/24h between October 2018 and May 2024. Clinical and biochemical variables analyzed: partial Mayo Score (PMS), endoscopic evaluation, fecal calprotectin (FC) and the adjuvant treatment-free response (corticosteroids or apheresis) at weeks 8, 16, 26 and 52. Other variables were also measured: disease characteristics, previous biologic treatments and concomitant use of corticosteroids and immunomodulators. Results The median age was 43 (IQR 32-53) years, 45% were women. The median disease duration was 7 (IQR 3-14) years. One patient smoked at the beginning of treatment, and ten were ex-smokers. 45% had extensive colitis (E3, according to Montreal classification), and 55% had left-sided colitis. In 13 patients, colonoscopy was performed prior to drug initiation, with 92% presenting an endoscopic Mayo score 2-3. The most unique feature of our cohort is the high refractoriness to previous biologic treatments. Only one patient was naïve to biologics, as he was not a candidate for anti-TNF due to a history of multiple sclerosis. Of the remaining 28 patients, the majority (97%) had failed anti-TNF treatment, 41% had also failed ustekinumab and 34% had failed vedolizumab. At the time of treatment initiation, 45% were receiving concomitant oral or intravenous corticosteroids. In terms of baseline disease activity, the median PMS was 6 (IQR 5-7), and the median FC was 2000 (IQR 1664-2000) µg/g. Median follow-up was 26 (8-52) weeks. At weeks 8, 16, 26 and 52, the clinical response (PMS reduction ≥2) and clinical remission (PMS ≤1) rates were 83%/45%, 80%/64%, 72%/56% and 62%/47%, respectively (image 1). There was a significant decrease in FC: 1124 (IQR 155-2000) µg/g, 860 (IQR 53-2000) µg/g, 187 (IQR 82-1107) µg/g and 165 (IQR 17-1910) µg/g at weeks 8, 16, 26 and 52, respectively. Adjuvant treatment-free response was 43% with an estimated Kaplan-Meier curve persistence of 48% at 1 year (image 2.1). During follow-up, filgotinib was discontinued in 7 patients, 4 of them in the first 8 weeks. Attached is the Kaplan-Meier curve for the persistence of Filgotinib (image 2.2) estimated at 72% at 1 year. Conclusion Filgotinib is effective in the treatment of biologic-refractory ulcerative colitis in selected patients, achieving a high clinical remission rate and significantly reducing the need for adjuvant treatment.

P0413 Clinical features of pediatric ulcerative colitis with atypical endoscopic findings

Abstract Background Atypical endoscopic features are not uncommon in newly diagnosed pediatric ulcerative colitis (UC) compared to adults. However, the clinical meaning of these atypical endoscopic features at diagnosis are obscure. We aimed to clarify the clinical characteristics of pediatric patients with UC who do not exhibit typical endoscopic findings. Methods This is a retrospective study of the newly diagnosed pediatric patients with UC. The inclusion criteria are as follows: (1) aged 15 years or younger at the time of diagnosis, (2) diagnosis of UC according to the criteria set by the Japanese Ministry of Health, Labour and Welfare, and (3) attendance at Kobe University Hospital (Kobe, Japan) between April 2018 to January 2024. Endoscopic activity was assessed using the Mayo Endoscopic Subscore. Patients were categorized into two groups based on the endoscopic findings at diagnosis. The “typical group” was defined as patients who showed endoscopic inflammatory activity starting in the rectum and expanding proximally in a continuous manner. All other patients were classified as the “atypical group”. We compared the background characteristics and the clinical course between the two groups. Results Thirty-three patients were included in this study. Sixteen patients (48.5%) were male, and the median age at diagnosis was 13 years. The median Pediatric Ulcerative Colitis Activity Index (PUCAI) score was 40, while the median serum level of albumin, hemoglobin, and CRP were 3.8 g/dL, 11.9 g/dL, and 1.0 mg/L, respectively. At the time of diagnosis, 2 patients had proctitis, 3 had left-sided colitis, 27 had pancolitis, and 1 had right-sided colitis. Endoscopic activity was mild in 4 patients (12.1%), and moderate in 29 (87.9%). Of the 33 patients, 21 (63.6%) were classified into the typical group and 12 (36.4%) into the atypical group based on colonoscopy at diagnosis. There was no difference between the two groups in terms of baseline characteristics such as sex, age at diagnosis, duration of symptoms before diagnosis, endoscopic activity, and the extent of the disease. The median albumin level was lower in the typical group than in the atypical group (p=0.006). Kaplan-Meier analysis showed that patients in the atypical group were more likely to maintain a biologic-free condition than those in the typical group (p=0.028). Patients in the atypical group were also likely to remain in a steroid-free condition compared with those in the typical group, although not statistically significant. Conclusion Pediatric patients with UC who have typical endoscopic findings of a continuous lesion extending from the rectum at diagnosis may have a poor prognosis and require advanced therapy compared to those with atypical endoscopic findings.

P0710 Effectiveness and Safety of Filgotinib After One Year in Patients with Ulcerative Colitis: Preliminary Results from the Filguito Registry in Andalusia (Spain)

Abstract Background Filgotinib represents a novel therapeutic option for the treatment of moderate-to-severe ulcerative colitis. This observational study aims to evaluate the efficacy and safety of Filgotinib in real-world clinical practice. Methods A retrospective registry was conducted across 10 hospitals in Andalusia, Spain, collecting clinical and biochemical data from 76 patients treated with Filgotinib. The analysis was performed at various treatment time points (baseline, 8 and 16 weeks, 6 and 12 months), irrespective of the treatment initiation time. Clinical remission (CR) was defined as a partial Mayo score ≤ 2 points, Clinical-Biochemical Remission (CBR) as a partial Mayo score < 3 and Calprotectin < 250 μg/g, and Steroid-Free Remission (SFR) as a partial Mayo score < 3 with no corticosteroid use since week 8. An intention-to-treat analysis was performed. Results The 76 enrolled patients had a mean age of 39.5 years (range: 19–76), with 54% being male. Extensive involvement was present in 60.3%, left-sided colitis in 34.2%, and proctitis in 5.5%. The mean duration of disease was 9 years (range 1-17). 3% were active smokers, and 17% were former smokers. 25% had extraintestinal manifestations, mainly articular (20%). The mean number of previous failed advanced treatments was 2. At treatment initiation, 79% were on 5-ASA therapy, 11% on Azathioprine, and 44% were using corticosteroids. 54% of patients had prior vaccination against the Zoster virus (Table 1a) The clinical and biochemical efficacy data are presented in Table 1b. At the time of the study, 19 patients had discontinued treatment before 6 months (27%), and 21 before 12 months (30%), primarily due to primary/secondary failure (85%), with two cases due to adverse effects (evening fever and intolerance), and one due to pregnancy. No serious adverse events were reported. Conclusion In a real-world cohort of patients with multi-refractory ulcerative colitis, Filgotinib demonstrated favorable efficacy and safety outcomes. References -Van Rompaey L, Galien R, van der Aar EM, et al. Preclinical characterization of GLPG0634,a selective inhibitor of JAK1, for the treatment of inflammatory diseases. J Immunol 2013;191: 3568–77. -Danese S, Argollo M, Le Berre C, Peyrin-Biroulet L. JAK selectivity for inflammatorybowel disease treatment: does it clinically matter? Gut 2019; 68:1893–99. -Feagan BG, Danese S, Loftus EV Jr et al. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double- blind, randomised, placebo-controlled trial. Lancet. 2021 Jun19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021Jun 3.

P0290 Predicting disease remission in Ulcerative Colitis patients - early results from the PRESAGER study

Abstract Background The disease course of Ulcerative Colitis (UC) remains unpredictable. While some patients experience years of remission, others experience frequent flares, hospitalization, and surgery. The PRESAGER study aims to develop decision models to predict UC disease activity. In this preliminary analysis, we created a logistic regression model to identify predictors of remission. Methods UC patients with disease activity (Mayo endoscopic score [MES] ≥ 1) were recruited into the study. Demographic data, disease history, IBD Disability Index (IBD-DI), biopsies, and blood samples were collected at inclusion. Eight weeks later, patients were followed up with IBD-DI, blood samples, and an optional sigmoidoscopy. Medications taken before inclusion and during the follow-up period were recorded. Symptomatic or endoscopic remission was noted depending on if patients opted for follow-up endoscopy. Using multivariate logistic regression, we examined the association between inclusion data and disease remission. Stepwise model selection by Akiake information criterion (AIC) was used to create a logistic regression model with the most relevant predictors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs) and p-values. AI was used for writing inspiration and help with R coding, and no work was copied directly from an AI source. Results As of September 2024, 250 patients were included in the study. 182 (73%) patients had completed eight-week follow-up with IBD-DI and blood samples, and 72 (29%) patients had completed the eight-week follow-up sigmoidoscopy. At inclusion, left-sided colitis and moderate disease activity were most common. When looking at medications taken within 14 days of inclusion, 66% of patients used mesalazine suppositories and 61% used oral mesalazine or sulfasalazine (Figure 1). Other treatments included mesalazine foam/enemas (30%), oral corticosteroids (26%), immunomodulators (18%), and biologics (14%). A multivariate logistic regression model showed that older age and higher IBD-DI scores significantly reduced the likelihood of remission, whereas a longer disease duration was linked to a greater likelihood (Table 1). Surprisingly, calprotectin levels above 500 was associated with increased likelihood of remission compared to levels below 250. Additionally, patients with moderate disease activity had a greater likelihood of remission than those with mild activity, likely due to the increased use of corticosteroids and biologics in these cases. Conclusion Older age and higher disability scores significantly reduced the likelihood of remission for UC patients, while longer disease duration, moderate disease activity, and high calprotectin increased the likelihood.

P1065 Rapid onset of action of ustekinumab in patients with moderate to severe Ulcerative Colitis (RAUCU Study)

Abstract Background Real-world data on the speed of onset of ustekinumab (UST) in patients with ulcerative colitis (UC) are limited. Current information regarding early response in these patients comes from the UNIFI trial. The primary outcome of this study was to evaluate the response to UST in patients with moderate-to-severe UC by assessing PRO2 at 14 days after the first intravenous dose (6mg/kg). Methods A multicenter, prospective observational study was designed in patients ≥18 years old with moderate-to-severe UC (partial Mayo score ≥6) who initiated UST 6mg/kg between June 2023 and September 2024. Patients received a diary to record the stool frecuency and rectal bleeding during first 14 days after first dose of induction. The proportion of patients achieving the combined outcome of rectal bleeding score = 0 and stool frequency score ≤ 1 (PRO-2: patient-reported outcome 2 remission) was assessed. FC was measured at baseline and at day 7 and 14. Health-Related Quality of Life was evaluated using the disease-specific shortened Spanish version of the IBDQ (SIBDQ-9) at baseline and at 4 weeks. Patients with previous panproctocolectomy with ileostomy or pouch and those who had received cyclosporine within one month prior to starting UST were excluded. Descriptive statistics are presented as frequencies with percentages for categorical variables. Results A total of 54 patients were included across 14 hospitals in Spain. Of these, 29 (53.7%) were men, with a mean age of 54 (± SD 16.1) years. Thirty (55.6%) patients had pancolitis, 20 (37%) had left-sided colitis, and 4 (7.4%) had proctitis. Five (9.3%) patients were bio-naïve, 32 (59.3%) had previously received one biological therapy, 10 (18.5%) had received two, and 7 (13%) had received three biologics prior to starting UST. Mean decreases in stool frequency and rectal bleeding are shown in Figure 1. By day 14, 26% of patients had achieved clinical remission. No significant differences in clinical remission were observed based on disease extent (p = 0.11) or the number of prior biologics (p = 0.39). By day 7, 12/31 (38.7%) patients with baseline bloody stools had achieved a rectal bleeding score = 0. A reduction in FC >50% was observed in 14/48 (29%) patients by day 7 and in 20/47 (43%) patients by day 14. The SIBDQ9 average score was 54.9 (± SD 6.2) at baseline and 61.3 (± SD 7.4) at week 4. Conclusion One-quarter of patients with moderate-to-severe UC achieved clinical remission by day 14 following the first induction dose of UST. Nearly 40% of patients achieved a rectal bleeding score = 0 (PRO2) by day 7. A reduction in FC >50% was observed in 43% of patients by day 14.

P0453 Intestinal Ultrasound Correlates with Patient-Reported IBD Disability in Ulcerative Colitis: A Step Towards Integrated Monitoring

Abstract Background Non-invasive imaging methods, particularly intestinal ultrasound (IUS), are increasingly pivotal in guiding management in ulcerative colitis (UC). While long-term treatment goals focus on reducing IBD-related disability, the link between ultrasonographic findings and patient-reported outcome measures (PROMs), such as IBD-related disability, remains unclear. Methods Data on IBD-related disability (using the IBD disk) were prospectively gathered through a digital questionnaire from patients with UC undergoing routine IUS, and performed within maximal one week of each other. Patients with isolated proctitis were excluded. Bowel wall thickness (BWT) was averaged from two independent measurements >1 cm apart, alongside colour Doppler assessments, all blinded to IBD disk data. The Milan Ultrasound Criteria (MUC) score was calculated, with relevant ultrasound activity defined as MUC >6.2 (worst affected segment).1 A high IBD-related burden was defined as an IBD disk score >40. Correlation analysis was performed using Spearman’s rank coefficient. Results Thirty-one paired assessments (median interval: 0.0 [IQR 0.0–3.0] days) were conducted on unique UC patients (38.7% female, median age 32.6 [28.0–45.9] years, median disease duration 1.3 [0.3–6.6] years, 71.0% left-sided colitis). Ultrasound activity (MUC >6.2) was present in 51.6% of patients, while 29.0% reported a high IBD-related disability. Total IBD disk scores correlated significantly with maximal BWT (r=0.41, p=0.02), modified Limberg Doppler signal (r=0.35, p=0.05), and MUC scores (r=0.44, p=0.01). Patients without MUC-defined inflammation showed significantly lower IBD-related disability (median IBD disk score: 41.0 [26.0–52.0]) compared to those with inflammation (72.0 [58.0–78.0], p=0.001) (Figure 1A). Individual IBD disk components—abdominal pain, body image, education/work impact, emotions, energy, interpersonal interactions, defecation regulation, sexual function, and sleep—differed significantly between patients with and without ultrasonographic inflammation (Table 1). Quartile analysis revealed that normal ultrasonographic findings were most likely in patients with the lowest IBD disk scores (Q1 vs Q2–Q4: 87.5% vs 53.3%, p=0.02) (Figure 1B). Receiver Operating Characteristic (ROC) analysis suggested a stricter MUC cutoff of 5.3, achieving 71.0% [48.1–93.8%] accuracy in estimating IBD-related disability with a negative predictive value of 88.2%. Conclusion In patients with UC, IUS findings correlate with IBD-related disability and warrant further exploration as potential endpoint and/or treatment target. However, these metrics seem complementary rather than fully interchangeable.

P0555 Quantitative Assessment of Colon Motility in Ulcerative Colitis using Magnetic Resonance Enterography: Correlation with Endoscopic Disease Activity

Abstract Background Changes in small bowel motility have been quantified by magnetic resonance enterography (MRE) in Crohn’s disease to assess disease activity, but there is no data about colon motility changes in ulcerative colitis (UC). The aim of this study was to examine the correlation between colon motility (bowel wall motion) and endoscopic and laboratory features of activity in patients with UC. Methods This prospective study included 33 adults with known UC (mean age 38 [SD: 12.9] years, 51% female) and 30 controls (mean age 46 [SD: 15.2] years, 73% female). Two board-certified radiologists, blinded to clinical and endoscopic information, assessed motility scores for each colonic segment from dynamic cine MRE sequences using FDA-approved software with higher GIQuant scores indicating greater motility. Mayo endoscopic scores (MES) were determined by two experienced gastroenterologists in a consensus for each segment. Colonoscopy and laboratory tests were performed within 14 days of MREs. We used a mixed-effects linear model to evaluate the correlation between MES and motility scores across the five segments per patient. Results UC group consisted of 12 (36%) and 21 (64%) patients with left-sided colitis and pancolitis, respectively. The median value of GIQuant score for all colonic segments was significantly lower in UC patients (1184, IQR 693 to 1675) than controls (1245, IQR 851 to 1693) (p= 0.006). There was a decreasing trend of motility from ascending colon to rectum in controls with the similar pattern in UC patients except for lower motility of sigmoid than rectum. Per segment analysis of UC cases revealed a weak negative correlation between GIQuant and MES only in sigmoid (r= -0.2, p= 0.01). The mixed-effects model in per patient analysis identified a significant negative association between MES and GIQuant, indicating that each one-score increase in MES corresponds to a 144.3-point reduction in GIQuant between the less and more-involved colonic segment (β = -144.30, SE = 33.19, p < 0.001, 95% CI: -209.34 to -79.25). No significant correlation was found between the median GIQaunt score of all involved colonic segments and fecal calprotectin or serum CRP levels. Conclusion Higher endoscopic UC activity in each colonic segment is associated with lower motility compared to the less involved segments in each patient. Given the significant between-patient variability, colon motility should be assessed individually. MRE-based colon motility scores may provide an objective, transmural and physiological impression to complement endoscopy which may aid personalized assessment of UC activity.

P0474 Five-Year Clinical Outcomes and Disease Course of Newly-Diagnosed Moderate-to-Severe Ulcerative Colitis: A Prospective Nationwide Multicentre MOSAIK Cohort Study in Korea

Abstract Background While the incidence of moderate-to-severe ulcerative colitis (UC) is rising in Asia, comprehensive data on its long-term disease course in Asian populations remain scarce. Methods The MOSAIK (MOderate-to-Severe ulcerAtive colItis in Korea) study is a prospective, multicentre, hospital-based, inception cohort that enrolled 353 patients newly diagnosed with moderate-to-severe UC between August 2014 and February 2017.1 Clinical outcomes and predictors of a disabling disease course were evaluated over 5 years of follow-up. Results Among 353 patients, the median age at UC diagnosis was 37.6 years (standard deviation, 15.2) with male predominance (58.9%, 208/353) (Table 1). Baseline disease activity was predominantly moderate (93.2%, 329/353) rather than severe (6.8%, 24/353), with median full Mayo Clinic Score (MCS) of 8 (Interquartile range [IQR], 7–9) and partial MCS of 6 (IQR, 5–7). Disease extent at diagnosis showed proctitis (10.7%, 37/353), left-sided colitis (46.7%, 162/353), extensive colitis (42.7%, 148/353). The median duration of follow-up was 4.9 years (IQR, 2.1–5.0), with 214 patients (60.6%) completing the 5 years (week 260). Treatment patterns during follow-up included: oral 5-aminosalicylates (96.3%, 340/353), topical 5-aminosalicylates (70.8%, 250/353), systemic corticosteroids (65.7%, 232/353), immunomodulators (38.5%, 136/353), biologics (20.1%, 71/353), and JAK inhibitors (1.7%, 6/353). At 5 years, the major disease outcomes were: relapse (62.9%), hospitalisation (26.9%), and proximal disease extension (29.5%). The colectomy rate was notably low (0.6%) with no mortality. A disabling disease course occurred in 171 patients (48.4%), with cumulative probabilities increasing from 41.0% at 1 year, 51.1% at 3 years, to 53.9% at 5 years. Baseline elevated white blood cell count was independently associated with a disabling disease course (adjusted hazard ratio, 1.062, 95% confidence interval, 1.004–1.123, P=0.0353). Using unsupervised clustering analysis (K-Means) of partial MCS, with missing data imputed using random forest, we identified 5 distinct disease trajectory patterns. These trajectories effectively discriminated clinical outcomes including relapse, persistent disease activity, hospitalisation, and disabling disease course (Figure 1). Conclusion In this Korean inception cohort, 48.4% of patients with moderate-to-severe UC revealed a disabling disease course over 5 years. Novel clustering analysis based on partial MCS identified 5 distinct disease trajectories that effectively predicted clinical outcomes, providing a potential framework for risk stratification. Funding This study was supported by Janssen Korea Ltd..

P0849 Real-world efficacy and safety of filgotinib in ulcerative colitis: results from the ENEIDA registry

Abstract Background Ulcerative colitis (UC) is a chronic inflammatory disorder characterized by periods of relapse and remission. Current treatment options aim to achieve mucosal healing and sustain long-term remission, yet many patients experience treatment failure. Filgotinib (FIL), a selective JAK1 inhibitor, has emerged as a promising therapeutic agent in UC management with favorable outcomes in clinical trials. This study aimed to evaluate the real-world efficacy and safety of FIL in patients with moderate-to-severe UC. Methods We conducted a multicenter, observational, retrospective study involving adult patients with moderate-to-severe UC who were treated with FIL within the ENEIDA registry, a nationwide prospectively-maintained database. Data were collected from 28 Spanish IBD units between 12/2021 and 10/2024. Patients were eligible if they had an established diagnosis of UC, had been initiated on FIL and without previous colectomy. The primary outcome was clinical remission (partial Mayo ≤2 with no subscore >1 and no rectal bleeding) at week 12 and 52, along with its safety profile. Results A total of 91 patients were included (mean age of 37.5 years (SD 18), 63% male, and a median disease duration of 83 months [IQR, 35-148], 65% non-smokers, 15% extraintestinal manifestations). Most of them had extensive (49%) or left-sided colitis (42%). Prior exposure to anti-TNF was present in 89%, vedolizumab in 43%, and ustekinumab in 38%, with 18% also exposed to JAK inhibitors. The majority of patients had Mayo 2 or 3 endoscopic score (87%). All but 2 patients started FIL 200 mg bid (98%) and 27% received concomitant steroids or immunosuppressants (5%). Steroid-free clinical remission was 42% and 48% after 12 and 52 weeks, respectively (Figure 1). FIL persistence was 64% with median treatment duration of 6 months (IQR, 3.8-9.7). Those previously exposed to JAK inhibitors showed a 80% and 40% persistence after 12 and 52 weeks, respectively. This subgroup showed similar steroid-free clinical remission rates of 33% and 17%, respectively. Overall, hospital admission was indicated in 7% and colectomy in 1%. FIL was generally well-tolerated, with 18% of patients reporting at least one adverse event, 19% of them considered as serious, including herpes zoster infection in 2% (both vaccinated, 1 severe infection requiring FIL withdrawal), with no cardiovascular or thromboembolic events reported. Conclusion In this real-world, multicenter observational study, FIL demonstrated its efficacy in the induction and maintenance of clinical remission in patients with active UC. The real-world safety profile was consistent with previous data, with no unexpected adverse events. These findings support FIL as a valuable therapeutic option in the management of UC.

P0577 Influence of Pregnancy on Outcomes of Inflammatory Bowel Disease and Medication Adherence

Abstract Background Treatment of inflammatory bowel disease (IBD) is challenging due to the maintenance of remission and associated fetal safety concerns during pregnancy. While existing literature emphasizes the importance of achieving remission prior to conception, optimal management of IBD during pregnancy remains underexplored, especially regarding medication continuation and efficacy. Methods This cross-sectional study was performed in pregnant patients with IBD between March 2019 and June 2023. Clinical features, treatment details, disease activation and outcomes were collected and analyzed. Results A total of 57 pregnant were included, of those 37 (64.9%) had UC, and 20 (35.1%) had CD. The overall median disease duration was 9.1 (6-12.8) years (8.2 years for UC and 9.9 years for CD). The disease location was 19 (51.4%) left-sided colitis, 15 (40.5%) extensive, and 3 (8.1%) proctitis in UC, while in CD 8 (40%) patients were ileal involvement, 8 (40%) ileocolonic and 4 (20%) colonic. 4 (20%) had stricturing disease and 4 (20%) had penetrating disease in CD. Before pregnancy, medical treatments for UC patients were mesalazine in 29 (78.4%) patients, thiopurine in 20 (54.1%), biologic therapy in 6 (16.2%), while it was 13 (65%) patients biologic therapy and 7 (35%) thiopurine in CD patients. The most prescribed biologic agent was infliximab in both diseases. During pregnancy, 16 (28.1%) patients [6 (18.8%) with UC and 10 (50%) with CD] had a history of drug withdrawal. 13 (%81) medications were withdrawn by the patient's wish. Disease activation occurred in 25 (43.9%) patients, 10 (50%) with CD, and 15 (40.5%) with UC. 12 (48%) patients required steroids due to activation. There were 54 (94.7%) live births when compared based on whether disease activation developed or not, there was no statistically significant difference in live birth rate 23, 92% vs. 31, 96.9%, p=0.576. There was no statistically significant difference between normal birth and cesarean section rates with activation development. 3 (5%) abortions occurred. Abortion rate was not associated with disease activation (p>0.05). No serious infection occurred during the first month following birth. Conclusion In this study, the disease activation was seen in 43.9% of pregnant patients with IBD. Consistent medication management of IBD during pregnancy enhances patient adherence, reduces risks, and promotes positive maternal outcomes. Proactive counseling and careful selection of medications are crucial for disease control and optimizing pregnancy outcomes in IBD patients.

P1110 Results from the UPITA-Colitis Registry on the Effectiveness and Safety of Upadacitinib in the Induction phase in Patients with Ulcerative Colitis

Abstract Background Upadacitinib, a next-generation JAK inhibitor, has shown positive results in phase 3 studies and was recently approved for moderate-to-severe ulcerative colitis. Our objective is to assess its effectiveness and safety in routine clinical practice. Methods Clinical and biochemical data were retrospectively collected from 14 hospitals in Andalusia, Spain. Clinical and analytical data up to week 16 were analyzed for patients who reached that point. Clinical remission (CR) was defined as a Partial Mayo Index ≤ 2 points, clinical-biochemical remission (CBR) as a Partial Mayo Index <3 and Calprotectin <250 μg/g, and remission without steroids (RWS) as a Partial Mayo Index <3 with no corticosteroid use since week 8. An intention-to-treat analysis was performed. Results A total of 70 patients were included, with a mean age of 37 years (range 17-69), 63.4% male. 59.2% had extensive disease, 30.8% left-sided colitis, and 10% proctitis. Of these, 82.1% were non-smokers, and 13.4% were ex-smokers. Extra-intestinal manifestations were present in 36%. The mean number of prior failed advanced treatments was 2. At the start of treatment, 33% were on 5-ASA therapy, 5% on Azathioprine, and 46% were taking corticosteroids. 67% of patients had prior Zoster virus vaccination. Induction with 45 mg for 8 weeks was administered to 57% of patients, 12 weeks to 18.5%, and 16 weeks to 4.1% (Table 1a)). Clinical and biochemical efficacy data are shown in Table 1b. At the time of the study, 6 patients had discontinued treatment before week 16, including two due to primary failure, one due to reactivation of Zoster virus, one due to pneumonia, and one for personal reasons. The following mild and transient adverse effects were reported (8.9% of total patients): 2 cases of cold sores, 2 cases of acne, and 1 case of paresthesia. Conclusion Upadacitinib proves to be an effective and useful treatment for induction of remission in refractory patients with ulcerative colitis, with an acceptable safety profile. References -Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hébuterne X, D’Haens G, Nakase H, Panés J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum in: Lancet. 2022 Sep 24;400(10357):996 -D’Haens G, Lindsay JO, Panaccione R, Schreiber S. Ulcerative colitis: shifting sands. Drugs R D 2019; 19: 227–34.9- Boland BS, Sandborn WJ, Chang JT. Update on Janus kinase antagonists in inflammatory bowel disease. Gastroenterol Clin North Am 2014; 43: 603–17