bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0708 Advanced Therapies in Elderly Patients with Inflammatory Bowel Disease: A Comparative Retrospective Cohort Study in Taiwan
Authors: Lin S H , Chiu H Y , Kuo C J , Chen C M , Wu R C , Chiu C T , Su M Y , Chang C W , Pan Y B , Le P H 
Published: January 2025

Abstract

Background
Inflammatory bowel disease (IBD) primarily affects young people, but increasing evidence indicates a shift toward older age. Elderly-onset IBD has several unique features, including atypical presentations and a higher risk for infections and malignancies. However, no studies have compared the clinical outcomes and analyzed the persistence of different advanced therapies in elderly-onset IBD patients. This study aims to address this gap.

Methods
In this retrospective cohort study, we included all IBD patients receiving advanced therapies and regular follow-ups at the Chang Gung IBD Center from October 2017 and September 2023. Patients were divided into two groups: the elderly-onset group (diagnosed with IBD at age 60 or older) and the control group (diagnosed with IBD before age 60). We compared one- year drug persistence, opportunistic infections, IBD-related admissions, complications, surgeries, and the number of acute flare-ups between the two groups. Additionally, we compared the one-year persistence of different advanced therapies within the elderly-onset group.

Results
We enrolled 511 IBD patients, with 107 in the elderly-onset group and the remaining in the control group. The elderly-onset group had higher body mass index, more cases of ulcerative colitis, fewer smokers, lower white blood cell count, lower hemoglobin, lower albumin, and a lower proportion of Montreal L3, B2, but a higher proportion of Montreal E1 and E3 diseases, and more Vedolizumab users compared to the control group. In terms of clinical outcomes, both groups had similar steroid-free remission rates, one-year persistence of advanced therapies, opportunistic infections, IBD-related complications, surgeries, and flare-ups. In the elderly group, Infliximab and Ustekinumab showed higher one-year persistence in Crohn’s disease (CD), but there was no statistically significant difference in ulcerative colitis (UC) according to the Kaplan-Meier analysis. There were three independent predictors for one-year advanced therapies persistence, included Montreal L1 (OR:6.722; 95% CI: 1.296-34.852; P=0.023) , Ustekinumab user (OR: 5.672; 95% CI: 1.138-28.267; P=0.034) and hemoglobin (OR: 1.612; 95% CI: 1.210-2.147; P=0.001) with an optimal cutoff value of 11.65 g/dL.

Conclusion
Elderly-onset IBD patients have unique clinical characteristics. Different advanced therapies persist in elderly-onset CD, but not in UC.

References
1.Sturm A, Maaser C, Mendall M, et al. European Crohn’s and Colitis Organisation topical review on IBD in the elderly. J Crohns Colitis. 2017;11:263-273.
2.Sousaa P, Bertanib L, Rodrigues C. Management of inflammatory bowel disease in the elderly: A review. Dig Liver Dis. 2023;55(8):1001-1009.
P0710 Effectiveness and Safety of Filgotinib After One Year in Patients with Ulcerative Colitis: Preliminary Results from the Filguito Registry in Andalusia (Spain)
Authors: Caballero Mateos A M , Suárez-Toribio Á , Trigo-Salado C , Rodríguez-González F J , Silva-Albarellos E , Martín-Rodríguez M D M , Gijón-Villanova R , Gómez-Delgado E , Benítez J M , Trapero-Martínez A M , Hernández-Martínez Á , Olmedo-Martín R V ,   GATEII
Published: January 2025

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 &lt; 3 and Calprotectin &lt; 250 μg/g, and Steroid-Free Remission (SFR) as a partial Mayo score &lt; 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.
P0715 Experience with Ustekinumab and Vedolizumab in Inflammatory Bowel Disease Patients: Single-Center Data
Authors: Kandemir H , Karataş A , Moral K , Bilican G , Kekilli M , Cindoruk M , Karakan T 
Published: January 2025

Abstract

Background
Ustekinumab and vedolizumab are used for patients with moderate to severe inflammatory bowel disease (IBD) who do not respond to anti-TNF therapy. This study aims to evaluate the effectiveness of ustekinumab and vedolizumab in this patient group and to assess response rates in both drug groups.

Methods
The study included a total of 134 patients, 67 of whom were on vedolizumab and 67 on ustekinumab, who were followed at the Gazi University Faculty of Medicine Hospital between January 2017 and October 2024. Age, gender, previous treatments, pre-treatment Harvey-Bradshaw index, Mayo score/disease activity index, and CRP values were recorded. Patients who did not respond clinically, in laboratory results, or endoscopically within the first 24 weeks were considered primary non-responders, while those who did not respond within the first 52 weeks were classified as secondary non-responders.

Results
Of the 134 patients, 77 (57.5%) were female, and 57 (42.5%) were male. A total of 71 (53%) patients had Crohn’s disease. Among the patients, 85 (63.4%) had previously used Infliximab, and 48 (35.8%) had used Adalimumab as anti-TNF therapy. In patients continuing Vedolizumab treatment, the average duration of use was 22.8 months for those with ulcerative colitis (UC) and 25.5 months for those with Crohn’s disease (CD). For those on Ustekinumab, the average duration was 15 months for UC patients and 21.1 months for CD patients.

Response Rates
• Primary Non-Response (24 weeks): For Ustekinumab, 6.9% (1 UC, 3 CD patients) and for Vedolizumab, 10.1% (4 UC, 2 CD patients).
• Secondary Non-Response (52 weeks): For Ustekinumab, 3.4% (1 UC, 1 CD patient) and for Vedolizumab, 18.6% (5 UC, 6 CD patients).
No statistically significant difference in non-response rates was observed between the two drug groups.

Conclusion
Both Ustekinumab and Vedolizumab exhibit comparable efficacy in IBD patients who are resistant to prior anti-TNF therapies, with no statistically significant differences in primary and secondary non-response rates between the groups.
P0717 Real-world data of Mirikizumab in the induction and maintenance therapy for ulcerative colitis
Authors: Eleftheriadou A M , Juhran K S , Hegazy A N , Haag L M , Siegmund B , Sonnenberg E ,   Charité IBD Group
Published: January 2025

Abstract

Background
Mirikizumab, a humanized IgG4 monoclonal antibody binding subunit p19 of interleukin 23, has been approved for the therapy of ulcerative colitis since May 2023. Phase 3 studies showed significant efficacy in both inducing and sustaining clinical remission in patients with moderate to severe active ulcerative colitis.

Methods
All patients with active ulcerative colitis who began induction therapy with Mirikizumab at our outpatient clinic between July 2023 and June 2024 were analyzed retrospectively with a follow-up period until October 2024. Patients with prednisolone therapy exceeding 20 mg, loperamide intake or deviation of standard clinical application period were excluded. The primary endpoints were defined as achieving clinical remission following the completion of intravenous induction (at weeks 12, 16 or 24) and the maintenance of clinical remission at any time between week 8 and week 49 following the initiation of subcutaneous application. Secondary endpoints included rates of clinical remission and relapse in patients previously treated with Ustekinumab, a monoclonal antibody targeting the p40 subunit of interleukin-12 and -23.

Results
A total of 40 patients started Mirikizumab induction therapy, with 23 meeting the inclusion criteria. Seventeen patients were observed in the maintenance period. After completion of induction, 20 out of 23 patients (87.0%) achieved clinical remission. Among these, 12 (60.0%) had previously been treated with Ustekinumab. During the maintenance period, 6 out of 17 patients (35.3%) experienced a relapse, of whom 5 (83.3%) had prior therapy with Ustekinumab. Within the Ustekinumab subgroup, 5 out of 10 patients (50.0%) suffered relapse after initially achieving clinical remission.

Conclusion
Mirikizumab is an effective therapy in patients with active ulcerative colitis, including those who had a prior loss of response to Ustekinumab therapy. Patients with prior Ustekinumab therapy exhibited a higher rate of relapse during the maintenance phase.
P0721 Anti-TNFs have similar safety profile to vedolizumab and ustekinumab as first line biologic treatment in elderly patients with Crohn’s disease
Authors: Thurm T , Javits L , Nachmias N , Cohen N A , Leibovitzh H , Hirsch A , Ron Y , Maharshak N 
Published: January 2025

Abstract

Background
The prevalence of Crohn’s disease (CD) in elderly patients is rising and is associated with aging-related challenges. Data on effectiveness and safety of first line biologic treatment (FLBT) in the elderly, are scarce. Our aim was to compare the safety, effectiveness, and drug persistence to FLBT in elderly patients with CD.

Methods
A retrospective, single tertiary center study, including all patients with CD who initiated their FLBT at age≥60 years, between 1/1/2010 to 31/12/2023. Clinical and demographic data were extracted and adverse events (AEs), treatment response and drug persistence were collected.

Results
A total of 214 patients with CD ≥60 years of age started FLBT, data were available for 168 (78.5%) patients. Anti-TNFs were initiated in 85 (50.6%) patients, and non anti-TNFs in 83 (49.4%) patients (71-vedolizumab, 12-ustekinumab). Patients starting anti-TNF were younger (67.3±6.1 vs 72.0±7.0 years, p&lt;0.001), with lower Charlson comorbidity index (CCI: 3.6±1.7 vs 4.9±2.2, p&lt;0.001), had higher rates of penetrating (31.8% vs 9.6%, p=0.002) and perianal (40.0% vs 18.1%, p=0.002) disease phenotype, and previous GI resections (37.6% vs 22.9%, p=0.038). Endoscopic disease severity was comparable [Table 1]. Drug persistence was calculated from 2014 (time of vedolizumabs’ approval for clinical use) and was similar between the groups (60 patients on anti-TNF: median 82.0 weeks [IQR 27.5-175.3] vs. 83 patients on non-anti-TNF median 89.7 weeks [IQR 41.0-183.9], p=0.765). Use of corticosteroids (CS) and immunomodulators (IMM) during 14-weeks of induction and 52-weeks of maintenance was comparable (p=NS). At 52-weeks, no difference was observed in clinical response and remission rates, nor in dose escalation and drug discontinuation rates (p=NS). Eighty-three AEs were recorded at 52-weeks: 50 (58.8%) in anti TNF vs. 33 (39.8%) in non-anti-TNF group. Serious infections: 7 (8.2%) patients in the anti-TNF group (3 hospitalized for sepsis: 1 urinary and 2 respiratory, 1 cellulitis, 1 pharyngitis, 1 systemic CMV and 1 clostridium difficile infection (CDI) vs 7 (8.2%) in the non-anti-TNF group (2 intra-abdominal abscess, 1 herpes zoster infection, 1 CDI, 1 cellulitis and 2 bronchitis, p=1). Hospitalization and surgery rates were 25.8% and 12.9% in anti-TNF vs 22.9% and 8.4% in non-anti-TNF groups respectively, (p=NS) [Table 2]. In a multivariate logistic regression analysis adjusted to type of FLBT, age, gender, CCI, dose escalation, and treatment with CS and IMM, no variable was significantly associated with the development of AEs (p=NS).

Conclusion
Anti-TNFs and vedolizumab/ustekinumab have similar safety and drug persistence as FLBT among elderly patients with CD. Larger prospective studies are needed to fortify our findings.
P0724 Endoscopic and radiological outcomes of strictureplasty in patients with small bowel stricturing Crohn’s disease
Authors: Zhang X , Li Y , Zhu W 
Published: January 2025

Abstract

Background
Strictureplasty has proven effective for alleviating clinical symptoms in patients with Crohn’s disease (CD). However, endoscopic and radiological results of strictureplasty remain largely unknown. This study aims to evaluate postoperative endoscopic and radiological outcomes of strictureplasty in patients with CD.

Methods
Patients who had symptomic small bowel CD undergoing strictureplasty, including Heineke-Mikulicz (H-M) and Finney techniques, at our center between October 2014 and January 2024 were included in this study. Endoscopic and radiological outcomes were studied, using postoperative computed tomography enterography (CTE) and enteroscopy. To evaluate endoscopic recurrence, we applied the Simplified Endoscopic Score for Crohn’s Disease (SES-CD), focusing solely on the ileum (score range: 0-12). Two independent radiologists with extensive experience reviewed CTE parameters, including mucosal enhancement, mural stratification, wall enhancement, comb sign, lymphadenopathy, thick non-enhancing wall, bowel wall thickness, luminal diameter, and the upstream lumen.

Results
A total of 59 patients were included in this study, with 30 patients having both preoperative and postoperative CTE performed at our center. The majority of patients (52/59) underwent simultaneous intestinal resection. The median hospital stay was 9 days (range: 5–28 days), with postoperative ileus being the primary cause of delayed discharge. Postoperative endoscopic examination showed mucosal healing at the primary strictureplasty site in 47 of 59 patients (Median follow-up 8 months). CTE showed a marked reduction in bowel wall thickness compared to preoperative measurements (8.25 mm vs. 5.6 mm, P &lt; 0.001, Fig.1) (Median follow-up 7 months). Endoscopic recurrence (SES-CD&gt;3), requiring adjustments to medical therapy, was observed in 26 patients (44%) after a median follow-up of 9 months (range: 4-17 months); notably, 16 (62%) of these recurrences involved new sites rather than the primary strictureplasty.

Conclusion
Significant mucosal and trasmural healing occurred at the primary stricture site within approximately one year. The preserved diseased bowel resulting from strictureplasty does not appear to be the main site of recurrence.
P0729 Comparative clinical outcomes of advanced therapy in bio-naïve versus bio-experienced patients hospitalized with Acute Severe Ulcerative Colitis: A retrospective cohort study
Authors: Hwang S W , Kim S , Lee C H , Kim J W , Kim M K , Lee S , Hong S W , Park S H , Yang D H , Ye B D , Byeon J S , Myung S J , Yang S K 
Published: January 2025

Abstract

Background
The characteristics of patients with acute severe ulcerative colitis (ASUC) in East Asia differ from those in Western countries. However, the clinical outcomes of ASUC treated with advanced therapies (ATs; biologics or small molecule drugs) have rarely been investigated in East Asia. This study aimed to analyse the clinical characteristics and outcomes of Korean ASUC patients receiving ATs based on prior exposure to biologics.

Methods
We retrospectively analysed 184 hospitalized ASUC patients treated with ATs at Asan Medical Center between 2014 and 2024. The clinical outcomes, including AT persistence, intestinal surgery, and ASUC-related hospitalization, were compared between bio-naïve and bio-experienced ASUC patients. Additionally, factors associated with 1-year AT persistence in ASUC patients were identified using Cox proportional hazards analysis.

Results
Of the 184 hospitalized ASUC patients, 137 were bio-naïve, and 47 were bio-experienced. Bio-experienced ASUC patients had a lower AT persistence rate and a higher rate of intestinal resection compared to bio-naïve ASUC patients during the follow-up period (p&lt;0.01, p&lt;0.0001, respectively). Among the 178 patients followed for more than 1 year at our center, 96.3% of bio-naïve ASUC patients were treated with anti-TNF agents, with a 1-year AT persistence rate of 84.5%. In contrast, 59.1% of bio-experienced ASUC patients received anti-TNF agents, resulting in a 1-year AT persistence rate of 38.5%; the remaining 40.9% received non-anti-TNF biologics or small molecule drugs, with a 1-year AT persistence rate of 72.2%. Previous exposure to biologics (hazard ratio [HR], 3.166; 95% confidence interval [CI], 1.734-5.782; p&lt;0.001), age greater than 40 years at diagnosis (HR, 2.909; 95% CI, 1.530-5.528; p=0.001), and disease duration less than 12 months (HR, 1.863; 95% CI, 1.009-3.441; p=0.047) were associated with a lower 1-year AT persistence rate in patients with ASUC.

Conclusion
This study suggests that bio-experienced ASUC patients have worse clinical outcomes with AT compared to bio-naïve ASUC patients.
P0733 REALASA: Real-world effectiveness assessment of first-line 5-ASA for the treatment of Ulcerative Colitis in Sweden
Authors: Christophersen B , Nielsen L , Landeira M , Guedes S 
Published: January 2025

Abstract

Background
Despite being a well-established therapy for patients with mild-to-moderate ulcerative colitis (UC), there is limited evidence on the effectiveness and patterns of use of 5-aminosalicylic acid (5-ASA) in routine clinical practice. The study objective was to understand the treatment patterns of 5-ASAs in UC using secondary data from Sweden.

Methods
A retrospective study was conducted using data from linked Swedish registries. Adult patients diagnosed with UC and a first prescription of 5-ASAs (index date) between 01/01/2008 and 31/12/2020 were included. The cut-off date was 31/12/2018, to allow for adequate data over a 2-year follow-up period. The main objective was to describe patients diagnosed with UC in Sweden by 1) the proportion of patients that stayed on initial 5-ASA treatment regimens at different follow-up duration after 5-ASA initiation (182, 365, and 730 days after index date) and to estimate the duration of continuous treatment with initial treatment regimens in different subgroups (overall, 5-ASA with no other UC medication, and 5-ASA + other UC medication) and formulations (oral + rectal, only rectal, and only oral). The proportion of patients who switched from initial 5-ASA treatment to another UC treatment during the 5-ASA continuous exposure period and the proportion of patients that were adherent to 5-ASA treatment at different time points was estimated.

Results
A total of 13,461 patients with UC who initiated 5-ASA during the selection period were included in the study. Most patients (99.18%) initiated 5-ASA without other UC medication; the most common formulation was only oral 5-ASA treatment (93.42%). Among patients starting any 5-ASA treatment, almost half stayed on the 5-ASA treatment at 182 days after initiation, while the median duration of continuous treatment was 138 days. Around 50% of the patients were adherent to the initial 5-ASA treatment at 182 days, but the proportion decreased to 30% at 730 days. The proportion of patients who initiated 5-ASA treatment at index with no other UC medication stayed on the initial treatment to a lesser extent than patients with 5-ASA + other UC treatment. Very few treatment switches from 5-ASA to other UC treatments were observed at the different time points.

Conclusion
In this real-world study, the median duration of continuous 5-ASA treatment was less than half a year, and only half of the patients were adherent to the initial treatment at 6 months, decreasing even more over time. Guidelines recommend that patients who achieve remission with induction therapy continue with the same medication as maintenance therapy. Treatment optimization and monitoring may allow optimal control of mild-to-moderate UC.