bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0799 Efficacy and Safety of Dual Therapy for Refractory Inflammatory Bowel Disease in a Danish Cohort
Authors: Haase A M , Bendix M 
Published: January 2025

Abstract

Background
Patients with Crohn’s disease (CD) and ulcerative colitis (UC) may become refractory to monotherapy with biologics or small molecules. Dual therapy, combining biologics and small molecules, has been proposed for this challenging population. While awaiting randomized studies, real-world data on its efficacy and safety are crucial. This study contributes to the evidence on dual therapy in a Danish adult IBD cohort.

Methods
Medical records from May 2018 to May 2023 were reviewed for CD and UC patients undergoing dual therapy with biologics and/or small molecules in outpatient gastroenterology clinics at Aarhus University Hospital and Regional Hospital Randers. Patients treated for at least three months were included and followed until treatment discontinuation or the end of the study period. Patient characteristics, clinical outcomes, adverse events, and efficacy data were collected at baseline and follow-up.

Results
Seventy-four patients (47 with CD and 27 with UC) received a total of 79 dual therapies. The median duration of dual therapy was 488 days for CD and 412 days for UC. The most common combinations were adalimumab and ustekinumab in CD (46%) and adalimumab and vedolizumab in UC (35%). Clinical remission was achieved in 56% of CD patients and 62% of UC patients. Steroid-free follow-up was observed in 81% of CD patients and 52% of UC patients (Table 1).
In CD, dual therapy significantly reduced stool frequency, bloody stools, calprotectin levels, and Harvey-Bradshaw Index (HBI) scores. In UC, stool frequency, nighttime stools, abdominal pain, CRP, calprotectin, and Simple Clinical Colitis Activity Index (SCCAI) scores significantly decreased, while hemoglobin and albumin levels significantly improved. Serious adverse events (SAEs) occurred in 12% of UC patients and 14% of CD patients, consistent with prior studies of adult and pediatric cohorts [1, 2]. No UC patients required colectomy during the study period.

Conclusion
This retrospective study demonstrates a substantial rate of clinical remission and acceptable safety in refractory IBD patients receiving dual therapy. The findings highlight prolonged treatment duration, significant clinical improvements, and a manageable SAE profile. Dual therapy represents a promising approach for refractory and complex IBD, though the risk of SAEs must always be balanced against therapeutic benefits.

References
1.Dual Biologic or Small Molecule Therapy in Refractory Pediatric Inflammatory Bowel Disease (DOUBLE-PIBD): A Multicenter Study from the Pediatric IBD Porto Group of ESPGHAN.Inflamm Bowel Dis, 2024. 30(2): p. 159-166.
2.Dual Biologic or Small Molecule Therapy for Treatment of Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol, 2022. 20(3): p. e361-e379.
P0800 Efficacy of filgotinib in patients with ulcerative colitis refractory to prior biologics
Authors: Suarez A , Ruz Zafra P , Leo Carnerero E , Rojas Feria M , De la Cruz Ramírez M D , Rodríguez Pérez A Á , Villalba Moreno Á M , Trigo Salado C 
Published: January 2025

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.
P0801 Real-world Effectiveness and Tolerability of Etrasimod in Active Ulcerative Colitis: A 26-week Observational Study
Authors: St-Pierre J , Choi D , Yanofsky R , Fear E , Rubin D T 
Published: January 2025

Abstract

Background
Etrasimod, a selective sphingosine-1-phosphate receptor modulator, has demonstrated efficacy in controlled trials for moderately to severely active ulcerative colitis (UC). However, real-world data on its effectiveness and tolerability have not been reported. This 26-week observational study evaluates clinical response and remission in UC.

Methods
Patient demographics, disease characteristics, prior therapies, and SCCAI scores were recorded at baseline and at weeks 2, 4, 8, 12, and 26. Clinical response (SCCAI reduction ≥3) and remission (SCCAI ≤2) were assessed, with statistical differences between time points determined by paired T-tests. Side effects and laboratory findings were collected at each time point.

Results
We treated 22 patients with etrasimod: median age 38.5 years (Q1-Q3: 33.5–45.8), median disease duration 5.5 years (Q1-Q3: 4–11.3). 82% of patients (n=18) had prior 5-ASA exposure, and 23% (n=5) had received advanced therapies. 82% of the patients (n=18) were started due to active inflammation confirmed by symptomatic, biochemical, or endoscopic findings, a subset (59%, n=13) had clinical symptoms (SCCAI ≥3) at etrasimod commencement. The mean SCCAI dropped from 3.4 at baseline to 2.0 at week 2 (p=0.04), 1.5 at week 4 (p=0.01), 1.3 at week 8 (p=0.05), 1.0 at week 12 (p=0.04) and 3.0 (p=0.07) among all patients (Figure 1A). At week 12, 64% had achieved clinical remission, however this dropped to 18% at week 26 in an intention-to-treat (ITT) analysis (Figure 1B). This was primarily driven by high rates of discontinuation during this period (10 patients by week 26). Similar trends were observed in the 13 patients with clinical symptoms at baseline (SCCAI≥3), where 62% achieved clinical remission at week 12 followed by a drop to 23% at week 26 (Figure 1C,D). As expected, the absolute lymphocyte count reduced over the initial weeks of treatment (Figure 1E); there were no infections reported. Only 1 patient received oral steroids at etrasimod start, and 3 received steroids by week 2; 3 of these 4 stopped etrasimod due to lack of efficacy. One patient remained on 5-ASA throughout, and 2 patients had 5-ASA added before week 12 due to symptom recurrence. Of the 5 patients with prior advanced therapies, none achieved remission at week 26. One patient reported transient light-headedness on etrasimod initiation, without arrhythmia.

Conclusion
We demonstrate the first real-world effectiveness of etrasimod in a tertiary population of UC, with the majority achieving remission within the first 12 weeks and about half maintaining it through week 26. Those who lost response were more often patients with prior advanced therapy treatment or those who needed steroids in the first 12 weeks. Etrasimod was safe and overall well-tolerated.
P0802 Effect of proctocolectomy with diverting ileostomy on Renal Function
Authors: Futatsuki R , Tani K , Kouroku M , Ito A , Yonezawa M , Ogawa S , Yamaguchi S 
Published: January 2025

Abstract

Background
Restorative proctocolectomy with ileal pouch anastomosis (IPAA) is the standard surgical procedure for ulcerative colitis, sometimes followed by diverting ileostomy. Renal function decline due to ileostomy has been reported, but there are few reports after IPAA with ileostomy. We investigated the changes in renal function and risk factors for its deterioration in patients after IPAA with ileostomy in this study.

Methods
Using the hospital medical record, we retrospectively reviewed patients with ulcerative colitis who underwent two stage IPAA (restorative proctocolectomy with ileal pouch anastomosis, either hand-sewn or stapled ileal pouch-anal anastomosis, diverting ileostomy at the first-stage and ileostomy closure in the second stage) between June 2003 and October 2020. The decline of renal function was defined as a decrease in estimated Glomerular Filtration Rate (eGFR) more than 30 ml/min/1.73m2 from the time of first-stage surgery to the time of ileostomy closure. The risk factors for renal function decline were examined in comparison with clinicopathological factors in two groups: patients with a decline in renal function (decline group) and patients without a decline in renal function (non-decline group).

Results
In total, 108 patients were included in the study. Eighteen patients (16.7%) were in the decline group and 90 patients (83.3%) were in the non-decline group. The eGFR of all patients decreased from 90.1 ml/min/1.73 m2 at the time of first-stage surgery to 84.3 ml/min/1.73 m2 at the time of ileostomy closure. The median time to ileostomy closure was 151 days (32-1221 days). In univariate analysis, the following factors were identified: severe (p=0.0154), laparoscopic (p=0.003), intraoperative blood loss (p=0.004), emergency surgery (p=0.009), and duration until ileostomy closure (p=0.008). In multivariate analysis, intraoperative blood loss of 192g or more (Odds ratio (OR): 3.724 (95% confidence interval (CI): 1.037-13.377, p=0.044)) and duration until ileostomy closure of 196 days or more (OR: 4.995 (95%CI: 1.451-17.201, p=0.011)) were identified as independent risk factors for worsening renal function.

Conclusion
eGFR decreased until ileostomy closure in patients with IPAA and diverting ileostomy. 16.7% of patients had a decrease in eGFR (eGFR) more than 30 ml/min/1.73m2. Factors associated with a decrease in eGFR were intraoperative blood loss more than 192g and duration until ileostomy closure more than 196 days.
P0803 Biosimilar Therapy in IBD: Real-World Evidence from Saudi Arabia
Authors: Mosli M H A , Bakkari S , Al Jahdali A , Batwa F , Hassanein A 
Published: January 2025

Abstract

Background
Inflammatory Bowel Disease (IBD) is a chronic condition with increasing incidence, particularly in newly industrialized countries. The high cost of biologic treatments has led to the development of biosimilars like infliximab CT-P13, which offer a more affordable alternative.
This study aims to evaluate the safety and effectiveness of a biosimilar (CT-P13) in Saudi Arabian patients with Crohn’s Disease (CD), fistulizing perianal CD, or ulcerative colitis (UC).

Methods
A non-interventional, observational cohort study was conducted in four medical centers in Saudi Arabia. The study included both naïve patients and those switched from the reference product. Patients received CT-P13 infusions over a period of 48 weeks. Safety was assessed by monitoring adverse events (AEs), and effectiveness was measured by clinical response and remission rates. Statistical significance was determined using p-values and confidence intervals.

Results
Participants: 156 patients (62 naïve, 94 switched). Adverse Events: 129 AEs reported in 57 patients; 95.3% were not related to treatment, 3.9% were treatment related. Effectiveness'Naïve CD Patients: Clinical response rates of 42.9% at week 14 (p &lt; 0.05) and 30.8% at week 46 (p &lt; 0.05); remission rates of 76.5% at week 14 (p &lt; 0.01) and 70.6% at week 46 (p &lt; 0.01). Naïve Fistulizing CD Patients: Clinical response rates of 27.3% at week 14 (p = 0.05) and 26.7% at week 46 (p = 0.05); remission rates of 13.6% at week 14 (p = 0.05) and 25.0% at week 46 (p &lt; 0.05). Naïve UC Patients: Clinical response rates of 41.7% at week 14 (p &lt; 0.05) and 42.9% at week 46 (p &lt; 0.05); remission rates of 38.5% at week 14 (p &lt; 0.05) and 50.0% at week 46 (p &lt; 0.01). Switched Patients: Disease control rates of 100% in CD, 93.1% in fistulizing CD, and 93.3% in UC at week 48 (all p &lt; 0.01).

Conclusion
Biosimilars are well tolerated and effective in achieving disease control, clinical response, and remission in Saudi Arabian patients with CD and UC. These findings support the use of CT-P13 as a cost-effective treatment option for IBD.

References
Najeeb H, Yasmin F, Surani S. Emerging role of biosimilars in the clinical care of inflammatory bowel disease patients. World J Clin Cases. 2022 May 16;10(14):4327-4333. doi: 10.12998/wjcc.v10.i14.4327. PMID: 35663066; PMCID: PMC9125297.
P0805 Sigmoidoscopy is sufficient as a surveillance tool in pediatric Ulcerative Colitis; full colonoscopy is not typically needed
Authors: Yuval Bar-Asher S , Lev-Tzion R , Orlanski-Meyer E , Ledder O , Shteyer E , Shamasneh I , Yogev D , Assa A , Baldassano R N , Griffiths A M , Turner D 
Published: January 2025

Abstract

Background
Sigmoidoscopy is a less invasive procedure than full colonoscopy, demands simpler preparation, requires shorter procedure time, and may be conducted with lighter sedation. Despite these advantages and the continuous nature of inflammation in ulcerative colitis (UC), which typically decreases from distal to proximal colon, the FDA recently requests full colonoscopy to assess UC in clinical trials (i.e. 3 colonoscopies in 54 weeks). Data to support this requirement are scarce in children. We, thus, aimed to assess the necessity of full colonoscopy versus limited sigmoidoscopy in pediatric UC.

Methods
We included two prospectively enrolled cohorts of children (0-18 years) with UC, both with identical data collection relevant to this study: one from a single-center prospective registry, and the other from a prospective validation of the TUMMY-UC, a patient-reported signs and symptoms for pediatric UC. In addition to explicit clinical, disease activity, labs and demographic data, the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) was recorded prospectively for each colonic segment. The first colonoscopy available after the time of diagnosis was included to better mirror the scenario of post-treatment follow-up monitoring, since the diagnostic procedure should always be full colonoscopy.

Results
A total of 85 patients were included (mean age 14 ± 3.4, 11 [13%] with endoscopic healing, 45 [53%] with mild colitis and 29 [34%] with moderate-severe colitis). The median UCEIS scores decreased progressively from the rectum and sigmoid (2, IQR:0-4) to the more proximal colon (descending 1, IQR:0-3; transverse and ascending 0, IQR:0-2; p &lt; 0.001). Only 3 patients (3.5%) had inflammation in proximal segments without having inflammation in the rectosigmoid region. Another 10 patients (12%) had higher inflammation scores in the proximal colon than in the rectosigmoid (i.e. reverse gradient), though inflammation was still present in the rectosigmoid region.

Conclusion
In 96.5% of cases, endoscopic healing in the rectosigmoid region reflected endoscopic healing in the entire colon in children with UC. When inflammation was present in the rectosigmoid, in 86% the degree of colitis reflected the maximal endoscopic severity of the entire colon. These findings suggest that sigmoidoscopy may be a suitable routine post-treatment surveillance tool for pediatric UC patients and in the research setting in order to maximize feasibility and ethical considerations of clinical trials.
P0811 Comparative efficacy of vedolizumab and infliximab in patients with moderate-to-severe ulcerative colitis: a multicenter real world cohort study
Authors: Sun Y , Yang H 
Published: January 2025

Abstract

Background
Vedolizumab (VDZ) and infliximab (IFX) are both recognized as first-line treatment options for moderate to severe ulcerative colitis (UC). However, there is a paucity of comparative studies examining their real-world efficacy.

Methods
Patients with moderate to severe UC were consecutively enrolled from 11 centers. Efficacy were evaluated after 14 and 52 weeks. Logistic regression was conducted to identify independent risk factors for clinical remission.

Results
A total of 235 patients were enrolled, of which 154 received VDZ treatment and 81 received IFX treatment. 154 (65.5%) were male, with a median age of 40 (32, 49) years, a median disease duration of 7.0 (2.8, 11.9) years. The median baseline Mayo score was 9 (7, 11), and the median baseline partial Mayo score was 6 (4, 8). 16 patients (6.8%) had perianal lesions, and 41 patients (17.4%) had extraintestinal manifestations. At week 14, patients treated with IFX had higher clinical response rate (84.6% vs 66.2%, p = 0.003) but lower endoscopic remission rate (14.5% vs 34.3%, p = 0.003) compared to those treated with VDZ. There were no statistical difference in clinical remission rate between the two groups (39.7% vs 44.8%, p = 0.462). At week 52, there were no statistically difference in the modified Mayo score, partial Mayo score, clinical response rate, clinical remission rate, and endoscopic remission rate between IFX treatment group and VDZ treatment group (p&gt;0.05). Multivariate regression analysis demonstrated that baseline disease extent was a predictor of clinical remission at week 14 of VDZ treatment (OR = 3.55, 95% CI 1.39–9.06, p = 0.008).

Conclusion
IFX group received higher clinical response rate but not endoscopic remission rate at week 14. The efficacy of IFX was comparable to VDZ at week 52. Disease extent was a predictor of clinical remission at 14 weeks with VDZ.
P0812 Establishing a target dysplasia detection rate (DDR) as a quality metric for Inflammatory Bowel Disease surveillance
Authors: Picardo S , Baker J , Geow R , Halpin S , Cheng W , Ragunath K 
Published: January 2025

Abstract

Background
Patients with inflammatory bowel disease (IBD) have an increased risk of developing dysplasia and colorectal cancer. Endoscopic surveillance is recommended, however, key quality performance metrics for surveillance are lacking. The aim of this study was to perform a systematic review and meta-analysis of the prevalence of dysplasia in patients undergoing IBD surveillance in the era of high-definition colonoscopy, in order to determine a target dysplasia detection rate (DDR) which can be used as a quality measure.

Methods
The trial protocol was registered with PROSPERO (CRD42024537521). An extensive search was performed of Medline, EMBASE, Web of Science and Cochrane Library databases to identify all prospective published studies (randomised controlled trials (RCT), observational cohort studies and crossover/tandem studies) of patients undergoing IBD dysplasia surveillance using high-definition colonoscopes. Several surveillance modalities were included (high-definition white light, dye spray chromoendoscopy, virtual chromoendoscopy, full spectrum endoscopy, autofluorescence and endomicroscopy with chromoendoscopy). Two reviewers independently evaluated studies for eligibility and methodological quality. All variables of interest were collected on a standardised form. A random-effects model was used to calculate an estimate of the pooled prevalence of dysplasia defined as the dysplasia detection rate. An estimate of the pooled prevalence of cancer was also determined. A sub-group analysis was performed, by surveillance modality, for all non-crossover/tandem studies where data was available.

Results
Twenty-five studies (11 RCT, 8 tandem/crossover studies and 6 observational cohort studies) were included, from a total of 3029 abstracts screened. For the calculation of dysplasia and cancer prevalence rates, a total of 4136 patients (55.2% male), mean age 49.4 years and mean disease duration 16.5 years met inclusion criteria. The pooled dysplasia detection rate was 16.5% (95% CI, 14% to 19%). (Figure 1). The pooled cancer detection rate was 0.1% (95% CI, 0 to 0.2%). Subgroup analysis by surveillance modality demonstrated similar pooled dysplasia detection rates with slight differences in mean procedural withdrawal times. (Table 1).

Conclusion
This is the first study that attempts to measure dysplasia detection rates in a systematic fashion in patients undergoing IBD surveillance colonoscopy in the high-definition colonoscopy era. The pooled dysplasia detection rate was 16.5% and cancer detection rate was 0.1%. We propose a conservative estimate dysplasia detection rate of 14% (the lower confidence limit in our study) as a target quality metric for IBD surveillance.