Introduction

Colonoscopy plays a crucial role in management of ulcerative colitis (UC) that helps to assess mucosal healing. Different scoring systems are available to assess severity, however most of them do not correlate with disease extent.

Aims & Methods

Our study aimed to assess the predictive value and accuracy of PanMayo score compared to MES, UCEIS and Dublin in mid- and long-term disease outcomes. This is a retrospective, two-center study. UC patients, who underwent colonoscopy due to any reason between 2016 and 2018, were consecutively enrolled. PanMayo, MES, UCEIS and Dublin scores were recorded with clinical and demographical data at baseline. Disease flare, need for change in therapy (incl. initiation of biologicals, need for systemic steroids), hospitalisations and colectomy were collected during an at least 3-years follow-up. Patients were stratified by using baseline clinical activity (pMayo>1). Log-rank, logistic regression and Chi² tests were used to analyze outcomes and Kaplan Meier curves were plotted.

Results

A total of 250 UC patients (Table 1.) were enrolled. 157 (male ratio 0.49; mean age 46 IQR 19.5 years) UC patients had clinical remission, while 93 had active disease at baseline (male ratio 0.43; mean age 42 IQR 25 years). PanMayo, MES, and Dublin scores were positively associated with risk of flare-up (p=0.002; p<0.01; p=0.003). Increasing MES score was coupled with risk of relapse. PanMayo score (above 12 points), but not MES or UCEIS, was associated with the need of new biological (p<0.001) and treatment escalation (p=0.018), similar trend was found for the Dublin score for need for new biologicals in the remission cohort. All scores were strongly associated with the need for systemic steroids in patients with baseline remission. In the cohort with active disease at baseline, PanMayo (p=0.016) and Dublin (p=0.009) scores were associated to colectomy risk.

Table 1. Baseline demographic and clinical characteristics of patients

	Total cohort (n = 250)	Clinical remission (pMayo < 2) at baseline (n = 157)	Clinical activity (pMayo > 1) at baseline (n = 93)
Sex, male (%)	117 (46.8)	77 (49.0)	40 (43.0)
Age at inclusion, years, median (IQR)	45.0 (22.3)	46.0 (19.5)	42 (25.0)
Disease duration at inclusion, years, median (IQR)	10.0 (13.0)	11.0 (13.0)	8 (9.0)
Disease activity
pMayo median (IQR)	1.0 (3.0)	0.0 (0.0)	4 (3.0)
MES median (IQR)	1.0 (2.0)	0.0 (1.0)	2 (1.0)
MES > 0 n (%)	158 (63.2)	71 (45.2)	87 (93.5)
PanMayo median (IQR)	2 (18)	0 (3)	18 (21)

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Abbreviations: n: number of patients, pMayo: partial Mayo score; IQR: inter-quartile range; MES: Mayo endoscopic score

Conclusion

Our study suggests that combined endoscopic assessment of the extent and severity may be more precise in predicting disease outcomes in UC. PanMayo score may be an alternative of the existing scoring systems and was associated more granularly with disease outcomes.

Disclosure

There are no conflicts of interest to disclose.

Introduction

High-quality endoscopy in IBD is associated with better clinical outcomes, while quality measurement supports effective quality control. The European Society of Gastrointestinal Endoscopy recommends using nine performance measures, depending on the indication for endoscopic examination in IBD.

Aims & Methods

Our study aimed to compare colonoscopy quality between tertiary and secondary referral centers for IBD patients, based on endoscopic reports. In this cross-sectional study, colonoscopy reports of IBD patients were analyzed. At our tertiary center, we consecutively enrolled patients over 18 years old with established IBD between July and October 2024, using their available colonoscopy reports. The secondary care group included patients referred to our tertiary center, with the last existing report from secondary care used for analysis, while the tertiary care group consisted of our patients whose most recent report was similarly used. Nine key performance measures (indication, bowel preparation, photo documentation, ileal intubation, biopsy, endoscopic activity score, high-definition and chromoendoscopy use, and neoplasia detection) were evaluated based on colonoscopy reports. Patients were stratified by procedure indication (diagnostic, activity assessment, or surveillance) as well. Descriptive statistics, Welch’s, and Fisher’s exact tests were used to compare groups, with p-values <0.05 considered significant.

Results

Overall, 207 colonoscopy reports were assessed, of which 68/207 were performed at secondary care level. A total of 78/207 patients were diagnosed with Crohn’s disease, while unclassified diagnoses were noted only at secondary centers. Activity control (88% vs. 38%, p<0.001) and surveillance (8% vs. 0%, p=0.02) examinations were more common at the tertiary level. Bowel preparation was better at tertiary centers (Boston Bowel Preparation Scale [BBPS] 8.3±2.3 vs. 7.2±1.2; p=0.003), and use of BBPS was more frequent at higher levels of care (p<0.001). Disease activity scores were more commonly used at the tertiary level during activity control examinations (51.2% vs. 19.2%, p=0.004), while ileal intubation was also more frequent at the tertiary level (53% vs. 28%; p<0.001). Procedure and withdrawal times did not differ between levels in diagnostic or activity control examinations. Neoplasia detection was low, and biopsy rates were similar.

Variables	Secondary care (n = 68)	Tertiary care (n = 139)	Sig.
Diagnosis, n (%)
CD	24 (35.3)	54 (38.8)	<0.001
UC	25 (36.8)	85 (61.2)
IBD-U	19 (27.9)	0 (0)
Examination time, mean (±SD)	20.2 (9.0)	16.2 (3.5)	0.004
Withdrawal time, mean (±SD)	10.4 (6.5)	8.2 (2.3)	0.008
Ileal intubation, n (%)	19 (27.9)	71 (51.1)	0.005
Disease activity score use, n (%)	7 (10.3)	71 (51.1)	<0.001
Neoplasia detected, n (%)	2 (2.9)	17 (12.2)	0.038

Conclusion

Quality indicator targets were met in neither secondary nor tertiary centers; however, wider investigation is needed to verify these results. Broad education can help to improve the quality of colonoscopy in IBD care.

Introduction

Patients with ulcerative colitis (UC) and their treating physicians are currently looking beyond symptom resolution to achieve mucosal healing for a better long-term outcome. The assessment of this target requires invasive tests at several occasions that has an impact on the quality of life.

Aims & Methods

To evaluate the role of serum, fecal and urine biomarkers for predicting endoscopic healing, histological improvement and long-term outcomes after medical treatment of UC.

Patients with newly diagnosed acute UC or relapse of UC between September 2018 and February 2020 were included and followed for three years for relapse of symptoms. Disease activity was measured using clinical, Mayo Endoscopic Subscore (MES), and histological scores (Geboes score and Robarts Histological index). Biomarkers such as ESR, CRP, Fecal Calprotectin, Serum NGAL and 24-hour urine potassium were done at baseline and at clinical remission. The utility of biomarkers to predict endoscopic healing (MES ≤ 1), histological improvement (Geboes ≤ 3), and disease flare on follow up were analysed.

Results

40 patients (43 episodes of UC) with a mean age of 35 ± 10 years were studied. Majority of patients had moderate to severe disease activity by clinical score (88%), MES (93%) and histology (82%). There was a significant reduction in baseline serum and fecal biomarkers and a significant increase in 24-hour urine potassium at clinical remission and those with endoscopic healing while those with histological improvement had significant reduction in fecal and serum markers only. Patients without endoscopic healing or histological improvement didn’t had significant changes in biomarkers.

Parameter	Achieved endoscopic healing(n=36)			Achieved histological improvement(n=18)
	Baseline	Clinical remission	P value	Baseline	Clinical remission	P value
Fecal calprotectin(µg/g)	612.57 (31.- 8249.2)	147.36 (10 – 4463)	0.01*	921.3(79.4 – 8249.2)	66.26(10.01 – 1345.2)	<0.001*
Serum NGAL(ng/ml)	35.4 (22.8 – 1077.8)	31.75 (19 – 682.6)	0.003*	36.04(25.6 – 1077.8)	28.49(19.08 – 682.6)	0.002*
24-Hour urine potassium(meq/day)	27(6.6 -200)	36.8(10-240)	0.002*	24.77 ± 12.05	47.47 ± 52.7	0.07#
	Endoscopic healing(n)			Histological improvement(n)
	Yes	No	P value	Yes	No	P value
Flare	14	4	0.25$	4	14	0.02$
No flare	13	1		9	5
*: Wilcoxon sign rank test, #: paired t test, $ : chisquare test

Among patients achieving clinical remission, 83.7% (n= 36) had endoscopic healing and 41.8% (n=18) had histological improvement. 14 patients (35 %) had worsening of fecal calprotectin despite a clinical remission. A reduction in the baseline fecal calprotectin levels by 33.89% (AUC: 0.802, sensitivity: 0.72, specificity: 0.86) and 67.8% (AUC: 0.869, sensitivity: 0.83, specificity: 0.68) predicted endoscopic healing and histological improvement respectively.

A total of 32 patients completed the three year follow up and 54.5% (n=18) had at least one disease flare. Fewer patients with histological improvement (n=4; 12.5%) after treatment experienced flares compared to those with endoscopic healing (n=14; 77.7%). Although two-third with worsening fecal calprotectin achieved endoscopic healing on follow up, none had histological improvement and everyone had symptom relapse on follow up.

Conclusion

Our study confirmed that one-third to two-third decline in fecal calprotectin with treatment predicted endoscopic healing and histological improvement in UC. As the disease flares during follow up was better predicted by an improvement in histology, a two-third fall in baseline calprotectin may be a useful marker for better long-term outcomes in UC.

Disclosure

None declared

Introduction

In ulcerative colitis (UC) clinical trials, endoscopic disease activity is commonly assessed via central reading of the overall Mayo Endoscopic Score (MES). Segmental MES can provide a more detailed evaluation of mucosal response, but it is limited by high inter-rater variability in both anatomical landmark localization and disease activity grading. Automatic MES grading can assist reducing reader discrepancies and detect local mucosal changes that may not be estimated by global scoring. In this study, we developed and evaluated an artificial intelligence (AI)-based system for automated segmental MES grading enabling disease extent quantification and granular endoscopic remission estimation.

Aims & Methods

In contrast to previous approaches, the proposed AI system introduces a novel hierarchical framework for automated MES grading at the frame-, segment-, and video-level. The system comprises three modules, trained on 5,897 retrospectively acquired, aggregated, and anonymized endoscopic videos. A foundation model (FM), trained on 22 million frames, was developed to extract clinically relevant frames from full-length colonoscopies. A colon segmentation module was built upon the FM to localize three anatomical segments: descending colon (DC), sigmoid colon (SI), and rectum (RM). An automated MES classification module was then trained to perform frame-level MES grading. Hierarchical aggregation of local scores, combined with temporal smoothing and non-informative filtering, enabled both segmental and global MES estimation. For independent testing, 915 colonoscopy videos were annotated for each segment for MES scoring by expert gastroenterologists using a 2+1 reading paradigm. Colon segment reference annotations were automatically extracted from endoscopic videos based on recording software annotations. System performance was evaluated using the Quadratic Weighted Kappa (QWK) for both segmental and overall MES agreement. Classification accuracy in detecting endoscopic granular remission (MES 0, 1 vs 2, 3) was reported for all colon segments.

Results

The AI system demonstrated strong agreement (QWK=0.752 [95% CI: 0.719, 0.782]) with gastroenterologist assessments for overall MES on the test dataset. Good agreement was confirmed for SI (QWK=0.647 [95% CI: 0.602, 0.687]) and RM (QWK=0.687 [95% CI: 0.646, 0.724]), moderate agreement was found for DC (QWK=0.592 [95% CI: 0.541, 0.638]). Frame-level colon segment classification accuracy was 41% for DC, 69% for SI, and 78% for RM; with lower performance in DC linked to high variability in reference annotations. Colon segmentation enabled a 37.72% reduction in mean colonoscopy video time by filtering out-of-body and insertion-phase sections. The system showed very high accuracy in detecting both overall (ACC=90.38%) and segmental (DC: 78.80%; SI: 82.84%; RM: 85.03%) endoscopic remission. Mean accuracy in detecting the number of colon segments per video with active disease was 59.13%.

Conclusion

We introduced a novel AI system for automated, granular MES scoring in ulcerative colitis patients, hierarchically grading colonoscopy videos. Our framework demonstrated strong agreement with gastroenterologists in both overall and segmental endoscopic activity assessments. By integrating continuous scoring with anatomical landmarking, the AI system can offer a more comprehensive view of total disease burden in UC patients which can lead to improved precision of disease estimation and treatment response evaluation in clinical settings.

Disclosure

All authors are employees of Clario Inc., Philadelphia, USA.

Introduction

Tofacitinib (TFB) is suggested to be an effective therapeutic option for ulcerative colitis (UC) and has even been implicated in the treatment of acute UC (ASUC). However, available data on the efficacy of TFB in the above indications from real-world studies are limited by cohort size.

Aims & Methods

We aimed to investigate the effectiveness and safety of TFB in moderate to severe colitis and ASUC. A retrospective, international, multicenter cohort study, enrolling UC patients with ≥6-week follow-up period was conducted between February 1 and July 31, 2022. Indications for TFB were categorized to ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Primary outcome was steroid-free remission (SFR), defined as partial Mayo score ≤ 1, no rectal bleeding and no steroid admission. Major secondary outcome was colectomy, and safety data were also analyzed.

Results

A total of 391 UC patients (median age 38 [IQR: 28-47] years; follow-up period 26 [IQR:14-52] weeks) were included. 27.1% of the patients received TFB for ASUC. SFR, as primary outcome, was achieved in 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. Baseline pMayo (OR: 0.850; p=0.006) was negatively associated with SFR at week 12. Biologic naive patients (OR: 2.078; p=0.04) more likely achieved week 52 SFR (56.8 % vs. 38.7 %). The colectomy rate at week 52 was significantly higher in the ASUC group (17.6% vs. 5.7%; p<0.001). Risk factor of colectomy was decreased with age (OR: 0.94; p=0.013). 67 adverse events were reported, and 17.9% resulted in the cessation of TFB. Thromboembolic event was reported in one patient.

Conclusion

TFB is equally effective in ASUC and chronic activity both in short-term and long-term. Higher baseline disease activity and previous biological therapy decreased the therapeutic efficacy. No new adverse event signals was found.

Disclosure

Daniela Pugliese received speaker fees from MSD, Takeda, Galapagos and Janssen, Pfizer; advisory board fees from Pfizer.
David Drobne is a speaker, consultant and an advisory board member for MSD, Abbvie, Takeda, Pfizer, Janssen, Amgen, Biogen and Krka.
Lukas Milan has been a speaker for: Abbvie, Takeda, Celltrion, Biogen, Janssen Cilag.
Peter L. Lakatos has been a speaker and/or advisory board member: AbbVie, Amgen, BioJamp, Bristol Myers Squibb, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Organon, Pendopharm, Pfizer, Roche, Sandoz, Takeda ,Tillots and Viatris and has received unrestricted research grant: AbbVie, Gilead, Takeda and Pfizer.
George Michalopoylos has received speaker fees from Abbvie, Takeda, Janssen, and Pfizer.
Klaudia Farkas has received speaker’s honoraria from AbbVie, Janssen, Ferring, Takeda, and Goodwill Pharma.
Tamás Molnár has received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer, Janssen, Sandoz, MundiPharma, Phytotec, Roche, Fresenius, and Teva.
Nitsan Maharshak has received speaking and/ or consulting fees from Pfizer, Takeda, Janssen, Ferring, BiomX, BMS, Nestle, Trobix and grant support from Takeda, Janssen, Abbott, Abbvie, Pfizer, BMS, Corundum Innovation Ltd, Nestle.

Introduction

Bowel urgency is one of the most bothersome symptoms of ulcerative colitis (UC) and have a great impact on quality of life and psychosocial function. The Urgency Numerical Rating Scale (U-NRS) is desinged to ojectify this subjective symptom. It measures the degree of faecal urgency experienced over the past 24 hours by patients with UC on a scale of 0-10. We assumed that the scale has a large variance, as patients evaluate their own symptoms differently, the urge may be different quality for two patients with the same score.

Aims & Methods

The objective of our study was to investigate the possible components of urgency and refine the assessment of urgency. Patients with UC older than 18 years treated at our departments for at least 3 months and having complaints were enrolled in our study. The patients filled out our non-validated questionnaire with questions about fecal urgency (U-NRS), pain level, speed of urge, incontinence and lifestyle characteristics associated with incontinence. Statistical analysis was performed using STATA 18 program.

Results

263 patients were enrolled, median age was 39.5 years, the mean of disease duration was 11.7±9.2 years. The mean U-NRS score was 3.2±3.2, 32% (84/263) had 0 score and 3% (9/263) has 10 score. 12% of the patients (n=31) felt most difficult to hold mucus, 37% (n=97) stool and 29% (n=76) other secretions. 8% (n=22) had urge with every stool in the last 24 hours, 36% (n=95) had less than half of defecations. The speed of urge defined more the level of urgency than the pain level (R2=0.798 p<0.001, β=0.894 vs R²=0.805, p<0.001, β=0.117). The duration of faeces holding in the last 7 days had significant connection to U-NRS (R²=0.211, p<0.001, β=-0.46). Patients using public restroom at least once during the last week had significantly higher score on U-NRS than other patients (4.6±3.1 vs 2.4±3 p<0.001). 12% (31/263) used diaper. The usage of diapers was also significantly more often in patients with higher U-RNS score (5.2±3.2 vs 2.9±3.1,p<0.0001). Faecal leakage both during the day and night was significiantly higher with higher U-NRS score (p<0.001 for both). Patient reported outcome (PRO2) had a weak correlation with U-NRS (R²=0.14). However if we examine bloody stool, the stool number and difficulty of faecas holding seperately we got a significant and better correlation with urgency (R²=0.43). Patients with moderately severe-severe disease (PRO2 > 5) had a higher chance to have urgency (AUC=0.9). The possibility was higher to have urgency among patients with painful defecation (R²=0.41). The level of urgency, duration of faeces holding and the frequency of faeces holding problems had the strongest correlation with U-NRS (R²=0.83). Patients defined urgency with these parameters according to this result. We created score with them, level of urgency points + half of duration points + frequency, which showed a good model to refine the definition of urgency (R²=0.83).

Conclusion

Bowel urgency affects UC patients' lives and is associated with more severe disability. Bowel urgency is common in UC affecting about two-third of patients and associates with more severe activity of UC. Fecal urgency can characterize with the level of urgency, duration of faeces holding and the frequence of stool more accurately than a single, subjective numeric scale. A new scoring system is needed to more accurately assess patients' complaints in this area and to objectify severity.

Disclosure

The authors have no potential conflict of interest to disclose

Introduction

The development of anti-TNF agents has brought major advances in the treatment of ulcerative colitis (UC), however, many patients still require the use of 2^nd-, 3^rd-, or even 4^th-line biologicals or small molecules.

Aims & Methods

We conducted a retrospective, multicentre study with the inclusion of UC patients who failed anti-TNF therapy due to primary non-response (PNR) or loss of response (LOR), and received sequential biological treatment for moderate-to-severe disease activity or for acute, severe exacerbation (ASUC). The primary aim was to evaluate and compare the effectiveness of 2^nd-, 3^rd-, or 4^th-line biological or small molecule therapies after anti-TNF failure. Treatment effectiveness was determined by persistence and colectomy-free survival. Logistic regression analysis was performed to identify the predictive value of demographic factors, clinical, endoscopic, and laboratory parameters for colectomy.

Results

To date, 454 UC patients have been included. The median follow-up time was 57.7 months (IQR: 92.9-33.3). The indication for the 1^th-line anti-TNF therapy was chronic, refractory UC in 307(67.6%) and ASUC in 147(32.4%) patients. The rate of PNR, as reason for treatment discontinuation progressively increased in accordance with the lines of sequential treatment (23.1%/31.7%/36.2%/45.0%), however, the incidence of LOR did not show a definite tendency among the various therapeutic lines (50.0%/56.1%/58.0%/40.0%). A significant difference with treatment persistence was seen among the most frequently used biologicals and small molecules following anti-TNF failure (Table 1.). Ustekinumab (UST) had superior persistence compared to vedolizumab (VDZ) and tofacitinib (TOFA) at 3, 6, 12 and 24 months, regardless of the number of previous anti-TNFs. The overall colectomy rate was 15.6%, mostly due to chronic, refractory UC (61.9%). The probability of colectomy-free survival was 97.2%, 93.3% and 91.2% at 1, 2 and 3 years, respectively. Cyclosporine use during the course of the disease proved to be protective against colectomy (OR: 2.88, 95% CI: 1.447-5.733, p=0.0026). Pancolitis (OR: 3.24, 95% CI: 1.604-6.562, p=0.0012) appeared to be predictive for colectomy. Following anti-TNF failure, the incidence of colectomy was shown to be significantly lower with 2^nd-line UST (n=3 (5.8%), p=0.0422) than with VDZ (n=57 (16.8%)) or TOFA (n=11 (20.4%)).

Table 1.: Treatment persistence among the most frequently used biologicals and small molecules following anti-TNF failure

Conclusion

According to the preliminary results of this ongoing cohort, sequential therapy was effective in avoiding colectomy in 84.4% of the patients and even after multiple lines of treatment we could expect a relatively low rate of colectomy. UST, as a 2^nd-line therapy after anti-TNF failure, was significantly superior, both in terms of persistence and colectomy-free survival, compared to VDZ or TOFA. Cyclosporine use reduced the risk of colectomy, while pancolitis was seen to be a predictive factor for surgery. Further analysis are being performed to identify factors that influence the efficacy of non-TNF agents and to clarify their role in the subsequent therapeutic lines.