bluuebunny/crossref_metadata_2025 huggingface dataset:
P1109 Evaluation of patient-reported outcome measures (PROMs) of IBD patients who completed upadacitinib induction period
Authors: Kav Prof. T , Unal N , Bakkaloglu O K , Kani T , Akpinar A , Akincioglu P , Eskazan T , Balamir M , Dagci G , Sendur İ N , Buyuktorun I , Barutcu S , Bengi G , Cavus B , Oruc N , Atug O , Dincer D , Hatemi A I , Erzin Y Z , Tezel A , Toruner M , Celik A F , Akyuz F
Published: January 2025

Background

Patient-reported outcome measures (PROMs) are used to assess the effectiveness of treatments received by patients in terms of clinical response in inflammatory bowel disease (IBD). We aimed to evaluate the perceived clinical response from the patient’s perspective using PRO2, IBD Control Questionnaire (ICQ) and Visual Analogue Scale (VAS) at the end of induction therapy in patients treated with upadacitinib. We also aimed to evaluate the correlation of PROMs with biochemical response.

Methods

We included IBD patients who underwent upadacitinib induction therapy from 01/07/2024 to 01/10/2024 in ten centers. ICQ and VAS assessments (Higher scores are better) were used in conjunction with CRP levels and PRO2 assessments (Lower scores are better) performed at baseline and at the end of induction treatment.

Results

A total of 75 patients who completed the induction phase were included, 52% were female and 50.7% were treated for Crohn’s disease (CD). Treatment was switched in 54.7% of patients due to uncontrolled chronic disease, in 42.7% for loss of response and in 2.7% for drug side effects. PRO2 mean scores were changed from 4.86 ± 3.06 to 1.67 ± 1.28 (p<0.05) and 18.61 + 10.42 to 7.36 + 5.10 (p<0.05) for ulcerative colitis (UC) and CD respectively. At the end of induction treatment, 47.2% of UC group and 66.7% in the CD group were classified as in clinical remission according to PRO2 scores. The rate of patients reporting side effects was 30.7%. Acne and skin rashes were reported more frequently (13.2 %). According to the visual analog scale, 80% of the patients reported improvement in their condition (p<0.05), and the mean VAS score and IBD control score were 71.9 and 13.7 (p<0.05) for patients in remission in the UC group and 70 and 14.7 (p<0.05) in the CD group compared to active patients. ICQ scores and VAS were negatively correlated with PRO2 scores and CRP levels (p<0.05 for both pairs). On the other hand both scores were not correlated with CDAI and mayo scores (p>0.05).

Conclusion

In this real-life cohort of patients treated with upadacitinib, 80% report a significant improvement in their condition. ICQ and VAS can be used to understand patients’ perspective on treatment efficacy. Conventional activity scores probably not helpful for early assessment of clinical activity compared to PROMs.
P1121 Longterm Outcomes of Balloon Assisted Endoscopic Stricture Dilation in Patients with Small Bowel Crohn’s Disease: A Tertiary Referral Center’s Retrospective Experience
Authors: Halloran B , Bowron J , Fazal A , Kroeker K , Wong K , Hoentjen F , Parsons D , Peerani F , Gozdzik M , Wasilenko S , Zepeda-Gomez S
Published: January 2025

Background

The natural history Crohn’s disease (CD) can be complicated by strictures. Balloon-assisted endoscopy (BAE) has significantly improved the ability to assess and treat small bowel CD, allowing for stricture dilation to improve patient symptoms and potentially delay or avoid surgery.

We present a single-centre CD cohort of patients that have undergone BAE for stricture dilation. We assess procedural success, outcomes and safety, evaluate factors associated with a risk of requiring surgical management.

Methods

All patient who underwent BAE for CD from the period oof April 2012 to January 2024 were assessed and recorded. Within this group, we identified patients who had undergone assessment and/or dilation of structuring CD. Patient demographic and procedural details were extracted. Long-term outcomes, including requirement for repeat dilation and requirement for surgery were recorded from time initial of initial BAE as surrogates for the durability of dilation in these patients. Patients required surgery post initial BAE were compared to the non-surgical group.

Results

At the University of Alberta Hospital, out of 532 BAE procedures in 231 patients, 157 pt underwent 282 BAE procedures with 629 strictures dilated. In our cohort, 16 strictures were non-traversable and 3 were failed dilations. We had a > 95% successful dilation rate. One perforation occurred requiring emergent surgery (n=1).

65 pts required surgery and 92 pts were managed with dilation. and pharmacotherapy. Overall, 28/65 patients were active smokers (43.08%) in the surgical group vs. 24/92 (26.09%). Biologic use was comparable (76.9% vs 73.9%). The average minimum diameter dilated was lower 15.2 mm (+/- 0.25) vs 16.2 mm(+/- 0.16) in the surgical group. Non-traversable strictures post-dilation was higher in the surgical group (14.72% vs 9.20%).

A total 65 patients undersent surgery with an average time of 32.22 months (excluding emergent/urgent surgeries) from index BAE and avg 8.79 months from most recent BAE. There was a total of 3 emergent surgeries (<24 hours from BAE to surgery, including one perforation from intraprocedural complication), 7 urgent surgeries (<30 days from BAE to surgery).

Conclusion

Based on this cohort, the majority of patients with CD strictures CD can be successfully managed with BAE stricture dilation, and in those requiring surgery the average time from initial BAE to surgery was 32 months. BAE stricture dilation may play an important role in preventing emergent/unplanned surgical interventions and preventing surgeries in select patients.

Although this study is currently descriptive, further data analysis of this group is ongoing currently.
P1132 Patterns and predictors of steroid use in people with IBD in routine care across ANZ
Authors: Rivas C , Su W K , Wilson W , Ng W , Ghaly S , Walker G , Forbes A , Su H , Schultz M , Lawrance I , Dutt S , Brett L , Begun J , Lynch K , Andrews J M , Connor S
Published: January 2025

Background

Despite known side effects, oral steroid use (Hydrocortisone) remains prevalent in the management of inflammatory bowel disease (IBD). We hypothesize that steroid use is multifactorial – historical practices, easy access, and quick response, are some factors that may explain the “overuse” of these medications. We sought to quantify and explore patterns and predictors of steroid use in real world IBD care.

Methods

Crohn’s Colitis Care (CCCare) is a cloud-based IBD-specific electronic medical record (EMR) used in Australia and New Zealand. Deidentified data prospectively entered by clinicians and consumers were retrospectively analysed, including people with an IBD assessment in the last 14 months. Data were extracted on 15th August 2024. Steroid exposure was defined as short (1-28 days), moderate (29-56 days), or prolonged (>56 days). Recency was defined as recent (within 365 days), previous (365-1085 days), or no exposure. Stepwise logistic regression was used to explore relationships amongst steroid use and demographic and/or disease characteristics.

Results

In 5441 eligible people, most had Crohn’s disease (CD) 3136 (57.6%), 2165(39.7%) had ulcerative colitis (UC) and 135 (2.4%) IBD-unspecified (IBD-U); 50.2% were female; median age was 42 years (IQR 56-32) and 43.9% were non-smokers. Only 994 people had steroid exposure (18.3%). In those exposed, median oral steroid daily dose was 0.22 mg (IQR 3.2-6.8); median oral steroid total dose was 246.1mg (IQR 351.2-69.2), and median annualized total steroid dose was 18.6 mg (IQR 31.6-13.3). Up to 10 courses of steroids were prescribed per person. IBD diagnosis, age, previous IBD surgery, stoma surgery, IBD therapy and age at disease onset reached statistical significance. Compared to people with UC, those with CD had less likelihood of both recent steroid exposure and prolonged exposure (OR 0.78, P=0.014 & OR 0.72, P=0.018 respectively). Adults between 20-29 years had a much higher likelihood of both recent and prolonged exposure compared to people > 70 years (OR 6.67, P=0.000 & OR 6.58, P=0.000 respectively). People on advanced therapies had a greater chance of both recent and prolonged exposure compared to people on 5-ASA alone (OR 1.65, P=0.05 & OR 1.71, P=0.000). Age at diagnosis reached statistical significance for steroid use parameters (OR 1.03, P=0.000), but with only modest effect size.

Conclusion

In this large real-world cohort, the majority had no recent steroid exposure. In those exposed, younger people, those with UC, and those with more active disease had higher likelihood of prolonged exposure. This suggests that steroid use may be further reduced by proactive tailoring of effective therapies for those with UC and focusing on disease control in younger people with IBD.
P1133 Safety and effectiveness of indigo naturalis for induction of remission in children with mild to moderate ulcerative colitis: a prospective open-label trial
Authors: Yogev D , Weintraub Y , Ledder O , Matar M , Krauthammer A , Shavit-Brunschwig Z , Salomon N , Assa A , Turner D , Orlanski-Meyer E , Shouval D
Published: January 2025

Background

Indigo naturalis (QingDai, QD) is effective in inducing remission in adults with ulcerative colitis (UC). However, data in pediatrics is limited and potential pulmonary hypertension and hepatitis remain a concern. In this prospective open-label study, we aimed to evaluate the efficacy and safety of QD for pediatric UC.

Methods

Children aged 4-18 years with mild-moderate UC (Pediatric Ulcerative Colitis Activity Index [PUCAI] 10-60) on stable medication, and not receiving steroids or biologics, were treated with QD for 6 weeks. Initial doses were weight-based (500/750/1000 mg/day for 20-30/30-40/40+ kg, respectively) with possible dose escalation at week 3. Echocardiography was performed at baseline and week 6. The primary outcome was corticosteroid-free remission at week 6 defined as PUCAI<10 and a ≥10-point reduction in PUCAI. Results were analyzed using intention-to-treat.

Results

Twenty children were enrolled (age 13.6±2.4 years, disease duration 7 [3-12] months, 50% female); all were treated at baseline with oral 5-ASA regimens. Two discontinued QD early (UC exacerbation, poor compliance), 18 completed the study and 9 required dose escalation at week 3. Clinical remission was achieved in 13 patients (65%). Calprotectin levels <250mg/kg and <100mg/kg at week 6 were observed in 13 (65%) and 10 (50%), patients, respectively. Significant reduction compared to baseline were noted in both PUCAI (30 [15-40] vs. 5 [5-15], p<0.01) and calprotectin (588 [305-1,137] vs 97 [44-438], p=0.03). Adverse events included headache (4 patients), vomiting (1) and nausea (1) and did not lead to treatment discontinuation. Mild transient hepatitis was noted in a single patient at week 3, and another patient had minimal ALT elevation at week 6. There was no evidence of pulmonary hypertension at week 6.

Conclusion

QD is effective in inducing remission in biologic-naïve children with mild-moderate UC. Headache was the most common adverse event; pulmonary hypertension was not observed. Additional efficacy and safety studies are required to determine whether QD can be used for maintenance.
P1151 6-month real-world results from the prospective FilgoColitis study on clinical effectiveness and psycho-social outcomes
Authors: Plachta-Danielzik S , Bokemeyer B , Hellms T , Landry W , Kahl M , Ehehalt R , Zimmermann L , Schiffelholz A , Efken P , Reiner J , Fajardo Salmon S , Wenske T , Schreiber S
Published: January 2025

Background

Treatment options for patients with ulcerative colitis have increased considerably in recent years. Here, we present the 6-month results on clinical effectiveness and psycho-social outcomes of the ongoing FilgoColitis study in patients with ulcerative colitis (UC) starting new treatment with filgotinib (FIL) in a real-world setting.

Methods

FilgoColitis is a prospective, multicentre, non-interventional, 24-month observational study in patients with active UC and newly introduced FIL therapy. Disease activity (clinical response: reduction of pMayo by ≥3 points from baseline to month 6 and a reduction of at least 30% or reaching remission at month 6; clinical remission (CR): pMayo ≤ 1 plus a bleeding subscore=0; steroid-free remission: CR and no systemic use of steroids or oral budesonide), quality of life (QoL) (sIBDQ and EQ-5D), and fatigue level (FACIT-F) will be analyzed. In a subgroup, the daily step count was recorded using the SensMotion® thigh accelerometer for at least 3 days after each visit (n=21).

Results

202 patients were enrolled in the study. After excluding missing outcomes, 164 patients were available for the 6-month analysis. Of these, 61.0% were male, and the median time since diagnosis was 8.0 years. Before treatment with FIL, 85.4% of patients had received biologic or small molecule therapies, and 57.3% had used immunosuppressants. Treatment persistence at month 6 was 87.2% (Fig. 1). After 6 months of treatment with FIL, the clinical response and remission rate were 59.2% and 41.7%, respectively (mITT (switchers=outcome failures), Table 1). There was no significant difference in clinical remission between biologic-naïve and biologic-experienced patients (41.7% vs 41.4%). Looking at week-10 responders only, the response rate at month 6 was 85.0%, and the remission rate was 58.8%. QoL improved significantly, with median EQ-VAS scores increasing from 64 to 80 at month 6 (p<0.001), and sIBDQ scores improving from 42.0 to 56.0 (p<0.001). Fatigue scores improved significantly from baseline to month 6 of FIL therapy (FACIT-F score part I: 8.0 vs 5.0, p<0.001). In patients who were in remission at month 6, the daily number of steps measured was higher than in patients who were not in remission (9918 (4861-11048) vs 5959 (4747-6323)). The steps measured during the night also differed between these two groups: 196 (142-559) vs 293 (164-479). This was consistent with asking the patients if they had nocturnal stools (0% vs 42.9%).

Conclusion

In this real-world study, FIL showed a clinical response rate of 59% and a clinical remission rate of 42% at month 6 in patients with active UC, demonstrating a further improvement compared to the induction phase. QoL was also significantly improved.
P1154 Impact of pharmacological therapies for moderate to severe Ulcerative Colitis on health-related quality of life: a systematic review and network meta-analysis
Authors: Katsoula A , Paschos P , Malandris K , Giouleme O , Tsapas A ,   This study was funded by a research grant 2020EOMIFNEp5 from the Hellenic Group for the Study of IBD (EOMIFNE)
Published: January 2025

Background

We performed a systematic review and network meta-analysis to evaluate the impact of pharmacological therapies on the health-related quality of life (HRQL) of patients with moderate-to-severe ulcerative colitis (UC) when used as induction therapy.

Methods

We conducted a comprehensive search of electronic databases and grey literature up to September 2024 to identify randomized controlled trials in adults with moderate-to-severe UC comparing advanced therapies. Outcomes included the mean difference in Inflammatory Bowel Disease Questionnaire (IBDQ) score, IBDQ response (defined as a ≥16-point increase from baseline), and IBDQ remission (total IBDQ score ≥170 points). We combined direct and indirect evidence through multivariate random-effects network meta-analyses, and the relative ranking of treatments was assessed using surface under the cumulative ranking (SUCRA) probabilities. Confidence in the estimates was evaluated using the CINeMA (Confidence in Network Meta-Analysis) framework.

Results

Twenty-six randomized, double-blind, placebo-controlled trials with 14 interventions (adalimumab, etrasimod, filgotinib, golimumab, guselkumab, guselkumab/golimumab, infliximab, mirikizumab, risankizumab, tofacitinib, upadacitinib, ustekinumab, vedolizumab and placebo) assessed HRQL using the IBDQ score. Moderate-to-low confidence evidence indicated that all interventions resulted in significantly improved mean IBDQ score compared to placebo (table). Based on SUCRA rankings, upadacitinib and filgotinib emerged as the most effective treatments for IBDQ change, with SUCRA values of 99.5 and 87.0, respectively. For IBDQ response, 18 trials assessing 13 treatments showed that all interventions, except etrasimod and golimumab, achieved clinically meaningful HRQL improvements (≥16-point increase in IBDQ score). Fourteen trials evaluated 11 treatments for IBDQ remission, showing that all therapies except golimumab had significantly higher remission rates than placebo. Upadacitinib, guselkumab and filgotinib had comparable high probability of being the best treatment across IBDQ remission and response outcomes.

Conclusion

Short-term pharmacological therapies consistently improved HRQL in patients with moderate-to-severe UC. Among the treatments evaluated, upadacitinib and filgotinib showed the most substantial benefits in improving IBDQ scores and were highly ranked for both IBDQ response and remission. Head-to-head trials are warranted to validate these comparative benefits and inform optimal treatment strategies.
P1157 Limited Willingness to Switch from Intravenous to Subcutaneous treatment in Pediatric Inflammatory Bowel Disease
Authors: Richter V , Eindor-Abarbanel A , Shalem T , Weiss B , Cohen D L , Shalev-Shamay R , Yerushalmi B , Yerushalmy-Feler A , Topf Olivestone C , Shirin H , Broide E
Published: January 2025

Background

Recent advances in inflammatory bowel disease (IBD) therapies have provided patients with a variety of medications with different routes of administration. We aimed to assess parental preferences regarding medication administration routes and to identify factors influencing these preferences

Methods

This cross-sectional study surveyed parents of children with IBD using a comprehensive questionnaire that focused on treatment experiences, preferences, and attitudes towards switching from intravenous (IV) to subcutaneous (SC) administration. The questionnaire explored various regimens, including oral pills, SC injections at different intervals, and IV infusions

Results

This study included 147 parents of pediatric IBD patients. The median age of the children was 16 years (IQR 14-18), and 64 (43.5%) were female. Most children (94, 63.9%) had CD. The median duration of the disease was 4 years (IQR 2-6). When the parents were asked to indicate their preferred medication route and schedule, the highest score was assigned to SC administration every 8 weeks although this difference was not statistically significant when compared to PO administration daily (2.93 and 2.86 respectively, p=0.68). Both SC every 8 weeks and oral administration were significantly more favored than IV administration every 8 weeks and SC every 2 weeks (p<0.01 for all these pairwise comparisons). There was no statistically significant difference in preference between IV every 8 weeks and SC every 2 weeks (2.16 and 2.05 respectively, p=0.44). [Fig. 1].

Despite new options allowing for SC administration, 67% of parents preferred not to switch from IV, citing concerns about self-injection, desire for nurse presence, and longer intervals between infusions [Fig. 2]. No significant correlation was found between treatment preferences and disease-related factors such as disease type or activity.

Medication doses were most frequently missed via the oral route, indicating challenges with adherence or patient preferences for this administration.

Conclusion

We evaluated the role of parental preferences on the choice of IBD medication administration routes in children, while highlighting the influence of prior treatment experience. The strong resistance to switching from IV to SC treatment, despite the availability of SC options, necessitates a patient-centered approach to clinical decision-making. Clinicians should actively involve parents in shared decision-making processes
P1160 Real-world comparative safety of filgotinib and upadacitinib for ulcerative colitis: a propensity score matching
Authors: Nogami A , Asonuma K , Okabayashi S , Ikenouchi M , Shinzaki S , Fukata M , Kobayashi T
Published: January 2025

Background

We previously reported that upadacitinib (UPA) demonstrated higher effectiveness than filgotinib (FIL) in the treatment of ulcerative colitis (UC) [1]. We aimed to compare safety profiles between FIL and UPA.

Methods

A multicenter, retrospective observational study was conducted in patients with UC over 18 years old who received FIL or UPA from March 2022 to December 2023 at three territory specialist centres in Japan. The adverse events (AEs) observed in each treatment group were reviewed in detail, and the incidence of AEs was compared using 1:1 propensity score matching (PSM), adjusting for gender, age, disease duration, disease extent, severity (partial Mayo score), previous exposure to biologics or tofacitinib, concomitant medications (5-aminosalicylic acid, immunomodulators, corticosteroids), laboratory data (CRP, Hb, Alb), past medical history, and smoking status.

Results

A total of 197 patients were enrolled, including 120 patients treated with FIL (median treatment duration 191 days) and 77 with UPA (median treatment duration 154 days). The incidence of AEs was 25.0% (30/120) in the FIL group and 45.5% (35/77) in the UPA group (p<0.01) (Table). The proportion of AEs that resulted in drug discontinuation was 5.0% (6/120) in the FIL groups and 18.2% (14/77) in the UPA group (p<0.01). Only five patients developed herpes zoster (FIL: 3, UPA: 2). No major adverse cardiovascular events, thrombosis or malignancy due to the medication were observed during the study period.

At the time of AEs identified, 77.1% of the administered UPA doses were 45 mg. In the PSM approach, a cohort of 55 patients in each group was obtained. After PSM (n=55 each) , the incidence of AEs was 14.6% in the FIL group and 43.6% in the UPA group (risk differnce 29.1, 95% confidence interval [CI]: 13.0-45.2, risk ratio 3.00, 95%CI: 1.48-6.09), which was significantly higher in the UPA group than the FIL group.

Conclusion

The higher incidence of AEs observed in this study needs to be taken into account when prescribing UPA although it has relatively high efficacy in UC patients.

References

1.Nogami.A, Asonuma K, Okabayashi S, et al. United European Gastroenterol J. 2024 Nov 13.
P1164 Consumption of red and processed meat may be associated with fatigue and anxiety in patients with IBD
Authors: Hardt H , Wilke E , Herrmann E K , Reindl W , Thomann A
Published: January 2025

Background

Patients with IBD often suffer from extraintestinal symptoms (EIS) such as fatigue, depression and anxiety. The beneficial role of a healthy nutrition is increasingly recognized in IBD as well as mental health, and a Mediterranean diet (MD) is generally recommended for IBD. However, it is not clear which aspects of MD are responsible for the beneficial effects, and dietary assessment can be difficult and time-consuming. We aimed to semi-quantitatively assess 5 simple aspects of dietary habits that are assumed to be either healthy (consumption of fresh/unprocessed products, vegetables, and olive/rapeseed oil) or unhealthy (red/processed meat, “fast food”) and analyze their relationship with EIS.

Methods

Consecutive outpatients (n=215) completed questionnaires regarding fatigue (FACIT-fatigue), depression and anxiety (HADS), and adherence to MD (MEDAS), and provided information about consumption of the abovementioned food choices. We applied a simple scoring system for each item (0-2 for oil, 0-3 for other items), with a possible combined score between 0 and 14 points, higher scores indicating healthier food choices. We calculated Spearman correlations between the 5 items’ scores and EIS scores.

Results

Adherence to MD in our sample was low (median MEDAS 6, range 2-13), median combined 5 items-score was 9 (range 3-13). There was a significant correlation between MEDAS and the 5-item score (ρ .428, p<.001). The majority of patients reported use of predominantly fresh products (77%), and a preference of olive or rapeseed oil over other fat sources (60%). Only 29% consumed at least 1 portion of fresh vegetables per day, and only 2 of 215 patients (<1%) reported to consume at least 3 portions of vegetables daily. Conversely, 47% consumed at least 1 portion of red/processed meat per week, and 15% at least 1 portion daily. Fast food was consumed regularly (1-7 times/week) by 15%. The consumption of red/processed meat correlated positively with fast food consumption (ρ .294, p<.001) and with symptoms of anxiety (ρ .169, p=.013) and fatigue (ρ .164, p=.014)

Conclusion

Our preliminary data show high rates of “unhealthy” dietary habits in an unselected IBD cohort, with surprisingly low vegetable intake. The negative association between consumption of red/processed meat and symptoms of anxiety and fatigue does not survive correction for multiple testing, but is nevertheless intriguing and should be further examined in larger samples. The simple 5-item score correlates with adherence to MD and may be useful as a very quick screening tool, but should optimally be complemented with other nutritional aspects considered relevant for patients with IBD. A respective screening tool is currently under development in our group.
P1166 Factors associated with mesalamine refractory Ulcerative Proctitis requiring advanced medical treatments
Authors: Borkovsky T , Cohen N A , Bannon L , Hirsch A , Ron Y , Thurm T , Maharshak N , Leibovitzh H
Published: January 2025

Background

Ulcerative proctitis, a subtype of ulcerative colitis (UC) affecting the rectum, that in the vast majority of cases is manageable with mesalamine therapy. However, a sub-group of patients become refractory to such treatment, necessitating advanced systemic therapies. We aimed to assess risk factors associated with the need for advanced therapy in proctitis.

Methods

Demographic and clinical data on patients with proctitis were collected retrospectively in a single tertiary center during 2010 to 2024. Proctitis was defined as maximal disease extent of 20cm from the anal verge. Patients who were prescribed immunomodulatory and/or biological therapy were considered refractory proctitis (R-proctitis). Univariate comparative analysis was used to select the features to be included in a multivariate logistic regression analysis to identify the risk factors associated with for R-proctitis. Two-sided p-value < 0.05 was considered significant.

Results

Two hundred and thirty-one patients were included in the analysis of whom 49 (21.2%) were considered R-proctitis. There were no differences between the mesalamine responsive and R-proctitis groups in terms of gender, baseline smoking status, body mass index and follow-up time (Table 1). Mean time to initiation of advanced treatment in the R-proctitis group was 6.2 ± 5.53 years. Compared to the mesalamine responsive group, patients in the R-proctitis group were younger at diagnosis (28.3 ± 14.7 vs. 34.3 ± 15.3, p=0.01), and their baseline colonoscopy showed higher rates of Mayo endoscopic score (MES) 2-3 (86.9% vs. 57.9%, p=0.04) and more extensive disease in cm from anal verge (12.6 ± 5.7 vs. 9.8 ± 5.4, p=0.01). Higher proportion of patients in the R-proctitis were prescribed with topical steroids (50% vs. 17.2%, p=0.001). In the multivariate model, only the use of rectal steroids was significantly associated with progression to R-proctitis (odds ratio [OR] 5.21, 95% confidence interval [CI] 1.56-17.32, p=0.007), while higher baseline MES 2-3 showed a trend (OR 4.31, 95% CI 0.96-19.32, p=0.056).

Conclusion

In this single center retrospective study, the need to use topical steroids was the only significant predictor to progression to R-proctitis necessitating advanced medical treatment. Our results may help stratify patients with ulcerative proctitis who may need closer follow-up and monitoring.
P1168 Real-world evidence comparison of the effectiveness of ustekinumab with anti-TNF or vedolizumab in ulcerative colitis: 2-year maintenance therapy results from the prospective, observational RUN-UC study
Authors: Bokemeyer B , Plachta-Danielzik S , Howaldt S , Mohl W , Efken P , Ehehalt R , Kahl M , Krause T , Trentmann L , Lügering A , Schnoy E , Jochum C , Fajardo Salmon S , Hartmann P , Gilman E , Schreiber S
Published: January 2025

Background

Observational real-world evidence (RWE) studies on the effectiveness of ustekinumab (UST) in ulcerative colitis (UC) are needed in addition to RCTs, which may not represent everyday clinical practice. For this reason, the prospective, controlled, propensity score (PS)-adjusted RUN-UC study was conducted on UC patients starting a new biologic therapy with a follow-up period of up to 3 years. The aim of the present analysis was to evaluate the effectiveness of 2-year maintenance therapy with UST vs. anti-TNF or vedolizumab (VDZ).

Methods

Between 2020-2022, 507 UC patients starting a new therapy with UST or other biologics were enrolled in 34 IBD-experienced centres in Germany. After the exclusion of patients with a stoma, small molecules and missing outcomes, the final sample consisted of 483 patients. Clinical remission (CR) (pMayo ≤ 1 plus a bleeding subscore=0) and steroid-free remission (CR and no systemic use of steroids or oral budesonide) were considered as outcomes. PS adjustment with inverse probability of treatment weighting (IPTW) was implemented to reduce confounders' effect.

Results

A total of 483 UC-patients [153 UST (bio-naïve: 13), 165 anti-TNF (ADA: 30.3%, IFX: 61.8%, GOL: 7.9%) (bio-naïve: 114) and 165 VDZ (bio-naïve: 106)] were included in the analysis. The PS-adjustment reduced systemic differences in the baseline parameters (UST/anti-TNF/VDZ: 43.1/46.1/50.9% males, 23.5/24.2/20.6% EIMs), in particular, the "bio-experienced" characteristic was also equalised, between the groups. Treatment persistence over 24 months showed differences between UST (68.6%), VDZ (73.3%) and anti-TNF (58.8%) (p=0.012), but this was only statistically significant for VDZ vs anti-TNF (p=0.005) but not for UST vs VDZ (p> 0.05) and UST vs anti-TNF (p>0.05) (Figure 1). The PS-weighted 24-month effectiveness (n=367) of UST (mITT analysis) in terms of clinical remission and steroid-free remission (Table 1) differed between the following groups (CR: UST 33.3%, anti-TNF 30.2%, VDZ 48.0%) compared to VDZ (p=0.031), but not compared to anti-TNF (UST vs anti-TNF p>0.05 and anti-TNF vs VDZ p=0.005). A sub-analysis evaluating steroid-free remission in bio-experienced patients after one prior anti-TNF treatment showed no statistical difference. was (UST 41.5%, anti-TNF 20.0% and VDZ 43.8%; p=0.130).

Conclusion

In this prospective RUN-UC study with PS-weighted groups, UST, anti-TNF and VDZ showed a more variable 24-month effectiveness, favouring VDZ over UST and anti-TNF. However, in a subgroup of bio-experienced patients with only one anti-TNF before baseline, steroid-free remission was numerically but not statistically higher with UST and VDZ than with anti-TNF.
P1173 Results of salvage ileal-pouch-anal anastomosis surgery in Ulcerative Colitis patients with restorative proctocolectomy
Authors: Altieri C , Emma E P , Luceri C , Vacca L , Cricchio M , Perna F , Ficari F , Scaringi S
Published: January 2025

Background

Restorative proctocolectomy (PCT) with ileal-pouch-anal anastomosis (IPAA) is the surgical treatment in medically refractory ulcerative colitis (UC).

Short and long-term complications are septic (abscess/fistula), inflammatory (pouchitis/cuffitis) or functional (stenosis/incontinence).

Salvage surgery can be performed in order to avoid permanent end ileostomy, but literature is scarce.

The aim of study is to evaluate the outcomes of IPAA salvage surgery.The primary endpoint was to analyze the percentage of patients who underwent an end ileostomy.The secondary one was to analyze risk factors for complications that lead to an end ileostomy.

Methods

Patients consecutively operated for PCT and IPAA between 1992 and 2020 were retrospectively collected, including demographics, first diagnosis, technical details of the primary IPAA, type of reconstructions and post-operative outcomes.

The group that developed complications was analyzed, describing the outcome of different surgical managements regarding each subgroup of complication. Statistical analysis was performed with a dedicated software.

Results

A total of 225 patients were reported in the observational period:169 were free from complications and 69 (30.6%) underwent pouch salvage surgery; 17 (10.9%) of them had a permanent end ileostomy, while on 52 patients pouch salvage was performed with a good rate of success (89.1%).Among 52.9% of the patients undergoing permanent end ileostomy, an inflammatory complication occurred.

Fistulas (40.5%) were the most frequent and had the best outcome. Pouchitis was present in 9 patients, but 5 of them had a permanent end ileostomy performed.The risk of end ileostomy was higher in male and in patients undergoing numerous surgeries, whilst it is lower in young patients.

Conclusion

IPAA salvage surgery is safe and provides good results with a high rate of success when performed in a referral center.

It has good outcomes concerning septic complications, while it is less effective in treating inflammatory complications.
P1174 Engineering therapeutic Tregs to overexpress GPR15 improves functional fitness for in vivo gut homing
Authors: Müller T M , Liu L J , Wiesinger M , Atreya I , Siegmund B , Atreya R , Berking C , Neurath M F , Voskens C , Zundler S
Published: January 2025

Background

Inflammatory bowel diseases (IBD) like Crohn’s disease and ulcerative colitis, are marked by an imbalance of pro- and anti-inflammatory T cells in the lamina propria of the intestinal tract. Only subgroups of patients respond to current therapeutic approaches designed to restrain pro-inflammatory cells or signalling. Adoptive transfer of autologous ex vivo expanded regulatory T cells (Tregs) has previously been suggested as a promising future therapeutic approach to resolve chronic intestinal inflammation by promoting anti-inflammatory pathways.

Methods

Using a previously established protocol for the ex vivo expansion of Tregs (Investigational Medicinal Product-Tregs; IMP-Tregs), we characterized the migration and homing capabilities as well as the immunosuppressive function of non-expanded and IMP-Tregs using 3D-motility, in vivo gut homing and T cell suppression assays. Furthermore, via electroporation with GPR15 mRNA, IMP-Tregs were engineered to express the gut homing marker GPR15 and tested for their functional fitness in dynamic adhesion, T cell suppression assays as well as in vivo gut homing assays.

Results

Our data show that while the expansion protocol generates highly suppressive Tregs, only a fraction of them is equipped with surface molecules for gut homing. In order to overcome this limitation, we successfully engineered IMP-Tregs to express the gut homing marker GPR15. On a functional level, this led to improved adhesion to the cell adhesion molecules MAdCAM-1 and VCAM-1, which are expressed on the intestinal endothelium, as well as to increased gut homing in a humanized in vivo mouse model without affecting the immunosuppressive character of the engineered IMP-Tregs.

Conclusion

In conclusion, our data indicate superior functional fitness of GPR15-engineered IMP-Tregs for homing to the inflamed gut nominating them a promising further development of autologous Treg transfer therapy for IBD.
P1176 Low serum albumin levels are associated with higher colectomy rates in patients with moderate-to-severe ulcerative colitis on tofacitinib
Authors: Parra PhD R , Fróes R D S B , Magro D O , Ferreira S D C , Mello M K D , Azevedo M F C D , Damiao A O M C , Carlos A D S , Barros L L , Miranda M L Q D , Zabot G P , Vieira A , Sales M P M , Chebli L A , Cassol O S , Lubini M , Alves Jr A J T , Machado M B , Flores C , Teixeira F V , Coy C S R , Zaltman C , Sassaki L Y , Feres O , Chebli J M F
Published: January 2025

Background

This study aimed to evaluate the real-world, long-term effectiveness and safety of tofacitinib in a large cohort of patients with refractory or difficult-to-treat ulcerative colitis (UC).

Methods

A multicentre, retrospective, observational cohort study was conducted, including patients with moderately to severely active UC who received tofacitinib for at least 8 weeks. Outcomes assessed included clinical remission and response, endoscopic response and remission, biochemical response and remission, steroid-free clinical remission, primary and secondary loss of response, drug discontinuation, dose optimisation, the need for colectomy, and adverse events over a follow-up period of up to 30 months.

Results

The study included 127 patients with UC, with a mean age of 40.3 ± 14.2 years; 58.2% were male, 75.6% had pancolitis, and 79.5% had previously failed at least one biological therapy, predominantly anti-TNF agents (70.1%). Clinical remission was achieved by 31.5% of patients at weeks 12–16, 46.5% at 26 ± 4 weeks, and 37.0% at 1 year. Steroid-free clinical remission was observed in 28.6%, 44.8%, and 37.1% of patients at these respective time points. Biochemical remission occurred in 33.6% of patients at 26 ± 4 weeks and 29.3% at 1 year. Endoscopic response and remission within 1 year were reported in 46.0% and 15.3% of patients, respectively. Ten patients (7.9%) required colectomy, and 13 patients (10.2%) were hospitalised, all of whom had previous exposure to biologics. The colectomy rate was significantly higher in patients with baseline serum albumin levels ≤ 3.5 g/dL (21.4% vs. 4.1%, p = 0.013) (Table 1).

Conclusion

This large, long-term real-world study demonstrated that tofacitinib effectively induced clinical remission and endoscopic improvement while preventing colectomy for over 30 months in patients with predominantly biologically refractory UC. The safety profile was favourable. However, baseline hypoalbuminemia was associated with higher colectomy rates, highlighting its prognostic significance.
P1177 Factors Driving Persistence to First-Line Advanced Therapies in Inflammatory Bowel Disease – A Real-World Study
Authors: Santacroce G , Lenti M V , Lepore F , Mordà F , Lo Bello A , Aronico N , Mengoli C , Delliponti M , Di Sabatino A
Published: January 2025

Background

Advanced therapies, including biologics and small oral molecules, are the mainstay of inflammatory bowel disease (IBD) management. Nonetheless, factors driving drug persistence - defined as the duration from initiation to discontinuation of a therapy- remain unclear. This study aimed to evaluate the persistence of first-line advanced therapies in a real-word IBD cohort and identify factors influencing it.

Methods

Demographic and clinical data from IBD patients who initiated first-line advanced therapies after 2010 at the San Matteo Hospital Foundation were retrospectively collected in September 2024. Persistence and discontinuation, due to failure or other reasons, were recorded. Differences in persistence probability between therapies were analysed using the log-rank test. Univariate (Fisher’s exact test for categorical variables and t-test or Mann-Whitney for continuous variables) and multivariate (logistic regression) analyses were conducted to assess factors influencing persistence versus discontinuation due to failure.

Results

Among the 274 recruited patients (median age 42.5 years; F/M 119/155; 146 with Crohn’s disease (CD) and 128 with ulcerative colitis), 159 (58%) started infliximab, 76 (28%) adalimumab, 26 (9.5%) vedolizumab, 3 (1%) ustekinumab, 3 (1%) Janus-kinase inhibitors and 7 (2.5%) other advanced therapies as first-line treatment. Persistence was observed in 141 patients (51.5%), while 70 (26%) discontinued due to failure, 19 (6.9%) due to allergy/intolerance, 18 (6.6%) due to remission, 2 (0.7%) due to immunogenicity, and 24 (8.8%) for other/unknown reasons. No significant difference in drug persistence was observed between therapies (p=0.11). Univariate analysis identified CD phenotype (p<0.01), disease duration (p=0.01), concomitant mesalamine (p<0.01) or steroids (p<0.01), and therapy optimisation (p<0.01) as factors influencing persistence. A trend toward higher faecal calprotectin levels was observed in the discontinuation group (550 vs 385 mg/kg, p=0.09), while subcutaneous administration showed a slightly higher persistence rate (45% vs 33%, p=0.11). Multivariate analysis confirmed the CD phenotype as factor associated with higher persistence, while therapy optimisation was identified as a risk factor for discontinuation.

Conclusion

While persistence rates were similar across therapies, multiple factors influence persistence or discontinuation, offering potential guidance for optimising IBD management.
P1186 Transperineal ultrasound is accurate in detecting perianal complications in Crohn’s disease: a systematic review and meta-analysis
Authors: Lim C T , Pruijt M , Lim G H , van Etten-Jamaludin F , Teichert C , de Voogd F , Christensen B , D'Haens G , Maconi G , Gecse K
Published: January 2025

Background

Perianal complications such as fistulas and abscesses are common in Crohn’s disease (CD) and contribute to significant morbidity. Transperineal ultrasonography (TPUS) has emerged as a non-invasive and accurate method for perianal CD (PACD). This review evaluates the diagnostic accuracy of TPUS compared with MRI, transrectal ultrasonography (TRUS), and examination under anaesthesia (EUA) for detecting and classifying perianal fistulas and abscesses.

Methods

A comprehensive literature search was conducted across multiple databases from their inception to December 2023 to identify studies evaluating TPUS accuracy in detecting perianal fistula and abscesses using MRI, TRUS, or EUA as reference standards. Meta-analysis was performed to assess TPUS accuracy for fistula detection (FD), fistula classification (FC), internal opening (IO) detection and abscess detection (AD) with a subgroup analysis carried out in CD patients. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to evaluate the risk of bias.

Results

Of the 994 studies identified, 25 (involving 1435 patients) met the inclusion criteria for the meta-analysis. These included 24 studies on FD, 11 on FC, 21 on AD and 10 on IO detection. Overall, these studies had a moderate risk of bias, with moderate applicability concerns due to high risk of bias in patient selection (non-consecutive enrollment) and reference standard chosen (non-blinding interpretation of scans). Significant heterogeneity was observed across study domains with I2 and X2 values of 98%, 88.0%, 93.0%, and 105.6, 16.0, 27.5 for FD, FC, and AD, respectively (p<0.001).

Pooled sensitivities for FD, FC, IO detection and AD were 97.7%, 99.9%, 91.5% and 94.2% respectively while pooled specificities for FD, IO detection and AD were 77.8%, 73.1% and 78.6% respectively. Diagnostic Odd’s Ratio for FD, IO detection and AD were 148.13, 29.39 and 280.07 respectively. The overall accuracy of TPUS for FD, FC, IO detection and AD was 92.5%, 90.7%, 88.3% and 94.3% respectively (Table 1).

A subgroup analysis focusing on CD patients (from 13 studies) showed pooled sensitivities of 96.6%, 99.9% and 85.5%, with overall accuracies of 85.2%, 86.5% and 83.4% for FD, FC and AD respectively. Stratification by publication date demonstrated improved accuracy in FD and AD in studies published after 2017 (91.6% vs 96.0% and 87.3% vs 96.8%).

Conclusion

TPUS demonstrates high accuracy in detecting perianal fistulas and abscesses in both CD and non-CD patients, supporting its use as a non-invasive, first-line diagnostic tool.
P1189 Rethinking disease clearance in ulcerative colitis: histological activity predicts long-term outcomes in an Argentine reference center cohort
Authors: Marturano M V , Gómez E J , Navar S , Rodriguez Mesias J L , Amante M F , Gonzalez R A
Published: January 2025

Background

Histological normalization in ulcerative colitis (UC) is not yet a formal treatment target, but STRIDE-II consensus recognizes it as a measure of remission depth. Recent studies show histological healing can diminish relapse risk after endoscopic remission, introducing the concept of "disease clearance" (DC) as clinical, biological, endoscopical and histological remission. This study investigates the association between histological activity and long-term outcomes in UC patients to better define this therapeutic goal.

Methods

We conducted a single center retrospective cohort study. Adult patients with a previous diagnosis of UC who underwent colonoscopy from Nov-2020 to Nov-2023 and with at least 1 year of follow-up were included. Data on demography, medications for IBD, measures of activity and follow-up were analyzed. Univariate and multivariate analysis were carried out to identify values of the histopathological Nancy index associated with adverse outcomes. Additionally, Kaplan-Meier survival analysis assessed the association between histological activity and long-term outcomes. The Log-Rank test compared survival curves between groups. A p value <0.05 was considered statistically significant.

Results

We reviewed the medical records of 451 patients with UC, 197 met the inclusion criteria. The mean age was 49 years (range 19–90), 56% were females and median disease duration was 9 years. Fifty patients (25%) were treated with biologics. Sixty six % were in endoscopic remission and 35% were in histological remission or had only chronic inflammatory infiltrate at baseline (Nancy score [NS] 0-1). Median follow-up was 20 months (range 12-46). Patients with significant histological activity at baseline (NS >1) were more likely to experience clinical relapse (30% vs 15%, p= 0.017), endoscopic relapse (22% vs 7%, p= 0.01), corticosteroid use (22% vs 1.5%, p<0.01), therapy intensification (23% vs 6%, p= 0.002) and treatment switch (24% vs 3%, p<0.01) compared to patients in the NS 0-1 group. The Kaplan-Meier curves confirmed that patients with Mayo Endoscopic Score (MES) and NS ≤1 at baseline had a lower risk of both clinical relapse (log-rank p=0.0374) and therapy switch requirement (log-rank p=0.0004). At multivariate analysis, the composite MES 0-1 and NS 0-1 was the only independent variable associated with a lower risk of clinical relapse and change in medical therapy.

Conclusion

Our study found that achieving an endoscopic MES and a NS ≤1 was associated with a lower rate of adverse outcomes during follow-up. We believe this could better define the concept of DC as a target in the treatment of UC. Clinical trials are warranted to demonstrate the benefits of DC versus other outcomes