bluuebunny/crossref_metadata_2025 huggingface dataset:
P1145 Comparison of Clinical Relapse between Tofacitinib and Filgotinib as Maintenance Therapy in Ulcerative Colitis Patients in Clinical Remission: A Retrospective Propensity Score-Matched Cohort Study
Authors: Yagi S , Fukui H , Ikenouchi M , Shiraishi T , Wakita M , Takagi Y , Sato T , Kawai M , Kamikozuru K , Yokoyama Y , Takagawa T , Shinzaki S
Published: January 2025

Background

Strategies to reduce relapse after induction therapy using JAK inhibitor are controversial in patients with ulcerative colitis (UC). In this study, we aimed to compare relapse rate between tofacitinib (TOF) treatment and filgotinib (FIL) treatment for UC patients in clinical remission.

Methods

We used the data of UC patients who received TOF 10mg/day or FIL 200mg/day as maintenance therapy between May 2018 and October 2024. We included UC patients in clinical remission at baseline. Clinical remission was defined as follows: partial Mayo score ≤2, each subscore ≤1 and a rectal bleeding subscore of 0. The primary outcome was the time to relapse, defined as the requirement of dose escalation or switching therapy for UC with the worsening of clinical symptoms. The secondary outcome was safety during the observation period. Kaplan-Meier analysis and log-rank test were used in order to assess difference in therapy duration between two groups. A propensity score-matched (PSM) analysis was performed to adjust for potential confounders.

Results

We enrolled patients with UC who received either TOF 10mg/day (n = 101) or FIL 200mg/day (n = 43) as maintenance therapy. The median age was 39 [IQR 28–50] and 44 [34–55] years, and the median disease duration was 4 [1–11] and 7 [5–16] years, respectively. The number of previous exposures to anti-TNF agent was 52 (51.5%) and 18 (41.9%), respectively. In the TOF group, cumulative relapse rates at 8, 16, 24, and 48 weeks were 0%, 8.8%, 12.7%, and 25.5%, respectively. On the other hand, in the FIL group, cumulative relapse rates at 8, 16, 24, and 48 weeks were 0%, 2.3%, 4.7%, and 7.0%, respectively. After PSM, forty-three patients in both the TOF and FIL groups were isolated. The cumulative clinical relapse rate was significantly higher in the TOF group than in the FIL group (p = 0.039). Adverse events that required treatment discontinuation were reported in 8 patients in the TOF group, but no adverse events leading to discontinuation were observed in the FIL group.

Conclusion

Our findings suggested that FIL could prevent relapse in UC patients who are in clinical remission more effectively than TOF.
P1146 Robotic approach to ileocolic Crohn disease surgery: does it increase the risk of intraoperative incidents compared to laparoscopy? Results of a comparative propensity matched multicentre cohort study
Authors: Husson T , Abdalla S , Duval Q , Zerbib P , Penna C , Benoist S , Cotte E , Brouquet A
Published: January 2025

Background

The robotic approach has gained interest in oncologic colorectal surgery. In Crohn’s disease (CD) patients presenting with marked mesenteric inflammation and bowel fragility, very little safety data have been reported (1, 2). The lack of haptic feedback and the restricted surgical field are potential disadvantages of the robotic approach that could lead to a higher risk of intraoperative incidents compared to laparoscopy.

Methods

A total of 259 patients undergoing minimally invasive ileocolic resection (ICR) for CD (66 robotic and 193 laparoscopic) were included in 3 tertiary IBD centers. Intraoperative incidents were defined as unintended gastrointestinal opening and hemorrhage and conversion. Intraoperative and postoperative outcomes of robotic and laparoscopic approaches were compared after propensity-score matching including CD severity.

Results

After matching, 66 robotic patients were compared to 66 patients who underwent laparoscopic surgery. CD was defined as complex (i.e. abscess, fistula or inflammatory mass) in most patients in the robotic and laparoscopic groups (71% vs 70%, NS). Ileocolic resection was performed as an iterative procedure in a few patients in both groups (7.6% vs 6.1%, NS), and the main indication for surgery was a symptomatic digestive fistula (50% vs 58%, NS). A primary anastomosis was performed in almost all patients (97% vs 92%, NS). No statistically significant difference was observed between the robotic and laparoscopic groups regarding the rates of intraoperative incidents (15% vs 12%, NS), conversion (12% vs 9%, NS), overall morbidity (36% vs 29%, NS), or intraabdominal septic complications (9.1% vs 9.1%, NS). Compared to laparoscopy, robotic surgery was associated with a longer operative time (183 vs 157 minutes, p = 0.009) and a higher rate of intracorporeal anastomosis (48% vs 1.5%, p < 0.001), with specimen extraction through a Pfannenstiel incision (44% vs 1.5%, p < 0.001).

Conclusion

The robotic approach does not increase the risk of intraoperative incidents compared with laparoscopy and should not be contraindicated for ICR in CD. In contrast, it may reduce the overall impact of surgery by facilitating intracorporeal anastomosis and Pfannenstiel extraction in a young patient population concerned about the cosmetic results of surgery.

References

(1)Calini, Giacomo et al. “Ileocolic resection for Crohn’s disease: robotic intracorporeal compared to laparoscopic extracorporeal anastomosis.” Journal of robotic surgery vol. 17,5 (2023): 2157-2166. doi:10.1007/s11701-023-01635-6

(2)Abdalla, Solafah et al. "Perioperative outcomes of minimally invasive ileocolic resection for complicated Crohn disease: Results from a referral center retrospective cohort." Surgery vol. 172,2 (2022): 522-529. doi:10.1016/j.surg.2022.01.046
P1148 The incidence and predictive factors of thromboembolism during hospitalizations for IBD flare-ups: A retrospective cohort study in Taiwan
Authors: Meng M J , Le P H , Chung C S , Chang C W , Pan Y B , Kuo C J , Chiu C T
Published: January 2025

Background

Thromboembolism (TE) notably increase morbidity and mortality among inflammatory bowel disease (IBD) patients. Despite ECCO's 2024 guidelines advocating routine anticoagulant prophylaxis, its application in Asia remains inconsistent due to a lack of regional studies. This research investigates the incidence and predictors of TE during IBD-related hospitalizations in Taiwan, aiming to improve prevention strategies.

Methods

Our retrospective cohort study included 282 adult IBD patients, accounting for 515 flare-up related hospitalizations at Linkou Chang Gung Memorial Hospital from January 2001 to March 2024. Patients were classified into two groups based on the occurrence of TE. Numerical data were presented as means ± standard deviations, and categorical data were expressed as absolute numbers and percentages. Data analysis involved chi-square or Fisher's test for categorical variables and the Mann-Whitney U test for continuous variables. Multivariable logistic regression was utilized to identify independent predictors of TE. The cutoff values for serum albumin were determined using receiver operating characteristic (ROC) curves. Statistical significance was set at P < 0.05. All statistical analyses were performed using IBM SPSS Statistics version 26.0 (IBM Corp., Armonk, NY, USA).

Results

The incidence of TE was 1.55%. The TE group had significantly lower body weight (p=0.02), body mass index (BMI) (p=0.019), hemoglobin (p=0.036), and albumin levels (p=0.001) but higher rate of sepsis (p=0.002) and concurrent autoimmune diseases (p=0.002) compared to the non-TE group. Multivariate analysis indicated that concurrent autoimmune diseases (OR: 0.001, 95% CI: 0.000-0.317, p=0.02) and hypoalbuminemia (OR: 0.031, 95% CI: 0.001-0.643, p=0.025) were independent predictors of TE. (Table 1) The optimal serum albumin cutoff was established at 3.01 g/dL, with sensitivities and specificities of 87.5% and 77.3%, respectively. (Figure 1)

Conclusion

This pioneering Asian study identifies concurrent autoimmune diseases and low serum albumin (< 3.01g/dL) as independent predictors of TE in hospitalized IBD patients. Prophylactic anticoagulant should be considered for this high-risk group of Asian IBD inpatients.
P1153 Intestinal Fibrosis Attenuates the Prophylactic Effect of Antitumour Necrosis Factor Therapy on Postoperative Recurrence of Crohn’s Disease
Authors: Ding Z , Wang Y , Zhang M , Li Y
Published: January 2025

Background

In biologic era, the postoperative recurrence (POR) of Crohn’s disease (CD) remains a significant concern. The objective is to examine if intestinal fibrosis increases the likelihood of POR when using anti-tumour necrosis factor (anti-TNF) α biologics following ileocecal resection (ICR).

Methods

We performed a single-centred, retrospective cohort study of CD patients who underwent an ICR. Recurrence was defined by endoscopy (Rutgeerts score, RS ≥ i2), radiography (active inflammation in the neoterminal ileum, neoTI) or surgery (another resection > 3 months from the index ICR) and patients were categorised based on the presence of intestinal fibrosis as determined by histopathological evaluation.

Results

102 patients with CD who underwent an ICR and received anti-TNFα prophylaxis within 18 weeks were identified. Of 74 (72.5%) were diagnosed with intestinal fibrosis. A cohort of 60 patients (58.8%) encountered POR in various forms: 52.6%, 41.2%, and 10.8% had endoscopic, radiographic, or surgical recurrence, respectively. Patients with intestinal fibrosis experienced radiographic recurrence at a more accelerated rate compared to those without fibrosis. However, no significant difference was observed when comparing other types of recurrence. After adjusting for factors associated with POR, intestinal fibrosis was found to be more likely to induce early development of radiographic recurrence (adjusted hazard ratio, 4.004; 95% CI, 1.031-15.555).

Conclusion

Despite the small sample size, our study revealed a strong correlation between the occurrence of radiographic POR and intestinal fibrosis in patients who received postoperative anti-TNFα prophylaxis.
P1158 Patients with refractory and difficult-to-treat Inflammatory Bowel Disease are underrepresented in randomized clinical trials
Authors: Parigi MD T L , Solitano V , Mekonnen H , Yuan Y , Jairath V , Danese S
Published: January 2025

Background

A significant proportion of patients with inflammatory bowel disease (IBD) do not respond to treatment. Recently, criteria to define difficult-to-treat (DTT) IBD have been proposed1. These include IBD refractory to at least 2 advanced therapies with different mechanisms of action. We aim to review the representation of patients with prior exposure to biologics, DTT-IBD, and other challenging phenotypes in randomized clinical trials (RCTs).

Methods

A scoping review was performed by reviewing all RCTs of advanced therapies in IBD. We updated the literature searches of two published systematic reviews of ulcerative colitis (UC)2 and Crohn’s disease (CD)3 searching MEDLINE, EMBASE, and the Cochrane Library up to December 2023.

Results

We included 140 RCTs, 73 in ulcerative colitis (UC), and 67 in Crohn’s disease (CD), comprising 44.799 patients.

In UC, 53% (39/73) of studies included patients with prior exposure to other biologics, but only 19% (14/73) included patients exposed to two or more biologics. Moreover, only 5% (4/73) of studies included participants exposed to biologics with multiple mechanisms of action, or DTT, and these accounted for 2% of the total participants of UC RCTs. None of the trials reported efficacy results specific for DTT.

In CD, 60% (47/67) of studies included patients with any prior biologic exposure, and 31% (21/67) allowed the participation of patients who received two or more biologics. Only one study (1.5%) reported efficacy results for patients exposed to multiple mechanisms of action, DTT-IBD, which accounted for 7.4% of the study participants and 0.1% of all those in CD trials.

In CD, history of prior intestinal surgery was reported only in 28 of 67 studies (42%) for 2977 patients, or 14.5% of the total participants. Similarly, upper gastrointestinal involvement of CD was included only in 21 trials (31%) and present in 808 participants (3.9%). Instead, the majority of trials either excluded patients with locations proximal to the terminal ileum (35 RCTs; 52%) or did not report whether some participants had upper gastrointestinal locations (11 RCTs; 16%)

In both UC and CD there was a trend towards greater inclusion of exposed and refractory patients in recent years.

Conclusion

Patients exposed to multiple advanced therapies and those with phenotypes of CD more challenging to manage remain underrepresented in clinical trials of IBD.

References

1.Parigi TL, et al. Lancet Gastroenterol Hepatology 2023

2.Sedano R, et al. Journal Crohn & Colitis 2021

3.Almradi A, et al. Journal Crohn & Colitis 2021
P1159 New onset acne reported in the majority of patients with upadacitinib-treated Inflammatory Bowel Disease
Authors: Omrani F , Sharma E , Irving P , Ray S , Anderson S , Mawdsley J , Dart R , Samaan M , Gecse K
Published: January 2025

Background

Upadacitinib (UPA), a janus kinase inhibitor (JAKi) with selectivity for JAK-1, is licensed in ulcerative colitis (UC) and Crohn’s disease (CD). Acne was seen commonly in the CD and UC registration studies of UPA. We sought to investigate the prevalence of acne in a real-world cohort of IBD patients using UPA.

Methods

We performed a retrospective review of all patients who received UPA for UC, CD or IBD-unclassified (IBD-U) between Sep 2022 and Sep 2024 at a large tertiary referral centre. Data were collated from electronic health records supplemented by telephone calls to individual patients. Demographic data, previous advanced treatments, dose and length of time on UPA were recorded in addition to skin related adverse effects. Self-reported acne was considered acceptable as a diagnosis, given that it is easily recognisable by the general public.

Results

The patient cohort is described in table 1. Out of 159 eligible subjects, 132 (83%) were reachable by telephone, 50 (38%) of whom were females. The indication for UPA was UC (67, 51%), CD (60, 45%), and IBD-U (5, 4%). 14 patients (11%) reported a history of acne at time of starting UPA and 60 (45%) were aware that acne was a potential side effect prior to starting the medication (Table 1).

After a median duration of UPA therapy of 10 months (IQR 4-12), acne was reported by 77 (58%) patients (34 (51%) UC and 39 (65%) CD; 50 (61%) male and 27 (54%) female). Acne was reported to have involved the face (n=30, 41%), body (n=7, 9%) or both (n=37, 50%). The majority of UPA-associated acne was reported during the initial higher dose 45mg daily induction period (70, 91%) although acne persisted in 45 (58%) patients after reduction to 30mg. Notably, 35 (45%) patients with UPA-associated acne consulted their general practitioners, and 15 (19%) required specialist input from dermatologists. Importantly, acne-induced UPA dose reduction occurred in 4 (5%) patients and 3 (4%) patients discontinued UPA because of acne (Table 1).

Conclusion

The study suggests that self-reported acne is very common amongst patients who are receiving UPA for IBD, although acne-driven dose reduction or discontinuation is infrequent. Nearly half of the affected patients required GP assessments, and one fifth needed specialist dermatology input, suggesting substantial patient inconvenience and considerable impact on healthcare resource utilisation. Specific risk factors for acne, as well as potential benefits of dose reduction, should be further explored amongst upadacitnib users in larger, prospective studies.
P1165 Longitudinal observation of symptoms of fatigue, depression and anxiety in Crohn’s disease
Authors: Stephan J C , Atanasova K , Knoedler L L , Ebert M P , Reindl W , Wolf R C , Thomann A K
Published: January 2025

Background

In IBD, extraintestinal symptoms (EIS) such as fatigue, depression and anxiety are a major burden on the patients’ quality of life (QoL). These EIS are more prevalent in active disease but can persist in remission. A deleterious effect of depression and anxiety on the course of disease has already been confirmed in longitudinal studies, but to our knowledge the relevance and nature of fatigue symptoms in this regard have not been addressed longitudinally. We examined patients with Crohn’s disease (CD) in an active disease state and followed them up after 3-6 months to evaluate the presence, course and relationships of EIS.

Methods

We recruited patients with CD in active disease and healthy controls (HC). Patients were instructed to complete self-report questionnaires to measure clinical activity (HBI), fatigue (WEIMuS), anxiety and depressive symptoms (HADS-A, -D) and QoL (IBDQ) before a change of therapy (T1, n=49) and 3-6 months later (T2, n=46). HCs (n=25) answered the same questionnaires except IBDQ.

We compared EIS scores between PAT and HC, as well as between T1 and T2, and evaluated EIS changes in PAT with regard to response vs. non-response at T2. Finally, we explored the influence of EIS on clinical activity at T2.

Results

At both visits and in each of the questionnaires analysed, patients showed higher scores for EIS compared to HC (all pcorr<0.004, FDR 0.05). In patients, fatigue scores were significantly lower at T2 compared to T1 (pcorr=0.034). Patients’ QoL improved (pcorr=0.003), while depression and anxiety didn’t change significantly between T1 and T2.

When comparing remitted vs non-remitted CD at T2 (see Table 1), remitted patients had larger differences in EIS scores from T1 to T2 (all pcorr=0.012). Also, remitted patients showed significantly higher and more positive changes in QoL compared to non-remitted patients (pcorr=0.005). In multiple regression analysis, BMI, HADS-D and WEIMuS at T1 were positive predictors for the HBI at T2 (all pcorr<0.019). In contrast, HADS-A at T1 was a negative predictor for HBI at T2 with pcorr=0.002 (see Figure 1).

Conclusion

As expected, EIS were higher in CD compared to HC. Patients who responded to therapy changes showed higher decrease of fatigue, depression and anxiety and higher increases of QoL compared to non-responders. Higher BMI, depressive and fatigue symptoms at T1 were associated with non-response, higher anxiety at T1 could be associated with response. These findings need to be confirmed in larger studies but indicate the importance of successful induction of remission to improve not only intestinal inflammation and QoL, but also fatigue and affective symptoms.
P1169 Guselkumab maintenance treatment improves health-related quality of life in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR maintenance study
Authors: Bressler B , Peyrin-Biroulet L , Afif W , Samaan M A , Wei S C , Yarandi S , Germinaro M , Mistry P , Han C , Allegretti J R , Lichtenstein G R
Published: January 2025

Background

Ulcerative colitis (UC) symptoms are associated with impaired health-related quality of life (HRQoL). The Phase 3 QUASAR maintenance study (NCT04033445) evaluated the efficacy and safety of guselkumab (GUS) in participants (pts) with moderately to severely active UC who demonstrated a clinical response to GUS intravenous (IV) induction. GUS is a selective dual-acting IL-23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. Here we report the effect of GUS subcutaneous (SC) maintenance therapy on HRQoL at Week (W) 44 in QUASAR pts as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29.

Methods

At maintenance baseline (BL), GUS IV induction W12 responders and placebo (PBO)→GUS IV induction W24 responders were randomized 1:1:1 to SC GUS 200 mg every 4 W (q4w; N=190), GUS 100 mg every 8 W (q8w; N=188), or PBO (GUS withdrawal; N=190) maintenance therapy. PROMIS-29 consists of 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and social participation) and a pain intensity numeric rating scale (NRS, range 0-10). The raw score of each domain is converted into a standardized T-score with a general population mean of 50 and standard deviation of 10. Physical component summary (PCS) and mental component summary (MCS) scores are derived from physical and mental domain T-scores, respectively. Higher scores indicate better outcomes for physical function and social participation domains and PCS and MCS scores and worse outcomes for all other symptom domains. Depending on the domain/score, improvement of ≥3 to ≥9 points from induction BL was identified as clinically meaningful.1

Results

At maintenance BL, mean PROMIS-29 domain T-scores, pain intensity NRS score, and PCS/MCS scores in all treatment groups reflected values in-line with the general population, as expected for clinical responders to GUS IV induction (Table). At W44, the PROMIS-29 domain T-scores, pain intensity NRS score, and PCS/MCS scores observed at maintenance BL were sustained in both GUS SC maintenance groups but had worsened in the PBO group (Table). The proportion of pts achieving clinically meaningful improvement from induction BL at W44 was greater with GUS vs PBO for each PROMIS-29 domain T-score, pain intensity NRS score, and PCS/MCS scores (Figure).

Conclusion

Among pts with moderately to severely active UC who responded to GUS IV induction, GUS SC maintenance therapy sustained clinically meaningful improvements in HRQoL at W44 as measured by the PROMIS-29. This study was funded by Janssen Research & Development, LLC.

References

1.Sands BE, et al. Value Health 2024;27:1225-1234.
P1170 Is it time to switch to subcutaneous infliximab? The RE-WATCH multicentre study
Authors: Bertani L , Ribaldone D G , Bossa F , Guerra M , Annese M , Manta R , Caviglia G , Armandi A , Barugola G , Todeschini A , Variola A
Published: January 2025

Background

Infliximab (IFX) biosimilars CT-P13 is available in a subcutaneous (SC) formulation. Both clinical trials and real life studies showed its effectiveness in maintaining remission in patients treated for several months of intravenous (IV) IFX. Although the current indications allow the switch from IV CT-P13 to SC CT-P13 after two IV administrations, several clinicians postpone the switch after achieving a stable clinical remission. What is the best time to switch to SC IFX is unknown. This study aims to evaluate the endoscopic response, treatment persistence, clinical remission, endoscopic remission, and safety profile after one year in the two groups.

Methods

The RE-WATCH study was an observational, multicentre, retrospective study performed in 4 IBD referral centres. All adult patients with an established diagnosis of IBD treated with IFX IV and subsequently switched to SC, from December 2021 to August 2023, were enrolled. The switch was performed in two different ways: at week 6 (Group 6W) or after 6 months (Group 6M). Data on medical history, laboratory tests and endoscopy were collected from health records.

Results

We recruited 104 IBD (49 CD, 55 UC) patients treated with IFX IV, 56 were in the Group 6W and 48 in the Group 6M. There were no statistically differences between the two groups after one year for endoscopic response (71.4% vs 70.8%, p = 0.95), steroid-free clinical remission (62.5% vs 68.7%, p = 0.51), and IFX retention rate (75.0% vs 66.7%, p = 0.35). We observed a trend of higher endoscopic remission rates in patients in Group 6W than in those in Group 6M, although not significant (69.6% vs 52.1%, p = 0.07). Switch back to IV IFX was needed in 1 out of 43 patients (2.3%) in Group 6W and in 3 out of 44 patients (6.8%) from month 6 to 12 in Group 6M (p = 0.31). Clinical indexes, fecal calprotectin and C-reactive protein levels significantly decreased after one year regardless of the switch group. Adverse events rates were similar between the two groups (4.5% vs 8.3% p=0.46). IBD- related hospitalization occurred in 3 patients and only one of them underwent surgery during follow-up in Group 6M.

Conclusion

Our study showed that an early switch to SC IFX at 6 weeks is effective in terms of clinical and endoscopic remission at one year, similarly -or even better- than a switch performed at 6 months.
P1175 Handheld ultrasound devices are an accurate alternative to cart-based ultrasound for IBD disease activity assessment
Authors: Fernandes R , Swe E , Khaing M M , Gilmore R , Khoo E , An Y K , Begun J
Published: January 2025

Background

Intestinal ultrasound has revolutionised inflammatory bowel disease (IBD) care, as a quick, cost-effective, accurate and reliable tool for assessing IBD activity. Recently high-quality handheld ultrasound devices (HHUS) have emerged, representing a more accessible, cheaper alternative to expensive and cumbersome cart-based ultrasounds (CBUS), however their accuracy for IUS has not been studied. We aimed to assess the accuracy of HHUS compared to CBUS in a real-world IBD population.

Methods

We prospectively recruited patients attending outpatient IBD clinics in a tertiary centre from 18 July to 1 October 2024. Patients were first scanned by IUS trainees or clinicians certified by the Gastroenterological Network of Intestinal Ultrasound using 1-2 HHUS (Clarius™ L15 HD3 (CL) and/or GE™ Vscan Air CL (GE) using linear and convex probes as needed) and then CBUS. We collected baseline demographics, standard ultrasound parameters, disease activity classification, concordance with CBUS, and the predicted impact on clinical management. Qualitative statistical analyses and diagnostic accuracy calculations were performed.

Results

We performed IUS on 101 patients (49% ulcerative colitis, 52% Crohn’s disease, 46% male, median age 39 years, median BMI 23.4 kg/m2), using CL in 69 (total segments 260) and GE in 57 (total segments 220). The demographics and scan results are detailed in Table 1. Overall concordance for disease activity status (classified as "active" or "inactive") with CBUS was 93% for CL and 91% for GE, and 100% and 95% respectively for patients with a BMI >25 kg/m2. There were 5 discordant scans each for CL (7%) and GE (9%) mostly related to discrepancies in bowel wall thickness in either the sigmoid colon or terminal ileum (there was a discrepant Doppler result in 1 case), in which 4 cases for both GE and CL reported high clinician confidence with the results. It was anticipated that the discordant result would negatively impact management in 4 (5.8%) cases for CL and 3 (5.2%) cases for GE. Overall sensitivity and specificity were high in both CL (85% and 100%) and GE (76% and 100%) and remained reasonably high for all segments (see Figure 1).

Conclusion

Both CL and GE HHUS represent viable alternatives to CBUS, with high diagnostic accuracy for IUS in IBD patients with normal and high BMIs. Given significantly lower costs, use of HHUS could improve access to IUS in IBD care internationally. There is a small risk that rare discordant results could negatively impact management, however this risk could be mitigated by interpreting IUS findings in the context of other disease activity markers and considering a repeat IUS using CBUS where there is uncertainty regarding findings.
P1178 A multi-centred retrospective cohort study comparing JAK inhibitor therapies in moderate to severe ulcerative colitis
Authors: Kumar A , Baxter J , Rimmer P , Noble B , Makki M , Chikhlia A , Cheesbrough J , Disney B , Muir J , Karova M , Butterworth J , Bower J , Sagar N , Al-Talib I , Nahal J , Hatta A , Ali N , Sagar V , Varyani F , Smith S , Bourne S , Hsu Y K , Eltahir A , de silva S , Harvey P
Published: January 2025

Background

Tofacitinib, filgotinib and upadacitinib are JAK inhibitors (JAKi) that are licensed for treatment in moderate to severe ulcerative colitis (UC). Whilst these drugs have demonstrated efficacy against placebo, there is no head-to-head data. This study aims to compare the clinical efficacy between these drugs.

Methods

This is a multi-centred, retrospective cohort study with data collected from January 2018 to June 2024. Patients with UC were recruited on their first JAKi, irrespective of previous advanced therapies. Clinical remission (faecal calprotectin (FCP) <250, Mayo £1, UCEIS £1, pMayo £2, SCCAI £2) and response (50% reduction in FCP from baseline, reduction in partial Mayo or UCEIS by 3 or more, or sustained <3) was measured at 3- and 6-months. If a patient stopped taking JAKi, they were considered to have failed both response and remission. Data was non-parametric and outcome measures were compared using Chi-squared tests.

Results

There was a total of 266 patients included in the final analysis. 70 (26%) were on upadacitinib, 47 (18%) on filgotinib and 149 (56%) on tofacitinib (Table 1). At least 87% (129/149) on tofacitinib had exposure to a previous biologic compared to 80% (56/70) for upadacitinib and 66% (31/47) for filgotinib. At 3-months, clinical response in upadacitinib, filgotinib and tofacitinib was demonstrated in 83%, 74% and 75% patients, respectively and clinical remission was seen in 69%, 64% and 52%, respectively. At 6-months, clinical response was demonstrated in 79%, 65% and 63%, respectively and remission was seen in 75%, 61% and 51%, respectively. Upadacitinib demonstrated significantly higher 3-months remission rate (p=0.019) and 6-months response (p=0.010) and remission rates (p= 0.001) compared to tofacitinib. In the bio-exposed cohorts, upadacitinib demonstrated greater 6-months remission rates (71%) compared to 64% on filgotinib (p=NS) and 52% tofacitinib (p= 0.022). In bio-naïve cohorts (n=50), upadacitinib demonstrated greater 6-months remission rates (93%) compared to 56% on filgotinib (p=0.024) and 50% tofacitinib (p= 0.009). Combining the JAKi, 90% of patients were not on steroids at 3-months and 94% were not on steroids at 6-months. A total of 26 patients had a colectomy at the time of their JAKi, 17 on tofacitinib, 5 on filgotinib and 4 on upadacitinib.

Conclusion

This study demonstrates that upadacitinib is more likely to achieve 3- and 6-month remission compared to tofacitinib. In a small sub-group of bio-naïve patients Upadacitinib was more likely to achieve 6-month remission compared to filgotinib and tofacitinib. JAKi were associated with minimal adverse events and importantly, the efficacy of JAKi does not appear diminished by prior biologic use.
P1179 Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy (RETUCAS): a Multicentre Prospective Study from the Italian Group for the Study of Inflammatory Bowel Diseases (IG-IBD)
Authors: Macaluso F S , Grova M , Bossa F , Carparelli S , Pugliese D , Cuccia G , Cappello M , Muscarella S , Saibeni S , Bezzio C , Armuzzi A , Gravina G A , Pellegrino R , Caprioli F A , Sorge A , Soriano A , Ribaldone D G , Festa S , Variola A , Ferracane C , Onali S , Fantini M C , Orlando A ,   Italian Group for the study of Inflammatory Bowel Diseases (IG-IBD)
Published: January 2025

Background

The efficacy of Tofacitinib (TOFA) in several rheumatic diseases led to expectations on a possible benefit of this drug for the treatment of ulcerative colitis (UC)-associated spondyloarthropathy (SpA).

Methods

Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy (RETUCAS) is a prospective, multicentre, observational study designed to assess the effectiveness of TOFA on UC-associated SpA and promoted by the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD). Patients with UC and an established diagnosis of active axial or peripheral SpA at baseline were included. The primary endpoint was the steroid-free joint response (SFJR - defined by a decrease of ≥ 1.1 units of ASDAS-CRP for axial SpA, and a decrease of > 0.6 units of DAS28-CRP for peripheral SpA compared with baseline with no steroids use) at week 8 and 52.

Results

Forty-four patients were included [axial Spa: 9.1%; peripheral SpA: 70.4%; combined axial and peripheral (mixed) SpA: 20.5%]. At 8 weeks, SFJR was reported in 52.3.% of patients, with a significant difference between patients with peripheral SpA compared with the subgroup of patients with axial and mixed SpA (67.7% vs. 15.4%; p=0.001). At 52 weeks, SFJR was reported in 59.1% of patients (peripheral SpA: 71.0% vs. axial and mixed SpA: 30.8%; p=0.01).

Conclusion

This is the first prospective study designed specifically for the assessment of IBD-associated SpA and based on rheumatological scores. In patients with UC and multiple previous therapeutic failures, TOFA was effective on peripheral SpA, while more data are needed on axial SpA.
P1180 Long-Term Outcomes of Enteroscopic Balloon Dilatation and Risk Factors for Surgery in Small Bowel Stricturing Crohn's Disease: A Prospective Observational Study
Authors: Hong S N , Kim J E , Kim E R , Chang D K , Kim Y H
Published: January 2025

Background

The long-term outcomes of enteroscopic balloon dilatation (EBD) for small bowel strictures in patients with Crohn's disease (CD) are not well understood. Although Crohn's strictures can be classified into web-like, ulcerated, and spindle-shaped strictures based on endoscopic findings, the outcomes of EBD according to the shape of Crohn’s strictures have not been analyzed. The primary outcome was to evaluate the cumulative surgery-free rate, and the secondary outcome is to evaluate the risk factor for subsequent surgery after EBD.

Methods

This prospective, longitudinal, observational study enrolled patients with CD who underwent EBD for small bowel strictures using single-balloon enteroscopy between 2015 and 2023 at Samsung Medical Center, Seoul, Korea.

Results

A total of 150 consecutive patients who underwent 238 EBDs were included in this study with mean follow-up of 42.4±19.1 months. Thirty-one patients (20.7%) underwent surgery after EBD, and the cumulative 1-, 3-, and 5-year surgery-free rates were 86.7%, 80.4%, and 76.6%, respectively. The cumulative surgery-free rates of EBD for web-like, ulcerated, and spindle-shaped strictures were 96.3%, 91.0%, and 73.3% at 1 year, 96.3%, 84.9%, and 63.0% at 3 years, and 96.3%, 78.3%, and 63.0% at 5 years, respectively (p=0.001). Multivariate Cox regression analysis identified spindle-shaped stricture (vs. web-like stricture: hazard ratio [HR], 10.97; 95% confidence interval [CI], 1.23-97.74, p=0.032) and starting/switching biologics (vs. no biologics: HR, 0.33; 95% CI, 0.12-0.89; p=0.029) as risk factors for surgery after EBD. The major complication rate of EBDs was 2.7% (4/150) on per-patient analysis and 1.7% (4/238) on per-procedure analysis.

Conclusion

EBD for small bowel strictures in patients with CD may be an effective and safe alternative to surgery. EBD for web-like strictures showed favorable outcomes, while EBD for spindle-shaped strictures showed poor outcomes.
P1187 Healthcare professionals’ experiences of assessing and managing IBD-related fatigue in clinical practice – a mixed methods study
Authors: Watson N , Chalmers D , Czuber-Dochan W
Published: January 2025

Background

Fatigue is one of the most debilitating symptoms of inflammatory bowel disease (IBD), significantly impacting quality of life. Healthcare professionals (HCPs) recognise this but are often unsure of how to address fatigue [1]. We explored HCPs experiences of assessing and managing fatigue in patients with IBD to identify potential avenues for improvement.

Methods

We conducted a mixed method study with (1) an online survey amongst 17 gastroenterologists, 81 IBD nurses, one pharmacist, and 36 other/unspecified HCPs working in IBD (n=135) and (2) semi-structured interviews with two gastroenterologists, three IBD nurses, and a psychologist (n=6). Descriptive statistics summarised the quantitative data, while thematic analysis was applied to the qualitative data.

Results

Fatigue assessment was seen as an important and prevalent issue by the HCPs; 93.5% reported fatigue as a common symptom with 83% stating that they encounter it “often” to “always”. Most HCPs reported that the assessment (85.1%) and re-assessment (61.5%) of fatigue was a standard part of their clinical practice . Assessment itself was mostly unstructured; 85% of HCPs predominantly relied on patient descriptions with 77.2% reporting systemic barriers to using quantitative measures. 62.9% of HCPs reported offering additional support for fatigue, mostly through additional medical testing (Table 1). 24.4% would refer individuals to other services.

Qualitative data highlighted discrepancies in assessment preferences. Two HCPs found the IBD-F scale [2] helpful as it provided a framework for them to consider the impact of fatigue, and offered patients direction. Meanwhile, Four reported systemic challenges with additional measures, like insufficient time to review the data and discuss issues around fatigue, as well as limited knowledge of management strategies to suggest.

Conclusion

While IBD-related fatigue is important to HCP’s, assessment is largely unstructured. Findings indicate a need for education on management strategies and resources to improve communication around fatigue.

References

[1]Czuber-Dochan, W., Norton, C., Bredin, F., Darvell, M., Nathan, I., & Terry, H. (2014). Healthcare professionals' perceptions of fatigue experienced by people with IBD. Journal of Crohn's and Colitis, 8(8), 835-844.

[2]Czuber-Dochan, W., Norton, C., Bassett, P., Berliner, S., Bredin, F., Darvell, M., ... & Terry, H. (2014). Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale. Journal of Crohn's and Colitis, 8(11), 1398-1406.
P1190 Generation of blood-derived reference samples with endogenous cytokines
Authors: Bain-Wendlinger C , Lavocat F , Poyau A , Silva J , Cousin E , Serraz C
Published: January 2025

Background

Biomarkers have become an integral part of drug development and decision-making. The quantification of cytokines, commonly used to gain insights into pathological processes in indications such as Inflammatory Bowel Diseases (IBD), and for monitoring therapeutic intervention, should rely on robust and performant methods.

Relevant reference samples are crucial for evaluating the performance of biomarker assays implemented in the context of clinical studies, but

oHow to evaluate the parallelism of a method for biomarkers that are non-detectable in healthy donors (HD)?

oDoes the selectivity of the recombinant protein in the biological matrix reflect the endogenous biomarker?

oHow does the stability of the recombinant protein compare with endogenous biomarker?

oCan you use incurred samples (informed consent, sufficient volume) for evaluating parallelism and stability?

Methods

To address these questions, we generated samples with endogenous biomarkers, named MAQC, by spiking supernatants of stimulated PBMC in the serum or plasma from HD. Three to four levels of MAQC per cytokine were prepared and used to assess parallelism, selectivity and long-term stability (LTS) at -80°C of pro- and anti-inflammatory cytokines and chemokines by use of V-plex, S-plex kits from MSD and ELLA kits. For all these parameters, accuracy was determined, with a target acceptance of 70-130% of the nominal value for selectivity and LTS or upstream dilution for parallelism.

Results

We were able to generate serum and plasma reference samples with low- to high-range levels of Th1 (IFN-g, IL-12p70, IL-2, TNF-α, CCL-2), Th2 (IL-4, IL-13, IL-10), Th17 (IL-17A) and Proinflammatory (IL-6, IL-8, IL-1β) cytokines. Selectivity was acceptable for most cytokines, except for IL-13, IL-4, IL-17A and IL-6. For IL-6, a major interference was observed in some samples, likely due to the presence of soluble IL-6 receptor in the original serum sample. For the other 3 cytokines, interference, leading to a bias close to -30%, was observed that could not be lifted by diluting samples. For all cytokines but IL-13, endogenous diluted similarly as recombinant protein from calibrator. Twelve months LTS was demonstrated for all cytokines in MAQC and comparable to recombinant proteins spiked in human serum.

Conclusion

To conclude, reference samples with endogenous cytokines/chemokines can be produced from primary immune cells. These can be used to assess parallelism and long-term stability when sufficient volume of matrices with high enough concentrations are not available. These would be even more valuable if they could be commercially available for use as quality controls in validation and clinical studies.
P1200 Increasing rate of hospitalization for inflammatory bowel disease is an age-related effect: A Canadian population-based study
Authors: Goodwin S , Wilk P , Yuan Y , Haan M , Jairath V
Published: January 2025

Background

Inflammatory bowel diseases (IBDs), including Crohn’s Disease (CD) and Ulcerative Colitis (UC), are chronic diseases that pose significant challenges to patients and healthcare systems. To understand trends in the risk of all-cause hospitalization for individuals with CD and UC we explored age, period, and cohort effects in Canada.

Methods

We utilized repeated cross-sectional survey data from the 2005-2014 Canadian Community Health Survey (CCHS) to identify individuals with self-reported CD or UC. These individuals were linked to their hospitalization records from the Discharge Abstract Database (DAD) and were followed for three years. Cross-classified random-effects two-level models were used to estimate fixed effects for age and its quadratic term (level 1) and random effects for time periods and birth cohorts (level 2), adjusted for sex, on the risk of hospitalization within three years.

Results

An estimated 84,000 CD and 113,000 UC individuals were eligible for study inclusion. From this, an estimated 30,250 and 39,890 all-cause hospitalizations occurred within three years post-entry into the study for CD and UC individuals, respectively. Broadly, the risk of hospitalization within three-years increased with age and across birth-cohorts, with older cohorts experiencing greater risks of hospitalization. A small, but statistically significant temporal effect was identified for both CD and UC groups. Within birth cohorts, the risk of hospitalization increased across ages for CD, but in individuals with UC, the risk of hospitalization decreased across ages, except for the two oldest birth cohorts.

Conclusion

Overall, results support the hypothesis that age effects are primarily responsible for fluctuations in the risk of hospitalizations1. Risk of all-cause hospitalization has remained relatively stable from 2005 to 2014 in Canada and differences across time periods may be a consequence of the age-distribution at each time period. As the prevalence of CD and UC continues to rise and the Canadian population continues to be comprised of growing number of older-aged individuals, increasing the allocation of healthcare resources to prevent age-related risks of hospitalizations would be beneficial to reduce hospital burdens.

References

1.Buie et al. 2023. Doi: 10.1093/ibd/izad020
P1202 Metabolic-dysfunction associated liver disease in patient with Inflammatory Bowel Disease: Is obesity the major driver of disease progression?
Authors: Bracciamà E , Di Giorgio F M , Melatti P , Amato L M , Salerno I A , Ajovalasit R , Di Prima L , Scalia S , Gambadauro D , Pennisi G , Petta S , Cappello M
Published: January 2025

Background

Prevalence of MASLD in patients with Inflammatory Bowel Disease (IBD) has been reported 24.4% in a recent metaanalysis and 21.6% in a previous cross-sectional study from our center. However, data on the progression of MASLD in IBD patients are scanty. We aimed to investigate the prevalence and the progression of MASLD, diagnosed by non-invasive tools, in a homogeneous cohort of patients with IBD followed in our referral center.

Methods

Consecutive IBD patients without known chronic liver disease were retrospectively enrolled and prospectively followed between 2020 and 2024. MASLD was defined as Controlled Attenuation Parameter (CAP) ≥275 dB/m according to EASL criteria. Significant fibrosis was defined as Liver Stiffness (LSM) ≥8 kPa by FibroScanÒ. Demographic, metabolic and biochemical data were collected at baseline and at the last follow-up visit. All patients were genotyped for PNPLA3 rs738409 C>G by Taqman assay. Univariate logistic regression analysis was performed to identify risk factors associated with the prevalence of MASLD and its progression.

Results

230 patients (mean age was 46.1±13.4 years, 49.2% were males, 50.8% had Crohn’s disease, mean disease duration was 9.4±7.5 years) were recruited. 14.8% of them were obese (BMI > 30 kg/m2), 9.8% diabetic. 49.2% were PNPLA3 rs738409 CG/GG. 62 out of 230 patients had complete metabolic and biochemical assessment at follow-up. Mean follow-up time was 4 years. At baseline, according to EASL criteria, 31.1% (19/62) had MASLD. 19.1% (8/42) of patients without steatosis at baseline, developed steatosis at follow-up; while 42.1% of those having steatosis at baseline, did not show steatosis at follow-up. Two patients without fibrosis assessed by LSM at baseline developed significant fibrosis, while two patients with fibrosis at baseline experienced fibrosis regression. 13.5% developed obesity. Obesity was significantly associated with the prevalence of MASLD both at baseline (p=0.01) and on follow-up (p=0.01) and was a predictor of steatosis progression (p=0.01); no association was found in relation to sex, PNPLA3 polymorphism, disease characteristics and the use of biologics. Diabetes was not significantly associated with MASLD in our cohort, but the number of patients was low.

Conclusion

One third of IBD patients had MASLD and obesity was the main predictor of its prevalence and progression, highlighting the relevance of active surveillance of MASLD and appropriate nutritional and lifestyle counselling especially in obese IBD patients. The use of biologics to control inflammation seems to have no influence on MASLD progression but data need further confirm in larger cohorts.