bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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 &lt; 0.001), with specimen extraction through a Pfannenstiel incision (44% vs 1.5%, p &lt; 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

Abstract

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 &lt; 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 (&lt; 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

Abstract

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 &gt; 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

Abstract

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

Abstract

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

Abstract

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&lt;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&lt;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

Abstract

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

Abstract

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.