bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0935 A systematic review and quality assessment of clinical practice nursing guidelines for ostomy care
Authors: Hutton M , Prins H , Yuan Y , Solitano V , Radford S , Vuyyuru S K , Rieder F , Jairath V 
Published: January 2025

Abstract

Background
Patients living with stomas face numerous challenges following abdominal stoma surgery. Stoma nurse specialists play a crucial role in supporting these patients by utilizing evidence-based practices and specialist expertise. We evaluate nursing guidelines focused on the management of patients with ostomies, identify knowledge gaps, and support the development of evidence-based patient care pathways.

Methods
A comprehensive literature search was conducted across MEDLINE, Embase, and major nursing organization websites up to March 25 2024, to identify evidence-based practical guidelines developed specifically for nurses managing patients with abdominal stomas post-ostomy. Pre-specified inclusion (n=5) and exclusion (n=16) criteria were applied (Table 1). Two researchers independently screened references, extracted data, summarized the evidence, and assessed guideline quality using the AGREE II instrument.

Results
The database search yielded 97 references, with an additional 23 guidelines identified through major nursing organization websites. A total of 14 nursing guidelines met the inclusion criteria, originated from Australia, Canada, Italy, UK, USA, and three international groups. The guidelines varied in scope; offered recommendations across all stages of care, including preoperative, peri-operative, postoperative, and post-discharge phases. Key topics are presented in Table 2. Notably, no guideline statements specifically addressed patients with Crohn’s disease and permanent ostomies.
Three guidelines did not specify whether a literature search and review were conducted. Five guidelines applied an evidence scale or numerical grading system, while only three used the GRADE approach. Most recommendations were based on a low level of evidence, often relying on retrospective or observational studies and expert opinion; two guidelines claimed their statements were consensus-based due to a lack of supporting evidence. In the AGREE II assessment, most guidelines were rated as moderate quality, with recommended modifications primarily in the rigor of development and applicability.

Conclusion
This quality assessment of clinical practice nursing guidelines for ostomy care highlights both strengths and weaknesses within current guidelines. Nursing guidelines offer extensive coverage of ostomy care topics and provide valuable first-line care experience and consensus statements, particularly for postoperative stoma and peristomal care. These insights are essential for non-nursing healthcare providers and contribute to the development of patient care pathways for individuals with Crohn’s disease and permanent ileostomies. However, the limited availability of high-quality evidence underscores the need for further research in ostomy care.
P0941 Questionnaire survey of Japanese patients with inflammatory bowel disease and physicians on shared decision making in advanced therapy: A web-based PAIR survey
Authors: Imai K , Hirai F , Matsumoto T , Goda Y , Fujimitsu Y , Kajioka T , Oiwa M , Honjo T , Higashikawa M , Ueno M 
Published: January 2025

Abstract

Background
With the recent increase in available treatment options for inflammatory bowel disease (IBD), shared decision-making (SDM) has gained considerable importance. To address potential disparities in patient and physician priorities, we conducted a survey for clarify these perspectives.

Methods
Patients with IBD and physicians treating IBD were asked to complete an online questionnaire focused on key factors influencing drug selection and preferred drug administration methods.

Results
Responses were obtained from 400 patients (327 with ulcerative colitis and 73 with Crohn’s disease) and 155 physicians. Among the factors in drug selection, physicians assigned significantly higher importance scores for experience with the drug than did patients. The expected time-to-onset of drug effects was significantly different between patients and physicians. Regarding preferences for drug administration method, patients and physicians assigned the highest acceptability scores for once-daily oral administration. For intravenous and subcutaneous routes, patients’ scores were significantly lower than those of physicians’ scores. Notably, 86.0% of patients and 62.0% of physicians preferred oral administration as the most preferred method. However, preferences varied based on treatment experience: 34.7% of patients with prior experience with subcutaneous injection preferred this method.

Conclusion
Patients and physicians generally shared similar priorities for drug selection; however, physicians emphasized their experience with the drug over patient preferences. Although the number of patients with prior treatment experience preferred intravenous or subcutaneous injections, oral formulations remained the preferred choice for both patients and physicians.
P0945 Improvement in Endoscopic Score in Patients with Moderately to Severely Active UC Treated with Risankizumab in the Phase 3 INSPIRE and COMMAND Studies
Authors: Panaccione R , Verstockt B , Hashash J G , Shah S , Morisset P , Kalabic J , Reguiero M 
Published: January 2025

Abstract

Background
The STRIDE-II recommendations highlighted the importance of targeting objective measures of disease control, including endoscopic healing, in patients (pts) with ulcerative colitis (UC).1 Risankizumab (RZB), an interleukin-23 specific inhibitor, showed improvement in the outcomes of clinical remission and endoscopic improvement compared to placebo in pts with moderately-to-severely active UC.2 Visualizing the changes of endoscopic scores from induction and maintenance may provide insight into pt disease course during treatment. Thus, this analysis sought to provide an overview of change in endoscopic scores of pts enrolled in UC clinical studies.

Methods
Using individual pt data from the Phase 2b/3 studies of RZB in UC, changes in Mayo endoscopic scores in induction and maintenance were assessed. For induction, pts received either intravenous (IV) placebo (PBO) or RZB for 12 weeks (wks). Pts from the Phase 2b and Phase 3 INSPIRE studies who had a clinical response to induction treatment were rerandomized into the maintenance study [COMMAND] and received subcutaneous PBO (withdrawal), RZB 180 mg, or RZB 360 mg every 8 wks for 52 wks. To be eligible for INSPIRE, pts had to have a baseline (BL) Mayo endoscopic score of 3 or 2 confirmed by central review. For this analysis, endoscopic scores are reported for induction BL and wk 12 and maintenance BL and wk 52 for each treatment. "Endoscopic improvement" was defined as a score of 1 or 0 at the time of follow-up.

Results
Among pts with a Mayo endoscopic score of 3 at induction BL, 28% achieved endoscopic improvement after 12-wk treatment with RZB 1200 mg; 57% of pts with a BL score of 2 showed endoscopic improvement (Fig. 1). In contrast, among PBO-treated pts with a score of 3 or 2 at BL, 11% and 18%, respectively, achieved endoscopic improvement after induction. Most PBO-treated pts (63%) had no score change at wk 12. During the maintenance study, 29%–35% of pts in the RZB treatment groups had an endoscopic score of 2 or 3 at maintenance BL. (Fig. 2). For those with a BL score of 3, most pts receiving RZB 360 mg achieved endoscopic improvement (62%); similarly, 65% of those with a BL score of 2 showed endoscopic improvement at wk 52. Trends were similar for RZB 180 mg with ≥80% of pts with a BL score of 1 or 0 maintained a 1 or 0 through wk 52. Among PBO-treated pts, ≥60% maintained a score of 3 or 2 from maintenance BL to wk 52; approximately one third of pts’ scores improved to 1 or 0.

Conclusion
This analysis showed that RZB treatment improved endoscopic outcomes from wk 0 to wk 12 of induction and wk 0 to wk 52 of maintenance. These findings may help inform treatment expectations and shared decision-making for pts with UC initiating RZB treatment.

References
1.Turner D, et al. Gastroenterology. 2021;160(5):1570-1583.
2.Louis E, et al. JAMA. 2024;332(11):881-897.
P0947 A switch to infliximab may be more effective than ustekinumab following adalimumab pharmacodynamic failure in pediatric patients with Crohn’s disease
Authors: Driban G , Matar M , Lev-Tzion R , Ledder O , Granot M , Yerushalmy-Feler A , Magen-Rimon R , Zifman E , Turner D , Assa A 
Published: January 2025

Abstract

Background
Loss of response (LOR) to first biologic agent is not uncommon. One of the most challenging mechanisms of LOR is pharmacodynamic LOR (inflammatory activity in the presence of adequate trough concentrations, TC). We aimed to explore the outcomes of pediatric patients with Crohn’s disease following adalimumab pharmacodynamic failure.

Methods
We conducted a retrospective longitudinal cohort study in 6 Israeli pediatric centers. Data of patients who experienced adalimumab LOR (as first biologic agent) with adequate TC (&gt;7.5 mcg/ml) and switched to either infliximab or ustekinumab were retrieved.

Results
The cohort included 67 patients (66% males, mean age at diagnosis 12.2±2.8, B2 or B3 phenotype 16%, perianal disease 24%), with median duration on adalimumab of 17 (IQR 8-24) months and follow-up of 13 months (IQR 7-29) on the subsequent therapy. Median adalimumab TC before switching was 11.4 (IQR 8.5-16 mcg/ml). For the overall cohort, corticosteroid-free clinical remission and response were achieved in 43% and 67%, respectively. Of 36 follow-up colonoscopies, 25% achieved endoscopic remission. Most patients (84%) received intensified regimen after switching. Nine patients (13%) underwent surgical resection during follow-up. The two treatment groups (infliximab (n=32) and ustekinumab (n=35)) were comparable for all basic, demographic and disease severity parameters at the time of switching. The median follow-up period of both groups was similar, 12 (6-24) months. The infliximab group demonstrated better outcomes over ustekinumab at the end of follow-up in terms of clinical response (97% vs. 57%; p&lt;0.001), corticosteroid-free clinical remission (56% vs. 31%; p=0.04), endoscopic response (83% vs. 28%; p=0.002), fecal calprotectin&lt;250 (60% vs. 27%; p=0.03), drug sustainability (91% vs. 31%; p&lt;0.001) and surgical rate (3% vs. 23%; p=0.02, 1 infliximab, 8 ustekinumab). Month 3 PCDAI was significantly lower [8.7 (IQR 0-17.5) vs. 21 (IQR 9-35); p&lt;0.01), CRP remission was higher (60% vs. 23%; p=0.01) and median albumin concentration was higher [4.3 (IQR 39-4.5) vs. 3.8 (IQR 3.4-4); p=0.005] in the infliximab group.

Conclusion
Pediatric patients with Crohn’s disease following adalimumab pharmacodynamic failure with TL&gt;7.5mcg/mL demonstrated moderate response to subsequent therapy. A switch in-class to infliximab may be more effective than a switch out of class to ustekinumab.
P0949 Long term real-world effectiveness and safety of upadacitinib in patients with moderate to severe Crohn’s disease: A Belgian multi-centric refractory cohort
Authors: Pavlidi A , Verstockt B , Vieujean S , Desmedt V , Couturier F , Rahier J F , Baert F , Somers M , Dewit O , Bossuyt P , Hoyois A , Holvoet T , Ouziel R , Willandt B , Lambrecht G , Salame M , Verreth A , Lenfant M , Franchimont D , Cremer A 
Published: January 2025

Abstract

Background
The therapeutic options for Inflammatory Bowel Disease (IBD) have expanded with the introduction of JAK inhibitors. However, real-world data on upadacitinib (UPA) in patients with moderate to severe Crohn’s disease (CD) are scarce. Our aim was to assess the long-term effectiveness and safety of UPA in multi-refractory Belgian patients.

Methods
Data from all patients with active CD initiating UPA between September 2022 and January 2024 were retrospectively collected from 17 Belgian centres. Effectiveness endpoints were evaluated at week 24 and 52. Steroid-free clinical response and remission were defined using the two-component patient-reported outcome. Endoscopic response was defined as a decrease in baseline Simple Endoscopic Score (SES-CD) with ≥50%, and endoscopic remission as SES- CD ≤ 4 or absence of ulcers. Adverse events (AE), treatment discontinuation, CD-related hospitalization and surgery were assessed throughout follow-up. Non-response imputation was applied for clinical evaluation.

Results
A total of 140 patients were included (Table 1) with a median follow-up of 33 weeks (IQR: 3-97). The majority of patients (89%) were exposed to at least 3 biologics. At week 24, 53% and 40% of patients achieved steroid-free clinical response and remission, respectively (Figure 1). At week 52, these numbers were 37% and 29%. Endoscopic data were available in 48/140 patients at week 24, of whom 52% and 27% reached endoscopic response and remission. At week 52, these numbers were 63% and 37%. Of patients with active articular extra-intestinal manifestations at baseline 37% and 34% had a quiescent articular disease by week 24 and 52, respectively. 5 out of 9 patients with active perianal disease at baseline and on UPA by week 52, had persistent perianal active disease. Overall, 66 patients (47%) discontinued UPA during follow-up: 23 due to primary non response, 13 due to secondary loss of response, 16 due to AE, 3 due to patient’s choice and 11 due to CD-related surgery. 16 patients required CD-related hospitalization within 52 weeks. AE occurred in 60% of patients (84/140). Of these patients, 11% experienced serious AE of which 2 cardiovascular events: 1 transit ischemic attack and 1 deep venous thrombosis. The most common reported AE were herpes simplex reactivation (5/140), respiratory tract infection (7/140), cutaneous reactions (7/140) and acne (17/140). Only 3 patients had reactivation of herpes zoster infection.

Conclusion
In this real-world cohort of highly refractory CD patients, UPA effectively induced both steroid-free clinical remission and endoscopic remission by week 52. UPA was relatively well tolerated with respect to adverse events.
P0961 Establishing a new cellular therapy for patients with Ulcerative Colitis
Authors: Skov J , Filidou E , Clement D L , Børsch A S , Steenholdt C , Maimets M , Jensen K B 
Published: January 2025

Abstract

Background
Inflammatory Bowel Diseases (IBD), which include Crohn’s Disease and Ulcerative Colitis (UC), show an accelerated incidence rate, affecting up to 1% in Western countries, and an increased burden in healthcare costs, reaching up to 5.6 billion euros per year. Although there are several treatment options, the remission rates are around 30-60%, with primary non-response and loss of response to be the main reasons for changing treatment plans. Thus, there is a need for new therapeutic strategies targeting these groups of non-responding patients. Towards this, we are developing a novel cellular therapy for UC, using autologous transplantation of intestinal epithelial organoids.

Methods
Here, colonic epithelial cells will be isolated, expanded under GMP conditions, and transplanted into ulcerated colonic regions of patients with UC, to promote and accelerate mucosal healing. This initial strategy targets patients with localized ulceration unresponsive to first- and second-lines of treatments.

Results
We have established a robust protocol for expanding intestinal epithelial organoids. These organoids contain all major cell type populations that orchestrate the intestinal epithelium. We have successfully transplanted both murine and human colonic organoids into NOG mice. After successful engraftment onto the damaged intestinal mucosa, they promote and accelerate mucosal healing. Currently, we are establishing scale-up culturing methodologies, in order to expand our cell cultures to a number of cells that would be enough to promote mucosal healing during transplantation in humans. Finally, we are refining the cell culture conditions to be GMP-approved, and thus, registering our final product as acceptable to be used during human clinical trials.

Conclusion
Our approach could offer a new therapeutic option for patients with UC that do not respond to current drug regimens and are in need for an effective treatment.
P0962 Relationship between Total Corticosteroid Dose Prior to Advanced Therapy Induction and Primary Non-Response
Authors: Yokoo T , Yoshikawa S , Masuda T , Terauchi S , Uchida H , Nakao T , Inagaki M , Tani T , Okamoto K , Shibata Y , Inatsugi N 
Published: January 2025

Abstract

Background
The PROFILE study1) highlighted the importance of top-down treatment with Advanced Therapy (AT) in Crohn’s disease. In ulcerative colitis (UC), the corticosteroid (CS) treatment cascade remains crucial for selecting AT candidates. CS treatment efficacy decreases with repeated use, affecting therapeutic outcomes of GMA and carotegrast. We hypothesized that total CS dose impacts subsequent AT efficacy and examined this relationship to optimize AT induction timing.

Methods
We retrospectively reviewed medical records of UC patients diagnosed after January 2010, analyzing the correlation between total CS dose prior to initial AT administration and AT response. Patients using steroids for other diseases or with incomplete CS dose information were excluded. Variables assessed included onset age, sex, disease extent, activity (PRO2), treatment details, and treatment failure rates. Nominal variables were analyzed using Fisher’s exact test and logistic regression analysis.

Results
Data from 92 UC patients (44 males) were analyzed. Median onset age was 41.5 years, with median AT induction age of 46.5 years. Disease extent: total colitis/left-sided/rectum = 57/33/2. Mean total CS dose before AT initiation was 1,743.2 mg, with a mean 479.1 days between CS initiation and AT start. AT breakdown: IFX/ADA/GLM/VDZ/UST/UPA/TOF/FIL = 37/19/13/13/6/2/1/1. Median PRO2 at AT initiation was 4. (TABLE 1)
Primary non-response (PNR) occurred in 23 cases (24.0%), and loss of response (LOR) in 18 cases (18.8%). Multivariate analysis identified total CS dose ≥3,000 mg as a significant risk factor for PNR (OR 4.21, 95%CI 1.32-13.5, p=0.02). (TABLE 2) No risk factors were identified for LOR.

Conclusion
As previously reported, elderly-onset UC requires careful management due to potentially poor treatment response. The total CS dose appears to significantly impact primary non-response, suggesting that early transition to Advanced Therapy may be crucial for optimal patient outcomes.

References
1)Nurulamin MN. A biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn’s disease (PROFILE). Lancet Gastroenterol Hepatol. 2024;9(5):415-427 doi:10.1016/S2468-1253(24)00034-7
P0964 The effect of alarms on completion of electronic diaries in patients with inflammatory bowel disease
Authors: Kusanto B , Visser M , Wandare N , Capece A , Lee E , Byrom B , Everhart A 
Published: January 2025

Abstract

Background
Clinical trials have contributed substantially to the development of novel therapies for inflammatory bowel disease, including Crohn’s disease (CD) and ulcerative colitis (UC). The Food and Drug Administration (FDA) recommends the use of the Crohn’s Disease and Activity Index (CDAI) and the modified Mayo Score (mMS) to measure primary endpoints in CD and UC trials, respectively. Both assessments use composite scores requiring the completion of a daily diary by subjects to report on symptoms, including stool frequency (SF), rectal bleeding, abdominal pain, and general well-being. In order to ensure the timely completion of diaries, and to limit missing days, it has been recommended to implement device alarms or reminders. The objective of this study was to investigate how device alarms and/or reminders can influence completion times of the daily electronic diaries (eDiaries) in CD and UC studies.

Methods
More than 3.7 million eDiary entries from 12 153 patients across 11 studies in CD and UC were evaluated. Only completed entries were included. Patients were required to complete eDiaries daily, either on their personal device or a provisioned device, throughout their participation in a specific study. Daily alarms were programmed to remind patients to complete their eDiary. For this analysis, the difference between the patient’s eDiary alarm time and the time the eDiary was first opened was determined.

Results
For CD trials, 65% (n=1 079 823) of eDiaries were opened after the programmed alarm time. Of these eDiary entries, 39% (n=652 138) were answered 30 minutes after the alarm time, and 8% (n=127 711) were answered between 30 minutes and an hour after the alarm time. In UC trials, 60% (n=1 277 090) of eDiaries were opened after the programmed alarm time. Similarly, 38% (n=822 552) of eDiaries were completed after 30 minutes of the alarm time, and 8% (n=170 433) were completed between 30 minutes and an hour after the alarm time.

Conclusion
The implementation of eDiary alarms is essential to support patient compliance in clinical trials and drive reliable inferences. The analysis performed here suggests that eDiary alarms are useful to encourage patients to answer their eDiary within an hour reporting window of their scheduled alarm time. Nevertheless, sites and study teams should continue to educate patients on the importance of eDiary completion.
P0965 Sequencing Therapy for Optimal Response in Mirikizumab (STORM) Study
Authors: Kubesch A , Lande R , Farrag K , Dienethal A , Sprinzl K , Zeuzem S , Blumenstein I 
Published: January 2025

Abstract

Background: Background & Aim
Mirikizumab was approved for the treatment of Ulcerative colitis (UC) in May 2023. However, real-world data especially in biological-experienced patients, is scarce. We aimed to determine treatment efficacy and persistence on Mirikizumab in mostly treatment-experienced UC patients.

Methods
All patients, who were treated for UC in the Inflammatory bowel disease (IBD) outpatient clinic of the University Hospital Frankfurt from 07/23-09/24 was retrospectively analyzed. Data on clinical (Simple Clinical Colitis Activity Index (SCCAI)) and biochemical disease activity (fecal calprotectin (FC)) as well and patient history were collected. Patients were followed-up for at least 12 weeks. Observational time-points were Week 0, week 8, week 12 (completion of induction) and after 6 months.

Results
A total of 46 patients were included in this study. Twenty-five patients were Anti-TNF experienced, whereas 21 patients were Anti-TNF naïve. Anti-TNF experienced patients were more likely to have received prior other biologic agents and more likely to have received more than two other biologic agents (p&lt;0.001). The use of concomitant steroids was reduced over time. The spectrum of previous biologic agents was more diverse in the Anti-TNF experienced cohort. Most Anti-TNF naïve patients received Vedolizumab prior to Mirikizumab treatment. We observed a significant increase in patients in clinical remission at week 12 (p&lt;0.05) and at 6 months (p=0.04) in the Anti-TNF experienced group. Furthermore, we observed a significant reduction in fecal calprotectin levels between weeks 0,12 and weeks 20-24 (p=0.018). No relevant side effects were reported, no patients discontinued Mirikizumab due to adverse events

Conclusion
Good efficacy and safety profile for Mirikizumab even in Anti-TNF experienced patients. Better response in Anti-TNF naïve patients indicating an early use of Mirikizumab in the therapeutic sequence.