Inflammatory Bowel Disease Questionnaire Research Articles

Structured Reporting of Computed Tomography Enterography in Crohn's Disease.

To compare the integrity, clarity, conciseness, etc., of the structured report (SR) versus free-text report (FTR) for computed tomography enterography of Crohn's disease (CD). FTRs and SRs were generated for 30 patients with CD. The integrity, clarity, conciseness etc., of SRs versus FTRs, were compared. In this study, an evidence-based medicine practice model was utilized on 92 CD patients based on SR in order to evaluate its clinical value. Then, the life quality of the patients in two groups was evaluated before and after three months of intervention using an Inflammatory Bowel Disease Questionnaire (IBDQ). SRs received higher ratings for satisfaction with integrity (median rating 4.27 vs. 3.75, P=0.008), clarity (median rating 4.20 vs. 3.43, P=0.003), conciseness (median rating 4.23 vs. 3.20, P=0.003), the possibility of contacting a radiologist to interpret (median rating 4.17 vs. 3.20, P<0.001), and overall clinical impact (median rating 4.23 vs. 3.27, P<0.001) than FTRs. Besides, research group had higher score of IBDQ intestinal symptom dimension (median score 61.13 vs. 58.02, P=0.003), IBDQ systemic symptom dimension (median score 24.48 vs. 20.67, P<0.001), IBDQ emotional capacity dimension (median score 65.65 vs. 61.74, P<0.001), IBDQ social ability dimension (median score 26.80 vs. 22.37, P<0.001), and total IBDQ score (median score 178.07 vs. 162.80, P<0.001) than control group. The SR of CTE in CD patients was conducive to improving the quality and readability of the report, and CD patients' life quality could significantly improve after the intervention of an evidence-based medicine model based on SR.

Effect of Suboptimal Disease Control on Patient Quality of Life: Real-World Data from the Observational IBD-PODCAST Canada Trial

BackgroundThe real-world application of STRIDE-II treatment targets to identify whether disease control is optimal in Crohn’s disease (CD) and ulcerative colitis (UC) is not well known.AimsThis study aimed to estimate proportions of patients with suboptimally controlled CD and UC in real-world Canadian healthcare settings and the impact on quality of life (QoL).MethodsThe noninterventional, multicenter, observational IBD-PODCAST Canada study comprised a single study visit involving routine assessments, patient- and clinician-completed questionnaires, and a retrospective chart review. Primary outcomes were proportions of patients with STRIDE-II-based red flags indicative of suboptimal disease control and mean ± standard deviation Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Secondary outcomes included proportions of patients and clinicians subjectively reporting suboptimal control.ResultsAmong 163 enrolled patients from 10 sites, 45/87 patients with CD (51.7%; 95% CI: 40.8%, 62.6%) and 33/76 patients with UC (43.3%; 95% CI: 32.1%, 55.3%) had suboptimal disease control based on STRIDE-II criteria. Suboptimal control was subjectively reported at lower proportions (patients: CD, 15.0%; UC, 18.6%; clinicians: CD, 19.5%; UC, 25.0%). Numerically lower SIBDQ scores were observed with suboptimal control (CD, 43.0 ± 10.8; UC, 42.5 ± 12.0) than with optimal control (CD, 58.2 ± 7.2; UC, 57.8 ± 6.6).ConclusionsApproximately 50% (CD) and 40% (UC) of patients from real-world Canadian practices had suboptimal disease control based on STRIDE-II criteria. Suboptimal control was underestimated by patients and clinicians and accompanied by reduced QoL, suggesting further efforts to implement STRIDE-II treat-to-target strategies are needed.

Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.

Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical remission at week 12 (W12) and maintaining clinical remission at W52 in patients with moderately to severely active ulcerative colitis. Results are presented from the open-label extension study through W104. Clinical, symptomatic, quality-of-life, and adverse event outcomes are reported for mirikizumab induction responders and extended induction responders, including biologic-failed patients, who entered LUCENT-3, with data shown for W52 maintenance responders or remitters. Discontinuations or missing data were handled by nonresponder imputation (NRI), modified NRI (mNRI), and observed case (OC). Among W52 mirikizumab responders, clinical response at W104 was 74.5%, 87.2%, and 96.7% and clinical remission was 76.6%, 89.0%, and 98.3% for NRI, mNRI, and OC, respectively. Among W52 mirikizumab remitters, clinical response at W104 was 54.0%, 62.8%, and 70.1% and clinical remission was 65.6%, 76.1%, and 84.2%. Using mNRI, remission rates at W104 for W52 clinical remitters were 74.7% corticosteroid-free, 79.5% endoscopic, 63.9% histologic-endoscopic mucosal remission, 85.9% symptomatic, 59.8% bowel urgency, 80.5% Inflammatory Bowel Disease Questionnaire (using NRI), 71.2% histologic-endoscopic mucosal improvement, and 77.5% bowel urgency improvement. Previous biologic-failed vs not-biologic-failed patient data were generally similar. Extended induction mNRI clinical response was 81.9%. Serious adverse events were reported in 5.2% of patients; 2.8% discontinued treatment due to adverse events. Endoscopic, histologic, symptomatic, and quality-of-life outcomes support the long-term benefit of mirikizumab treatment up to 104 weeks in patients with ulcerative colitis, including biologic-failed patients, with no new safety concerns.

Patient experiences in ulcerative colitis: conceptual model and review of patient-reported outcome measures

PurposeTo identify symptoms and their impacts on daily functioning and health-related quality of life (HRQoL) experienced by adult patients with ulcerative colitis (UC) and evaluate patient-reported outcome (PRO) measures for UC clinical studies.MethodsA conceptual model of symptoms and impacts of UC were developed from a literature review. PRO measures were identified from the literature, clinical trials databases, health technology assessment submissions, and regulatory label claims, and were selected for conceptual analysis based on disease specificity and use across information sources. PRO measures covering the most concepts when mapped against the conceptual model were assessed for gaps in psychometric properties using Food and Drug Administration (FDA) guidance and consensus-based standards for the selection of health measurement instruments (COSMIN) criteria.ResultsThe conceptual model grouped the 52 symptom concepts and 72 proximal and distal impacts into eight, two, and five dimensions, respectively. Of 65 PRO measures identified, eight underwent conceptual analysis. Measures covering the most concepts and assessed for psychometric properties were the Inflammatory Bowel Disease Questionnaire, Symptoms and Impacts Questionnaire for UC, UC-PRO symptoms modules, UC-PRO impact modules, and Crohn’s and UC Questionnaire; all had good or excellent support for content validity. The UC-PRO Signs and Symptoms fully met FDA guidance and COSMIN criteria for content validity and most psychometric properties.ConclusionExisting PRO measures assess concepts relevant to patients with UC, but all PRO measures reviewed require further psychometric evaluation to demonstrate they are fit for purpose.

Investigating the Role of Gastrointestinal-Specific Anxiety and Perceived Disability in the Adjustment to Inflammatory Bowel Disease

In this study, an exploratory model was tested to investigate the mediating role of gastrointestinal-specific anxiety and perceived disability in the relation between disease activity and the outcomes of quality of life and depression in patients with inflammatory bowel disease (IBD). In a cross-sectional design, data from an online survey of patients with IBD (over the age of 16) recruited through a UK-based IBD charity were used to test a model of serial mediation. Measures targeted disease activity (self-reported), gastrointestinal-specific anxiety (Visceral Sensitivity Index), perceived disability (Perceived Disability Scale), IBD-specific quality of life (UK Inflammatory Bowel Disease Questionnaire), and depression (Depression subscale of the Depression, Anxiety, and Stress Scale). The theoretical model was investigated using model 6 of the PROCESS macro for SPSS. Bootstrapped 95% confidence intervals were constructed for each estimate A total of 320 participants provided valid responses to the survey. Gastrointestinal-specific anxiety and perceived disability were found to serially mediate the relationship between disease activity and quality of life (95%CI = −0.80 to −0.19) and disease activity and depression (95%CI = 0.13 to 0.59). Findings suggested that the effect of multiple psychosocial variables in the experience of people living with IBD and its respective outcomes should be taken into account when planning treatment. The theoretical and clinical implications of these findings are discussed.

A278 ACCEPTABILITY, FEASIBILITY, AND IMPACT OF THE MYGUT DIGITAL HEALTH PLATFORM IN THE MONITORING AND MANAGEMENT OF INFLAMMATORY BOWEL DISEASE

Abstract Background Inflammatory bowel disease (IBD) is a chronic gastrointestinal disorder that has been associated with depression, anxiety, and decreased quality of life. With new technological advancements, digital health monitoring platforms offer a promising avenue to integrate self-management strategies into the care of patients with IBD. Aims This study aimed to investigate patients’ acceptability to implementing the MyGut IBD health monitoring platform into their care, evaluate whether its use leads to better quality of life/improved health outcomes, and determine the feasibility of its long-term use. Methods We conducted a multi-centre, single-arm trial at McMaster University and McGill University, among their affiliated hospitals, from September 2020 to September 2023. Patients with IBD were recruited in gastroenterology clinics and asked to install the MyGut application onto their mobile devices. Various metrics such as willingness to use the application, patient satisfaction, symptom control/quality of life scores (measured through the short inflammatory bowel disease questionnaire (SIBDQ)), resource utilization, and feasibility statements were collected throughout the study. Patients exhibiting abnormal SIBDQ scores were identified for follow-up. After one year, patient outcome metrics were compared to baseline values. Results Out of the 84 patients initially enrolled, 58 patients (69%) continued until study completion at one-year. At recruitment, all 84 patients (100%) were willing to use the MyGut application after a brief tutorial and 72.6% (61/84) had already been using technology for health-related purposes. There was a significant improvement in SIBDQ scores after one year of MyGut use (median = 57.5, IQR 50.25–62) when compared to baseline (median = 54.5, IQR 47.25–58.75) (p = 0.01). However, only 42.9% of patients (21/49) were willing to continue using the application after one year, a significant decrease compared to the 71.9% (41/57) who were willing to continue after two months (p = 0.002). No differences were observed in patient satisfaction measures (p = 0.42 to 1) or number of ER visits/hospitalizations (p = 0.78) before and after one year of MyGut use. Conclusions Overall, IBD is a condition that often necessitates frequent medical follow-up and may benefit from proactive symptom management strategies. This study demonstrates that patients with IBD are very willing to integrate digital health monitoring platforms into their care and these may subsequently lead to improved symptom control and enhanced quality of life. Future studies should aim to investigate the subset of patients that would benefit most from these health interventions, and as illustrated, continued efforts must be made to optimize the acceptability/feasibility of its long-term use. Funding Agencies CCC

Physical Activity and IBD: State of Art and Knowledge, Patients and Healthcare Professionals Points of View, A French Multicenter Cross Sectional Study

Abstract Background Several studies have reported low levels of physical activity (PA) in patients with inflammatory bowel diseases (IBD), possibly related to a lack of information and support, despite the many recognized benefits such as cardiovascular prevention or quality of life (QoL) improvement. Methods The purpose of our study was to identify challenges faced by patients and to evaluate IBD impact on PA and QoL by using the International Physical Activity Questionnaire short form and the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32) questionnaire, respectively. We also assessed the expectations and knowledge of patients and healthcare professionals using the MICI-Active questionnaire that we developed. Results We included 298 IBD patients in 4 French hospitals, with a mean age of 38 years. We found a decrease in training frequency since IBD diagnosis, regardless of age, gender, symptom intensity, or type of disease. Moreover, there was an increase in low intensity activities like walking and a decrease in competitions and sports club registrations. Intensity of symptoms has a negative impact on QoL, as evidenced by the worsening of IBDQ score. Conversely, a higher PA intensity was correlated with a higher IBDQ score, regardless of symptoms intensity. The main barrier to PA was fatigue (56%), and the main fear was diarrhea (42%). Furthermore, 75% of patients did not feel sufficiently informed, and 61% were interested in coaching. A total of 112 healthcare professionals were interviewed, 62.5% said they had already discussed of PA with their patients, but 98% felt that they lacked knowledge. Conclusions Inflammatory bowel disease constraints and symptoms have a strong impact on PA. Work needs to be done to better train practitioners to improve IBD patient management, who have much to gain from better PA.

Deficits in geriatric assessment are important in relation to fatigue in older patients with Inflammatory Bowel Disease

BackgroundNo previous study has investigated fatigue in older patients with Inflammatory Bowel Disease (IBD). AimsTo describe the prevalence of fatigue in older patients and compare it to the prevalence in younger patients with IBD, and to determine factors associated with fatigue. MethodsA prospective, multicenter cohort study, including older- (≥ 65 years) and younger patients with IBD (18–64 years). A geriatric assessment was performed in older patients to measure deficits in geriatric assessment (DiG). Fatigue was defined by one item from the short Inflammatory Bowel Disease Questionnaire. Active disease was defined as the presence of clinical or biochemical disease activity. ResultsFatigue prevalence in the 405 older patients varied between 45.4% (71/155) in active disease to 23.6% (60/250) in remission. Fatigue prevalence in 155 younger patients was 59.5% (47/79) and 57.4% (89/155), respectively. Female sex, clinical disease activity, use of immunomodulators and presence of DiG were associated with fatigue in older patients with IBD. ConclusionsFatigue prevalence is lower in older patients with IBD compared to younger patients with IBD, but increases when active disease is present. Clinicians should be aware that fatigue is a relevant symptom in older patients with IBD, as it is associated with DiG.

PREVALENCE OF FRAILTY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. A PILOT STUDY

Abstract Frailty is a multidimensional syndrome that leads to greater vulnerability to stress, increasing the risk of adverse health outcomes. It is a dynamic process, with transitions between being robust, pre-fragile and fragile over time, suggesting that it is modifiable. Inflammatory bowel disease (IBD) results in altered immune function with amplified inflammation. When severe, it manifests with features associated with frailty, such as weight loss, fatigue, and sarcopenia. The first studies on frailty in IBD were carried out in a surgical context. Subsequent studies have associated frailty with increased risk of mortality as an independent factor in IBD patients. Of the available evidence, all are retrospective -except one- and the majority measures frailty with associated ICD-10 diagnoses, which can underestimate its prevalence in younger patients. There is no consensus in the literature on the best tool to measure frailty, however, this pilot study will objectively evaluate, using a risk score, the prevalence of this syndrome, which will allow, in the future, to carry out prospective studies that characterize frailty in IBD, understand the dynamic and longitudinal relationship between frailty and disease activity and, if appropriate, design and test interventions to alleviate this syndrome and its consequences in this population. This was a descriptive study, with the objective to determine the prevalence of frailty in IBD patients in a teaching hospital in Chile. We also compared the characteristics of frail vs non-frail IBD patients. Frailty was measured using SHARE-FI tool, which is a validated score to measure frailty in primary care, even in patients under 65 years of age. 64 patients were recruited, 28 had ulcerative colitis, 33 had Crohn’s disease and 3 had indeterminate colitis. 62.5% were female, with an average age of 42,3 ± 13,65 years. Average years since diagnosis were 11,6 ± 9,89. The prevalence of frailty was 40,62%. No association was observed between the presence of frailty and the type of IBD, IBD activity indices, use of corticosteroids, use of biologic therapy, surgeries associated with IBD, IBD flare-ups with hospitalization within the last year, calprotectin levels, vitamin D levels. The odds of the presence of frailty in women are 4,2 times greater than in men, being women a possible risk factor for frailty. The frailty group had worse quality life measured with the IBD Questionnaire 9 (OR 0,86 [IC95% 0,79-0,94). In conclusion, the prevalence of frailty in IBD was 40,62%. Contrary to what might be assumed, frailty turned out to be a condition independent of the type of IBD, time of evolution, activity and treatment, mostly associated with female sex and a worse quality of life. New studies are required to determine factors predisposing to frailty in IBD patients and prevent its appearance in order to improve their prognosis.

P990 A Multi-center, Single-arm, Prospective, Observational, Real-world Study in China to Evaluate Effectiveness of Vedolizumab in the Treatment of Inflammatory Bowel Diseases: First Interim Analysis of Patient-reported Outcomes

Abstract Background Crohn’s disease (CD) and ulcerative colitis (UC) are types of inflammatory bowel disease (IBD), causing abdominal pain, diarrhea, rectal bleeding and weight loss which is concerning due to increased prevalence and morbidity. As IBD affects quality of life (QoL), improving it is a major treatment goal. Current therapy in IBD includes corticosteroids, immunomodulators, biologics, small molecule drugs, etc. Vedolizumab (VDZ), a gut-specific antibody against α4β7 integrin, is approved in China in moderate to severe UC/CD treatment. This multi-center, single arm, prospective, observational, real-world study (NCT04872491) evaluated safety and effectiveness of VDZ in Chinese UC/CD patients. This first interim analysis presented changes in symptomatic relief and QoL. Safety results are shown separately. Methods Enrolled UC/CD patients (&amp;gt;18 years) were treated with 300 mg VDZ by intravenous infusion at week 0, 2, 6, and every 8 weeks till 54 weeks. At data cut-off (October 21, 2022), 307 patients were assessed for symptomatic relief and QoL by patient reported outcomes (PRO) scores, partial Mayo score rectal bleeding sub-score [RBS], stool frequency sub-score [SFS]) in UC; abdominal pain sub-score [APS], loose stool frequency sub-score [LSFS]) in CD at days 3, 7 and 14 and IBD questionnaire (IBDQ), EuroQol-5-Dimension-5-Level index (EQ-5D-5L) and EQ-visual analog scale (VAS) scores in UC and CD from baseline to week 14. Descriptive statistics summarized the effectiveness. Results Of 265 patients (UC: 211, CD: 54) analysed for effectiveness, 62.9% were males with mean(±SD) age 43.1±15.0 years and median IBD duration of 883 days. At baseline, mean(±SD) for partial Mayo and HBI scores were 5.185±1.936 and 5.362±3.674 for UC and CD patients respectively. Compared to baseline, UC patients showed significant difference in RBS and SFS scores from days 3 and 7 respectively reflecting rapid onset effect of VDZ (Figure 1). Patients with RBS=0 and SFS≤1 scores improved from 34.78% at baseline to 62.79% at day 14 after treatment. IBDQ, EQ-5D-5L and EQ-VAS mean±SD score changes of 38.853±39.569, 0.046±0.125 and 10.258±14.756 signified improved QoL (Table 1). At baseline, mean±SD APS and LSFS scores in CD patients were 0.692±0.832 and 1.462±1.570 (n=39), which decreased to 0.425±0.594 and 1.325±1.207 (n=40) at day 14 with a mean change of -0.211±0.528 and -0.105±0.981 (Figure 1). VDZ effectively maintained remission in patients with APS≤1 and LSFS≤3 which increased from 35.90% at baseline to 50.00% at day 14. Improved QoL was observed with changes in IBDQ (13.194±31.592) (Table 1). Conclusion VDZ effectively improved and maintained symptomatic relief and QoL in Chinese UC/CD patients in real-world settings.

N45 Nurse intervention in patients with Inflammatory bowel disease: impact in their quality of life

Abstract Background Physical inactivity is considered as a modifiable risk factor in chronic diseases1 and IBD. Regular physical activity could help patients with IBD by reducing some IBD complications, such as improving immune response, increasing muscle mass and strength, and improving bone density. The aim of this study is to determine the impact of a Nurse intervention, on Physical Activity, in quality of life of IBD patients. Methods Quasi-experimental study before and after. 20 patients, both sex, with IBD from Hospital Universitario del Henares, 18-65 years old, in clinical remission or mild activity; IBD ≥ 6 months. Exclusion: physical impairment for daily activities (cardiac, orthopedic or cognitive impairment); pregnancy; surgery &amp;lt; 3 months. Nurse intervention on physical exercise: 4 group sessions of 60 minutes, 10 months follow-up. Training on strength and endurance exercises by a physiotherapist adapted to each patient’s special needs. Data were collected in Inflammatory Bowel Disease Questionnaire 32 (IBDQ-32), Rapid Assessment of Physical Activity (RAPA), Hospital Anxiety and Depression Scale (HADS). Variables: quality of life, physical activity, IBD activity, socio-demographic, health status and lifestyle. A descriptive analysis was carried out with qualitative and quantitative variables. Four dimensions of quality of life index and impact of exercise on quality of life were calculated, before and after intervention with Students-T. Results Quasi-experimental study before and after. 20 patients, both sex, with IBD from Hospital Universitario del Henares, 18-65 years old, in clinical remission or mild activity; IBD ≥ 6 months. Exclusion: physical impairment for daily activities (cardiac, orthopedic or cognitive impairment); pregnancy; surgery &amp;lt; 3 months. Nurse intervention on physical exercise: 4 group sessions of 60 minutes, 10 months follow-up. Training on strength and endurance exercises by a physiotherapist adapted to each patient’s special needs. Data were collected in Inflammatory Bowel Disease Questionnaire 32 (IBDQ-32), Rapid Assessment of Physical Activity (RAPA), Hospital Anxiety and Depression Scale (HADS). Variables: quality of life, physical activity, IBD activity, socio-demographic, health status and lifestyle. A descriptive analysis was carried out with qualitative and quantitative variables. Four dimensions of quality of life index and impact of exercise on quality of life were calculated, before and after intervention with Students-T. Conclusion There are non-significative differences in quality of life before and after intervention. Patients increased their physical activity after intervention. Regular physical activity is a useful tool for improving quality of life in patients with IBD.

P859 Sodium Butyrate supplementation significantly improved clinical outcomes and quality of life in patients with Crohn’s Disease – results from a randomized placebo-controlled study

Abstract Background Butyrate has shown anti-inflammatory effects and plays an important role in maintaining gut homeostasis, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. Methods In this randomised, double-blind, placebo-controlled study 140 IBD patients in remission or with mild disease (n=60 Crohn's disease, CD and n=80 Ulcerative Colitis, UC) were randomized to oral administration of BLM/placebo for 90 days in addition to conventional therapy. As primary aim: changes in microbiome composition induced by BLM treatment. Fecal microbiota from stool samples was assessed by 16S sequencing. Clinical disease activity assessed by using Harvey Bradshaw Index (HBI) for CD and partial-Mayo Score (pMS) for UC, quality of life assessed by using Inflammatory Bowel Disease Questionnaire 32 (IBDQ-32) and adherence-dietary-raccomandation( WCRF) were evaluated before and after treatment. Results Demographics, clinical and dietary characteristics were similar between the two populations. The microbiota sequencing highlighted two different enterotypes in CD population: the first one was characterized by a low F/B ratio (with a genus prevalence of Fusobacteriota, Alistipes, and Blautia). The second enterotype was characterized by a higher F/B ratio (with a genus prevalence of Escherichia-Shigella and Lachnoclostridium)(Fig1). BLM had a more pronounced effect on enterotype-1 where the taxa associated with intestinal comfort, SCFA production, increased after treatment, while the taxa associated with CRC and intestinal inflammation, decreased. After treatment was observed: a)improved quality of life (IBDQ-32: CD: treat. 170/184 vs Pb. 188/197 p&amp;lt;0.001 vs p=0.021; UC: treat.185/195 vs Pb.188/188 p=0.003 vs p=0.4), b)lower disease activity in CD patients (the HBI score, showed a significant improvement for those treated with BLM as compared to placebo (McNemar’s p=0.013 vs p&amp;gt;0.9).c) reduced Calprotectin levels (Table1.) Finally, a significant separation was observed in samples from patients who have undergone minor surgery (ileo-colon), compared to non-surgery patients. The variable "surgery" seems to be associated with the enterotype-1. Conclusion Sodium butyrate supplementation significantly improved clinical outcomes and quality of life in patients with CD. Our data showed that the differential response to BLM treatment is based on enterotype, suggesting that Enterotype-1 patients may experience greater clinical benefits and improvements in QoL compared to Enterotype-2 patients in both UC and CD populations.

P862 Effects of induction and maintenance therapy with risankizumab on health-related quality of life outcomes in patients with moderately to severely active ulcerative colitis: A post-hoc analysis of Phase 2b/3 trials

Abstract Background Ulcerative colitis (UC) has a detrimental impact on patients’ health-related quality of life (HRQoL).1 Long-term treatment goals for patients with moderately to severely active UC include restoration of HRQoL. This post-hoc analysis evaluated the effect of induction and maintenance treatment with risankizumab (RZB) on HRQoL outcomes. Methods Data from two Phase 2b/3 clinical trials (INSPIRE induction: NCT03398148 and COMMAND maintenance: NCT03398135) were evaluated. Patients received RZB 1200 mg intravenous (IV) or placebo (PBO) induction treatment at weeks 0, 4, and 8. Patients with a clinical response per Adapted Mayo score to RZB IV were randomised 1:1:1 to subcutaneous (SC) RZB 180 or 360 mg, or placebo (PBO [RZB withdrawal] SC) every 8 weeks for 52 weeks of maintenance. The proportion of patients achieving a meaningful within-person change (MWPC) for each HRQoL outcome was reported. HRQoL outcomes included Functional Assessment of Chronic Illness Therapy-Fatigue, disease-specific instruments such as Inflammatory Bowel Disease Questionnaire (IBDQ) and Ulcerative Colitis Symptom Questionnaire (UCSQ), as well as generic quality-of-life questionnaires like Work Productivity and Activity Index-Ulcerative Colitis (WPAI-UC), 36-Item Short-Form Survey (SF-36), and EuroQoL 5 Dimensions 5 Levels. MWPCs were measured from baseline to induction Week 12 and to maintenance Week 52. Estimated differences in proportions with 95% confidence intervals and p-values between RZB and PBO were compared using the Cochran-Mantel-Haenszel test adjusting for baseline strata. Results For RZB 1200 mg IV (n=650) versus PBO IV-treated (n=325) patients, a greater proportion of patients achieved MWPC across all HRQoL outcomes at Week 12 of induction (p&amp;lt;0.01; Table). At Week 52 of maintenance, a greater proportion of patients treated with RZB 180 mg SC (N=179) versus PBO (withdrawal) SC (N=183) achieved MWPC across all HRQoL outcomes (p&amp;lt;0.05), except for absenteeism from WPAI-UC (p=0.33). For RZB 360 mg SC (N=186) versus PBO (withdrawal) SC, a greater proportion of patients achieved MWPC for UCSQ, IBDQ, and SF-36 physical component summary (all p&amp;lt;0.05). Conclusion In this analysis, a greater proportion of patients treated with RZB versus PBO achieved MWPC on various HRQoL outcomes after completing 12-week induction IV therapy. HRQoL improvements were sustained up to Week 52 of treatment. This suggests RZB has the potential to help patients achieve restoration of HRQoL as a long-term goal of treatment in patients with moderately to severely active UC. 1. Mavroudis G. Therap Adv Gastroenterol. 2022;15:17562848211062406.

OP12 Mirikizumab improves fatigue, bowel urgency, and quality of life in patients with moderately to severely active Crohn’s Disease: Results from a phase 3 clinical trial

Abstract Background Mirikizumab (miri), an anti-IL-23p19 antibody, is approved for the treatment of ulcerative colitis and under development for Crohn’s disease (CD). We investigated how miri impacted fatigue, bowel urgency, and health-related quality of life (HRQoL) through 52 weeks in patients with moderately to severely active CD in the Phase 3 VIVID-1 study. Methods In the treat-through VIVID-1 (NCT03926130) study, patients (N=1065) with moderately to severely active CD and a Simple Endoscopic Score for CD (SES-CD) score ≥7 (or ≥4 for patients with isolated ileal disease) and failure to biologic and/or conventional therapy were randomized in a 6:3:2 ratio to receive miri (N=579) (a single 900mg intravenous (IV) dose at W0, W4, and W8 followed by a subcutaneous (SC) dose of 300 mg at W12 and then every 4 weeks), ustekinumab (N=287) (6mg/kg IV at W0 and SC dose of 90mg at W8 and then every 8 weeks), or PBO (N=199). At W12 PBO responders continued PBO to W52; PBO-non-responders received the same blinded miri regimen as described above. This analysis focuses on results in patients randomized to either miri or PBO. The change from baseline for Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Urgency Numeric Rating Scale (UNRS), and Inflammatory Bowel Disease Questionnaire (IBDQ) total and domain scores (bowel symptoms, systemic symptoms, emotional function, social function) were analyzed through W52. IBDQ response (≥16-point improvement from baseline) and remission (total score ≥ 170) rates were also analyzed at W12 and W52. For binary variables, adjusted risk differences were compared between miri and PBO using the Cochran-Mantel-Haenszel (CMH) test. For continuous variables, least squares mean changes from baseline were compared between treatment groups using ANCOVA. Results Significant improvement in mean change from baseline to W12 and W52 were observed with miri for FACIT-F, UNRS, and IBDQ total and domain scores (all p&amp;lt;0.000001 at W52) (Figure 1&amp;2). Miri-treated patients showed improved UNRS scores versus PBO as early as W8 with statistical significance sustained to W52 (Figure 1B). At W12 and W52, a greater percentage of miri-treated patients achieved IBDQ response (W12: p&amp;lt;0.000001; W52: p&amp;lt;0.000001) and remission (W12: p&amp;lt;0.000001; W52: p&amp;lt;0.000001) compared to PBO (Figure 2A&amp;B). Conclusion Treatment with miri resulted in improvements in fatigue, bowel urgency, and HRQoL at W12 and W52 in patients with moderately to severely active CD.

P1010 Guselkumab improves abdominal pain and bowel urgency symptoms in patients with moderately to severely active ulcerative colitis: Results from the phase 3 QUASAR induction study

Abstract Background Abdominal pain and bowel urgency are prevalent, burdensome symptoms experienced by patients (pts) with ulcerative colitis (UC) that impact daily life, including social activities. In this study, we use data from the Phase 3 QUASAR Induction Study to assess efficacy of guselkumab (GUS) on abdominal pain, bowel urgency, and the impact of bowel urgency on pts’ lives. Methods Pts were randomized 3:2 to receive IV GUS 200mg or placebo (PBO) at Weeks (Wks) 0, 4, and 8. Abdominal pain and bowel urgency were evaluated at baseline and Wk12 using items from the Inflammatory Bowel Disease Questionnaire, where pts rated trouble with abdominal pain, symptoms of bowel urgency, and the impact of bowel urgency over the past 2 wks using 7-point scales (1=all of the time to 7=none of the time). A ≥2 point increase from baseline was clinically meaningful improvement. All analyses were prespecified but not multiplicity controlled; all p-values are nominal. Results At baseline, percentages of pts with abdominal pain (GUS 77.7% and PBO 77.9%), symptoms of bowel urgency (GUS 86.0% and PBO 83.2%), and impact of bowel urgency (GUS 70.8% and PBO 70.4%) at least a little of the time (score ≤5) were similar between groups. GUS-treated pts showed greater improvements at Wk12 in these outcomes compared with PBO (Table 1). For abdominal pain, 52.0% of GUS-treated pts had clinically meaningful improvements from baseline at Wk12 vs 33.0% in the PBO group (p&amp;lt;0.001), and 21.1% vs 12.3%, respectively, of those with abdominal pain at baseline had resolution at Wk12 (p=0.004; Fig. 1A). For symptoms of bowel urgency, 58.6% vs 33.0%, respectively, had clinically meaningful improvements (p&amp;lt;0.001; Fig. 1B), and 24.0% vs 9.8%, respectively, of those with symptoms of bowel urgency at baseline had resolution at Wk12 (p&amp;lt;0.001). Similarly, 57.7% vs 33.0%, respectively, had clinically meaningful improvements in the impact of bowel urgency (p&amp;lt;0.001; Fig. 1B), and 32.4% vs 13.1%, respectively, of those impacted at baseline had resolution at Wk12 (p&amp;lt;0.001). Symptoms and impact of bowel urgency were combined into a bowel urgency score; of pts with symptoms or impact scores ≤6 at baseline, 19.7% versus 8.2%, respectively, had resolution of both at Wk12 (p&amp;lt;0.001; Fig. 1B). Conclusion Pts receiving GUS showed clinically meaningful improvements in health-related quality of life measures related to abdominal pain and bowel urgency, including both the symptoms of bowel urgency and impact on pts’ lives.

P422 Prevalence of poor sleep quality assessed by wrist actigraphy and sleep questionnaire in Inflammatory Bowel Disease patients and its association with disease activity and quality of life

Abstract Background An association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed, however studies evaluating both subjective and objective assessment of disease activity and sleep quality are limited. Our study aimed to investigate the prevalence of poor sleep quality assessed by wrist actigraphy and sleep questionnaires in IBD patients and its association with disease activity and quality of life. Methods A prospective observational study was conducted in Siriraj Hospital, Mahidol University, Bangkok, Thailand from March 2021 to December 2022. Eligible IBD patients were categorized into remission, mild, and moderate-to-severe groups, based on standard clinical disease activity scores. Demographic data, inflammatory markers, inflammatory bowel disease questionnaire (IBDQ), sleep questionnaire (Pittsburgh Sleep Quality Index, PSQI), and seven-day sleep data from wrist actigraphy (Actiwatch®, CamNtech, Cambridge, United Kingdom) were obtained. The prevalence of sleep disorder and group comparison were analyzed. Results Eighty-four participants (40 Crohn’s disease, 44 UC), consisting of 60 remission, 16 mild, and 8 moderate-to-severe disease activity, were enrolled. Baseline demographic data were comparable between each group. Lower hemoglobin and albumin levels, and higher serum C-reactive protein, and fecal calprotectin levels were found in the more clinically active groups (table1). Fifty patients (60%) had poor sleep defined by PSQI &amp;gt; 5 with a trend to be higher in the group with active symptoms (57% in remission, 63% in mild, and 75% in moderate-to-severe group, p=0.31). Using actigraphy, the group with moderate-to-severe symptoms tended to have longer sleep latency, more frequently awake after sleep, and poorer sleep efficiency than the other groups (Figure 1). Patients with more severe disease activity had poorer quality of life with a mean IBDQ of 190 in remission, 159 in mild, and 134 in moderate-to-severe group (p&amp;lt;0.001). Conclusion Poor sleep quality is common among IBD patients, even those with clinical remission. Those with more severe symptoms had poorer sleep quality and worse quality of life. Sleep assessment and treatment should be integrated into IBD standard clinical care.

P332 The role of Handgrip Strength in Nutritional Status Assessment of Patients with Inflammatory Bowel Disease. A cross-sectional study

Abstract Background Inflammatory bowel disease (IBD) has been extremely prevalent in recent years. Multiple factors such as chronic inflammation, insufficient nutrient intake, malabsorption and high energy requirements during disease flares increase the risk of malnutrition and impaired body composition leading to complications such as thromboembolism, prolonged hospital stay and surgery. Nutritional status assessment through screening tools, anthropometry and body composition analysis requires experienced personnel and is time consuming. The purpose of this single center cross-sectional study is to assess nutritional status of patients with IBD and investigate various methods for the early detection of malnutrition. Methods Eligible participants were patients diagnosed with Corhn’s disease (CD) or ulcerative colitis (UC) from August to October 2023. Exclusion criteria comprised corticosteroid or diuretic treatment and high output stoma or fistulas. Nutrition status was assessed with Subjective Global Assessment (SGA). Body composition analysis was performed with bioelectric impedance analysis (BIA, Bodystat Quadscan 4000). Handgrip strength (HGS) was measured to detect reduced muscle activity through Jamar dynamometer. BIA derived values were compared to reference values from epidemiological studies. Quality of life impairment evaluated through Inflammatory Bowel Disease Questionnaire (IBDQ). Data was analyzed with SPSS Statistics 29.0.1. Results 104 patients were included (68 with CD, 36 with UC) with a mean age of 46 years (20-79). Based on body mass index (BMI) of the examined sample: 2% were underweight, 47% normal, 31% overweight and 18% obese. Body composition analysis revealed high level fat mass in 50% of females and in 48% of males. Fat free mass index (FFMI) was found low in 30% of females and in 17.5% of males, respectively. Not significant differences were observed between patients with CD and UC. Malnutrition assessment through SGA revealed 7 (6%) severely and 10 (7%) moderately malnourished patients. HGS was negatively strongly correlated with SGA (R2=0.52) and the percentage of fat mass (R2=0.51), whereas positively moderately correlated with FFMI (R2=0.48) and IBDQ score (R2=0.30). Conclusion A large percentage of patients with IBD appear to have disturbed body composition and higher levels of fat mass compared to healthy population. Handgrip strength measurement is a fast and cost-effective method of muscle function assessment that correlates well with nutritional status and quality of life. Further studies are needed to validate these findings and incorporate handgrip strength measurement in every day clinical practice to detect malnourished patients.

P651 A randomised controlled trial of IBD-BOOST, a digital cognitive behavioural self-management programme for fatigue, and/or pain, and/or faecal incontinence in inflammatory bowel disease

Abstract Background Many people with IBD experience fatigue, pain and faecal incontinence (FI), impacting quality of life (QoL). We developed an interactive digital online self-management intervention (IBD-BOOST) based on a theoretically informed logic model and cognitive behavioural techniques, to treat these symptoms. We aimed to assess if IBD-BOOST, alongside health care professional (HCP) support and care as usual (CAU), provides greater relief from symptoms and improvement of QoL compared with CAU alone. Methods We conducted a pragmatic multi-centre two-arm parallel group randomised controlled trial (RCT) recruiting patients from clinics and national registries who rated the impact of fatigue and/or pain and/or FI as ≥5/10. Those in the IBD-BOOST arm received 6 months access to the 12-session IBD-BOOST programme, a 30-minute telephone support call with a trained HCP after session 1 and weekly in-site email messages from the HCP for 3 months. The UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months were dual primary outcomes (alpha=0.025 was considered statistically significant as there were two primary outcomes). Other secondary outcomes, including individual symptoms, were measured at 6 and 12 months. Complier-averaged causal effects (CACE), sensitivity and pre-specified subgroup analyses were conducted. Results 780 participants were randomised (Figure 1), 432 with Crohn’s disease, 348 with ulcerative colitis or other IBD; 520 (66.7%) were female, mean age 49 years. At 6 months, both UK-IBDQ and GRSR were similar between the BOOST and CAU arms, p=0.19 for IBDQ and p=0.39 for GRSR (Table 1). Adverse events were similar between groups. FI score and EQ5D utility score (secondary outcomes) were significantly in favour of IBD-BOOST at 6 months, but pain and fatigue were no different. 57% of the intervention group completed a pre-defined minimum “dose” of 4 sessions (i.e. compliers). The CACE analysis suggested that compliers were more likely to report better QoL (p=0.03). Subgroup analysis of those meeting criteria for irritable bowel syndrome (IBS), showed that IBD-BOOST was more effective in improving IBDQ and GRSR at 6 months when compared with CAU for the IBD-IBS group (pinteraction=0.015 and 0.046, respectively). Conclusion This large RCT found that IBD-BOOST did not improve IBDQ and GRSR in patients with IBD and fatigue and/or pain and/or FI relative to CAU. Participants reported less FI at 6 and 12 months. Those who complied with the intervention showed a more pronounced IBDQ treatment effect. Those with IBD-IBS at baseline improved more than those without, suggesting a possible for further effectiveness research on IBD-BOOST. Trial registration: ISRCTN71618461

P833 Burden of steroid use in patients with moderate ulcerative colitis in Europe and the United States

Abstract Background Steroids are an effective short-term therapy option for induction of remission of ulcerative colitis (UC). However, long-term and frequent steroid use is common in clinical practice despite the risks of complications and adverse events.1 We aimed to describe disease burden in moderate UC patients (pts) based on their steroid use history. Methods Data were drawn from the Adelphi UC Disease Specific Programme™, a cross-sectional survey of gastroenterologists (GIs) and their pts in France, Germany, Italy, Spain, the UK and US from Jan 2020–Mar 2021. GIs reported patient demographics, clinical characteristics, treatments and healthcare resource utilization (HCRU). Pts reported quality of life (QoL) via the EQ-5D, short inflammatory bowel disease questionnaire (SIBDQ), and work productivity and activity impairment (WPAI) questionnaire. Pts had received 5-ASA or immunomodulator with no biologic or Janus kinase inhibitor in the 90 days following treatment initiation, had a history of physician-assessed moderate disease severity or a Mayo endoscopic subscore of 2, and no history of colectomy. Pts were categorized as: no steroids (NS; never received steroids), short term/intermittent (ST/I; currently receiving intermittent steroids or received steroids within the last two years for &amp;lt;90 days), or long term/escalated (LT/E; received steroids for ≥90 days within the last two years or had undergone steroid dose escalation within their current course). Analyses were descriptive. Results Overall, 217NS, 88 ST/I and 172 LT/E pts were analysed (Table 1). Median (interquartile range) total steroid use duration was 4.1 (1.6–22.3) months for ST/I and 14.9 (5.8–36.7) months for LT/E. NS (24.4%), ST/I (25.0%) and LT/E (26.2%) pts experienced abdominal pain; 0.5%, 4.6% and 5.2% had severe/extremely severe pain, respectively. Non-bloody diarrhoea was reported by 16.6%, 14.8%, 20.9% of pts, respectively. In the last 12 months, mean (standard deviation; SD) number of health care visits for NS, ST/I and LT/E was 6.1 (6.2), 7.3 (4.8), 8.0 (7.1); mean (SD) number of tests was 20.8 (17.2), 23.3 (15.7), 25.2 (18.2), respectively. NS, ST/I and LT/E patients reported mean EQ-5D scores (0.85, 0.81, 0.79), SIBDQ total scores (54.6, 49.7, 48.3) and overall work impairment (19.4, 23.1, 27.7). Key comorbidities experienced by ST/I and LT/E were hypertension, depression and diabetes (Figure 1). Conclusion Patients with long-term or escalated steroid use had high symptom burden, frequent comorbidities, high HCRU, and poor QoL. This highlights the need for alternative treatment approaches for moderate UC patients to avoid long-term steroid use. 1. Cross R.K. Inflamm Bowel Dis. 2017;23(10):1689–1701

P370 Quality of life in inflammatory bowel diseases – is the flare all that matters?

Abstract Background Burden in inflammatory bowel diseases (IBD) is high and affects both physical and psychological status. Short inflammatory bowel disease questionnaire (SIBDQ) is a self-administered health-related quality of life questionnaire that evaluates social, bowel, emotional and systemic dimension. Our aim is to evaluate the impact of IBD status on patients’ daily life. Methods We analysed 82 patients diagnosed with Crohn’s disease or ulcerative colitis or that were admitted between March 2021 and April 2022 in Fundeni Clinical Institute, Bucharest. SIBDQ consists of ten questions, with score ranging from 10 (poor) to 70 (optimal). Patients completed SIBDQ and we assessed disease status and determined biological and clinical markers. Results 51% of patients were diagnosed with Crohn’s Disease. 79% were in clinical remission. The mean age was 39.53±12.9 years old and 52.4% were men. Mean illness duration was 8.03±7.18 years. Mean SIBDQ score was 50.25±14.51, with significantly higher scores in the remission subgroup (55.26±10.30 vs. 31.11±12.24, p&amp;lt;0.001) and it correlated with faecal calprotectin level (ρ=-0,502) and C-reactive protein level (ρ=- 0,531), without regard to disease type or sex. There were no correlations between SIBDQ score and Crohn’s disease or ulcerative colitis phenotype, duration since diagnosis, presence of extraintestinal manifestations or history of abdominal surgery related to IBD. Conclusion Patients with IBD flares have low quality of life and SIBDQ scores correlate with markers of disease severity, comparable to previously-published literature. Patients in clinical remission presented with higher SIBDQ scores, independently of IBD phenotype or previous surgery. Acute flares of IBD have a major impact on daily life, additional psychological and social support is needed in order to improve management.