IBDQ Scores Research Articles

P0514 Assessing the relationship between physician perspective and subjective disabilities in IBD patients: a comparative study using IBD-Disk and IBD-Q

Abstract Background Inflammatory Bowel Diseases (IBD) are chronic conditions that often affect young patients throughout their lives. Treating patients with IBD, it is essential not only to achieve deep remission (clinical, biochemical, and mucosal) but also to completely restore the patient’s quality of life. Addressing and reducing the cumulative burden of disease, enabling a return to a “normal life,” and preventing disability have become major therapeutic goals in the management of patients with IBD management. Recently, a brief and patient-friendly questionnaire, the IBD-Disk, has been proposed as a tool for monitoring disability in IBD outpatients. This study aims to assess the relationship between gastrointestinal symptoms, biochemical parameters, and subjective disabilities in patients affected by IBD. Methods In this prospective study, we enrolled consecutive patients with IBD who completed the IBD-Disk during an in-person visit. We also recorded demographic data, clinical features, disease activity, biochemical data, and ongoing treatments. Clinical activity was evaluated using the partial Mayo score (p-Mayo) for Ulcerative Colitis (UC) and the Harvey-Bradshaw index (HBI) for Crohn’s disease (CD). The IBD-Q was also administered at the time of evaluation and a cut-off of 170 was considered to define symptomatic remission. Results We included 95 patients with IBD (49 males, 51.6%), median age of 52.9 years (IQR 37-61), with 45 (47.4%) having CD and 50 (52.6%) having UC. 76 patients (80 %) of patients were on conventional therapy, and 12.6% were receiving concomitant steroids. At the time of evaluation, 29 (30.5%) patients had clinically active disease, and 31 (32.6%) had biochemically active disease. An inverse linear correlation was found between the IBD-Disk and IBD-Q (r² = 0.66, p<0.001). Patients with clinically active disease had significantly higher IBD-Disk scores (40, IQR 24-60 vs. 26, IQR 10-51, p=0.016) and lower IBD-Q (148, IQR 140-176 vs. 180, IQR 159-200) compared to those in clinical remission. The AUROC for clinical remission for IBD-Disk and IBD-Q were 0.650 (95% CI 0.54-0.76) and 0.755 (95% CI 0.65-0.85), respectively. Among patients in remission, 39.3% had an IBD-Q score below 170, while the median IBD-Disk value was 26 (IQR 10-51). The majority of patients preferred completing the IBD-Disk (71, 74.7%). Conclusion Both the IBD-Disk and IBD-Q are associated with objective disease activity, with the IBD-Q demonstrating slightly superior performance. However, most patients preferred the IBD-Disk. Despite achieving satisfying clinical endpoint, doctors often fail to perceive patient’s quality of life.

P0375 Fibromyalgia as a predictive factor of fatigue and reduced quality of life in patients with inflammatory bowel disease

Abstract Background Inflammatory bowel disease (IBD) patients often experience extraintestinal manifestations, which significantly impact their quality of life, contribute to disability, and impose substantial costs on healthcare systems. Osteoarticular manifestations are the most common type of EIMs. Fibromyalgia (FM), the second most common rheumatic disease, affects an estimated 2% to 8% of the global population, with a higher prevalence among females. FM is characterized by widespread pain, frequently accompanied by fatigue, cognitive difficulties, and sleep disturbances. Evidence indicates a strong association between FM and IBD, with numerous studies reporting a higher prevalence of FM among IBD patients compared to the general population. Methods The aim of this study was to evaluate the prevalence of FM in patients with IBD. We conducted a cross-sectional analysis at our IBD outpatient clinic from July 2023 to July 2024, including patients aged over 18 years. The diagnosis of FM was made based on the criteria established by the American College of Rheumatology in 2016. Data on demographics, IBD phenotype, clinical and endoscopic activity, quality of life (IBDQ) and fatigue (FACIT) measurements were recorded. Results A total of 250 patients were included. The overall prevalence of FM was 15.2%, predominantly in females (53.6%) (p < 0.001). The mean age at the time of inclusion was 34.5 years (SD 15.3) and the mean disease duration was 10.9 years (SD 8.1). Most patients in our cohort were White (55.7%) and non-smokers (65.3%). There was no significant difference in C-reactive protein levels between IBD-FM patients and IBD-only patients (5.1 vs. 8.6 mg/dL; p = 0.324). Patients with ulcerative colitis exhibited a higher frequency of FM compared to those with Crohn’s disease (22 vs 16, p = 0.041). Patients with FM were statistically older (40.7 years vs. 33.4 years; p = 0.008) and had a higher BMI (27.8 vs. 24.8; p = 0.001) compared to those without FM. Additionally, patients with FM had a significantly longer mean disease duration (14 years vs 10.3, p = 0.015) and reported notably lower mean scores of IBDQ (147.4 vs 183.1; p < 0,001) and lower mean FACIT scores (31.5 vs 42.1; p < 0,001) compared to patients without FM. Conclusion The association between FM and IBD was substantial in the studied cohort, with a prevalence exceeding that reported in the general population and in previous literature. There was a slight predominance of FM among female patients diagnosed with UC. The co-occurrence of IBD and FM was associated with a significantly reduced quality of life and elevated levels of fatigue.

Anxiety and Depression Are Associated with Poor Long-term Quality of Life in Moderate-to-Severe Ulcerative Colitis: Results of a 3-Year Longitudinal Study of the MOSAIK Cohort.

We previously reported that patients with moderate-to-severe ulcerative colitis (UC) often experience common mental disorders (CMDs) such as anxiety and depression, necessitating immediate psychological interventions within the first 4 weeks of diagnosis. In this 3-year follow-up study of the MOSAIK cohort in Korea, we examined the effects of CMDs at initial diagnosis on clinical outcomes and health-related quality of life (HRQoL). We examined differences in clinical outcomes (evaluated based on clinical response, relapse, hospitalization, and medication use) and HRQoL (assessed using the Inflammatory Bowel Disease Questionnaire [IBDQ] and Short Form 12 [SF-12]) according to Hospital Anxiety and Depression Scale (HADS) scores at diagnosis. In a study involving 199 UC patients, 47.7% exhibited significant psychological distress (anxiety and/or depression) at diagnosis. Clinical follow-up showed no major differences in outcomes, including remission rates, response rates, or hospitalization rates, between patients with anxiety or depression at diagnosis and patients without anxiety or depression at diagnosis. The HRQoL at the end of follow-up was notably lower in those with baseline CMDs, particularly anxiety, across all domains of the IBDQ and SF-12. Linear mixed-effect models revealed that higher HADS scores, as well as higher Mayo scores, were independently associated with lower IBDQ scores and both summary domains of the SF-12. Additionally, regular attendance at follow-up visits during the study period was also related to improvements in HRQoL (all p<0.05). While CMDs present at the time of UC diagnosis did not influence long-term clinical outcomes, they persistently impaired HRQoL. Our findings support the routine incorporation of psychological interventions into the long-term management of moderate-to-severe UC.

Prevalence and risk factors of depression among patients with perianal fistulizing Crohn's disease.

Psychological distress, especially depression, associated with perianal fistulizing Crohn's disease (PFCD) is widespread and refractory. However, there is a surprising paucity of studies to date that have sought to identify the prevalence and risk factors of depression associated with PFCD. To estimate the prevalence of depressive symptoms and investigate the depression-related risk factors in patients with PFCD. The study was conducted in the form of survey and clinical data collection via questionnaire and specialized medical staff. Depressive symptoms, life quality, and fatigue severity of patients with PFCD were assessed by Patient Health Questionnaire-9, Inflammatory Bowel Disease Patient Quality of Life Questionnaire (IBDQ), and Inflammatory Bowel Disease (IBD) Fatigue Patient Self-assessment Scale. The basic demographic information, overall disease features, perianal clinical information, and laboratory inflammation indicators were also gathered. Multivariate regression analysis was ultimately used to ascertain the risk factors of depression associated with PFCD. A total of 123 patients with PFCD were involved, and 56.91% were suffering from depression. According to multivariate logistic regression analysis, Perianal Disease Activity Index (PDAI) score [odds ratio (OR) = 0.69, 95% confidence interval (CI): 0.50 to 0.95], IBDQ score (OR = 0.93, 95%CI: 0.88 to 0.97), modified Van Assche index (OR = 1.24, 95%CI: 1.01 to 1.53), and IBD Fatigue score (OR = 1.72, 95%CI: 1.23 to 2.42) were independent risk factors of depression-related prevalence among patients with PFCD (P < 0.05). Multiple linear regression analysis revealed that the increasing perianal modified Van Assche index (β value = 0.166, 95%CI: 0.02 to 0.31) and decreasing IBDQ score (β value = -0.116, 95%CI: -0.14 to -0.09) were independently associated with the severity of depression (P < 0.05). Depressive symptoms in PFCD patients have significantly high prevalence. PDAI score, modified Van Assche index, quality of life, and fatigue severity were the main independent risk factors.

Evaluation of a Multimodal Stress Management and Comprehensive Lifestyle Modification Program on Quality of Life and Gastrointestinal Symptoms in Patients with Crohn’s Disease: A Randomized Controlled Pilot Trial with 9-Month Follow-Up

Introduction: Stress and lifestyle factors impact the course of Crohn’s disease (CD). Our primary objective was to assess whether patients with CD benefit from a mind-body-medicine stress management and lifestyle modification (MBM) program. Methods: This 9-month two-arm pilot trial was conducted in Bamberg, Germany (2020–2021). Patients (18–75 years) with mild to moderate activity of CD and stable medication were enrolled and randomly assigned to either a 10-week MBM program (intervention group, IG) or a single 90-min education session (waiting list control group, CG). Primary endpoints were quality of life (IBDQ) and disease activity (HBI). Secondary endpoints were emotional distress, core self-evaluation, and inflammatory biomarkers 3 and 9 months after baseline assessment. Results: We analyzed data from 37 patients (IG: n = 19, mean ± SD age 49.6 ± 13.1 years, 68% female; CG: 18, 46.8 ± 11.4, 67% female). Immediately after the intervention, 79% (IG) and 44% (CG) experienced a clinically relevant improvement (IBDQ score ≥16 points). This was similar after 9 months (63% vs. 44%). There was no difference in disease activity (3 months: p = 0.082, 95% CI −1.3 to 2.6; 9 months: p = 0.251, 95% CI −1.2 to 2.5). Secondary outcomes indicated improvements in emotional distress, core self-evaluation, erythrocyte sedimentation rate after three and in emotional distress, T-cell profiling in the blood, and fecal lactoferrin and calprotectin group after 9 months in the IG. Conclusion: Our study suggested benefits of a multimodal stress management and lifestyle modification program for patients with CD. Larger trials are needed to determine if the program can supplement or at least partially replace pharmacological treatment approaches.

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

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. 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. 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. 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.

P678 Long-term efficacy, safety and health-related quality of life in patients who achieved comprehensive disease control with filgotinib in SELECTION: analysis of ~3 years in SELECTIONLTE

Abstract Background Filgotinib (FIL), an oral, once-daily, Janus kinase 1 inhibitor, was approved for Ulcerative Colitis (UC) treatment after the phase 2b/3 SELECTION trial (NCT02914522). In SELECTION, a greater proportion of FIL200 mg (FIL200)-treated than placebo-treated patients achieved comprehensive disease control (CDC), a stringent multi-component endpoint. We examined the long-term outcomes of achieving CDC in patients continuing on FIL200 in the ongoing long-term extension (LTE) study SELECTIONLTE (NCT02914535). Methods This interim analysis included adult patients with UC who completed SELECTION and received ≤144 weeks of FIL200 in the LTE (up to data cut-off 24/02/22). CDC (biomarker remission, endoscopic improvement, IBDQ remission and partial Mayo Clinic Score [pMCS] remission achieved concurrently) was assessed at SELECTION week 58 (LTE baseline [BL]). Mean pMCS and IBDQ score, use of corticosteroids (CS) and incidence of TEAEs and serious TEAEs in the LTE were compared between SELECTION CDC achievers and non-achievers. A mixed model for repeated measures was fitted on pMCS and IBDQ score, with CDC achiever status, study visit and the interaction between CDC achiever status and study visit as fixed effects; p values were nominal. Results We analysed 148 patients (CDC achievers, n=41; CDC non-achievers, n=107). Mean pMCS was stable in CDC achievers (0.44, LTE BL; 0.50, LTE week 144) and decreased in CDC non-achievers (1.49, LTE BL; 0.77, LTE week 144; Figure). Mean IBDQ score was stable in CDC achievers (204.05, LTE BL; 197.21, LTE week 144) and increased in CDC non-achievers (181.55, LTE BL; 196.37, LTE week 144; Figure). There was a significant beneficial effect of achieving CDC on pMCS and IBDQ score overall (pMCS: fixed effect estimate: −0.5542, p=0.0025; IBDQ score: fixed effect estimate: 13.1585, p=0.0042). There was a significant interaction between achieving CDC and study visit for IBDQ score (p=0.0183), with the benefit of achieving CDC lessening by week 144. Generally, a lower proportion of CDC achievers used CS than non-achievers; 2.4–7.3% of CDC achievers used CS vs 1.9–15.9% of CDC non-achievers. Incidence of TEAEs and serious TEAEs were stable over time and similar between CDC achievers and non-achievers. Conclusion Follow-up for ~3 years showed high levels of long-term benefit with continued FIL200 treatment. Achieving comprehensive disease control at the end of the randomized trial with FIL200 was associated with long-term efficacy, improved HRQoL and low overall use of CS. This may demonstrate the value of filgotinib-induced achievement of CDC in UC disease course. The safety profile of FIL200 was consistent between CDC achievers and non-achievers, suggesting an acceptable long-term benefit–risk profile.

P1003 Dietary pattern can influence the level of fatigue in patients with Inflammatory Bowel Disease in remission

Abstract Background It is well known that dietary pattern can play an important role in the onset of inflammatory bowel diseases (IBD). In patients with established disease, they can influence the risk of relapse and the disease course. The aim of the study is to explore the impact of dietary patterns on health-related quality of life (HR-QoL), fatigue, anxiety and depression in patients with IBD in corticosteroid-free clinical remission. Methods A total of 96 consecutive patients diagnosed with IBD that were in corticosteroid-free remission for at least 12 weeks were enrolled in this observational, cross-sectional study. During an interview, patients were asked about their dietary patterns. Twelve categories of foods were identified, 6 of them being considered "healthy" (vegetables and fruits &amp;gt;4 portions/day, cereals &amp;gt;3 portions/day, seeds &amp;gt;4 portions/week, cheese &amp;gt;1 portion/day, yoghurt &amp;gt;1 portion/day, fish &amp;gt;2 portions/week) and the other 6 "unhealthy" (fatty red meat &amp;gt;1 portion/day, sweetened beverages &amp;gt;1L/day, cured meat &amp;gt;2 portions/day, fried food &amp;gt;1 portion/day, chips &amp;gt;1 portion/day, mayonnaise &amp;gt;1 portion/day) (see Figure 1). An "unhealthy" dietary pattern was considered if the proportion of "unhealthy" food categories from the total food categories consumed by the patient exceeded 50%. HR-QoL, fatigue, anxiety and depression were evaluated using the following self-administered questionnaires: IBDQ-32, FACIT-Fatigue and HADS. Results Out of the 96 patients included, 60 (62.5%) were men. The median patient age was 38 years (IQR 31.5 – 45.5). Sixty patients (62.5%) were diagnosed with CD, and 36 (37.5%) with UC. Most of the patients were treated with biologics (93.8%). An unhealthy dietary pattern was identified in 58 (60.4%) patients. Patients with an "unhealthy" dietary pattern experienced significantly more fatigue compared to patients with a "healthy" dietary pattern (mean FACIT-F score 40.3 vs. 44.4 points, p=0.02). Even though not statistically significant, patients with "unhealthy" dietary pattern had a trend towards a lower HR-QoL (mean IBDQ score 187.3 vs. 192.8, p=0.24). Anxiety and depression were less frequent among patients with "unhealthy" dietary pattern, but the differences were not statistically significant (anxiety: 24.1% vs. 31.6%, p=0.57; depression: 13.8% vs. 21.2%, p=0.51). Conclusion Patients with an "unhealthy" dietary pattern experience significantly higher levels of fatigue compared to patients that are eating "healthier" food. There is also a trend towards lower HR-QoL in this category of patients.

Effect of inflammatory bowel diseases on household chores.

More than a half of inflammatory bowel disease (IBD) patients experienced a moderate negative effect on their household chores due to their IBD. The negative effect was more common amongst women.

P545 Does gender matter? Gender-related nutritional behaviour, disease activity and quality of life in patients with inflammatory bowel diseases

Abstract Background The latest research clearly indicates that diet plays an important role in the onset and course of inflammatory bowel diseases (IBD). But especially data on gender specific aspects of diet in IBD patients are still lacking even though we know from the general population that gender matters in case of diet. Methods We hypothesised an interaction of gender and diet in IBD patients and that this is linked to disease behaviour. In a subgroup analysis of a previously published prospective trial (Wiestler M. et al., Clinical and Translational Gastroenterology, 2019) 91 IBD patients were stratified into 4 groups (Crohn’s disease - CD [n=50] and ulcerative colitis – UC [n=41], female and male, respectively) to compare nutritional behaviour by sex and diagnosis. We evaluated disease-specific quality of life (IBDQ), physical activity (accelerometery), body composition (bioelectrical impedance analysis (BIA)), as well as clinical (HBI, SCCAI) and biochemical (CRP, faecal calprotectin) parameters of disease activity in comparison to nutritional behaviour (food frequency questionnaire (FFQ)). Results The nutritional behaviour of CD patients showed significant gender-related trends and differences in correlation with disease activity (Spearman correlation analysis). In male CD patients HBI significantly negatively correlated with the amount of fish (p=0.005, r=-0.612) and meat consumed per month (p=0.023, r=-0.519). In female CD patients the amount of fish consumed per month significantly negatively correlated with the IBDQ score (p=0.029, r=-0.438). The nutritional behaviour of UC patients showed significant gender-related trends and differences in correlation with disease activity as well. In female patients SCCAI significantly negatively correlated with the amount of cake, pie/ sweet baked goods (p=&amp;lt;0.001, r=-0.832) and significantly positively correlated with the amount of poultry consumed per month (p=0.006, r=0.715). Furthermore, in female patients the amount of pizza consumed per month significantly positively correlated with the IBDQ score, subscore social (p=0.016, r=0.653). Conclusion In this subgroup analysis of a cross-sectional study, nutritional behaviour of IBD patients showed significant gender-related differences in correlation with disease activity and disease related quality of life. Due to the close correlation between IBD and nutrition and the different nutritional needs according to disease activity, our results illustrate the importance of gender-sensitive collection of a nutritional history as well as the need for gender-sensitive nutritional recommendations in IBD patients to further optimize individual patient care.

OP35 Efficacy and safety outcomes up to ~4 years of treatment with filgotinib 200 mg among patients with Ulcerative Colitis: Results from the SELECTIONLTE study

Abstract Background Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). FIL 200 mg (FIL200) was effective in inducing and maintaining clinical remission vs placebo (PBO) and well tolerated in patients with UC in the randomized, phase 2b/3 SELECTION trial (NCT02914522).1 The efficacy and safety of continued FIL200 therapy are being assessed in the continuing SELECTION long-term extension (LTE) study. Methods The SELECTION programme comprises SELECTION and the associated LTE study (SELECTIONLTE; NCT02914535). In SELECTION, adults with moderately to severely active UC received induction (IND) FIL200, FIL 100 mg (FIL100) or PBO once daily for 11 weeks. Patients in clinical remission or with a Mayo Clinic Score (MCS) response at week 10 (responders) could enter the 47-week Maintenance (MNT) Study. SELECTIONLTE enrolled patients who completed IND and MNT (completers), patients who were not responders at IND week 10 (non-responders), and patients with disease worsening during MNT. This interim analysis assessed the efficacy and safety of open-label FIL200 through LTE week 144 in completers and LTE week 192 in non-responders, respectively, representing a total of 3.9 years of treatment each (completers: 58 + 144 weeks; non-responders 10 + 192 weeks). The cut-off date was 24 February 2022. Continuous measures of partial MCS (pMCS) and proportions of patients achieving the minimal clinically important difference (MCID) in total IBDQ score (≥16-point increase vs baseline) were assessed without imputation (as observed). Safety was assessed by the exposure-adjusted incidence rate per 100 patient-years of exposure (PYE) for treatment-emergent adverse events (TEAEs) and TEAEs of interest. Results This analysis included 148 completers and 372 non-responders (IND FIL100, n=212; IND FIL200, n=160). Among completers, the reductions in mean pMCS in SELECTION over weeks 0–10 were maintained up to LTE week 144 (Figure 1). In non-responders, mean pMCS decreased from LTE baseline to week 192 (Figure 2). High proportions of completers (&amp;gt;90%) and non-responders (&amp;gt;60%) achieved the MCID in IBDQ score; proportions were maintained over time (Table 1). Safety events among all patients treated with open-label FIL200 in the LTE study (total PYE=2055.5) are reported in Table 2. Conclusion: FIL200 was effective in maintaining symptomatic remission and health-related quality of life for up to ~4 years. No new safety signals were observed over ~4 years of treatment, and safety events were comparable with those seen in previous analyses.2 1. Feagan BG et al. Lancet 2021;397:2372–84. 2. Feagan BG et al. J Crohns Colitis 2022;16(Suppl1):i456–7.

P436 Efficacy and safety of intravenous ustekinumab re-induction therapy in Crohn’s disease patients with secondary loss of response to ustekinumab maintenance therapy: Week 16 results from the POWER trial

Abstract Background After successful induction, a subset of patients with Crohn’s disease (CD) experience a secondary loss of response (LoR) to ustekinumab (UST) maintenance therapy. Dose intensification may assist in regaining response. The phase 3b randomised, double-blind, multicentre POWER study evaluated efficacy and safety of a single intravenous (IV) re-induction UST dose vs continued UST subcutaneous (SC) treatment in CD patients with LoR to standard UST every 8 weeks (q8w) maintenance therapy. Methods Adults with moderately–severely active CD who initially responded to UST IV induction therapy per label and subsequently experienced LoR were included. LoR for inclusion was defined as CDAI score of ≥220 and ≤450, in addition to elevated CRP (&amp;gt;3mg/L), fCal (&amp;gt;250mg/kg) or endoscopy performed ≤3 months before W0 with evidence of active CD (≥1 ulcerations in the ileum and/or colon). At baseline (W0), randomised patients received either ~6mg/kg IV UST/SC placebo (IV arm), or IV placebo/SC UST 90mg (SC arm), followed by SC UST 90mg dosing in both groups at W8/16. Clinical and biomarker assessments were made at W0/8/16 and optional ileocolonoscopy at W0/16. Primary endpoint: clinical response (CRes; decrease of ≥100 points from W0/CDAI &amp;lt;150) at W16. Additional outcome measures included clinical, biomarker, endoscopic and quality of life endpoints assessed at W8/16. Results The analysis set comprised 215 patients at W0 (IV, n=108; SC, n=107). At W16, 92.6% and 86.0% completed treatment from IV and SC arms, respectively. In both arms (IV, 58.3%; SC, 57.9%) most patients experienced ≥2 biologic failures before initiating UST (Table 1). At W16, 49.1% in the IV arm and 37.4% in the SC arm achieved CRes (p=0.089). Percentages of patients with normalisation of fCal, normalisation of CRP and/or fCal, endoscopic remission and improvement, and improvement in IBDQ score were greater in the IV vs SC arm (Table 2). At W16, similar proportions of patients had ≥1 adverse event (AE) (IV, 60.2%; SC, 61.7%) and serious AEs (IV, 5.6%; SC, 5.6%). The proportions of patients with infections were similar between arms (IV, 23.1%; SC, 21.5%), with only 1 serious infection in each arm. Conclusion POWER is the first randomised, controlled, double-blind trial to assess the efficacy and safety of UST IV re-induction in patients with LoR during UST maintenance therapy. The CDAI-based primary endpoint at W16 was not met. However, patients in this heavily pre-treated population who received IV re-induction showed clinically meaningful improvements at W16 compared with those receiving SC, particularly for objective endpoints, including inflammatory biomarkers and endoscopic outcomes.

Quality of life in Anemic Patients with Inflammatory Bowel Disease

INTRODUCTION: Anemia is a common complication in inflammatory disease bowel (IBD). Many patients have this comorbidity ignored during clinical follow-up. Nonetheless, studies of anemic patients have a significant relationship between anemia and low quality of life. This study evaluated the quality of life before and after treatment for anemia in mild anemic, IBD patients from the IBD Center of the UFJF University Hospital. OBJECTIVE: The objective of the present study was to investigate the improvement of quality of life after treatment of anemia in IBD patients. METHODS: In this cross-sectional study, 100 patients with CD (Crohn's disease) and 100 with RCUI (ulcerative colitis) were screened for anemia. For evaluation of anemia, complete blood count, ferritin, saturation index transferrin, serum levels of folic acid, serum iron and vitamin B12 was performed. In anemic patients, was evaluated and compared the levels of quality of life before and after anemia treatment. For the evaluation of quality of life, the disease-specific quality of life (QOL) was acessed. RESULTS: The baseline IBDQ score for the cohort was 157 (±37) with a mean increase in the score by 26.4 (P &lt;0.001) at week 8 compared to the baseline. CONCLUSION: Treatment with oral liposomal iron was effective in improving the treatment of anemia in IBD Brazilian outpatients showed statistically significant improvement in quality of life of patients with inactive or mildly active IBD.

Evaluation of health-related quality of life and influencing factors in patients with Crohn disease.

ObjectiveWe assessed levels of anxiety and depression in patients with Crohn disease (CD) to identify predictors of health-related quality of life (HRQOL).MethodsIn this case-control study, we enrolled 50 adult patients with CD and 50 matched, healthy controls. All participants completed self-administered questionnaires including the Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Short Form-36 Health Survey (SF-36), and Short Inflammatory Bowel Disease Questionnaire (IBDQ, patients only). We analyzed the relationship between HRQOL and influencing factors.ResultsMean total scores on the SAS, SDS, and SF-36 were significantly different between patients and controls. IBDQ scores among patients in the active phase of CD were significantly lower than those in remission phase. SF-36 scores were significantly lower in patients with CD compared with healthy controls. SF-36 scores among patients with active CD were significantly lower than scores among those in remission, and SF-36 scores in patients without complications were significantly higher than in those with complications. SF-36 scores in patients with good nutritional status were also significantly higher than scores in malnourished patients with CD.ConclusionsDepression, anxiety, disease activity, complications, and nutritional status were predictive factors of decreased HRQOL in patients with CD.

Impact of COVID-19 Pandemic on the Quality of Life of IBD Patients.

Background and Objectives: The COVID-19 pandemic has had a considerable impact on inflammatory bowel disease (IBD) patients by limiting their access to medical services due to restrictions and the reorganization of the healthcare systems, which affects their quality of life (QoL). We aimed to assess the impact of the COVID-19 pandemic on the QoL of patients with IBD. Materials and Methods: We conducted a descriptive observational study, which included 90 adult patients diagnosed with IBD. The study sample consisted of two subgroups: a retrospective-pre-pandemic group (group A) and a prospective-pandemic group (group B). Group A included 45 IBD patients who were evaluated in 2018. Group B included 45 patients with confirmed diagnosis of IBD, evaluated between June and December 2021—the period of the COVID-19 pandemic (prospective), consecutively recruited. All the patients filled in a QoL assessment questionnaire—IBDQ-32. Subsequently, the two samples were comparatively assessed. Results: The average values of the IBDQ scores were significantly lower in 2021 compared to those recorded in 2018: 145.56 vs. 128.3 (p < 0.05). We also we found significant differences between the subscores: IBDQ1 (p = 0.043), IBDQ2 (p = 0.034), IBDQ3 (p = 0.045), IBDQ4 (p = 0.025). Conclusions: IBDQ scores were significantly lower in 2021 compared to 2018 (p < 0.05), showing that during the COVID-19 pandemic, patients with IBD had a more influenced QoL.

Health-Related Quality of Life in Patients with Inflammatory Bowel Disease in Clinical Remission: What Should We Look For?

Background and Objectives: Inflammatory bowel diseases (IBD) are chronic conditions with an unpredictable evolution that can have a negative impact on patients’ quality of life (QoL). Even though patients in remission have a better QoL compared to patients with active disease, they still have a lower QoL compared to healthy people. The aim of this study is to identify the factors that are associated with a lower QoL in patients with IBD in clinical remission, in a tertiary IBD center in Romania. Materials and Methods: Ninety-seven adult patients with a current diagnosis of IBD for over 3 months who were in clinical remission were enrolled in this study. Pregnant women, patients with ostomy, perianal disease, extraintestinal manifestations or other significant comorbidities were excluded. Out of the 97 patients, 63.9% were men. The median age was 39 years (IQR 29–47), and the median disease duration was 5 years (IQR 2–10). Disease activity was assessed using the SCCAI score for ulcerative colitis and HBI score for Crohn’s disease. Remission was defined for SCCAI score ≤ 1 and HBI score ≤ 4. The health-related quality of life (HR-QoL) was assessed using the IBDQ32 score. FACIT-Fatigue was used to evaluate the level of fatigue. Patients with symptoms of anxiety or depression were identified with the HADS score. Symptoms of anxiety were considered when HADS-A >7 points and symptoms of depression when HADS-D >7 points. Results: Sixty-five patients (67%) were diagnosed with CD and the remaining 32 (33%) with UC. Ninety-three patients (95.9%) were on biological therapy. The mean IBDQ score (total score) was 190.54 points (SD +/− 8.2). The mean FACIT Fatigue score was 42.5 (SD +/− 8.2), with 6.2% of patients suffering from severe fatigue (FACIT Fatigue < 30 points). A total of 33% of patients had symptoms of anxiety and 16.5% of depression. Exposure to more than one biologic therapy (p = 0.02), fatigue (p < 0.001) and symptoms of anxiety (p < 0.001) were associated with a lower HR-QoL in the multivariate analysis. Female patients, patients with Crohn’s disease, patients with anemia and patients with symptoms of depression also had a lower HR-QoL, but this did not reach statistical significance in our study. Conclusions: Exposure to a higher number of biological agents (patients that switched multiple biologics), the presence of fatigue and symptoms of anxiety impair the HR-QoL of patients with IBD in clinical remission. Further studies should assess in a prospective manner whether early identification of these factors with prompt clinical interventions could lead to a better HR-QoL in these patients.

Clinical and Psychological Factors Associated with Addiction and Compensatory Use of Facebook Among Patients with Inflammatory Bowel Disease: A Cross-Sectional Study.

BackgroundInflammatory bowel diseases are chronic conditions characterized by incapacitating symptoms, which can compromise patient’s quality of life and social interaction. As social media use is continuously increasing and Facebook is one of the most accessed social media worldwide, this study aimed to evaluate the use of Facebook and identify clinical and psychological factors associated with addiction and compensatory use among patients.MethodsThis case-control study enrolled 100 outpatients and 100 healthy individuals, who were classified into the patient and control groups, respectively. Facebook use was evaluated using the questionnaire Psycho-Social Aspects of Facebook Use (PSAFU). The IBD Questionnaire and the 36-Item Short-Form Health Survey (SF-36) were used to measure Health-related quality of life. Anxiety and depression were evaluated using the Hospital Anxiety and Depression Scale; self-esteem, using the Rosenberg Self-Esteem scale.ResultsThe patient group included 54 patients with Crohn’s disease and 46 with ulcerative colitis. Facebook use was similar between the patient and control groups in all evaluated aspects (p=0.21). In the patient and the control groups, the compensatory use of Facebook was directly related to the symptoms of depression (patients: R = 0.22; p = 0.03; controls: R = 0.34; p = 0.0006) and inversely related to self-esteem scale (patients: R = −0.27; p = 0.006; controls: R = −0.37; p = 0.0001). Facebook addiction showed an inverse correlation with self-esteem (patients: R = −0.32; p = 0.001; controls: R = −0.24; p = 0.02) and quality of life (patients: IBDQ score, R = −0.30; p = 0.003; controls: SF-36 score, R = −0.29; p = 0.004).ConclusionThe use of Facebook was not different between study groups. Psychological aspects such as depression and low self-esteem were associated with the compensatory use of Facebook in both groups, which may be related to unsatisfactory personal aspects of social interaction.

P491 Efficacy and safety outcomes of long-term treatment with filgotinib 200 mg among patients with Ulcerative Colitis: An interim analysis of SELECTIONLTE

Abstract Background Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor in development as an ulcerative colitis (UC) therapy. In the phase 2b/3 SELECTION trial, FIL 200 mg (FIL200) was well tolerated and effective in inducing and maintaining clinical remission vs placebo (PBO) in patients with UC.1 We assessed the efficacy and safety of continued FIL200 therapy in the SELECTION long-term extension (LTE) study. Methods The SELECTION programme comprised SELECTION (NCT02914522)1 and an ongoing LTE study, SELECTIONLTE (NCT02914535). Adults with moderately to severely active UC received induction (IND) FIL200 or FIL100 or PBO for 11 weeks in SELECTION. Patients in clinical remission or Mayo Clinic Score (MCS) response at week 10 (responders) could enter the 47-week Maintenance (MNT) Study. Patients who completed the SELECTION IND and MNT studies (completers), IND non-responders and patients with disease worsening during MNT could enter SELECTIONLTE. This interim analysis assessed the efficacy of open-label FIL200 among completers and non-responders in SELECTIONLTE up to LTE weeks 48 and 96, respectively. Partial MCS (pMCS) and achievement of the minimal clinically important difference (MCID) in total health-related quality of life (HRQoL) IBDQ score (≥16-point increase vs baseline) were assessed over time. Exposure-adjusted incidence rates per 100 patient-years of exposure (PYE) of treatment-emergent adverse events (TEAEs) and TEAEs of interest were assessed in patients treated with open-label FIL200 in the LTE. Results These analyses included 147 completers and 372 non-responders (IND FIL200, n=160; IND FIL100, n=212). Data were available for 136 completers at LTE week 48 and for 97 IND FIL200 and 139 IND FIL100 non-responders at LTE week 96. Among completers, the mean pMCS reductions observed in SELECTION were maintained up to LTE week 48 (Figure 1). Among IND FIL200 and FIL100 non-responders, mean pMCS decreased from LTE baseline to week 96 (Figure 2). The proportion of patients achieving the MCID in total IBDQ score increased over time among completers (IND week 10, 90.4%; LTE week 48, 96.1%) and IND FIL200 non-responders (LTE week 48, 60.6%; LTE week 96, 66.7%) (Table 1). Safety events among patients treated with open-label FIL200 in the LTE study (total PYE, 970.9) to the date analysed are reported in Table 2. Conclusion FIL200 was effective in maintaining long-term improvements in UC symptoms and HRQoL among patients who completed SELECTION. Among non-responders, initiating open-label FIL200 in the LTE study led to improvements in UC symptoms and HRQoL that were sustained over time. Safety events were as expected in the LTE study based on initial data. Reference 1. Feagan BF et al. Lancet 2021;397:2372–84.

P521 Correlation of histological assessment of mucosal healing with long-term clinical and patient-reported outcomes in patients with moderately to severely active ulcerative colitis treated with upadacitinib: results from the Phase 3 U-ACHIEVE maintenance trial

Abstract Background Establishing mucosal healing (MH) as a treatment goal for ulcerative colitis (UC) requires evidence of improvement in both endoscopic and histologic assessments of the intestinal mucosa and long-term sequalae. Currently, guidelines on how to interpret the histological index, Geboes Score (GS), with respect to clinically meaningful outcomes, are lacking. We examined the relationship between GS and long-term clinical and patient-reported outcomes in patients with active UC treated with upadacitinib. Methods GS and long-term clinical and patient-reported outcomes from the U-ACHIEVE maintenance trial (NCT02819635) were analysed. Patients were assigned to the following GS intervals [0, 2.0), [2.0, 3.1], and (3.1, 5.4]. The intervals were selected to assess patients who achieved the histology threshold for MH (&amp;lt;2.0) and those who achieved the histologic and endoscopic mucosal improvement threshold without MH [2.0, 3.1]. A predictive analysis (n=497) assessed the relationship between outcomes at Week 52 and GS intervals at end of induction (Week 8/16), and a cross-sectional analysis (n=211) examined outcomes at Week 52 and GS intervals at end of maintenance (Week 52). Odds ratios (ORs) with 95% confidence intervals (CIs) were derived from logistic regression adjusting for baseline characteristics. Results Adjusted ORs for long-term outcomes and GS intervals at Week 8/16 are provided in the Table 1. Patients with GS &amp;lt;2.0 at end of induction had a significantly higher likelihood of achieving clinical remission per adapted Mayo score (OR=1.8, p&amp;lt;0.030) and endoscopic improvement (OR=1.8, p&amp;lt;0.015) at Week 52 than patients with GS &amp;gt;3.1. Results were directionally similar, but not statistically significant, for all other outcomes. No significant differences were seen in the likelihood of achieving any outcome at Week 52 among patients with GS between 2.0 and 3.1 vs those with GS &amp;gt;3.1. Patients with GS &amp;lt;2.0 at Week 52 had a significantly greater likelihood of achieving all clinical endpoints and clinically meaningful improvements in UC-SQ, IBDQ, SF-36 PCS, and EQ-5D index scores at Week 52 compared to patients with GS &amp;gt;3.1 (Table 2). In patients with GS between 2.0 and 3.1 vs GS &amp;gt;3.1, results were numerically smaller than for patients with GS &amp;lt;2.0, and not significant for absence of rectal bleeding, low faecal calprotectin levels, and all patient-reported outcomes. Conclusion Evidence from the U-ACHIEVE maintenance trial of upadacitinib demonstrates that histological assessment of MH by GS at end of induction or maintenance is associated with long-term benefits, with GS &amp;lt;2.0 representing a relevant threshold for desirable clinical and patient-reported outcomes after one year of maintenance therapy.

P120 First year remission rates among patients with newly diagnosed Crohn’s disease: data from a real-world prospective inception cohort

Abstract Background There are sparse data regarding the effectiveness of novel treatment strategies for newly diagnosed patients with Crohn’s disease (CD). Data from clinical trials demonstrate 30–40% remission rates after 1-year. We aim to assess remission rates among newly diagnosed patients with CD in a referral center. Methods A prospective observational cohort study of patients with newly diagnosed CD between 03/2018- 01/2021. Patients were scheduled for semi-annual visits for assessment, data collection, and education by an IBD-oriented gastroenterologist who determined a treatment plan, IBD nurse, and dietitian. Disease activity was determined by Crohn’s disease activity index (CDAI). Clinical remission (CR) at 1-year-period (9–18 months) was defined as: CDAI &amp;lt; 150, no active perianal disease, and steroid-free&amp;gt; 3 months. Biochemical remission: C-reactive protein (CRP)&amp;lt;1mg/dl, fecal calprotectin (FC)&amp;lt;150 ug/g and normal albumin levels. Endoscopic remission: SES-CD&amp;lt;3. Deep remission: composite of clinical, biochemical, and endoscopic remission. Predictors for clinical remission were assessed by multivariable logistic regression. Results Out of 110 enrollees, 77 completed 1-year period: 50.6% female, median age 27 years (22–38), median BMI 22 kg/m2 (20–25), 16.9% smokers. At diagnosis 72.7% had an inflammatory phenotype (B1), and 26% had complex perianal disease, 55.8% had moderate-severe CD (CDAI&amp;gt;220). During the first year after diagnosis 59.7% were treated with a biologic (58.5% anti-TNF, 1.3% ustekinumab, 3.9%&amp;gt;1 biologic), diagnosis-biologic interval 4.3 months (IQR:2.6–7.3), and 9.1% required surgery. At 1-year-period 63.6% achieved CR (comparable CR rates in patients recruited with mild-moderate vs moderate-severe CD:61.8% vs 65.1%, p= 0.814). Biochemical, endoscopic and deep remission rates: 51.9% (40/77), 44.4% (24/54), and 25.9% (14/54), respectively. Significant decrease in clinical and biochemical activity during follow up: median CDAI 233 (IQR:143–286) to 83 (IQR:29–150); median CRP 1.8 mg/dl (IQR:0.4–4.1) to 0.2 (IQR:0.1–1); median FC 714 ug/g (IQR:128–1538) to 114 (IQR:18–355); all p&amp;lt;0.001. Paired endoscopic data, available for 54 patients, demonstrated decrease in median SES-CD from 8 (IQR:5–11) to 3 (IQR:0–5), p&amp;lt;0.001. Short IBDQ score increased from a median of 43 (IQR:36–55) to 56 (IQR:42–61). B1/P0 phenotype and lower BMI at diagnosis were associated with higher probability to achieve CR (OR 3.37, 95% CI, 1.08–10.46; p=0.036, and 1.2, 95% CI, 1.37-1.05; p=0.06, respectively). Conclusion In a cohort of patients with newly diagnosed CD treated by a multidisciplinary team, there were favorable 1-year outcomes; specifically, CR demonstrated in &amp;gt;60%.