Inflammatory Bowel Disease Disability Index Research Articles

Multi-dimensional patient-reported outcomes and quality of life at diagnosis of IBD: A population-based inception cohort study

Background and aimsPatient-reported outcomes (PROs) are pivotal in assessing treatment efficacy and estimating the burden of inflammatory bowel diseases (IBD). We investigated PROs at the time of IBD diagnosis. MethodsThe Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD-Disability Index (IBD-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and disease activity-related PROs were assessed in the Copenhagen IBD Inception Cohort, a prospective, population-based cohort of patients newly diagnosed with IBD between May 2021 and May 2023. ResultsA total of 203 UC and 116 CD patients were recruited. At diagnosis, 160 (78.8%) and 99 (85.3%) patients with UC and CD, respectively, reported moderate-to-severe impairment in at least one PRO (p=0.18), with 89 (43.8%) and 74 (63.8%), respectively, reporting moderate-to-severe impairment in at least two PROs (p<0.01). Being female, the disease extent of UC, and extraintestinal manifestations were associated with impaired PROs. There were no differences found according to CD phenotype. FACIT-F, IBD-DI, and SIBDQ scores showed weak, but significant, correlations with the Mayo Endoscopic Score in UC, and the FACIT-F score with C-reactive protein (CRP). In CD, SIBDQ, IBD-DI, and FACIT-F correlated moderately with CRP and fecal calprotectin, but not with the endoscopic severity of CD. None of the PROs correlated with iron, ferritin, or vitamin D levels. Among the most prevalent symptoms reported were fatigue, abdominal pain, urgency, and passing of blood in both CD and UC. ConclusionWe found a substantial patient-reported disease burden in newly diagnosed IBD, underscoring the importance of vigilant PRO monitoring in clinical practice. FundingThis study was funded by an unrestricted grant from the Novo Nordisk Fonden.

Introducing the Arabic inflammatory bowel disease disk as a tool for assessing disability in patients with inflammatory bowel disease in Jordan

Background and study aimInflammatory bowel diseases (IBD) are chronic relapsing-remitting disorders of the gastrointestinal tract. IBD causes significant impairment in the patient’s quality of life that should be assessed and monitored in a flexible and easy way. The IBD-Disability Index (IBD-DI) is the only validated tool to assess disability in IBD patients, but it is difficult to use in clinical practice. The IBD Disk is a new shortened, self-administering version of the IBD-DI that allows quick assessment of IBD patients and tracks changes in disease burden over time. However, the IBD Disk has not been used yet in clinical practice in Jordan. The aim of the study was to translate the IBD Disk to Arabic language and introduce it in clinical practice in Jordan. Patients and methodsAfter translating the original IBD Disk to Arabic language, IBD patients referred to outpatient clinic or admitted to the medical department at the new Al-Hussein hospital, Al-Salt, Jordan, from September 2021 until March 2022, filled the translated IBD Disk. ResultsA total of 50 IBD patients (52 % males) were included in the study and filled the IBD Disk. The IBD Disk was easy to complete by the patients. Energy, regulating defecation, and emotions were the most disabling domains for relapsing patients. Polygonal shape area of the mean for IBD Disk scores decreased during remission. Education & work and energy had the strongest correlation at relapse. ConclusionThe IBD Disk is a reliable visual representation of IBD disability. In this study, a translated version of IBD Disk to Arabic language was introduced for the first time in clinical practice in Jordan. The reduction in the polygonal shape area of the scores’ mean represents decreased disease burden.

Changes Over Time in the Lémann Index and the Inflammatory Bowel Disease Disability Index in a Prospective Cohort of Patients With Crohn's Disease.

Crohn's disease (CD) is a progressive, destructive, and disabling disorder. Our study aimed to assess changes over time in the Lémann index (LI) and the Inflammatory Bowel Disease Disability Index (IBD-DI) in a cohort of CD patients. This was a single-center prospective cohort study of 130 consecutive CD patients with a follow-up of at least 4 years. The LI 1 and the IBD-DI 1 questionnaires were assessed in 2016 and again between September 2020 and October 2021 (LI 2 and IBD-DI 2). Of the 130 patients with assessment of both LI 1 and IBD-DI 1, 61 had calculation of the LI 2 and 98 patients answered the IBD-DI 2 questionnaire, with a median time between the 2 evaluations of 4.2 years. The LI increased for 16 (26%), decreased for 26 (43%), and remained unchanged for 19 (31%) patients. The median LI did not change over time (9.6 vs 9.3; P = .14). Clinical disease activity was significantly associated with bowel damage progression. A high initial LI (>7.9) was not associated with CD progression (surgery, drug dose escalation, or change of biologic). The IBD-DI decreased for 59 (60.2%), increased for 37 (37.8%), and remained unchanged for 2 (2%) patients. The median IBD-DI decreased significantly over time (23.2 vs 21.4; P = .006). There was no correlation between the 2 indexes. This is the first prospective cohort study assessing changes over time in both the LI and the IBD-DI in CD patients. After 4 years, the LI appeared to be stable and the IBD-DI decreased, with no correlation between the 2 indexes.

HAND GRIP STRENGTH IS ASSOCIATED WITH CLINICAL SYMPTOM BURDEN IN CROHN'S DISEASE

Abstract INTRODUCTION Inflammatory bowel disease (IBD) is a chronic inflammatory condition that may result in malnutrition and alteration of body composition, such as the development of sarcopenia. Sarcopenia is a known component of frailty, which is a driver of poor health outcomes and a significant independent predictor of mortality in patients with IBD. The purpose of this study was to determine whether grip strength, as a predictor of sarcopenia and frailty, is associated with clinical symptoms, endoscopic disease activity and disease-related disability in patients with IBD. METHODS This is a prospective cohort study performed at a single tertiary care center. Outpatient adults aged 18 to 89-years-old with a diagnosis of ulcerative colitis (UC) or Crohn’s disease (CD), were consented and enrolled at the time of an outpatient colonoscopy. Study participants were asked to complete two paper surveys addressing clinical symptoms and IBD Disability Index. Grip strength measurements were obtained using a Jamar dynamometer and adjusted for age and sex by Z-score calculation. RESULTS There was a total of 74 patients, with a mean age of 47.06 years, 51.4% male and 48.6% female with a diagnosis of either UC (38%) or CD (62%). The mean disease duration was 15.7 years (0.5-50.7). Mean hand grip Z-score amongst all patients was lower in patients not in clinical remission compared to those in clinical remission (–0.160 vs 0.480, p = 0.025), though in subgroup analysis based on diagnosis, statical significance only maintained in the CD, but not the UC group (-0.230 vs 0.610, p=0.044; 0.020 vs 0.340, p=0.544 respectively). Mean hand grip Z-score was not associated with IBD Disability Index (–0.070 vs 0.250, p= 0.669) or endoscopic disease activity (UC 0.210 vs 0.070, p=0.513; CD –0.108 vs 0.274, p=0.638). CONCLUSION Low hand grip strength is associated with clinical disease activity in patients with CD but not UC. Our study does not suggest hand grip strength to be associated with IBD-related disability or endoscopic disease activity in either patients with UC or CD. Data on clinical outcomes at 6-months will be collected. DISCUSSION From the findings in our study, hand grip measurements alone may not be the best predictor of disease activity or related disability. There is a lack of validated diagnostic criteria for sarcopenia and frailty in the IBD population and additional diagnostic modalities may be required. While our study suggests that hand grip may be correlated with clinical disease activity in patients with CD, additional studies with a large population size and wider representation of disease severity, such as including hospitalized IBD populations, are needed to further validate these findings.

DOP05 Bowel damage and its correlation with the disability index in patients with recently diagnosed Crohn´s Disease

Abstract Background Crohn’s disease (CD) progression can lead to bowel damage (BD) and disability. However, the longitudinal characterization of BD and disability in early CD patients remains limited. Methods The Crohn´s Disease Cohort (CROCO) is a multicentre, European cohort study of newly diagnosed CD patients (&amp;lt;12 months following diagnosis) intended to prospectively characterize BD progression and disability. At one year following inclusion (Y1), BD progression was evaluated using the Lémann Index (LI). Magnetic resonance enterography was completed by all patients, with additional endoscopy and/or pelvic MRI based on disease location. Absence of BD was defined as a LI=0, and any presence of bowel damage was indicated by LI&amp;gt;0. Disability was assessed using the validated IBD-disability index (IBD-DI) encompassing various domains. We report the LI at Y1 and its association with significant disease features and with the IBD-DI. Results Among the 261 included patients, 135 have completed the Y1 visit, with 100 having their LI calculated [57% male, median age at diagnosis of 36 years old (IQR 26-48)]. Most patients (90%) had ileal or ileocolonic involvement, 68% had inflammatory phenotype, and 11% had perianal disease. At inclusion, 7% of patients had undergone surgery (5 intestinal and 2 perianal), and 53% had initiated biological therapy within the first year of disease, primarily anti-TNF in mono or combination therapy. Of those with stricturing (B2) or penetrating (B3) behaviour, 77% and 79%, respectively, were on anti-TNF therapy. Overall, 61% of the patients exhibited some degree of BD (LI&amp;gt;0), yet the median LI at Y1 was low [0.6 (IQR 0-2)]. Univariate analysis revealed an association between the presence of any bowel damage at Y1 and disease behaviour at inclusion (B2 OR 3.33, 95%CI 0.84-13.18 and B3 OR 8.5, 95%CI 1.82, 39.66; p&amp;lt;0.01). Additionally, there was a significant association with anti-TNF therapy (OR 2.88, 95%CI 1.24-6.66, p=0.012). In a multivariate logistic model, only older age at diagnosis appeared protective against any BD (Table 1). Among those evaluated for the LI, 84 completed the IBD-DI at Y1. The median IBD-DI was 17.3 (IQR 10.7-32.6) and 30% experienced moderate-to-severe disability (IBD-DI&amp;gt;35). No association was observed between LI and IBD-DI at Y1 (OR 1.09, 95%CI 0.39-3.04, p=0.86) and there were no differences in the median LI across disability categories (p=0.67) (Figure 1). Conclusion In a cohort of newly diagnosed CD patients, one-third exhibited no bowel damage as per the LI evaluation. For those presenting any degree of damage, the global LI remained low. No association was found with disability assessed by the IBD-DI. These data add to the growing concept that early disease represents a window of opportunity.

P766 No difference in progression of disability 2 years after stopping infliximab or immunosuppressant vs. continuing combination therapy in patients with CD in sustained steroid-free remission: a subanalysis of SPARE

Abstract Background In the SPARE trial, the discontinuation of infliximab (IFX) in patients with Crohn’s disease (CD) in sustained remission under combination therapy (IFX and immunosuppressant therapy), was associated with a significantly higher relapse rate than when continuing combination therapy or discontinuing immunosuppressant therapy. However, a high proportion of patients rapidly recover remission when resuming treatment. The impact of this treatment strategy on functional disability, a major endpoint in assessing CD progression, has been poorly studied. We aimed to compare the evolution of the IBD-disability index (IBD-DI) in patients continuing combination therapy, discontinuing IFX or immunosuppressant therapy. Methods The study of the evolution of the IBD-DI in the 3 groups (combination, IFX withdrawal, immunosuppressant withdrawal), between baseline and the end of study (2 years), was a pre-defined secondary endpoint of the trial. Changes in scores (between baseline and the end of study) were compared using Wilcoxon tests between the arms “combination group” versus “IFX withdrawal group” and between “immunosuppressant withdrawal group” versus “IFX withdrawal group”. Results IBD-DI was available at baseline and at the end of study for 153 patients out of the 211 randomised in the SPARE trial between November 2015 and April 2019 (46 in the combination group, 55 in the IFX withdrawal group, and 52 in the immunosuppressant withdrawal group) and those were included in the analysis. Table 1 summarizes baseline characteristics of these patients. 30 patients had a relapse (6 [13%] of 46 in the combination group, 19 [34.5%] of 55 in the IFX withdrawal group, 5 [9.6%] of 52 in the immunosuppressant withdrawal group). Of 23 patients who had a relapse and were retreated or optimised according to protocol, remission was achieved in 21 patients (1 of 2 in the combination group, 18 of 19 in the IFX withdrawal group, and 2 of 2 in the immunosuppressant withdrawal group). The median IBD-DI at baseline was 12.5 (IQR, 5.36-21.43), without significant differences between the 3 groups. Figure 1 shows changes in the IBD-DI between baseline and the end of study in the 3 groups. There was no significant difference in terms of changes in IBD-DI between the arms "combination group" and "IFX withdrawal group" (p=0.56), or between the arms "immunosuppressant withdrawal group” and "IFX withdrawal group" (p=0.29). Conclusion In patients with CD in sustained steroid-free remission under combination therapy with IFX and immunosuppressant therapy, there was no difference in progression of disability over 2 years between those who continued combination therapy, stopped IFX or stopped the immunosuppressant with the possibility of recycling the medication after a relapse.

P220 IBD-Disk: italian translation and validation in a population-based cohort

Abstract Background As an objective endpoint in IBD Disease-Modification Trials, measures of disability and health-related quality of life have been proposed. IBD-DISK is an easy-to-use, and self-administered analogic visual tool designed for assessing disability. However, successful dissemination of this tool will require a cultural adaptation and translation process. To date, the IBD-Disk has not been validated in Italian clinical practice. Hence, we aimed to validate the IBD-Disk in an Italian population-based cohort according to the COSMIN recommendations. Methods The IBD-Disk italian translation and validation study was a cross-sectional multicentre study conducted in 8 Italian IBD referral centres. After forward-backward translation into Italian, patients were consecutively recruited from February 2023 to October 2023. Patients completed the following questionnaires: IBD-Disk (at baseline, T0, and after seven days, T1) and IBD-Disability Index (IBD-DI) for disability, IBDQ-32, and SF-36 for quality of life. Validation included assessment of validity, reproducibility, internal consistency. We further investigated the correlation between IBD-Disk and IBD activity and clinical factors associated with IBD-Disk. Results At baseline, 513 patients (237,46.2% CD; 276,53.8% UC) completed the IBD-Disk[Table.1]. Internal consistency was excellent with a Cronbach’s α of 0.93. The intraclass correlation coefficient (ICC) was 0.94 for test-retest (T0 and T1) (p&amp;lt; 0.001). To evaluate construct validity, the IBD-Disk was compared with the IBD-DI, revealing a significant positive correlation (r = 0.70; p &amp;lt; 0.001). Furthermore, it exhibited a positive correlation with both IBDQ-32(r=0.82, p&amp;lt; 0.001) and SF-36(r=0.093, p= 0.035). The overall IBD-Disk median score was 32(12-52), with 219(42.7%) reporting moderate-to-severe disability (IBD-DISK ≥ 40). The IBD-Disk score was significantly higher in patients with active CD disease based on HBI ≥ 5 compared to patients with inactive disease(p &amp;lt; 0.001). Similarly, for UC, patients with active disease, measured with a partial Mayo score ≥2, showed a higher IBD-DISK score than those in clinical remission[Fig.1]. Additionally, moderate-to-severe disability significantly increased in female [OR =2.83; 95% CI(1,97-4,07)] and in patients with active extraintestinal manifestations [OR = 1,71; 95%CI(1,23-2,81) p=0.04]. Conclusion This study validated the IBD-Disk in a large cohort of Italian IBD patients, demonstrating that it is a valid, reliable and responsive tool for quantifying disability. This validation enables the broad implementation of IBD-DISK across Italy, facilitating its integration into the daily clinical management of IBD patients.

Inflammatory Bowel Disease Disability Index is a valid and reliable measure of disability in an English-speaking hospital practice and predicts long-term requirement for treatment escalation

ObjectiveThe Inflammatory Bowel Disease Disability Index (IBD-DI) was developed according to WHO standards and has been validated in population-based cohorts. However, there are limited data on its relationship to various...

The Inflammatory Bowel Disease-Disk Tool for Assessing Disability in Inflammatory Bowel Disease Patients: Validation of the Greek Version.

The Inflammatory Bowel Disease-Disk (IBD-Disk) is a physician-administered tool that evaluates the functional status of patients with Inflammatory Bowel Disease (IBD). The aim of our study was to validate the content of the IBD-Disk in a Greek cohort of IBD patients. Two questionnaires [the IBD Disk and the IBD-Disability Index (IBD-DI)] were translated into Greek and administered to IBD patients at baseline visit, after 4 weeks and 6 months. Validation of the IBD Disk included measuring of concurrent validity, reproducibility, and internal consistency. A total of 300 patients were included at baseline and 269 at follow-up. There was a good correlation between the total scores of the IBD-Disk and IBD-DI at baseline (Pearson correlation 0.87, p < 0.001). Reproducibility of the total IBD-Disk score was very good [intra-class correlation coefficient (ICC), 95% confidence interval (CI) 0.89 (0.86-0.91)]. Cronbach's coefficient alpha for all items achieved 0.90 (95%CI 0.88-0.92), demonstrating a very good homogeneity of the IBD-Disk items. Female gender and extraintestinal manifestations were significantly associated with a higher IBD-Disk total score. The Greek version of the IBD-Disk proved to be a reliable and valid tool in detecting and assessing IBD-related disability in a Greek cohort of IBD patients.

P377 Changes over time in the Lémann Index and the Inflammatory Bowel Disease-Disability Index in patients with Crohn’s disease

Abstract Background Crohn’s disease (CD) is a progressive, transmural disorder that leads to intestinal damage (fistula, abscesses, stenosis) and worsens the patient’s quality of life. The Lémann Index (LI, assessing cumulative bowel damage in CD) and the Inflammatory Bowel Disease-Disability Index (IBD-DI) have recently been validated. The objective of the present study was to assess changes over time in the LI and the IBD-DI and to identify factors associated with these changes. Methods In a cohort of 130 patients with CD being followed up prospectively at Lille University Hospital (Lille, France), the LI and the IBD-DI were evaluated first in 2016 (assessment #1, results previously published) and then again between September 2020 and October 2021 (assessment #2). Factors associated with the differences in the LI and IBD-DI were probed with a Mann-Whitney test or a bivariate analysis of variance. Survival curves for the progression of CD (surgery, drug-related events) were plotted according to the Kaplan-Meier method. Spearman’s coefficient was calculated as a guide to the strength of the correlation between the LI and the IBD-DI. Results 101 patients were included. More than half of the included patients had a long-standing disease (&amp;gt;15 years), 35% had ano-perineal involvement and 56% had a history of resection. Clinical activity was reported in 40% of patients at assessment#2. The median time interval between the two evaluations was 4.2 years. The LI (assessed in 61 patients) did not change significantly (median: 9.6 at #1 vs. 9.3 at #2; p = 0.14). The LI increased for 16 patients (26%), decreased for 26 (43%) and was stable for 19 (31%). Persistent clinical activity was the only factor significantly associated with worsening of the LI (p=0.01). A LI &amp;gt;7.9 was not associated with CD progression. The IBD-DI score (assessed in 98 patients), decreased significantly over time (median: 23.2 at #1 vs. 21.4 at #2; p = 0.006). The IBD-DI decreased for 59 patients (60.2%), increased for 37 (37.8%) and was stable for two (2%). Factors associated with improvement in the IBD-DI were younger age at diagnosis, a longer time interval before initiation of the first biologic, drug optimization, and exposure to combination therapy. There was no correlation between LI and the IBD-DI (r 0.125, p=0.27). Conclusion This is the first cohort study assessing changes over time in both the LI and the IBD-DI in CD patients. After more than 4 years of follow-up, the LI appeared to be stable and the IBD-DI decreased, without correlation between the indices. Persistent clinical activity was associated with worsening LI reinforcing the interest in monitoring these patients.

P542 Short term efficacy, safety and thromboembolic risk of tofacitinib in moderate to severe Ulcerative Colitis

Abstract Background Tofacitinib is a small oral molecule approved to treat moderate to severe ulcerative colitis (UC), which effectiveness and safety is still poorly known in UC patients. Recent concerns have been raised regarding its administration at high dosage in UC patients because of a likely higher incidence of drug-related thromboembolic events. Methods The aim of this study was to evaluate short-term effectiveness and safety of tofacitinib. As secondary aim, we analyzed the state of blood coagulation at baseline in order to evaluate whether it could predict thromboembolic events in relation to demographic, clinical and biochemical characteristics. A multicenter, retrospective, observational study was conducted, including patients from March 2021 to October 2022; a prospective single-centre sub-study concerning the thromboembolic risk was performed. At baseline, demographic, clinical, biochemical and endoscopic data, and previous therapies were recorded; quality of life was evaluated through IBD-Disability Index (IBD-DI) and Pittsburgh Sleep Quality Index (PSQI). In a subgroup of patients, a thrombophilic screening and a Rotational Thromboelastometry (ROTEM) were performed at baseline. Patients were reassessed after 8 weeks, 6 months and 1 year, evaluating for each timepoint clinical and biochemical characteristics, IBD-DI and PSQI, and reporting adverse events (AEs) and discontinuation of therapy. The following clinical outcomes were considered: benefit, steroid-free remission and response. Results 44 adult patients were enrolled. The overall clinical benefit was 54.2%, summing up 45.8% of subjects in steroid-free clinical remission and 8.3% with clinical response; significant short-term improvement of IBD-DI and PSQI scores (p=0.000 in both cases after 6 months of therapy) was observed. Patients previously treated with less than two different biological therapies had major rates of clinical benefit at 6 months (p=0.045). Ten AEs, including one venous thrombosis, were reported; global therapy failure rate was 31.4%. In the subgroup with additional data on coagulation (17 patients), we did not observe significant alterations of coagulating factors or inhibitors, nor of ROTEM parameters, although some coagulation features were significantly increased in obese patients (FII, p=0.030; FIX, p=0.000; FX, p=0.000; fibrinogen blood levels, p=0.030) and subjects older than 40 years old (FVIII, p=0.020). We did not find significant correlation with gender, smoking habit, concomitant steroid therapy, CRP, fecal calprotectin. Conclusion Our data confirm literature ones on effectiveness and safety of tofacitinib in UC patients, while the risk of thrombosis needs to be better evaluated in larger longitudinal studies.

Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial

BackgroundTransition in care is defined as the “purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers.” Currently, there are no Level 1 evidence-based interventions to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the clinical and implementation effectiveness of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada.MethodsThis multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0–17.5 years. The intervention program consists of 4 core components: (1) individualized assessment, (2) transition navigator, (3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and (4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness and success, anxiety and depression scales, and health service utilization rates. Additionally, we will measure implementation outcomes and related barriers and facilitators for the intervention program.DiscussionThe type 1 hybrid effectiveness-implementation design will allow for the development of a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will allow centralization of interventions and funding in order to minimize the impact on local clinical practice or hospital resources. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.Trial registrationNCT05221281. Registry: ClinicalTrials.gov. Date of registration: February 2, 2022. https://clinicaltrials.gov/ct2/show/NCT05221281.

P656 The impact of periodontitis on IBD disease activity

Abstract Background Inflammatory bowel disease (IBD) and periodontitis are chronic, progressive, inflammatory diseases with similarities in their respective pathogenesis, which involve a complex interplay between a dysbiotic microbiota and a dysregulated immune-inflammatory response. Periodontitis has been associated with an adverse impact on other inflammatory diseases and the general health. Whether presence of periodontitis is associated with IBD disease activity is uncertain. Methods A questionnaire-based survey was conducted in Denmark. A total of 1,093 patients with IBD, i.e., 527 patients with Crohn’s disease (CD) and 566 patients with Ulcerative colitis (UC), answered the questionnaire. The survey included questions on social demographics, oral health, as well as IBD-related characteristics. Oral health was assessed by the number of teeth, the state of teeth and gums, and the Periodontal Screening Score (PESS) which is a validated instrument to screen for severe periodontitis. Disease activity in patients with UC and CD was assessed by the Simple Clinical Colitis Index (SCCAI) and the Harvey &amp; Bradshaw’s Activity Index (HBI), respectively. Disease related disability was assessed by the Inflammatory bowel disease disability index (IBD-DI). Univariate and multivariate statistical analyses were performed to assess each variable. Results Patients with CD reported significantly fewer remaining teeth (p=0.004) and poorer state of teeth and gums (p=0.001) in comparison to patients with UC. Irrespective of IBD disease subtype, patients with a reduced number of teeth scored significantly higher on the IBD disability index (p=0.001) and reported an increased disease activity in the last 12 months (p=0.001). Patients with self-reported severe periodontitis scored significantly higher on the IBD disability index (p=0.041) and reported an increased disease activity in the last 12 months (p=0.001). For patients with UC, self-reported severe periodontitis was associated with a higher SCCAI score (p=0.031). Likewise, patients with CD who had a reduced number of teeth scored significantly higher on the HBI (p=0.017). Conclusion Periodontitis was significantly associated with increased IBD disease activity as well as increased IBD disease related disability. CD patients had significantly poorer oral health compared with UC patients. Our results highlight a need for an increased focus on oral health in patients with IBD.

P649 The impact of COVID-19 on quality of life among patients with inflammatory bowel diseases – A Danish prospective population-based cohort study

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic raised concerns among patients with ulcerative colitis (UC) and Crohn’s disease (CD) fearing an increased susceptibility to infection and increased risk of poor outcomes. Furthermore, the impact of COVID-19 on subsequent health-related quality of life (HRQoL) has so far not been described. We aimed to evaluate the HRQoL in relation to the severity of COVID-19 in a cohort of survivors.MethodsWe conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. HRQoL was assessed using several validated questionnaires, including the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire, EuroQol Visual Analogue Scale (EQ-VAS), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD Disability Index (IBD-DI), and IBD Fatigue Score.ResultsHRQoL after COVID-19 was assessed among 137/319 (42.9%) patients with UC of whom 125 (91.2%) and 12 (8.8%) patients experienced mild and adverse COVID-19, respectively. Furthermore, HRQoL was assessed among 85/197 (43.1%) patients with CD of whom 74 (87.1%) and 11 (12.9%) patients experienced mild and adverse COVID-19, respectively. HRQoL was assessed after a median of 5.1 months (IQR 4.5–7.9) after infection. Baseline characteristics are presented according to the availability of HRQoL data in Table 1. No difference was observed in terms of EQ-5D-5L among patients with UC and CD or patients with mild, adverse, or severe COVID-19 (Table 2). Accordingly, the SIBDQ scores were similar among patients with mild, adverse or severe COVID-19 and UC (mild: median 59 (IQR 50–65), adverse: 62 (54–65), severe: 62 (54–65), p=0.89) or CD (mild: 57 (46–65), 58 (49–64), 58 (49–64), p=0.91) as well, and no difference was observed in the subscores (Table 2). In line with these results, the IBD Disability Index (UC: median 10 (IQR 6–16), CD: 13 (6–20), p=0.16) were not associated with the severity of COVID-19 (Table 3). Finally, CD patients with adverse COVID-19 experienced more fatigue than patients with mild COVID-19 (26 (IQR 25–35) vs. 41 (IQR 29–46), p=0.03). Conclusion This Danish population-based study found no durable impact of COVID-19 on health-related quality of life among patients with inflammatory bowel disease providing further assurance for the clinical guidelines for IBD care during the pandemic.

Validation of the IBD-Disk in a Portuguese cohort.

The aim of this study was to validate the IBD-Disk in a Portuguese cohort according to the COnsensus-based Standards for the selection of the health Measurement INstruments (COSMIN) recommendations. After translation of the original IBD-Disk to Portuguese, a group of IBD patients was invited to complete the IBD-Disk at baseline (T0), after 1-4 weeks (T1) and after more than 3 months (T2), from July 2020 to February 2021. At T0 and T2, the patients also completed the IBD Disability Index. We evaluated reliability (internal consistency, test-retest, interrater reliability and measurement error), construct validity, responsiveness, interpretability of IBD-Disk, sociodemographic and clinical factors associated with IBD-Disk. At T0, 154 patients (107 - Crohn's disease; 46 - ulcerative colitis) completed the IBD-Disk; 1 - IBD-unclassified). At T1 and T2, 64 and 114 patients repeated the questionnaire, respectively. Factor analysis confirmed the unidimensionality of the scale and reduced the final version to 10 items. Internal consistency was excellent with a Cronbach's α of 0.916. The intraclass correlation coefficient was 0.95 for test-retest (T0 and T1). To evaluate construct validity, the IBD-Disk was compared with the IBD Disability Index and Manitoba IBD Index with a significative positive correlation (r = 0.850 and r = 0.459, respectively; P < 0.001 for both). IBD-Disk scores ranged from 0 to 93 with a mean of 38.18 ± 25.39. Female sex, professional inactivity, longer IBD duration and clinical activity were associated with significantly higher IBD-Disk scores. The Portuguese version of IBD-Disk is a reliable and valid tool to assess disability in Portuguese IBD patients.

Inflammatory bowel disease negatively impacts household and family life

BackgroundInflammatory bowel disease (IBD) has a major impact on different aspects of life of patients with IBD, but functioning in the home environment is under-reported in literature. The aim of...

IBD Disability Index Is Associated With Both Direct and Indirect Costs of Inflammatory Bowel Disease.

We aimed to determine both direct (medical) and indirect (lost wages) costs of IBD and the association between the degree of IBD-related disability and extent of IBD-related costs. Persons age 18-65 from the population-based University of Manitoba IBD Research Registry completed a survey including the IBD Disability Index (IBDDI) and questions related to employment, missed work (absenteeism), and reduced productivity at work (presenteeism). Administrative health data including surgeries, hospitalizations, physician claims, and prescriptions were linked to the survey and assessed. To calculate annual wage loss, number of days of missed work was multiplied by the average wage in Manitoba for the given occupation per Statistics Canada. Costs were adjusted to 2016-17 Canadian dollars. Using descriptive and regression analysis, we explored the association between IBDDI and annual direct and indirect costs associated with IBD. Average annual medical costs rose from $1918 among those with IBDDI 0-4 to $9,993 among those with IBDDI 80-86. Average annual cost of lost work rose from $0 among those with IBDDI 0-4 to $30,101 among those with IBDDI 80-86. Using linear regression, each additional unit of IBDDI was associated with an increase of $77 in annual medical cost (95% CI, $52-102; P < .001) and an increase of $341 in annual cost of lost wages (95% CI, $288-395; P < .001). Costs related to IBD are significantly associated with the degree of IBD-related disability. Among the approximate 30% of the IBD population with IBDDI scores ≥40, the indirect costs of absenteeism and presenteeism accounts for ~75% of the total IBD-related costs.

S911 Sexual Dysfunction Improves With Biologic Therapy in Men and Women With IBD

Introduction: Patients with inflammatory bowel disease (IBD) have a high degree of sexual dysfunction (SD). Few studies have tracked SD longitudinally or with IBD-specific scales. We aimed to correlate SD with clinical and psychosocial IBD indices and track SD longitudinally using the IBD- Female and Male Sexual Dysfunction Scales (IBD-FSDS and MSDS). Methods: We surveyed patients with Crohn’s disease (CD) and ulcerative colitis (UC) starting a new biologic or small molecule therapy (anti-TNF, anti-integrin, anti-IL12/23, JAK inhibitor) at start of induction and 2- and 6-months. Surveys also included the PROMIS Brief Sexual Function and Satisfaction Profile, disease activity indices [Harvey-Bradshaw index (HBI), partial Mayo score], and psychosocial scales [Patient Health Questionnaire-9 (PHQ-9), Short IBD Questionnaire (SIBDQ), and IBD-Disability Index (IBDDI)]. Clinical data included endoscopic scores, inflammatory biomarkers (ESR, CRP, calprotectin), and IBD history. Therapy response was defined as a reduction in HBI, pMayo, SCCAI ≥3 or total HBI ≤ 4, pMayo < 2, SCCAI ≤2 at survey 3. Results: 123 patients (68 males and 53 females) completed survey 1, 89 completed survey 2, and 74 completed survey 3. The median age was 31 years. 58% had CD, 42% had UC, and 31% were non-white. At induction, the median MSDS score was 6 out of 40 (IQR 2.5-13.5) and FSDS was 12 out of 60 (3-27.5); (Table 1Table 1.: Median Sexual Dysfunction, Clinical Disease Activity and Psychosocial Scores Stratified by Therapeutic Response.). SD scores strongly correlated with PROMIS scores (r=-0.75, p< 0.001), Mayo endoscopic score (r=0.71, p< 0.001), and moderately correlated with HBI (r=0.49, p=0.002) and pMayo scores (0.44, p=0.03), but not with inflammatory biomarkers. SD also correlated with SIBDQ (r=0.55, p< 0.001), PHQ-9 (r=0.42, p< 0.001), and IBD-DI (r=0.47, p< 0.001). MSDS scores significantly improved from survey 1 to survey 3 (p= 0.039). FSDS scores numerically improved but did not reach significance. Over 50% of patients had a significant response to therapy. When stratified by treatment response, MSDS and FSDS scores improved significantly among therapy responders (p=0.006 and p= 0.041, respectively) as did Male-PROMIS scores. This improvement was not observed in non-responders (p=0.27). HBI, SCCAI, pMayo, SIBDQ and IBD-DI also improved among responders. Conclusion: In this longitudinal cohort, there was a strong correlation between SD, disease activity, and psychosocial indices. Among therapy responders, there was a significant improvement in SD. These findings further clarify the relationship between SD and therapeutic response in IBD.

Body Mass Index and Disease Activity Are Associated With Moderate to Severe Disability in Crohn's Disease: A Cross-Sectional Study in Shanghai.

Background: The inflammatory bowel disease disability index (IBD-DI) was used to access body functional consequences and disease burden. However, Chinese population data are considerably limited.Objective: We aimed to screen for disability in patients with Crohn's disease (CD) and to assess potential associations with clinical parameters as well as indices related to sarcopenia.Methods: This cross-sectional study includes 146 CD patients from Ruijin Hospital in Shanghai, China. All patients were screened for disability and sarcopenia on the basis of the IBD-DI scale, and the criteria for Asian Working Group for Sarcopenia, respectively. Clinical and demographic variables were collected.Results: Approximately 52.05% of the subjects suffered from moderate or severe disabilities. The prevalence of sarcopenia (48.68 vs. 31.43%, P = 0.043), Patient-Generated Subjective Global Assessment score or PG-SGA≥4 (39.47 vs. 17.14%, P = 0.003), and high-level C- reactive protein (27.63 vs. 11.43%, P = 0.021) were higher in patients with moderate to severe disability than in those without to minimal disability. By multivariate regression modeling, the following were identified as independent factors related to moderate to severe disability: disease activity (OR:10.47, 95% CI: 2.09–52.42) and body mass index (BMI) (OR:4.11, 95% CI: 1.80–9.38).Conclusions: Disability is common in CD patients. Our study showed that moderate to severe disability is not directly associated with muscle mass or muscle quantity but is mostly correlated with disease activity as well as BMI. Thus, close monitoring and follow-up should be conducted on patients who are at high risk of disability, and effective measures should be taken, which may be the best way to prevent disability.

P454 Treatment with biologics improves disability from Inflammatory Bowel Disease in therapy responders

Abstract Background The IBD-Disability Index (IBD-DI) is a quantitative measure of disease impact on physical activity and social participation, with higher sores indicating greater disability. Prior studies have been cross-sectional, but few studies have longitudinally measured disability with IBD treatment. Methods Patients with Crohn’s disease (CD) and ulcerative colitis (UC) starting a new biologic or small molecule therapy were surveyed using the IBD-DI at induction, and 2- and 6-months. Surveys also included the Harvey Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI), partial Mayo score (pMayo), depression index (PHQ-9), quality of life index [Short IBD Questionnaire (SIBDQ)], and illness perception scale [Brief Illness Perception Questionnaire (BIPQ)]. Clinical data included endoscopic scores, biomarkers (ESR, CRP, calprotectin), comorbidities, and IBD history. Therapy response was defined as a reduction in HBI, pMayo, SCCAI ≥3 or total HBI ≤ 4, pMayo &amp;lt; 2, SCCAI ≤2 at survey 3. Results 111 patients (65 males and 46 females) completed survey 1, 79 completed survey 2, and 63 completed survey 3. There were no significant differences in baseline demographic, disease activity, or psychosocial scores between participants who completed only survey 1, and those who completed all 3 surveys. The median age was 31 years, 58% had CD, 42% had UC, and 32% were non-white (Table 1). At induction, the median IBD-DI score was 34.0 out of 100. IBD-DI scores did not correlate with age, race, sex, comorbidities, IBD-type, or surgery, but there was a weak correlation with prior biologic use, specifically anti-TNF therapy (Table 1). There was a moderate correlation between clinical disease activity scales and the IBD-DI [HBI, pMayo, and SCCAI (r=0.63, r= 0.56, r=0.55; p &amp;lt;0.001)] (Table 2). Endoscopic scores and biomarkers did not correlate with the IBD-DI. Psychosocial scales correlated strongly with the IBD-DI: SIBDQ, PHQ-9, and the wellbeing and emotional domains of the BIPQ (r=-0.83, r=0.78, r= 0.60, p &amp;lt;0.0001, respectively). Among therapy responders, there was a significant improvement in IBD-DI scores from survey 1 to 3 [median 32 (IQR, 20–43) to 24 (IQR, 14–38), p =0.04] (Table 3). This difference was not observed in treatment non-responders. Conclusion Disability is not commonly measured in clinical studies, but it plays a large role in patients’ overall wellbeing. In this longitudinal cohort, there was a strong correlation between IBD-DI, clinical disease activity, depression, and quality of life indices. Among therapy responders, there was a significant improvement in IBD-DI from a moderate to mild degree of disability. These findings further clarify the relationship between disability, disease activity, and therapeutic response in IBD.