Short Inflammatory Bowel Disease Questionnaire Scores Research Articles

Cannabis Use in Patients With Inflammatory Bowel Disease Following Legalization of Cannabis in Canada.

Cannabis is used by patients with Crohn's disease (CD) and ulcerative colitis (UC) as an alternative to, or in combination with, conventional therapies to treat symptoms such as abdominal pain, poor sleep, and reduced appetite. The clinical efficacy of cannabis for these disorders is controversial, with some studies showing harmful outcomes associated with its use. Previous studies suggest that cannabis is used by ~12% of patients with UC and ~16% of patients with CD in the USA despite legal prohibition. We conducted a prospective cohort study of adult patients with inflammatory bowel diseases (IBD) followed in a Canadian tertiary care center. Patients completed an online 40-question survey that included demographics, IBD disease history, cannabis use, and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Completed surveys were obtained from 254 participants (148 with CD, 90 with UC, and 16 with indeterminate colitis). Recent cannabis use was reported by 41% of CD and 31% of UC participants. Interestingly, only 46% of participants who used cannabis discussed their use with their physician. Participants who recently used cannabis reported more abdominal pain, poor appetite, and flatulence, and importantly this was associated with lower SIBDQ scores (recent use 37 vs non-recent use 40). Cannabis use among patients with IBD has more than doubled since its legalization. Cannabis use is associated with worse abdominal symptoms and quality of life. Physicians should inquire about cannabis use and optimize symptom control with evidence-based therapies.

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.

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

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<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.

P854 Tofacitinib demonstrates preliminary efficacy in induction of remission in chronic pouchitis

Abstract Background Pouchitis is common following total proctocolectomy for ulcerative colitis (UC) and ileal pouch-anal anastomosis (IPAA) and generally responds to antibiotics. However, up to 20% of patients develop either antibiotic-dependent or antibiotic-refractory pouchitis, collectively referred to as chronic pouchitis. Methods We report our preliminary induction results from a multi-center open label induction with randomized withdrawal trial to assess the efficacy of tofacitinib in chronic pouchitis. All eligible participants received 10mg tofacitinib twice daily for 8 weeks, with an additional 8 weeks of therapy given to patients with an inadequate initial clinical response. The primary endpoint was clinical response (a reduction of clinical PDAI≥2) at week 8. Secondary endpoints included endoscopic response (a reduction of endoscopic PDAI≥2), mPDAI remission (modified pouchitis disease activity index (mPDAI)≤ 4 and a reduction of mPDAI≥2), mPDAI response (a reduction of mPDAI≥2) and improvement in health-related quality of life (HRQoL) using the short inflammatory bowel disease questionnaire (SIBDQ). Serum cytokine levels was analyzed using LEGENDplex human inflammation panel 1. Univariate analysis was performed to identify clinical and biochemical predictors of response to tofacitinib. Results A total of 33 patients with chronic pouchitis (Table 1) were included in the preliminary analysis. The clinical and endoscopic response rates at week 8 were 55% and 58% respectively, with a median improvement of 1 (p<0.05) and 3 (p<0.05) respectively (Figure 1). The mPDAI remission rate was 49% at week 8 with an mPDAI response rate of 73%. Endoscopic responders exhibited significant improvements in endoscopic oedema, granularity, friability, and mucous exudate (p<0.05). There was significant improvement in HRQoL, with the median SIBDQ score increasing from 35 at baseline to 54 at week 8 (p<0.05). Eleven patients received a further 8 weeks of therapy with a clinical response rate of 36%, yielding an overall response rate including extended induction of 67%. Univariate analysis did not reveal significant differences in baseline characteristics, clinical, or biochemical markers between responders and non-responders. However, a history of corticosteroid use (p=0.08) and high baseline levels of faecal calprotectin (p=0.15) demonstrated a non-significant association with treatment response. Elevated baseline serum levels of IL-1b, IFN-a and IL-33 were associated with a treatment response at week 8 (p<0.05). Conclusion Tofacitinib demonstrated preliminary efficacy in inducing both clinical and endoscopic response in patients with chronic pouchitis who have undergone IPAA for UC.

Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease.

Dose escalation of self-injectable biologic therapy for inflammatory bowel diseases may be required to counteract loss of response and/or low drug levels. Payors often require completion of a prior authorization (PA), which is a complex approval pathway before providing coverage. If the initial PA request is denied, clinic staff must complete a time and resource-intensive process to obtain medication approval. This study measured time from decision to dose escalate to insurance approval and evaluated impact of approval time on disease activity. This was a single-center retrospective analysis of adult patients with IBD prescribed an escalated dose of biologic therapy at an academic center with an integrated specialty pharmacy team from January to December 2018. Outcomes included time to insurance approval and the association between approval time and follow-up C-reactive protein (CRP) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Associations were tested using linear regression analyses. 220 patients were included, median age 39, 53% female, and 96% white. Overall median time from decision to dose escalate to insurance approval was 7days [interquartile range (IQR) 1, 14]. Approval time was delayed when an appeal was required [median of 29days (IQR 17, 43)]. Patients with a longer time to insurance approval were less likely to have CRP improvement (p = 0.019). Time to insurance approval did not significantly impact follow-up SIBDQ scores. Patients who had a longer time to insurance approval were less likely to have improvement in CRP, highlighting the negative clinical impact of a complex dose escalation process.

A86 CANNABIS USE IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE IS HIGHER FOLLOWING LEGALIZATION OF CANNABIS IN CANADA AND IS ASSOCIATED WITH LOWER QUALITY OF LIFE

Abstract Background Patients with inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), often experience fluctuating and unpredictable symptoms. Most individuals require chronic therapy with immunomodulators or novel biologics to maintain disease remission. In addition to conventional medical therapy, many patients also seek out alternative therapies such as cannabis. Reports in the USA suggest that cannabis is used by ~12% of UC and ~16% of CD patients, despite it being legally prohibited. Purpose The aim of our study is to evaluate the use of cannabis in a cohort of patients with IBD following its legalization in Canada, and to assess its effects on IBD disease severity. Method We conducted a prospective cohort study of adult IBD patients seen in clinic at a tertiary care center in London, ON. Patients completed an online 40-question survey that collected data on demographics, IBD disease history, cannabis use, and included the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The survey was distributed and collected by the REDCap platform maintained by Western University. The study was approved by the Western University Ethics Committee. Result(s) Completed surveys were obtained from 254 individuals (148 individuals with CD, 90 with UC and 16 with indeterminate colitis). Over half of participants were between 35-64 years of age and female. Fifty-three percent of participants reported life-time cannabis use and 51% of users started using cannabis only in the preceding 3 years. Individuals with CD had higher rates of recent use, defined as use within the past 6 months, when compared with UC (41% vs 31%). Cannabis was taken multiple times per week by 57% of users. Cannabis was used to treat GI symptoms by 30% of users, as well as to help with sleep (26%) and for recreation (27%). Despite side effects such as dry mouth, anxiety and concentration issues, 79% of users felt the benefits of cannabis outweighed its harms. Interestingly, only 46% of cannabis users discussed their use with their family physician or gastroenterologist. Recent cannabis users did not differ in the use of IBD medication or self-reported rates of GI symptoms. Furthermore, recent users did not differ in the rates of surgical procedures for IBD (recent 35% vs non-recent 32%). Recent cannabis users did have a significantly lower quality of life as indicated by SIBDQ scores when compared to non-recent users (recent use 37 vs non-recent use 40). Conclusion(s) Cannabis use among patients with IBD after its legalization is more than double the rate previously reported in the literature. Importantly, physicians are likely to be unaware of its prevalence in their practice. Cannabis was used by patients to treat GI and non-GI symptoms, and it was associated with lower SIBDQ scores. Our results suggest that physicians should inquire about Cannabis use amongst their patients with IBD, and that further studies are required to determine its effects on disease severity. Please acknowledge all funding agencies by checking the applicable boxes below CIHR Disclosure of Interest None Declared

P468 Association of uncontrolled disease with quality of life and healthcare resource utilisation in Ulcerative Colitis patients treated with advanced therapy in the United States

Abstract Background Advanced therapies (AT; i.e., biologics, biosimilars, Janus kinase inhibitors) are used to treat patients with moderate to severe ulcerative colitis (UC) after inadequate response to conventional treatments; yet some patients continue to have uncontrolled disease. We examined the association between uncontrolled UC and health-related quality of life (HRQoL) and healthcare resource utilisation (HCRU) in a real-world clinical setting. Methods The analysis was conducted using secondary data from the Adelphi UC Disease Specific Programme™,1 a cross-sectional, retrospective survey of gastroenterologists and patients, from January 2020-March 2021. Gastroenterologists provided clinical characteristics and HCRU information for 5-7 consecutive UC patients, while EuroQol-5-dimensions (EQ-5D), EQ-visual analogue scale (EQ-VAS), short inflammatory bowel disease questionnaire (SIBDQ) and work productivity and impairment questionnaire (WPAI) were patient-administered to capture HRQoL status. Patients receiving AT for ≥6 weeks were classified as uncontrolled if: physician assessment was currently moderate or severe, they had ≥2 flares in the last 12 months, or currently had ≥3 symptoms. Patient characteristics and outcomes were compared using T-test and Fisher’s exact test. Multivariable linear regressions estimating the association between UC control status and HRQoL were adjusted for age, ethnicity, disease duration and severity at diagnosis. Results Of the 236 patients included in the sample, 57.6% had uncontrolled disease and were likely to be non-White (27.9% v 14.0% controlled; p=0.01). Although healthcare provider consultations were similar in both groups, uncontrolled patients had more radiological imaging (mean 1.9 v 1.3, p<0.01), endoscopies (mean 0.6 v 0.3, p<0.01) and hospitalisations (mean 0.2 v 0.1, p=0.01) in the last 12 months compared to controlled patients. Uncontrolled patients reported significantly lower (worse) total and subdomain SIBDQ scores (total: 47.2 v 59.6; systemic symptoms: 4.8 v 5.9; bowel symptoms: 4.7 v 6.1; emotional function: 4.6 v 5.6; social function: 4.8 v 6.2; all p<0.01; Table 3). EQ-5D (0.85 v 0.92, p<0.01), EQ-VAS scores (76.3 v 86.1, p<0.01) and activity impairment (29.2 v 16.7, p<0.01) were significantly worse in the uncontrolled group. Conclusion A substantial number of UC patients continue to have uncontrolled disease and high unmet need despite AT use. These patients experience poorer HRQoL and contribute a significant burden on healthcare resources. Study findings highlight the need for innovative therapeutic options that would further reduce disease burden for patients and the healthcare system. 1. Anderson P et al. Curr Med Res Opin 2008;24;3063–72.

TRENDS AND RELATED FACTORS OF QUALITY OF LIFE IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Abstract INTRODUCTION Inflammatory bowel disease(IBD) affects health-related quality of life(HRQoL). The short inflammatory bowel disease questionnaire(SIBDQ), measuring physical, social, and emotional status(score 10-70, poor to good HRQoL), is known to be well correlated to HRQoL of IBD patients. AIM/METHODS We aimed to evaluate factors that impact IBD patients' HRQoL. This prospective study included a cohort of patients with ulcerative colitis(UC) and Crohn’s disease(CD). IBD patients completed a SIBDQ questionnaire at enrollment and 20% of those patients completed a second SIBDQ questionnaire at follow-up. Data were analyzed using multiple linear regression analysis and Pearson’s correlation. RESULTS A total of 1,058 patients with IBD(UC 68%, CD 32%) were included. A SIBDQ score was median 52(IQR: 44-58). The first and follow-up SIBDQ score were not significantly different between UC and CD patients (p=0.243 and p=0.893, respectively). The distributions of SIBDQ change were as follows: decrease over 10%: 28%, -10% < change < 10%: 29%, increase over 10%: 43%. In UC patients, significant factors that negatively associated with SIBDQ score, were physician’s global assessment(r=-3.562, p<0.001), corticosteroids use(r=-5.478, p<0.001), fecal calprotectin level(r=-2.313, p=0.008), presence of joint symptoms(r=-2.925, p=0.017). In CD patients, significant factors that negatively associated with SIBDQ score, were Crohn's disease activity index score(r=-0.035, p=0.009), level of abdominal pain(r=-3.400, p=0.013) and presence of skin symptoms(r=-3.842, p=0.016). Factors that associated with SIBDQ score in both UC and CD patients were stool frequency(r=-2.913, p<0.001 in UC patients; r=-2.347, p=0.014 in CD patients). CONCLUSION SIBDQ questionnaire shows that IBD patients' HRQoL was mainly affected by the patient-reported outcome. However, it was also influenced by biochemical markers and extraintestinal symptoms depending on the specific type of IBD.

The effect of medical cannabis in inflammatory bowel disease: analysis from the UK Medical Cannabis Registry

ABSTRACT Objectives Cannabis-based medicinal products (CBMPs) have shown promising preclinical activity in inflammatory bowel disease (IBD). However, clinical trials have not demonstrated effects on inflammation. This study aims to analyze changes in health-related quality of life (HRQoL) and adverse events in IBD patients prescribed CBMPs. Methods A case series from the UK Medical Cannabis Registry was performed. Primary outcomes included changes from baseline in the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Generalized Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), and EQ-5D-5L Index score at 1 and 3 months. Statistical significance was defined using p < 0.050. Results Seventy-six patients with Crohn’s disease (n = 51; 67.11%) and ulcerative colitis (n = 25; 32.89%) were included. The median baseline SIBDQ score improved at 1 and 3 months. EQ-5D-5L index values, GAD-7, and SQS also improved after 3 months (p < 0.050). Sixteen (21.05%) patients reported adverse events with the majority being classified as mild to moderate in severity. Conclusion Patients treated with CBMPs for refractory symptoms of Crohn’s disease and ulcerative colitis demonstrated a short-term improvement in IBD-specific and general HRQoL. Prior cannabis consumers reported greater improvement compared to cannabis-naïve individuals.

Burden of Fatigue Among Patients with Ulcerative Colitis and Crohn's Disease: Results from a Global Survey of Patients and Gastroenterologists.

To assess the prevalence of fatigue and its association with disease activity and patient-reported outcomes among patients with ulcerative colitis (UC) or Crohn's disease (CD). Data from a cross-sectional survey conducted with gastroenterologists and their consulting adult patients with UC or CD were analyzed. Data were collected via gastroenterologist-completed patient record forms and patient-self completion forms. Patient demographics, clinical characteristics, disease activity and medication use were reported by the gastroenterologist, while current symptoms (fatigue, rectal urgency, abdominal pain, sleep disturbance), work productivity and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) were reported by the patient. Logistic regression models were used to identify measures associated with fatigue and expressed as odds ratio (OR) with 95% confidence interval. p < 0.05 was considered statistically significant. A total of 1057 patients with UC and 1228 patients with CD were included in this analysis. Fatigue was reported in 22.6% of UC and 26.0% of patients with CD. Higher proportion of patients with UC and fatigue had moderate/severe disease activity (p = 0.0001), had a higher Mayo score (5.0 vs. 4.0, p < 0.0001) and were unemployed (5.6% vs. 3.9%, p = 0.0149) compared to those without fatigue. In patients with CD reporting fatigue, a higher proportion were female (55.9% vs. 48.2%, p = 0.0193), were unemployed (5.8% vs. 4.9%, p = 0.0069), had moderate/severe disease (p < 0.0001) and had a higher mean Crohn's Disease Activity Index score (145.0 vs. 96.2, p < 0.0001) than patients without fatigue. Patients with UC and fatigue had higher mean level of pain (p < 0.0001) and sleep disturbance (p < 0.0001), whereas patients with CD and fatigue had lower SIBDQ scores (p < 0.0001) and greater work impairment (p = 0.0015) than patients without fatigue. Abdominal pain (OR: 2.01, p = 0.001) and use of immunomodulators (OR: 1.69, p = 0.006) increased the odds of having fatigue in patients with UC. In patients with CD, abdominal pain (OR: 2.29, p < 0.001) and use of biologics or biosimilars (OR: 2.02, p = 0.003) increased the odds of having fatigue. Fatigue is a common symptom among patients with UC or CD that is associated with higher levels of disease activity and decreased work productivity and is driven by various factors. A multidisciplinary approach may be needed to manage fatigue.

Translation and evaluation of the simplified Chinese version of the rating form of IBD patient concerns

BackgroundInflammatory bowel disease (IBD) has become a global public health problem. The prevalence of IBD in China increased annually in past two decades.MethodsThis study was to translate and validate the rating form of IBD patients' concerns (RFIPC), and to describe disease-related worries and concerns of patients with IBD. The simplified Chinese version of the RFIPC was developed according to translation and back-translation procedure. Patients with IBD were consecutively enrolled from the First Affiliated Hospital of Guangzhou University of Chinese Medicine. The participants were assessed using the RFIPC and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Internal consistency, test–retest reliability, measurement error, confirmatory factor analysis (CFA) and correlation of the RFIPC with the SIBDQ were performed to evaluate the psychometric characteristics of the RFIPC.ResultsA total of 116 patients with IBD, 73 with ulcerative colitis (UC) and 43 with Crohn’s disease (CD), were enrolled in this study. Thirty-seven of them recompleted the questionnaires for the second time between 7 and 14 days after the first interview. The results of CFA indicated the original structure of the RFIPC was reasonable. Cronbach's alpha value of the RFIPC were 0.97. The intraclass correlation coefficients of four domains ranged from 0.85 to 0.92. The standard error of measurement was 7.10. The correlation coefficients between total score of the RFIPC and the SIBDQ score ranged from − 0.54 to − 0.70. Median total score of the RFIPC was 39.4 (IQR 24.0–59.3). Patients with severe symptoms reported higher scores of the RFIPC. The uncertain nature of disease, having surgery, having an ostomy bag, developing cancer, feeling out of control, being a burden on others and financial difficulties were highest concerns of patients with IBD. Comparing with patients with UC, patients with CD had more concerns of the ability to have children and being treated as different (P < 0.05).ConclusionsThe simplified Chinese version of RFIPC is a valid and reliable tool. It could be used for assessing disease-related worries and concerns of patients with IBD in China. Specific concerns of patients with UC and CD are different, therefore, health workers should consider the specific needs of UC and CD patients.

Real-world evidence of quality of life improvement in patients with distal ulcerative colitis treated by mesalazine: the Quartz study.

Distal ulcerative colitis (UC) is responsible for distressing symptoms and reduces quality of life (QoL). Oral and topical formulations of 5-amino-salicylic acid are the first line therapy for mild to moderate distal UC. Our aim was to evaluate the impact of mesalazine treatment for mild to moderate ulcerative proctitis and proctosigmoiditis on patient QoL. Ninety-three patients with mild to moderate ulcerative proctitis and proctosigmoiditis, initiating a treatment with Pentasa, were prospectively included. The primary endpoint was the change from baseline to W8 in patient health-related QoL (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score. More than 80% of patients were prescribed with a rectal formulation, either alone (47.9%) or with an oral formulation (35.1%), and 17.0% of patients were prescribed oral formulation alone. Mean SIBDQ score was improved at W8 in patients affected with mild and moderate disease ( P &lt; 0.001 versus baseline in both groups, as well as in patients who achieved clinical remission ( P &lt; 0.001). Patients who achieved clinical remission at W8 reached a mean change of +6.7 (±7.1), whereas those who did not achieve clinical remission had a mean change of +1.1 (±8.9). Seventy-five per cent of patients had an improvement of their disability index at W8. Fecal incontinence was also improved at W8. HRQoL measuring with the SIBDQ is proportionally related to disease activity in patients with distal UC treated with mesalazine.

A Low-FODMAP Diet Provides Benefits for Functional Gastrointestinal Symptoms but Not for Improving Stool Consistency and Mucosal Inflammation in IBD: A Systematic Review and Meta-Analysis.

Background: A low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet (LFD) is claimed to improve functional gastrointestinal symptoms (FGSs). However, the role of LFD in inflammatory bowel disease (IBD) patients with FGSs remains unclear. Objective: To systematically assess the efficacy of LFD in IBD patients with FGSs. Methods: Six databases were searched from inception to 1 January 2022. Data were synthesized as the relative risk of symptoms improvement and normal stool consistency, mean difference of Bristol Stool Form Scale (BSFS), Short IBD Questionnaire (SIBDQ), IBS Quality of Life (IBS-QoL), Harvey-Bradshaw index (HBi), Mayo score, and fecal calprotectin (FC). Risk of bias was assessed based on study types. A funnel plot and Egger’s test were used to analyze publication bias. Results: This review screened and included nine eligible studies, including four randomized controlled trials (RCTs) and five before–after studies, involving a total of 446 participants (351 patients with LFD vs. 95 controls). LFD alleviated overall FGSs (RR: 0.47, 95% CI: 0.33–0.66, p = 0.0000) and obtained higher SIBDQ scores (MD = 11.24, 95% CI 6.61 to 15.87, p = 0.0000) and lower HBi score of Crohn’s disease (MD = −1.09, 95% CI −1.77 to −0.42, p = 0.002). However, there were no statistically significant differences in normal stool consistency, BSFS, IBS-QoL, Mayo score of ulcerative colitis, and FC. No publication bias was found. Conclusions: LFD provides a benefit in FGSs and QoL but not for improving stool consistency and mucosal inflammation in IBD patients. Further well-designed RCTs are needed to develop the optimal LFD strategy for IBD.

A166 CANNABIS USE IN CANADIAN INDIVIDUALS WITH INFLAMMATORY BOWEL DISEASE FOLLOWING LEGALIZATION OF CANNABIS

Abstract Background Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are characterized by remitting and relapsing symptoms of abdominal pain, diarrhea, nausea, fatigue, and poor sleep. Most patients with IBD require chronic immunosuppressive therapy to maintain their disease in remission. Due to their disease chronicity, individuals often seek additional complementary or alternative medicines such as cannabis to treat their symptoms. Reports from the US show cannabis use in 12% of UC and 16% of CD patients. However, these numbers are likely underestimates given that cannabis remains illegal in many states. Aims The aim of our study is to evaluate the use of cannabis in a cohort of patients with IBD and to assess its association with IBD disease severity. Methods We conducted a prospective cohort survey of adult patients with IBD seen in tertiary care in London Health Sciences Centre. A 40-question online survey was completed by consenting patients and collected data on demographics, IBD disease history, cannabis use, and included the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) as a measure of disease severity. The study was approved by the Western University Ethics Committee. Statistical analyses was performed using a Chi squared test for categorical data, and a two-tailed t-test for continuous data. Results Completed surveys were obtained from 210 individuals (135 individuals with CD and 75 with UC) and demographics were similar between the CD and UC cohort. Fifty-six percent of participants reported cannabis use at least once in their lifetime, with 38% of participants reporting cannabis use in the preceding 6 months. Interestingly, 46 percent of life-time cannabis users did not divulge their cannabis use to their physicians. In patients with UC, those who actively used cannabis were less likely to be on 5-ASA therapy (9 active users vs 22 non-users, p&amp;lt;0.05). Medical therapy was otherwise similar between cannabis users and non-users. Surgical rates were similar between cannabis users and non-users amongst both IBD subtypes. With respect to the burden of disease, patients with CD reported higher rates of abdominal pain if they were active users, however, overall SIBDQ scores were not altered by cannabis use (21 user vs 20 non-user). Similarly, SIBDQ scores were similar amongst patients with UC who were cannabis users and non-users (20 user vs 16 non-user). Conclusions Cannabis use in patients with IBD is very common and much higher than previously reported prior to the legalization in Canada, but its use is not associated with lower disease severity based on patient reported outcomes. Our study also reveals that patients often do not report this use to their doctors so physicians must be aware of its prevalence amongst their IBD patient population. Funding Agencies None

Impact of iron deficiency anemia on quality of life in patients with ulcerative colitis

AbstractAdvances in the last two decades have resulted in better long‐term remissions in patients with ulcerative colitis (UC), which is defined as an idiopathic, chronic inflammatory disorder of the colonic mucosa. This better remission has not transformed into a better quality of life. Almost one‐third of these patients have mild to moderate anemia, which is one of the main factors leading to decreased quality of life; hence we aimed to determine the prevalence of iron deficiency anemia (IDA) in UC during remission and its impact on the quality of life in this subpopulation. In this prospective study, all consecutive patients of UC in remission for the last 3 months were evaluated for disease activity by Simple Clinical Colitis Activity Index (SCCAI), IDA by blood parameters and quality of life by Short Inflammatory Bowel Disease Questionnaire (SIBDQ). All patients with proven IDA were given oral iron supplements (Ferrous Ascorbate elemental iron 100 mg) for 3 months. Blood parameters, SCCAI, and SIBDQ scores were evaluated at the end of therapy to compare them before iron supplementation. Out of 125 patients of UC seen during the study period, 69 were in remission. IDA was seen in 34 patients (49.27%). Median pre‐intervention and postintervention quality of life scores—SIBDQ (4.9 [4.2‐5.8] vs 5.4 [5.0‐6.1]) and blood parameters [hemoglobin 10.7 (9.8‐11.4) g% vs 13.2 (12.8‐13.7) g%]—showed significant improvement after iron supplementation. Prevalence of IDA in UC during remission is common (49.27%). Oral iron supplementation improves the quality of life and anemia significantly without increasing disease activity in UC under remission.

REAL-WORLD UTILIZATION OF ADALIMUMAB BIOSIMILAR (ABP 501) IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE IN EUROPE

Abstract OBJECTIVE ABP 501 (AMGEVITA®) was the first approved biosimilar to adalimumab reference product (RP) by the European Medicines Agency and has been marketed in the European Union since 2018. Additional real-world data on its efficacy and safety, particularly for treating patients with inflammatory bowel disease (IBD), an indication approved on the basis of extrapolation, has the possibility of addressing barriers to utilization. METHODS This was a retrospective analysis of data collected between April and June 2021 from the Adelphi IBD Disease Specific Programme (DSP) covering ulcerative colitis (UC) and Crohn’s disease (CD) in Germany, France, Spain, Italy, and United Kingdom. Gastroenterologists provided data on demographics, clinical characteristics, treatment history, and treatment satisfaction. Patients had the option to complete the short IBD questionnaire (SIBDQ) aimed at measuring the burden of disease, work productivity and activity impairment (WPAI) questionnaire, and to indicate their assessment of treatment satisfaction. Descriptive analyses were conducted; continuous variables were reported as means or medians, categorical variables as number of patients and percentages. RESULTS 82 physicians reported data on 396 patients (189 UC and 207 CD): 239 initiated ABP 501 as first advanced therapy (AT) (initiators), 157 switched to ABP 501 from RP with no prior use of other AT (switchers) (Table). Median time from IBD diagnosis to initiation of ABP 501 was 13.9 months for initiators with median time on ABP 501 being 7.5 months at the time of data collection. Switchers previously received RP for a median of 14.1 months and had been on ABP 501 for a median time of 7.7 months since switching. The main reasons for switching from RP to ABP 501 were related to the potential to lower healthcare cost. At the time of reporting, more than two-thirds (67% initiators, 83% switchers) had mild disease, more than three-quarters were in clinical remission (74% initiators, 88% switchers), and a majority were in improving or stable disease status (96% initiators, 98% switchers). Mean SIBDQ scores (56 vs. 59) and overall work impairment (4.7% vs. 3.2%) were similar across initiators and switchers, respectively. Physicians and patients (&amp;gt;90% each of initiators and switchers) reported being satisfied with current treatment with ABP 501. CONCLUSION ABP 501 was used as initial or continuing adalimumab therapy in the real-world setting to treat patients with IBD. At least three-fourths of patients currently on ABP 501 were in clinical remission, with a higher proportion in the switching group. Both physicians and patients reported very high levels of satisfaction with treatment.

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.

P483 Patient-reported quality of life, anxiety, and depression associated with switching originator infliximab to biosimilar

Abstract Background Non-medical switching from biologics to biosimilars is becoming increasingly common. Previous studies have demonstrated efficacy and safety of switching originator to biosimilar infliximab in inflammatory bowel disease (IBD) patients. Limited data exist on patient-reported quality of life (QOL) and possible emotional duress associated with these switches. The purpose of this study was to describe the impact of non-medical switches to infliximab biosimilars on QOL, anxiety, and depression. Methods This was a retrospective review of all IBD patients switched from originator to infliximab biosimilar at a large multicenter gastroenterology private practise in Texas. Patients were asked to complete standardised questionnaires on a quarterly basis beginning 3/2021, concurrent with large US payor policy changes mandating non-medical biosimilar switches. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was used to assess disease-specific QOL. The Hospital Anxiety and Depression Scale (HADS) was used to determine anxiety and depression. All questionnaires through 10/2021 were collected and designated as “pre” or “post” based on the date of the patient’s non-medical switch to infliximab biosimilar. Wilcoxon rank sum test was used to compare scores. We also performed subset analyses on patients with both “pre” and “post” questionnaires with paired t-test. Results From 3/2021 to 10/2021, a total of 81 questionnaires were submitted by 54 patients who underwent non-medical switches to an infliximab biosimilar. 30 questionnaires were submitted prior to (“pre”) and 51 questionnaires were submitted after (“post”) the non-medical switch. Median “pre” SIBDQ score was 58 (IQR 53–63). Median “pre” HADS-Anxiety and HADS-Depression score were 3.5 (IQR 1–6) and 1 (IQR 0–5), respectively. As shown in Figure 1, “post” scores were unchanged [SIBDQ 59 (IQR 54–63); HADS-Anxiety 3 (IQR 1–7); HADS-Depression 2 (IQR 1–4)]. Subset analyses included 14 patients who submitted both “pre” and “post” questionnaires. Similarly, no significant changes were observed [Figure 2]. Conclusion Non-medical switches to infliximab biosimilar did not affect QOL or mental health. To our knowledge, this is the first biosimilar switch study to incorporate anxiety and depression measures. These relationships should continue to be assessed.

P152 Impact of disease location on burden of illness in patients with moderate-severe Crohn’s disease: A real-world survey in the United States, France, Germany, Italy, Spain, and United Kingdom (5EU)

Abstract Background Presentation and risks of progression and complications differ according to Crohn’s disease (CD) location. The objective of this study was to investigate how disease burden differs based on CD location, from physician and patient perspective. Methods Data drawn from the Adelphi Inflammatory Bowel Disease (IBD) Disease Specific Programme™, a point-in-time survey of gastroenterologists (GEs) and their IBD patients from two waves (Nov 2014-Mar 2015; Sep 2017-Jan 2018) in the United States, and 5EU. GEs completed physician-reported questionnaires for 5–10 consecutively consulting patients with CD, covering demographics, treatment, symptoms, and CD location. Same patients completed voluntary patient-reported questionnaire including outcome measures such as Short IBD Questionnaire (SIBDQ), EuroQol 5-dimension questionnaire (EQ-5D), and Work Productivity and Activity Impairment questionnaire. Comparisons were drawn between patients with CD in 3 locations: ileal only (IL), ileocolonic (IC), and colonic only (CO). Outcomes such as patient-reported level of pain, sleep disturbance, and fatigue, were compared between locations using linear regression analyses that included potential confounding variables age, gender, body mass index, comorbidities (using Charlson Comorbidity Index [CCI]) and severity at diagnosis. Least square (LS) means were generated for each location and compared using a p-value generated from Wald tests. Variables such as current treatment and symptoms, were compared using univariate tests (ANOVA, chi2 test). Base sizes varied due to the voluntary nature of patient participation. Results 686 GEs collected data on 2354 patients with moderate-severe CD, identifying patients with IL (28.3%), IC (45.7%), and CO (26.0%) location. Overall demographic characteristics were similar, mean age 39 years, proportion of male patients 51.4%, mean Body Mass Index 24.0, mean CCI 0.14. Differences were observed between the 3 groups (Table 1). Patients with ileal involvement (IL and IC) were prescribed biologics more often and had greater symptom burden than CO patients, except for rectal urgency. IL patients tended to have slightly greater burden overall in terms of symptomatology and severity. There was similarity across SIBDQ and EQ-5D scores; however, absenteeism was higher amongst IL and IC patients, compared with CO patients. Conclusion Differences were observed between IL, IC, and CO CD location groups. Despite IC patients experiencing the greatest burden overall, there were key distinctions between IL and CO patients, particularly in medication, symptoms, and work productivity impairment, suggesting that disease management with attention to CD location could lead to better patient outcomes.