Adult IBD Patients Research Articles

MY SCD PROTOCOL - AN ONLINE, COMPREHENSIVE, REMOTELY-SUPERVISED PROTOCOL FOR IBD PATIENTS TO IMPLEMENT AN EFFECTIVE DIETARY INTERVENTION

Abstract Many IBD patients are keen to modify their diet to better manage their disease. However, little or no dietary guidance is offered to IBD patients or is not comprehensive and lacks practical resources to implement and sustain the modification. Up to 70% of IBD patients self-prescribe dietary restrictions with demonstrated risk of nutrient deficiencies. There is currently no comprehensive IBD dietary intervention presented in a customizable, easy-to-follow protocol format. To meet this need, we developed and tested a full-featured online version of an effective IBD dietary intervention. METHOD: ‘My SCD Protocol’ is a comprehensive, customizable protocol based on the specific carbohydrate diet (SCD). The online, self-paced protocol provides educational resources, self-assessment tools, and step-by-step instructions to start and advance through SCD. Ingredients are presented in 4 ordered Stages (Elimination, Reintroduction, Maintenance, Expansion) to help methodically expand tolerable ingredients. Stage-specific curated recipes support implementation and offer variety and personalization. Patients self-report symptoms, meals, and progress using a HIPAA-compliant mobile app. Entries are accessible in real-time by the patient’s care team. The protocol currently holds 304 SCD ingredients and 164 recipes. Patients (n=87) referred to Modulla Health IBD Nutrition Clinic, or seeking support directly, implemented My SCD Protocol based on preference and ingredient tolerance. Symptoms were self-reported using the accompanying app. Interim results are reported here. RESULTS: Patients successfully accessed and personalized My SCD Protocol. Table 1 summarizes patient profiles. Table 2 presents self-reported symptom changes, showing improvements in all categories except urgency and appearance of mucus. Additional outcomes, including fecal calprotectin, will be reported. DISCUSSION: SCD has been shown to induce clinical response and biochemical remission in adult and pediatric IBD patients. SCD is either self-implemented by patients using a trial-and-error approach, or is dietitian-supervised, primarily using the ‘legal’ SCD ingredient list and little else. SCD was implemented in a clinical trial setting using a predefined, prescriptive meal model with little room to personalize diet (DINE-CD). My SCD Protocol is the first comprehensive protocol to help implement, personalize, and safely advance through SCD. Patients reliably accessed the educational videos, staged ingredients, matching recipe libraries, and logging tools using mobile and web tools. We show self-reported symptom improvements during the first 21 days of the protocol leading to longer-term adherence to diet modification. Care teams who recommend My SCD Protocol to patients can conveniently and continuously monitor patient progress in real-time and supervise patients throughout the intervention.

P059 Diet controls segmented filamentous bacteria in driving Crohn’s disease-like inflammation in TNFdeltaARE mice

Abstract Background Crohn’s disease (CD)-like inflammation in TNFdeltaARE mice (ARE) mice is triggered by dysbiotic gut microbial communities. Similar to the therapeutic effect of exclusive enteral nutrition in CD, dietary intervention using semi-synthetic experimental diet prevents disease development in ARE mice. The aim of this study is to identify the causal microbial cues responsible for CD-like inflammation and to dissect the protective role of diet in ARE mice. Methods Bacterial communities in ARE and wildtype (WT) mice were profiled by 16S rRNA gene sequencing, FISH and qPCR. Germfree WT and ARE mice were colonized with segmented filamentous bacteria (SFB) from dysbiotic ARE mice. Disease activity, cytokine expression, mucosal immune cell infiltrates as well as Paneth and goblet cells phenotypes were assessed in murine ileal and colonic tissue. To assess the influence of diet on disease development, ARE mice were fed either chow, purified semi-synthetic experimental diet (SED) or fiber-rich diet. Impact of SFB on ileo-colonic inflammation was tested in additional mouse models (XIAP-/- and IL10 -/-). Mucosal biopsies from adult and pediatric IBD patients (N=407) were screened for the presence of human SFB using SFB-specific PCR primers. Results Under specific pathogen-free (SPF) conditions, ARE mice developed CD-like ileal inflammation which correlated strongly with increasing abundance of SFB. Mono-colonization of germfree ARE mice with SFB resulted in severe enterocolitis. Parallel to high tissue levels of TNF and IL-17, SPF-mediated inflammation was associated with neutrophil infiltration and the expansion of IFNγ expressing Th1 cells in the mucosa. Loss of Paneth and goblet cell function allowed SFB to penetrate mucus layers towards the epithelium. SED eradicated SFB and completely abolished inflammation in ARE mice. In contrast, fiber-rich diet partially restored SFB colonization and led to increased levels of inflammatory cytokines. SFB mono-colonization of GF XIAP-/- and IL10 -/- failed to induce inflammation, emphasizing host specificity to the mucosa-adherent SFB. Presence of SFB was confirmed in 12 ileal and 11 colonic mucosal biopsies from IBD patients with active or inactive disease. Conclusion We identified a novel pathogenic role of SFB in driving severe CD-like ileo-colonic inflammation characterized by loss of Paneth and goblet cell functions in ARE mice. Detection of SFB in mucosal biopsies of patients with IBD opens new perspectives about therapeutic strategies targeting SFB-mediated processes. Purified diet antagonized SFB colonization and prevented disease development in ARE mice in contrast to fiber-rich diet, clearly demonstrating the important role of diet in modulating a novel IBD-relevant pathobiont.

P231 Emergency Colectomy for IBD Is Not Associated with Increased Risk of Postoperative Infection, Reoperation or Readmission

Abstract Background The current literature suggests that IBD patients have worse outcomes after emergency surgery when compared to elective surgery. We hypothesized that this association will be lost after matching cohorts of emergency and elective patients. We aimed to confirm the current emergency IBD surgery literature in a large cohort of unmatched IBD patients. We then aimed to determine if postoperative outcomes are worse in matched patients undergoing elective vs emergency colectomy. Methods We utilized the NSQIP PUF IBD Cohort 2005–2019 to assess 30-day outcomes in adult IBD patients undergoing emergency vs elective colectomy. Our primary outcome was any complication. Our secondary endpoints were readmission, reoperation, and mortality. Univariable and multivariable logistic regression models were used to examine the association between emergency surgery and complications in the unmatched cohort. Propensity-score matching was performed to match emergency patients to non-emergency patients on a 1:1 basis. A logistic regression model was used to assign a propensity score to each patient using emergency surgery as the outcome. All preoperative and perioperative characteristics were included in the model except those with > 20% missing data. The probability of emergency surgery based on these factors was used as the propensity score. A greedy matching algorithm was used to find the best controls matches for each case. A Love plot was used to show the covariate balance. Conditional logistic regression were used to evaluate the association between outcomes and emergency surgery on the matched sample. Results A total of 16,790 patients (15,849 elective, 941 emergency) were included in the unmatched cohort analysis. 30-day outcomes in 21 categories including length of stay, surgical site infection, sepsis, death and cardiovascular, renal and thrombotic complications were worse in the emergency cohort (Table 1). After matching, 632 sets were constructed. The majority of adverse outcomes demonstrated in the unmatched cohort lost significance. Only unplanned intubation (OR 2.6, p=.006), >48 hours on a ventilator (OR 2.8, p<.001), septic shock (OR 3.6, p<.001) and any complication (OR 1.3, p=.03) retained significance (Table 2). Conclusion In concordance with the current literature, we demonstrated increased rates of postoperative infection, cardiovascular and renal complications, reoperation and length of stay in unmatched groups of IBD patients undergoing emergency vs elective surgery. However, the majority of these complications were not significantly different after propensity matching. This suggests that emergency surgery is not associated with poorer outcomes in terms of length of stay, mortality and most morbidities as previously thought.

P011 Prevalence of Cannabis Use Disorder in Inflammatory Bowel Disease Hospitalizations in the United States and Effect on Length of Stay.

The prevalence of cannabis use has been increasing in the United States in recent years. We examined the prevalence and predictors of cannabis use disorder among IBD hospitalizations and its effect on length of stay. Using the 2017 National Inpatient Sample, cannabis use disorder was identified using ICD-10-CM code F12.xxx in adult IBD patients. Other variables of interest included age, sex, race, Crohn's disease (vs. ulcerative colitis), region, metropolitan status, zip code household income, primary insurance, and length of stay. Multivariate logistic and Poisson regressions were used in statistical analysis. Of the 17,857 IBD hospitalizations, 565 (3.1%) had cannabis use disorder. Patients with cannabis use disorder were younger (mean ± standard deviation [years]: 35.1 ± 11.8 vs. 45.6 ± 18.1), less likely female (32.7% vs. 54.1%), more likely African American (24.8% vs. 13.9%), and more likely Crohn's disease (72.0% vs. 62.2%) (all p < 0.001). There were also significant differences by region, income, and insurance. Multivariate logistic regression confirmed age (odds ratio [95% confidence interval]: 0.964 [0.957, 0.971]), female (0.444 [0.369, 0.531]), African American (1.405 [1.124, 1.750]), and Crohn's disease (1.363 [1.126, 1.657]) as predictors of cannabis use disorder. There was no association between cannabis use disorder and length of stay, confirmed in multivariate Poisson regression. Young age, male sex, African American race, and Crohn's disease were positively associated with cannabis use disorder in IBD hospitalizations. There was no effect of cannabis use disorder on length of stay.

Improving Care for Recently Diagnosed Inflammatory Bowel Disease Patients: Lessons Learned From a Patient-Centred, Mixed-Method Study.

Newly diagnosed inflammatory bowel disease [IBD] patients need to deal with the physical and emotional impact of the disease. We aimed to evaluate care for recently diagnosed IBD patients from the patient perspective and assess themes for improvement. A mixed-method study with adult IBD patients 4-15 months after diagnosis was performed. First, relevant themes were identified through semi-structured interviews until data saturation. Next, a questionnaire assessing satisfaction with care [SATI-Q] was developed and validated with 15 items divided into two domains: medical care and information and psychosocial care. Higher scores indicate higher patient satisfaction [0-100]. We interviewed 20 patients. Next, 84/107 patients completed the SATI-Q: 51% female, aged 37 years (interquartile range [IQR 25-58]), 36% Crohn's disease, disease duration 9 months [IQR 6-12] and 74% in clinical remission. The median SATI-Q score was 82 [IQR 72-92]. Patients were more satisfied with medical care than with information and psychosocial care (score 92 [IQR 81-98] vs 74 [IQR 60-90], p < 0.001). Patients were least satisfied with the attention given to IBD-related emotions and information on IBD medication, diet and future perspectives [77, 76, 57 and 54% of patients satisfied]. Patients [81%] preferred spoken information. Only 26-27% preferred brochures and websites. In this study, the SATI-Q questionnaire was developed and validated to assess patient satisfaction with care in early IBD. Our findings suggest that psychosocial care and information on IBD medication, diet influence and future perspectives for recently diagnosed IBD patients require improvement.

Inflammatory bowel diseases in Tamil Nadu: A survey of demographics, clinical profile, and practices.

BackgroundInflammatory bowel disease (IBD) is increasingly diagnosed in South Asia. This survey by the Tamil Nadu Chapter of the Indian Society of Gastroenterology (TNISG) documents the demography, clinical profile, and therapeutic practices related to IBD in Tamil Nadu.MethodsTNISG members from 32 institutions completed an online cross‐sectional questionnaire on IBD patients from March 2020 to January 2021.ResultsOf 1295 adult IBD patients, 654 had Crohn's disease (CD), 499 ulcerative colitis (UC), and 42 IBD‐unclassified (IBD‐U). CD and UC showed a unimodal age distribution. A total of 55% were graduates or postgraduates. A positive family history was noted in 30, other risk factors were uncommon. In CD, the pattern of involvement was ileocolonic (42.8%), ileal (34.7%), colonic (18.9%), and upper gastrointestinal (3.5%); while in UC, disease was characterized as extensive (44.9%), left‐sided (41.7%), or proctitis (13.4%). Perineal disease, perianal fistulae, and bowel obstruction were noted in 4.3, 14.0, and 23.5%, respectively, of CD. The most widely used drugs were mesalamine, azathioprine, and corticosteroids. Surgery was undertaken in 141 patients with CD and 23 patients with UC. Of the 138 patients with pediatric IBD (≤16 years), 23 were characterized as very early onset IBD (VEO‐IBD), 27 as early‐onset, and 88 as adolescent IBD. VEO‐IBD were more likely to have a positive family history of IBD and were more likely to have perineal disease and to have the IBD‐U phenotype. Among pediatric IBD patients, corticosteroids, mesalamine, and azathioprine were the most commonly used medications, while 25 pediatric patients received biologics.ConclusionThis study provides important information on demography, clinical profile, and treatment practices of IBD in India.

S3358 Room for Continued Improvement in Transition of Pediatric to Adult IBD Patients: Benefits and Pitfalls of a Comprehensive EMR Template

S3358 Room for Continued Improvement in Transition of Pediatric to Adult IBD Patients: Benefits and Pitfalls of a Comprehensive EMR Template

Mobile application to monitor inflammatory bowel disease patients on intravenous biologic treatment: a feasibility study

Background Monitoring of IBD patients on intravenous biologic treatment is recommended but time-consuming for patients and nurses. We developed a mobile application (app) to promote self-management and studied its feasibility in clinical practice. Methods Adult IBD patients treated with intravenous infliximab or vedolizumab used the app over four biologic treatments. The app includes information modules and an interactive timeline with notifications of blood tests and health checks before treatment. Results In total, 55 patients participated of whom 71% had Crohn’s disease and 85% used infliximab. Compliance with health checks and blood tests was 67% before the first biologic treatment and 70, 87, and 80% before the second, third, and fourth treatment, respectively. The median number of times the app was used per treatment varied from 6 to 8 times (≥4 considered sufficient). Patients were satisfied with the app [median VAS score 8 (IQR 7–9)] and remained equally satisfied with IBD care [score 8 (IQR 8–9) before and after app use]. Nurses contacted all patients by telephone before the first biologic treatment, as previous standard care. Before the second, third, and fourth treatment only 47, 35, and 49% of patients were contacted. The majority (92%) wanted to continue using the app after the study. Conclusions Monitoring of IBD patients treated with intravenous biologics using an app is feasible. We saw high compliance, sufficient app use, and high patient satisfaction. Moreover, health-care utilization was reduced and almost all patients preferred using the app over previous standard care (ClinicalTrials.gov NCT04254614).

Systematic review and meta-analysis: real-world data rates of deep remission with anti-TNF\u03b1 in inflammatory bowel disease

BackgroundDeep remission (DR) is a treatment target in IBD associated with reduced hospitalization and improved outcome. Randomized control trial (RCT) data demonstrates efficacy of anti-TNFα agents in achieving DR; however, real-world data (RWD) can provide information complementary to RCTs, specifically regarding treatment duration. In this systematic review with meta-analysis, we use real-world data (RWD) to determine rates of DR in IBD treated with anti-TNFα.MethodsWe completed a systematic search of MEDLINE and EMBASE on July 8, 2019 with review of major gastrointestinal conference abstracts from 2012 to 2019. Studies utilizing RWD (data not from phase I-III RCTs) of adult IBD patients treated with anti-TNFα agents were included. DR was defined by clinical and endoscopic remission at minimum. DR was assessed at 8 weeks, 6 months, 1 year, and 2 years. Risk of bias was assessed with the Newcastle Ottawa Scale.Results29,033 publications were identified. Fifteen publications, nine manuscripts and six conference abstracts, were included encompassing 1212 patients (769 Crohn’s disease-CD, 443 ulcerative colitis-UC), and analyzed using Comprehensive Meta-Analysis. Rate of DR was 36.4% (95% CI 12.6–69.4%) at 8 weeks, 39.1% (95% CI 10.4–78%) at 6 months, 44.4% (95% CI 34.6–54.6%) at 1 year, and 36% (95% CI 18.7–58%) at 2 years. DR in CD at 1 year was 48.6% (95% CI 32.8–64.7%) and in UC was 43.6% (95% CI 32.8–55.1%).ConclusionsThe rate of DR was highest after 1 year of therapy, in nearly 45% of IBD patients treated with anti-TNFα. Similar rates were achieved between patients with UC and CD. The findings highlight the efficacy of anti-TNFα in real-world setting. Future studies using RWD can determine efficacy of newer IBD therapeutics in routine clinical practice.

P520 ‘Eetscore’ in patients with Inflammatory Bowel Disease: an online tool to assess diet quality and provide personalised dietary advice

Abstract Background Many patients with IBD believe diet affects the course of disease and is at least as important as medication in their IBD treatment. However, easy assessment of patients’ food intake and structured support of a healthy diet are lacking. The Eetscore is an online tool which assesses diet quality and subsequently gives personal dietary advice. We used the Eetscore to assess diet quality of IBD patients, evaluated if diet quality improved over time and studied correlations with quality of life (QoL) and clinical disease activity. Methods A prospective cohort study with adult IBD patients was performed. Participants completed the Eetscore, the short IBDQ and a clinical disease activity questionnaire (P-HBI or P-SCCAI) at baseline and after 1 month. The Eetscore is a validated web-based screening tool to assess diet quality based on 16 food components (e.g. meat, vegetables, fruit and fish). It consists of a short Food Frequency Questionnaire and is scored with the Dutch Healthy Diet 2015-index based on the Dutch dietary guidelines. The score of each component ranges from 0 to 10, resulting in a total score between 0 and 160. Higher scores indicate better adherence to Dutch dietary guidelines. The Eetscore subsequently provides personalised dietary advice based on the assessment. We assessed changes over time using paired samples t-tests or McNemar’s test and correlations using Pearson’s or Spearman’s correlation. Results We included 212 participants. At time of this preliminary analysis, 175 participants (60% female, 49% Crohn’s disease) completed baseline and 1-month assessments. Their median age was 49 years [IQR 32–58], BMI 25 kg/m2 [IQR 22–28] and disease duration 10 years [IQR 4–18]. At baseline, mean Eetscore was 98 ± 19, with highest median scores (≥8.5) on red meat, fat and oils, sweetened beverages, alcohol and salt intake, and lowest median scores (≤5) on nuts, legumes, processed meat and unhealthy choices (Figure 1). Diet quality increased with 5.6 points (95%CI 3.7–7.5) to a mean Eetscore of 103 ± 21 (p&amp;lt;0.001) after 1 month. QoL improved from 53 ± 10 to 55 ± 9 (∆2.0 (95%CI 1.2–2.8); p&amp;lt;0.001). The proportion of participants with clinically quiescent disease was comparable at both time points (71% vs 74%, p=0.29). Diet quality was not correlated with QoL or clinical disease activity. Conclusion This study suggests the Eetscore is a useful tool to monitor and support a healthy diet in IBD patients. Diet quality improved significantly following personalised dietary advice of the Eetscore. Short term results did not indicate a correlation between diet quality and QoL or clinical disease activity.

P515 A 12-week tailored physical training program including dietary advice in children with Inflammatory Bowel Disease: a randomized crossover trial

BackgroundInflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract. Recently, physical activity has been suggested to improve the quality of life and course of disease in adult IBD patients. The aim of this study was to investigate physical functioning in paediatric IBD patients and to determine the effects of a tailored 12-week lifestyle intervention including a physical training program.MethodsFigure 1 shows our study design and measurements. The tailored 12-week lifestyle intervention consisted of 3 strenuous physical training sessions a week and dietary advice. Effects on exercise capacity, endurance, physical activity levels, disease activity, quality of life, and fatigue were measured in paediatric IBD patients. Mild disease activity was defined as a PCDAI between 10 - 27.5 or PUCAI between 10 - 34. ResultsSixteen paediatric IBD patients (median age 15 [9 - 17]) were included, 13 patients successfully completed the training program, 2 patients are still participating. At baseline, most patients had mild disease activity (n=9). Patients had reduced exercise capacity (76.8%±17.7% of predicted PeakVO2 , and reduced physical activity levels as shown by 80.3%±7.4% of measured time being spent in sedentary activity. PCDAI/PUCAI scores decreased significantly over the intervention period (13.8±11.7 vs. 3.65±4.5, P=0.002). Fecal calprotectin also decreased significantly (400 [18–3089] vs. 128 [20–2704], P=0.041). All patients but one had no changes in medical regimens before or during the lifestyle intervention that could have influenced disease activity. After the 12-week lifestyle intervention period, 9 out of 13 patients were in clinical remission. Maximum walked distance increased significantly (503±69 vs. 540±77 meters, P=0.001), although PeakVO2 and percentage of time spent in moderate-to-vigorous activity did not. Patients improved on overall quality of life measured by the Impact III questionnaire (+2.4 points, p=0.017). The Child Health Questionnaire showed a significant improvement on the child-reported physical functioning scale and on 5 parent-reported scales of quality of life. Child-reported fatigue measured by the PedsQol MFS did not improve significantly, parents-reported fatigue did. No changes were found on mentioned outcomes during the control period. After baseline measurements, the COVID-19 lock-down period started, possibly affecting normal daytime activities of the patients during the lifestyle intervention period.ConclusionA 12-week tailored physical training program including dietry advice is safe and beneficial for paediatric IBD patients and may contribute to better control of inflammation.

P213 Having Inflammatory Bowel Disease Negatively Impacts Household and Family Life

Abstract Background Inflammatory bowel disease (IBD) can have a major impact on different aspects of life. This study aimed to provide insight into the impact of IBD on household and/or family life, and to determine whether this differed between sex. Methods Between September and December 2020, adult IBD patients from the outpatient clinic of the Erasmus Medical Center (Rotterdam, the Netherlands) were invited to fill out a survey. A questionnaire was developed to measure the impact of IBD on functioning in the household and on family planning. Generic disability and work disability were measured with the IBD Disability Index (IBD-DI) and the Work Productivity and Activity Impairment Questionnaire (WPAI-IBD). Data were analysed using descriptive statistics and tests for independent groups. Results Of the 229 patients who participated (response rate 74%), 68% had Crohn’s disease, 69% was female and the median age was 38.0 years. Many patients experienced difficulties with domestic activities (55.0%), leisure (53.9%), parenting (50.6%), sexual activities (48.4%) and interpersonal relationships (39.1%) because of IBD in the past week. Furthermore, 32.7% of patients felt that IBD interfered with their desire to have children. Female sex was associated with more severe limitations in various aspects of household life, more interference in family planning and higher generic disability scores. Conclusion IBD had a markedly negative impact on household and/or family life in many patients. In order to optimize patient care, physicians need to be aware of household and family related difficulties and strive for a holistic treatment approach.

P392 A mobile application to monitor Inflammatory Bowel Disease patients during intravenous biologic treatment: Results of a feasibility study

Abstract Background Active monitoring of IBD patients during intravenous (iv) biologic treatment is recommended but time-consuming and inconvenient for both patients and nurses. We developed a mobile application to promote self-management and monitor IBD patients cost-effectively during iv biologic treatment. We aimed to study the feasibility of the mobile application. Methods A prospective cohort study was performed in a secondary care centre with adult IBD patients treated with infliximab (iv) or vedolizumab (iv) for at least three months. The mobile application was used during four rounds of iv biologic treatment (figure 1). The application includes information modules and a personal interactive timeline with messages one week prior to iv biologic treatment (figure 1). Patients are asked to fill in a health check prior to each treatment to screen for contra-indications, such as respiratory infections or severe side-effects. Patients can also note any particularities or request contact with the IBD nurse. Blood tests are performed before every other infusion. Previously, patients were contacted by telephone prior to each biologic treatment by the IBD nurse. Using the application, patients are only personally contacted in case of abnormalities or upon request. Results Of 55 included patients, 52 patients completed the study. Mean age was 42 years (min 19 – max 68), 71% had Crohn’s disease, 76% had clinically quiescent disease, 85% used infliximab and 15% vedolizumab. Most patients used internet for over three years (98%) and their smartphone or tablet every day (98%). Compliance to health checks and blood tests was 67% during the 1st round of biologic treatment and 70%, 87% and 80% during the 2nd, 3rd and 4th round respectively. Patients used the application between median 6 (IQR 5 – 9) and 8 (IQR 5 – 11) times per round of biologic treatment. Patient satisfaction with the application was median 8 (VAS score, IQR 7 – 9). Prior to the 1st round of biologic treatment, all patients (100%) were contacted by telephone as in previous standard care. Using the application the number of patients requiring telephone contact decreased to 47%, 35% and 49% before the 2nd, 3rd and 4th round respectively. Patients remained equally satisfied with IBD care: median VAS score 8 (IQR 8 – 9) before and after implementation of the mobile application. The majority of patients (92%) wanted to continue using the application after the study ended. Figure 1: Study procedures Conclusion Monitoring of IBD patients treated with biologics using a mobile application is feasible. We saw a high compliance and satisfaction of patients, and reduction of health-care utilization. Almost all patients preferred using the application over previous standard care.

Acceptance and Perceived Control are Independently Associated With Quality of Life in Inflammatory Bowel Disease: Introduction of a New Segmentation Model.

Segmentation of patients based on psychological determinants of subjective health may provide new ways to personalized care. The cross-disease segmentation model developed by Bloem & Stalpers discriminates patients based on disease acceptance and perceived control. We aimed to validate the segmentation model, compare segments and evaluate whether segments independently correlate with quality of life in inflammatory bowel disease [IBD]. A cross-sectional study of adult IBD patients was performed with questionnaires on quality of life [32-item inflammatory bowel disease questionnaire], acceptance and perceived control [six items with 7-point Likert scale]. Four segments were formed [cut-off > 5]: [I] high acceptance, high control; [II] high acceptance, low control [III]; low acceptance, high control and; [IV] low acceptance, low control. We included 686 patients. The acceptance and perceived control scales were unidimensionally structured and internally consistent. Segments differed significantly in age, smoking behaviour, diagnosis, disease duration, extra-intestinal manifestations, IBD medication, clinical disease activity and quality of life. High acceptance (standardized beta coefficient [ß] 0.25, p < 0.001), high perceived control [ß 0.12, p < 0.001] or both [ß 0.53, p < 0.001], were associated with a significantly better health-related quality of life compared with low acceptance and low perceived control. Sociodemographic and clinical factors explained 25% of the variance in quality of life. The explained variance significantly increased to 45% when the patients' segment was added to the model [ΔR2 20%, p < 0.001]. The segmentation model based on disease acceptance and perceived control is valid in IBD patients and discriminates different segments that correlate independently with quality of life. This may open new strategies for patient care.

The impact of vedolizumab on COVID-19 outcomes among adult IBD patients in the SECURE-IBD registry

The impact of vedolizumab on COVID-19 outcomes among adult IBD patients in the SECURE-IBD registry

The Impact of Vedolizumab on COVID-19 Outcomes Among Adult IBD Patients in the SECURE-IBD Registry.

BackgroundThe impact of immune-modifying therapies on outcomes of coronavirus disease 2019 [COVID-19] is variable. The purpose of this study was to determine the impact of vedolizumab [VDZ], a gut-selective anti-integrin, on COVID-19 outcomes in inflammatory bowel disease [IBD] patients.MethodsUsing data from the Surveillance of Coronavirus Under Research Exclusion for IBD [SECURE-IBD], an international registry of IBD patients with confirmed COVID-19, we studied the impact of VDZ on COVID-19 hospitalization and severe COVID-19 [intensive care unit stay, mechanical ventilation and/or death].ResultsOf 3647 adult patients on any IBD medication in the registry, 457 [12.5%] patients were on VDZ. On multivariable analyses using backward selection of covariates, VDZ use was not associated with hospitalization or severe COVID-19 when compared with patients on all other medications (adjusted odds ratio [aOR] 0.87; 95% confidence interval [CI] 0.71, 1.1 and aOR 0.95; 95% CI 0.53, 1.73, respectively). On comparing VDZ monotherapy to anti-tumour necrosis factor [anti-TNF] monotherapy, the odds for hospitalization, but not severe COVID-19, were higher [aOR CI 1.39; 95% CI 1.001, 1.90 and aOR 2.92; 95% CI 0.98, 8.71, respectively]. In an exploratory analysis, VDZ monotherapy, compared to anti-TNF monotherapy, was associated with new-onset gastrointestinal symptoms at the time of COVID-19, especially among patients whose IBD was in remission.ConclusionsCOVID-19 outcomes among IBD patients on VDZ are comparable to those on all other therapies. Hospitalization, but not severe COVID-19, is more likely with VDZ monotherapy than with anti-TNF monotherapy. Overall, VDZ appears to be safe in IBD patients with COVID-19.

S3204 Patients With BMI &gt;25 Less Likely to Achieve Clinical Response to Anti-TNF or Tofacitinib but Not Mucosal Healing

INTRODUCTION: Increasing evidence suggests that obesity has a negative impact on disease outcomes in inflammatory bowel disease. We aimed to further explore the effect of obesity on treatment response. METHODS: We conducted a retrospective observational cohort study of 157 adult IBD patients receiving either anti-tumor necrosis factor (TNF) therapy or tofacitinib at a single referral center from 2016 to 2020. We assessed the impact of obesity on treatment response as measured clinically and endoscopically. Obesity was defined as a Body Mass Index of ≥25 which encompasses overweight and obese individuals. RESULTS: A BMI of ≥25 at the time of treatment initiation was observed in 25% of patients (n = 23 Crohn’s disease, n = 27 ulcerative colitis). Baseline disease severity was not significantly different between patients with a BMI ≥25 versus those less than 25. Persistent clinical symptoms were observed in 17% (n = 7) of the BMI ≥25 patients versus 9% (n = 8) of the normal BMI patients (P = 0.03). Conversely, persistent endoscopic inflammation was observed in 33% (n = 14) of the BMI ≥25 patients and 50% (n = 44) of the normal BMI patients (P = 0.04). When stratified by biologic type, this effect of obesity on treatment response was greatest among tofacitinib treated individuals. CONCLUSION: In this single-center observational cohort study, we observed an effect of obesity on treatment clinical response which appeared most prominent among tofacitinib treated individuals. However, this was not seen in mucosal healing. Further research in larger cohorts is needed to confirm this observation and better understand potential mechanisms for non-response.

TNF Inhibitors and Risk of Malignancy in Patients with Inflammatory Bowel Diseases: A Systematic Review.

The association between tumour necrosis factor inhibitors [TNFi] and malignancy in patients with inflammatory bowel disease [IBD] is not well understood. Our aim was to systematically evaluate the impact of TNFi use on risk of malignancy in IBD patients in daily clinical practice. We searched Pubmed, Embase and Scopus until March 1, 2020 for observational cohort studies on adult IBD patients reporting malignancy occurrence and TNFi use. Twenty-eight studies [20 retrospective and eight prospective] were included, involving 298 717 IBD patients. Mean age at inclusion ranged from 28 to >65 years. Mean follow-up varied from 7 to 80 months. Infliximab was the most frequently used TNFi [13/28 studies, 46.4%], followed by adalimumab [3/28, 10.7%], while both infliximab and adalimumab were evaluated in five studies [17.8%]. In total, 692 malignancies were diagnosed in IBD patients treated with TNFi, accounting for an overall occurrence of 1.0%. The most frequent malignancies were non-melanoma skin cancers [123/692, 17.8%], digestive malignancies [120/692, 17.3%] and haematological malignancies [106/692, 15.3%]. The association between TNFi and malignancy was evaluated in 11 studies [39.3%]: no significant association was found in ten studies, while an increased risk of lymphoma in patients exposed to TNFi was reported in one study. TNFi treatment is not associated with an increased risk of malignancy in IBD patients in real-life settings. Further large studies are needed to assess the prognosis of patients exposed to TNFi and risk of recurrence or new cancers in subjects with personal malignancy history.

Limited added value of laboratory monitoring in thiopurine maintenance monotherapy in inflammatory bowel disease patients.

To timely detect myelotoxicity and hepatotoxicity, laboratory monitoring at 3-month intervals is advised throughout thiopurine maintenance treatment for IBD. However, reported incidence rates of myelotoxicity and hepatotoxicity in maintenance treatment are low. To assess incidence rates and clinical consequences of myelotoxicity and hepatotoxicity in thiopurine maintenance therapy after at least 1year of thiopurine treatment. Retrospective analysis of therapy adjustment for laboratory toxicity in adult IBD patients after 12 consecutive months of azathioprine (AZA) or mercaptopurine monotherapy (ie baseline) between 2000 and 2016. Incidence rates of laboratory toxicity (ie myelotoxicity [leucocyte count <4.0×10e9/L, and/or platelet count <150×10e9/L] and/or hepatotoxicity (gamma-glutamyltransferase [GGT], alkaline phosphatase [AP], ALT and/or AST above ULN, excluding isolated increased AST/AP]) and associated diagnostic procedures and complications were assessed. In total, 12,391 laboratory assessments were performed on 1132 patients (56% female, AZA 74%) during 3.3years of median follow-up. Median monitoring frequency was 3.1 assessments/treatment year. Only 83/12,391 (0.7%) assessments resulted in therapy adjustment, dose reduction in 46 patients, cessation in 28 and allopurinol initiation in nine; risk of therapy adjustment was 1.9% per treatment year. Incidence rates of myelotoxicity were 7.1% (5.1% mild/1.8% moderate/0.1% severe) and hepatotoxicity 5.1% (3.8% mild/1.1% moderate/0.2% severe) per treatment year. Treatment-related complications with concurrent laboratory toxicity occurred in 12 patients (1.1%) and would not have been prevented by monitoring. Severe laboratory toxicity is uncommon after 1year of thiopurine monotherapy at 4-month monitoring intervals. Therapy adjustments are rare after detection of laboratory toxicity. After 1year of thiopurine monotherapy, laboratory monitoring may be lowered to less than a 4-month interval.

A67 EVALUATING ACCESS TO IBD CARE ACROSS CANADA: PROCEEDINGS FROM THE 2017 IBD ACCESS SUBMMIT

Abstract Background Inflammatory Bowel Disease (IBD) is a chronic, immune-mediated disease, with Canada demonstrating the highest incidence and prevalence rates in the world. Patients with IBD often require lifelong treatment and, therefore, lifelong interactions with the healthcare system. Access to care can have a direct impact on patient health-related outcomes. Although acknowledged as a problem, the complexity of accessing IBD specialty care in Canada has not been reviewed. This lack of understanding presents a barrier in evaluating and implementing changes in IBD specialty care. Aims To identify key barriers and facilitators for and to develop a national working strategy to address limitations in access to IBD specialty care by exploring the perceptions and experiences of key stakeholders (pediatric and adult gastroenterologists, IBD patients, researchers, and policy makers). Methods The IBD Summit was held in Toronto, Ontario in November 2017, sponsored by SPOR-CIHR catalyst funding and in partnership with Crohn’s &amp; Colitis Canada. Perceptions and experiences of key stakeholders were gathered during two audio-recorded stakeholder dialogues held during the Summit. The audio recordings were transcribed and coded to compare and contrast between key stakeholders to determine potential differences in access to IBD care. Five final themes are highlighted in this report. Results A total of 21 key stakeholders attended, including pediatric and adult gastroenterologists, patients, researchers, and policy makers. Five key themes of importance relating to access to IBD care arose from The IBD Summit:(1) Integrated Models of Care, (2) IT Enhanced Care, (3) Health System Process, (4) Communication and Advocacy, and (5) Community Supports. The IBD Summit identified similar perceptions and experiences, highlighting common barriers and facilitators that transcend provincial borders. Shared perceptions included a need for common medical records and overall improved IT-enhanced care for managing IBD; improved centralized triage systems; increased comprehensive care support for patients and primary care physicians; and increased community supports for patients and providers. Conclusions Highlights from the IBD Summit present several clinically relevant and actionable suggestions for improved access to IBD speciality care across Canada. The suggestions provided by key stakeholders highlight the need for a system-level redesign in order to improve access to enhanced models of care. Improvements in access to IBD specialty care can only occur through partnerships between those working within the healthcare system and those within the community. Future research will involve pursuing deeper insight into the experience of patient and provider stakeholders as they navigate the healthcare system in order to access and provide care. Funding Agencies CIHRNova Scotia Health Authority Research Fund