Adult Inflammatory Bowel Disease Research Articles

Nursing Interventions Targeting Fatigue in Inflammatory Bowel Disease: A Systematic Review

A prevalent symptom among Inflammatory Bowel Disease (IBD) patients is fatigue, characterized by a persistent sense of energy depletion that affects all aspects of daily life. This review aims to evaluate nursing interventions reported in the literature to alleviate fatigue in IBD patients. A comprehensive search was conducted across four electronic databases—PubMed, CINAHL, Cochrane, and Scopus—and four scientific journals: “Gastroenterology”, “Inflammatory Bowel Disease”, “Journal of Crohn’s and Colitis”, and “United European Gastroenterology Journal”. Inclusion criteria were clinical trials involving adult IBD patients in remission or mild disease activity. Out of 234 studies, 2 were selected for review. These studies assess the effectiveness of Solution-Focused Therapy (SFT) that emphasizes solving problems and developing strategies for improvement, and Problem-Solving Therapy (PST) that focuses on identifying problems and coping strategies. SFT showed a positive impact on fatigue with a significant improvement in the Checklist Individual Strength after three months: 45.5% in the control group, 85.7% in the SFT group, and 60% in the PST group, but its impact declined over time. Additionally, SFT demonstrated potential for reducing healthcare costs compared to standard of care and PST. Further research is needed to provide nurses interventions for managing fatigue in IBD patients. The review protocol has been registered at OSF.io.

Measured and predicted resting metabolic rate in patients with inflammatory bowel disease

ObjectiveThe present study aimed to compare measured and estimated resting metabolic rate (RMR) predicted by selected equations in patients with nonactive inflammatory bowel disease (IBD) on an outpatient university clinic regimen. Research Methods & ProceduresSeventy-two adult (≥20 years) IBD patients (45 with Crohn's disease-CD) had RMR measured (mRMR) by indirect calorimetry and also estimated by predictive equations (Cunningham, Henry, Anjos et al., and Marra et al.). Body composition was assessed by DXA. Absolute Bias (estimated - mRMR) and % Bias (Bias/mRMR) were calculated. Agreement was assessed as the limit of agreement (LoA) in the Bland & Altman approach. ResultsThere was no difference in age, body composition and mRMR between individuals with CD (5414.2 ± 1023.7 kJ/day) and ulcerative colitis (5443.9 ± 1008.9 kJ/day). Among the equations, only the Anjos et al.'s population-specific equation (-52.1 [642.0] kJ/day, P = 0.493; LoA: -1311; 1206 kJ/d) accurately estimated RMR. The equations of Marra et al. produced the highest % Bias (24.1 ± 14.8%). The Bland & Altman plots showed that the range of the LoA was relatively similar for all equations. In the simple regression analysis, the model with FFM resulted in a higher coefficient of determination (R2 = 0.51 for DC 0.74 for UC) compared to the model that included BM (R2 = 0.35 for DC and 0.65 for UC). ConclusionsAmong the equations analyzed, only Anjos et al.'s accurately estimated RMR in outpatients with nonactive IBD. However, caution is advised when applying it at the individual level, due to the wide observed LoA.

Identification and prioritization of patient-centred strategies to enhance IBD-related care for older adults: a modified Delphi approach

Abstract Background The older adult age group makes up one of the fastest-growing groups of individuals with inflammatory bowel disease (IBD). It is important to hear the perspectives of older adults living with IBD about care experiences and managing their illness. The purpose of this patient-oriented study was to identify and prioritize patient-centred strategies that have the potential to enhance IBD-related care for older adults in Saskatchewan. Methods The interprofessional research team, consisting of older adult individuals living with IBD, gastroenterology providers, and researchers specializing in IBD or older adult education used a modified Delphi approach to identify and prioritize strategies that may enhance IBD-related care for older adults. Thirty-one older adults with IBD participated in ranking, revising, and prioritizing statements related to their chronic illness care. Nine statements were developed that highlighted strategies for older adult IBD care. Results Through the consensus process, 6 statements were retained. Co-creating a treatment plan with the IBD provider was ranked as the top priority statement for older adults with IBD. Conclusion Facilitating collaborative relationships and understanding individual priorities for IBD-related care for older adults has the potential to enhance positive health outcomes and quality of life for these individuals.

Development and validation of stability-indicating method of etrasimod by HPLC/DAD/MS/MS technique with greenness profiling

Etrasimod, a novel selective sphingosine-1-phosphate receptor modulator, was recently approved by the U.S. Food and Drug Administration and the European Medicinal Agency for the treatment of moderately to severely active ulcerative colitis in adults. In this research, the forced degradation study as an integral part of drug product and packaging development, which generates data on degradation mechanisms, is published. The development and validation of the stability-indicating method using a superior high-performance liquid chromatography technique coupled with a diode array detector and tandem mass spectrometer was performed to support the forced degradation study and monitor the formation of degradation products. Etrasimod demonstrated good stability under elevated temperature and basic stress conditions, while acidic hydrolysis, oxidative, and photolytic degradation produced eight degradation products. The knowledge of degradation products will be useful in the long-term stability study for establishing the acceptance criteria of etrasimod as a drug substance and dosage form during quality control and stability assessment. The eco-friendliness of the developed forced degradation procedure was evaluated using various greenness appraisal tools. The green metric tools showed that the forced degradation procedure obeys eco-friendly conditions.

Serum CXCL 9 as a Potential Biomarker for Patients with Ulcerative Colitis

Background: Ulcerative colitis (UC) is an inflammatory bowel disease restricted to the large intestine, characterized by superficial ulceration. It is a progressive and chronic disease requiring long-term treatment. Although its etiology remains unknown, it is suggested that environmental factors influence genetically susceptible individuals, leading to the onset of the disease. (C-X-C) ligand 9 is a chemokine that belongs to the CXC chemokine family, it plays a role in the differentiation of immune cells such as cytotoxic lymphocytes, natural killer T cells, and macrophages. Its interaction with its corresponding receptor CXCR3 which is expressed by a variety of cells such as effector T cells, CD8+ cytotoxic T cells, and macrophage, leads to stimulation of the production of IFN-γ and TNF-α and in turn, stimulates the production of Th1 chemokines which results in promoting the inflammation. Objectives: To assess the significance of serum chemokine (C-X-C) ligand 9 as a potential marker for identifying ulcerative colitis in adults with inflammatory bowel disease. Patients and Methods: This is a case-control study that included 50 patients diagnosed with UC, aged between 18 and 75 years, compared to 50 healthy controls, aged between 18 and 60 years. The study was conducted between November 2022 and March 2023, at the Gastroenterology and Hepatology Teaching Hospital at the Medical City Complex in Baghdad. The serum samples were analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Results: The mean ± SD in pg/ml of serum CXCL9 in patient group was 26.9 ± 9.05 and in control group was 6.4 ± 2.37 (p< 0.0001) which indicates a highly significant difference. Conclusion: CXCL 9 may be employed as a biomarker for identifying ulcerative colitis and it can be used as a tool for measuring disease activity, in addition to the possibility of being a potential therapeutic target.

The Transitioning From Pediatric to Adult Inflammatory Bowel Disease Services: A Qualitative Study of Adolescents and Their Parents.

Inflammatory bowel disease (IBD) often has its onset during late childhood and adolescence, a time of significant change. Young people may be required to transition from a pediatric to an adult IBD service during this time. The transition from pediatric to adult services can be a high-risk period for poor outcomes for emerging adults with IBD. We seek to understand the concerns of patients and carers during this period. Semi-structured interview and interpretative phenomenological analysis were used to explore the experiences of 16 young persons and 10 of their parents during transition. The narrative analysis reflected the importance of three aspects of transition to the young people and their parents during transition. The process of adjusting to illness, parents letting go, and the young person "growing up" were key themes. In addition to patient needs, parental grief and adjustment may be easily overlooked in the transition period: children who only recently needed intensive parental care and involvement may now be seeking higher degrees of autonomy. These findings indicate a role for including psychological interventions addressing the well-being of parents in transition programs.

Vaccine Acceptance in Patients with Inflammatory Bowel Disease: Lessons Learned from the COVID-19 Pandemic.

Immunomodulating therapies, which are commonly used in patients with Crohn's disease (CD) and ulcerative colitis (UC), have been linked to an increased risk of contracting opportunistic infectious diseases, the majority of which are preventable through vaccination. Nonetheless, vaccination rates in these patients are suboptimal, and frequently lower than in the general population. The COVID-19 immunization schedule provided a new scenario for investigating vaccine acceptance in patients with inflammatory bowel disease (IBD), with uncertainty and concerns emerging and the number of subjects receiving the third and fourth doses of the vaccine gradually decreasing. This study investigated IBD patients' attitudes towards previous COVID-19 vaccine programs and identified the factors that influence their adherence. It considered demographic and disease-related factors as well as the role of gastroenterologists and primary care physicians (PCPs). Data were collected through a self-completed questionnaire administered to all adult IBD patients (age > 18) who visited the Gastroenterology, Hepatology, and Nutrition division at the University of L'Aquila (Italy) for a regular follow-up between November 2021 and December 2022. Non-IBD gastroenterological outpatients who visited during the same period were included as a control group. A total of 178 patients were included in the analysis. The IBD group consisted of 77 patients, 48.1% with CD and 51.9% with UC; the mean age was 49.5 years and 51.9% were female. Overall, 94.8% of IBD patients had undergone at least one vaccine dose and 79.2% had received two doses, versus 8% of the control group (p < 0.0001). A total of 84.4% of IBD patients reported their propensity towards COVID-19 vaccination, with an average agreement score significantly higher than the controls (p = 0.0044). The trust of IBD patients in the effectiveness of the COVID-19 vaccine (p < 0.0001) and its role in hastening pandemic resolution (p < 0.0001) is strongly related to motivation and propensity. Concerns about the safety of the COVID-19 vaccine in IBD (p = 0.0202) and fear of vaccine-induced flare-ups (p = 0.0192) were reported as the main barriers. No correlation was found between COVID-19 vaccine propensity and clinical features like the type of IBD, years of disease, activity, and ongoing treatment. Regarding the recommendations received from physicians to get vaccinated against COVID-19, IBD patients relied heavily on their gastroenterologists for advice, while the control group relied mainly on their PCPs. The overall positive attitude towards vaccinations reported in our study was better than that observed for other vaccines. The relationship of trust with the gastroenterologist should be used to boost vaccination against other preventable diseases in IBD patients. Our findings add information on the factors influencing vaccine propensity, which can be used to improve current vaccination strategies.

Biomarkers predicting the effect of anti-TNF treatment in paediatric and adult inflammatory bowel disease.

Paediatric and adult inflammatory bowel disease (pIBD, aIBD) patients may lose response to anti-TNF treatment within the first year. Adult-extrapolated weight-based dosing is incorrect in children, due to age-related pharmacokinetic differences. We investigated biomarkers for initial and maintenance of response to infliximab (IFX) or adalimumab (ADA), comparing pIBD and aIBD patients. In this prospective, observational study, pIBD (n = 24) and aIBD (n = 21) patients were included when initiating anti-TNF. Escalation from standard dosing and continued anti-TNF at 12 and 18 months were assessed. Biomarkers included clinical laboratory parameters, faecal calprotectin (FCP) and IFX trough levels (TLs). Plasma proteomics was performed in pIBD. During our study, treatment escalation (in clinical loss of response) occurred more common in pIBD versus aIBD (p = 0.02). We established that IFX therapy escalation in pIBD patients was not due to low infliximab levels. We identified 9 pro-inflammatory proteins that were elevated in patients losing response. Anti-TNF exposure-response relationship may be different in pIBD versus aIBD. No biomarkers for maintained response were identified, but 9 inflammatory proteins were of interest as potential predictors for loss of response in pIBD.

Association between dietary inflammation index and inflammatory bowel disease in adults: Results from National Health and Nutrition Examination Survey 2009-2010.

Previous study has demonstrated that the Dietary Inflammation Index (DII) played a role in the risk of inflammatory bowel disease (IBD), however, the prevalence and risk factors for IBD are distinct across locations and groups, and therefore, the findings are debatable and warrant further investigation. A total of 4363 participants were calculated in the National Health and Nutrition Examination Survey (NHANES) 2009 to 2010, of whom 1.21% self-reported a history of IBD. DII values were performed as a good predictor of dietary inflammation based on data from two 24-h dietary reviews in the NHANES database. Comparing the multifarious effects along with variations of the whole population by grouping populations according to DII quartiles, dietary inflammation levels increased progressively from DII quartile 1(Q1) to quartile 4(Q4). The association between DII and IBD was tested with multi-variable logistic regression models, subgroup analyses and weighted generalized additive models. Participants in the Q4 group showed the highest levels of C-reactive protein and reduced haemoglobin and albumin levels. Logistic regression confirmed the odds ratios (95% confidence intervals) of IBD for DII were 0.99 (0.86, 1.15), 0.97 (0.84, 1.13) and 0.80 (0.66, 0.98) in models 1, 2 and 3, respectively. The negative correlation between DII and IBD among United States adults from the NHANES database became increasingly apparent as covariates were adjusted. Subgroup analyses and smoothed curve fitting confirmed the inverse results. The study revealed that DII was correlated with the overall physical well-being of participants. However, there was no significant association between DII and IBD.

Consistent efficacy outcomes between phase 2 and phase 3 trialsin Crohn's disease or ulcerative colitis in adults: a meta-analysis.

The approval of novel biologic agents and small molecules for the treatment of Crohn's disease (CD) and ulcerative colitis (UC) is dependent on phase 3 randomized controlled trials (RCTs). However, these trials sometimes fail to achieve the expected efficacy outcomes observed in phase 2 trials. We conducted a systematic review of RCTs that evaluated biologic agents and small molecules using paired regimens in both phase 2 and phase 3. We searched Medline, EMBASE, and Cochrane databases up until February 13, 2024. The revised Cochrane tool was utilized to assess the risk of bias. A generalized linear mixed-effects model (GLMM) was employed to estimate the odds ratios (ORs) for efficacy outcomes in phase 2 trials compared to phase 3. We identified a total of 23 trials with 10 paired regimens for CD and 30 trials with 11 paired regimens for UC. The GLMM analysis revealed that phase 2 CD trials had higher outcomes measured by the Crohn's Disease Activity Index (CDAI) by 9-13% without statistical significance: CDAI-150: OR, 1.12 (95% CI 0.83-1.51, p = 0.41); CDAI-100: OR, 1.09 (95% CI 0.88-1.35, p = 0.40); or CDAI-70: OR, 1.13 (95% CI 0.61-2.08, p = 0.66). For UC, two efficacy outcomes were estimated to be equally reported in phase 2/phase 3 pairs: clinical remission: OR, 1.00 (95% CI 0.83-1.20, p = 0.96); endoscopic improvement: OR, 0.98 (95% CI 0.83-1.15, p = 0.79). However, the rate of clinical response was underestimated in phase 2 by 19%: OR, 0.81 (95% CI 0.70-0.95, p = 0.03). The inclusion criterion for the type of Mayo score for UC had a significant interaction with the study phase to influence the difference in clinical response (p = 0.002). Our findings suggest that the main efficacy outcomes for CD and UC remain consistent between phase 2 and phase 3 trials, except for UC response rates. The efficacy data obtained from phase 2 trials can be considered reliable for the design of subsequent phase 3 trials. PROSPERO (CRD42023407947).

Perceptions, behaviours and barriers towards exercise practices in inflammatory bowel disease.

Inflammatory bowel disease (IBD), a chronic disease affecting the digestive tract, has a significant impact on health-related quality of life. Pharmaceutical treatment is typically adopted, yet exercise is increasingly becoming recognized as an adjunct therapy. This study aimed to explore the perspectives, behaviours, and barriers of IBD patients in terms of their exercise habits. A 16-item closed-ended questionnaire was completed by 463 adult IBD patients (Ulcerative colitis = 57.02%, Crohn's dis-ease = 40.60% and Other = 2.38%) (Female = 76.67%, Male = 22.46 and Non-binary = 0.86%). The questionnaire was divided into three sections: baseline/demographic characteristics, disease characteristics, and exercise perceptions, beliefs, and behaviours. Significantly (P<0.001) more participants (63.07%) reported that they engage regularly with exercise compared to those who do not; however, engagement was significantly lower in female patients (59.72%) compared to males (74.04%). Respondents also rated significantly (P<0.001) that a combination of factors prevents engagement in exercise (74.30%). Moderate intensity exercise was the predominant (P<0.001) aerobic modality (39.04%), the majority (P<0.001) response was that patients undertake no resistance training (27.74%), and significantly more (P<0.001) patients indicated that they don't know whether resistance training can influence IBD either positively (57.53%) or negatively (62.33%). Whilst it is encouraging that IBD patients are engaging regularly with exercise, the reduced levels of engagement in females and lack of knowledge/ engagement with resistance training, indicate that future implementation and educational developments are necessary to enhance exercise in females and resistance training engagement in all IBD patients.

Inflammatory Bowel Disease exercise and diet (IBDeat) habits study: exploring lifestyle habits and cardiometabolic disease risk factors

Patients with inflammatory bowel disease (IBD) have higher risk of developing cardiometabolic diseases due to chronic gut and systemic inflammation which promotes atherogenesis. Adopting healthy lifestyle habits can prevent development of cardiometabolic diseases, but can be challenging for people with IBD. The IBD exercise and diet (IBDeat) habits study describes the lifestyle habits and cardiometabolic disease risk factors of adults with IBD in Aotearoa, New Zealand (NZ).This is a cross-sectional study including adult NZ IBD patients recruited online via Crohn’s and Colitis NZ and Dunedin hospital from 2021 to 2022. An online questionnaire collected demographics, smoking status, comorbidities, medications, disease severity scores, quality of life, physical activity, and dietary intake. The Dunedin cohort had physical measurements taken including anthropometrics, handgrip strength, blood pressure, body composition (bioelectrical impedance), blood nutritional markers, and faecal calprotectin. Data were compared to established reference values and linear regression analysis investigated associations between lifestyle habits and cardiometabolic risk factors. The study received University of Otago ethical approval (reference: H21/135). A total of 213 adults with IBD (54% Crohn’s disease; 46% ulcerative colitis) completed the online questionnaire and a subset of 102 from Dunedin provided physical measurements. Participants characteristics were: median age 37 (IQR 25, 51) years, 71% female, 82% NZ European, 4% smokers, and 1.4% had active IBD. Thirty-five percent of participants had at least one comorbidity and 34% of participants had poor quality of life. Known dietary risk factors associated with cardiometabolic diseases were common: low intakes of vegetables (77%), fruit (51%), fibre (35%) and high intakes of total fat (84%) and saturated fat (98%). Physical activity recommendations were met by 61% of participants and 63% reported barriers to being more active from fatigue (63%) and joint pain (54%). Other cardiometabolic risk factors were common in the Dunedin cohort: high LDL (79%) and total cholesterol (76%), central adiposity (64%), high body fat percentage (44%), high blood pressure (26%), and low handgrip strength (25%). Regression analysis showed that vegetable (per serve) and carbohydrate (per 5% of total daily energy intake (TE)) were associated with 0.22 mmol/L (95%CI 0.43, 0.013) and 0.20 mmol/L (95%CI 0.34, 0.057) lower LDL cholesterol. Discretionary food items were associated with higher LDL cholesterol, 0.11 mmol/L per daily serve (95%CI 0.028, 0.19). A 5% difference in TE intake from carbohydrate was associated with 1.11% (95%CI 2.22%, 0.0038%) lower body fat percentage while protein was associated with 3.1% (95%CI 0.81%, 5.39%) higher body fat percentage. Physical activity had weak associations with cardiometabolic disease risk factors. Adults with IBD have multiple modifiable risk factors for cardiometabolic diseases. Vegetable and carbohydrate intake were associated with lower LDL cholesterol concentration while discretionary food items showed otherwise. Protein intake was associated with higher body fat percentage.

Dietary therapies for adult and pediatric inflammatory bowel disease.

Diet is an environmental exposure implicated in the development of inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). Dietary therapy is also a tool for management of these conditions. Nutrition therapy for IBD has been shown to reduce intestinal inflammation, promote healing, and alleviate symptoms, as well as improve patients' nutrition status. Although the mechanisms of action of most nutrition therapies for IBD are not well understood, the diets are theorized to eliminate triggers for gut dysbiosis and mucosal immune dysfunction associated with the typical Western diet. Exclusive enteral nutrition and the Crohn's disease exclusion diet are increasingly being used as the primary treatment modality for the induction of remission and/or maintenance therapy in children, and in some adults, with CD. Several other diets, such as the Mediterranean diet, anti-inflammatory diet for IBD, and diets excluding gluten, FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), lactose, or other compounds, may be helpful in symptom management in both CD and UC, though evidence for biochemical efficacy is limited. In this review, we discuss the role of diet components in IBD pathogenesis and examine diets currently used in the management of children and adults with IBD. We also address practical, psychosocial, and cultural considerations for dietary therapy across diverse populations.

Is dependent cannabis use in adult hospitalizations with inflammatory bowel disease associated with major adverse cardiovascular and cerebrovascular events? Insights from National Inpatient Sample Analysis

Background Inflammatory bowel disease (IBD) and dependent cannabis use or cannabis use disorder (CUD+) are independent risk factors for cardiovascular diseases. Usage of cannabis for pain increased in IBD patients. However, associated cardiovascular safety remains unclear. This study aims to investigate the major adverse cardiac and cerebrovascular events (MACCE) associated with CUD + in hospitalized IBD patients. Methods We analyzed the National Inpatient Sample 2020 using ICD-10-CM codes; hospitalized IBD patients were identified and divided based on CUD's presence or absence. Multivariable regression models were performed to evaluate MACCE [in-hospital mortality, acute myocardial infarction (AMI), cardiac arrest (CA), and acute ischemic stroke (AIS)] odds after adjusting for baseline demographics, hospital-level characteristics, and relevant cardiac/extra-cardiac morbidities. Results Among the 302,770 hospitalized adult IBD patients, 3.1% (9,490) had CUD+. The majority of patients in the CUD + cohort were white (67.7%), male (57.5%), and aged between 18 and 44 years (66.2%). Cardiovascular risk factors like hypertension, diabetes, hyperlipidemia, and prior myocardial infarction were higher in the CUD − cohort (p <0.001) compared to the CUD + cohort. The CUD + cohort had a lower rate of MACCE (3.1% vs. 5.8%), crude in-hospital mortality (0.7% vs. 2.2%), AMI (1.7% vs. 2.6%), CA (0.3% vs. 0.7%), and AIS (0.6% vs. 1.2%) with statistical significance (p <0.001). However, after adjusting for baseline characteristics and comorbidities, the adjusted odds ratios (aORs) did not show a statistically significant difference for MACCE (aOR = 0.9, 95% CI = 0.65–1.25, p = 0.530), CA (aOR = 0.54, 95% CI = 0.2–1.47, p = 0.227), and AIS (aOR = 0.86, 95% CI = 0.43–1.73, p = 0.669). Conclusion Our study did not find a statistically significant difference in MACCE among hospitalized IBD patients with and without CUD. This emphasizes the need for more extensive prospective studies focusing on the quantity, method, and duration of cannabis use (recreational or medicinal) in patients with IBD.

Outcomes in Adult Inflammatory Bowel Disease Clinical Trials: Assessment of Similarity Among Participants with Adolescent-onset and Adult-onset Disease.

Most paediatric inflammatory bowel disease [IBD] studies are performed after medications are approved in adults, and the majority of participants in these studies are adolescents. We hypothesised that adolescent-onset IBD is not fundamentally different from adult-onset IBD. If this is correct, the value of delaying access to novel drugs in adolescents becomes questioned. Data from 11 randomised, double-blind, placebo-controlled, adult Phases 2 and 3 trials of four biologics were analysed. Participants were categorised as having adolescent- or adult-onset disease [diagnosed 12 to <18, or ≥18 years]. Multivariable modelling explored the association between age at diagnosis and response to treatment, after adjustment for disease duration, extent, and severity at baseline. Data from dose arms were pooled to evaluate similarity of therapeutic response between adolescent- and adult-onset IBD within the same trial [not between doses or across trials]. Ratios of odds ratios [ORs] between the two groups were evaluated. Data from 6283 study participants (2575 with Crohn's disease [CD], 3708 with ulcerative colitis [UC]) were evaluated. Of 2575 study participants with CD, 325 were 12-<18 years old at diagnosis; 836 participants [32.4%] received placebo. Of 3708 participants with UC, 221 were 12-<18 years old at diagnosis; 1212 [33%] were receiving placebo. The majority of the ratios of ORs were within 2-fold, suggesting that responses in adolescent- and adult-onset participants are generally similar. Data presented lend support for extrapolating efficacy of biologics from adults to adolescents with IBD, which would facilitate earlier labelling and patient access.

A249 PARADOXICAL PSORIASIS FOLLOWING ANTI-TNFΑ THERAPY IN INFLAMMATORY BOWEL DISEASE AND ASSOCIATION WITH AN IL-23 RECEPTOR VARIANT: A PRELIMINARY REPORT

Abstract Background Patients with inflammatory bowel disease (IBD) who receive anti-tumor necrosis factor (TNF) α therapy are at risk of developing drug-related psoriatic skin lesions known as paradoxical psoriasis (PP). This is a severe unpredictable adverse drug event that often leads to discontinuation of anti-TNFα therapy. To date, there are no tools for identifying high-risk individuals. Variation in the IL-23 receptor (IL23R) gene has been linked to psoriasis onset and may be implicated in PP. Aims To evaluate the frequency of the IL23R variant (IL23R1142Gampersand:003EA) in anti-TNFα exposed IBD patients who develop PP versus those who do not. Clinical variables associated with PP development will also be assessed. Methods A case-control study is ongoing, including anti-TNFα-exposed adult IBD patients. Participants are divided based on the development of PP (cases n=11; controls n=48, identified to date, 500 additional patients will be screened). All participants were retrospectively genotyped for the occurrence of the IL23R1142Gampersand:003EA variant. Clinical variables and outcomes were assessed from the time of anti-TNFα exposure for at least one year of follow-up or to the time of anti-TNFα discontinuation. Results To date, we have included 59 adult IBD patients treated with infliximab or adalimumab. Eleven patients developed PP after a median duration of treatment of three months with anti-TNFα therapy. The most common presentations were guttate, plaque, and pustular psoriasis. Six patients had PP that involved 50% or more of their body surface area (BSA). Nine participants discontinued their anti-TNFα therapy due to PP. None of the cases had a personal or family history of psoriasis. PP patients were similar to controls with respect to age, sex, ethnicity, IBD type, disease duration, and concurrent immunomodulator use. The variant genotype occurred more frequently in PP patients compared to controls (54.5% vs. 4.2%, OR 27.6, 95%CI 4.3-145.4). Those with the variant genotype also had more extensive psoriasis compared to wildtypes (mean BSA 61% vs. 25%, p=0.045). Conclusions In this preliminary analysis, there was an increased frequency of the IL23R1142Gampersand:003EA variant in patients who developed PP compared to those who did not after anti-TNFα exposure. We did not identify any other clinical variables associated with development of PP. Interpretation of these results is limited by the small sample size. Completion of this study may help clarify the association between PP and the IL23R gene as well as other clinical risk factors implicated in PP development. Funding Agencies None

A274 COVID-19 INFECTION RISK BETWEEN VACCINATED PATIENTS WITH ULCERATIVE COLITIS AND CROHN’S DISEASE : A RETROSPECTIVE COHORT STUDY IN TAIWAN

Abstract Background The effectiveness of coronavirus disease 2019 (COVID-19) vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with inflammatory bowel disease (IBD) is well established, but it is not clear whether patients with ulcerative colitis (UC) and Crohn’s disease (CD) have different risks of COVID-19 infection after vaccination. Aims The aim of this study was to compare the risk of COVID-19 infection after vaccination in patients with UC and CD. Moreover, we also investigated risk factors related to COVID-19 infection and collected data on any adverse events and disease symptoms. Methods We conducted a retrospective cohort study in adult IBD patients who had received at least two doses of COVID-19 vaccination and compared the prevalence of infection between UC patients and CD patients using the medical records of China Medical University Hospital between 1 January 2020 and 31 March 2023. All data management and odds ratios calculations were performed using version 9.4 of SAS software (SAS Institute, Cary, NC, USA). Results Total 169 IBD patients (96 with UC, 73 with CD) were included in this study. UC patients were older than CD patients (44.92±13.72 vs. 37.27±15.27 years, p=0.0008)(Table 1). A high proportion were male (IBD 70.41%; UC 65.63%, and CD 76.71%). Most (57.4%) received three doses of COVID-19 vaccines. Azathioprine, steroid, and mesalazine medication histories were different between the groups (pampersand:003C0.05). COVID-19 infection prevalence was 49.11% (UC 56.25%, CD 39.73%; p=0.0333) (Figure 1). Logistic regression analysis suggested UC patients had an odds ratio of 1.95 (95% CI=1.05-3.62) and adjusted odds ratio of 2.78 (95% CI=1.20-6.44) for COVID-19 infection compared to CD patients, indicating a 1.95-fold to 2.78-fold higher risk (Figure 2). There was a trend towards a decreasing risk of COVID-19 infection with increasing number of vaccine doses. Medication was not identified as a risk factor. (Figure 3) Conclusions Our study identified a greater risk of COVID-19 infection in vaccinated patients with UC than those with CD. However, most patients who became infected with COVID-19 did not have severe symptoms and only one case was hospitalized. The mortality rate of COVID-19 in IBD patients is not specifically higher than the general population. Supporting the view that SARS-CoV-2 vaccination is effective in patients with IBD. Odds ratios (95% confidence interval) for logistic regression model predicting COVID-19 infection among vaccinated IBD patients Figure 1. The medications used before COVID-19 infection between vaccinated patients with ulcerative colitis (UC) and Crohn’s disease (CD). Figure2. The prevalence of COVID-19 infection between vaccinated patients with ulcerative colitis (UC) and Crohn's disease (CD). Figure 3. The symptoms after COVID-19 infection between vaccinated patients with ulcerative colitis (UC) and Crohn's disease (CD). Funding Agencies None

Etrasimod: First Approval.

Etrasimod (VELSIPITY™) is an orally available, small-molecule selective sphingosine-1-phosphate (S1P) receptor modulator being developed by Pfizer for the treatment of ulcerative colitis and other immune-mediated inflammatory disorders. Etrasimod is selective for S1P receptor subtypes S1P1, S1P4 and S1P5 while having minimal activity on S1P3 and no activity on S1P2. Etrasimod received its first approval, in the USA, in October 2023 for the treatment of moderately to severely active ulcerative colitis in adults. Subsequently, the European Medicines Agency adopted a positive opinion in December 2023, recommending the granting of marketing authorisation for etrasimod for the treatment of patients aged ≥ 16years with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. Etrasimod is also under regulatory review for the treatment of ulcerative colitis in several other countries. Clinical development of etrasimod for use in the treatment of Crohn's disease, atopic dermatitis, eosinophilic oesophagitis and alopecia areata is ongoing worldwide. This article summarises the milestones in the development of etrasimod leading to this first approval for the treatment of ulcerative colitis in adults.

Factors associated with corticosteroid use in Crohn's disease and ulcerative colitis patients in Israel: A multicenter cross-sectional study

BackgroundWe examined corticosteroid use among Israeli patients with Inflammatory Bowel Disease (IBD), focusing on demographic, disease-related, and psychosocial factors. The objective was to contribute to the development of strategies minimizing corticosteroid dependence and improving patient outcomes, given the adverse effects associated with prolonged corticosteroid use. MethodsA comprehensive analysis was conducted on data collected from adult IBD patients attending six gastroenterological outpatient clinics in Israel. The data collected encompassed disease characteristics, demographic information, service level characteristics, social data, and steroid use. Statistical analyses were performed to associate these variables with steroid use. ResultsOut of 402 patients, 26 % had been treated with corticosteroids in the previous year, with a majority of these having only one treatment course. Of patients treated with steroids, 57% (n-44) met steroid dependent/excess criteria. Steroid use was more common in patients diagnosed with ulcerative colitis (UC) compared to those with Crohn's disease. Factors such as a diagnosis of UC, male gender, elevated C-reactive protein and fecal calprotectin, and decreased albumin and hemoglobin were associated with steroid use. ConclusionCorticosteroid use among Israeli IBD patients was associated with disease-related factors and some demographic characteristics. The results highlight the need for continued research to inform strategies aimed at reducing corticosteroid dependence in managing IBD, thereby improving patient outcomes.

FECAL URGENCY ASSOCIATED WITH POOR QUALITY OF LIFE IN QUIESCENT IBD: A CROSS-SECTIONAL STUDY OF SPARC IBD COHORT

Abstract BACKGROUND Fecal urgency (FU) is common in patients with active inflammatory bowel disease (IBD) and has been associated with reduced well-being and poor quality of life (QOL). Despite greater therapeutic options, clinical symptoms may persist in some patients. Data is lacking regarding FU in patients with objectively documented quiescent disease. OBJECTIVE Among endoscopic quiescent disease: (1) estimate prevalence of urgency, (2) assess predictors of FU, (3) describe its impact on validated QOL measures. METHODS This cross-sectional study used prospectively collected data from SPARC (Study of a Prospective Adult Research Cohort) IBD, a multicenter longitudinal study of well-phenotyped adult IBD patients initiated by the Crohn’s &amp; Colitis Foundation in 2016. Quiescent IBD was defined as Mayo endoscopy score &amp;lt;2 for ulcerative colitis (UC) and SES-CD score &amp;lt;3 for Crohn’s disease (CD). Patient reported outcomes (PROs) within 30 days of endoscopy were analyzed. Patients with ostomy or IPAA were excluded. Self-reported urgency was categorized as none, mild, or moderate/severe. Univariate statistics used Pearson’s Chi-square and Kruskal-Wallis tests. RESULTS A total of 943 patients with quiescent IBD (579 CD; 364 UC) were included in the study (Table 1). Fecal urgency was more commonly reported in quiescent CD (37.5% mild, 27.8% moderate/severe) as compared to quiescent UC (33.5% mild, 19.8% moderate/severe) (p&amp;lt;0.001). In the entire quiescent cohort, those with mild or moderate/severe FU were more likely to be female sex (58.4%; 63.2%), higher BMI (28.2; 29.5) and have an IBD-related surgery (p=0.030). Mild and moderate/severe urgency was associated with subjective abdominal pain, stool frequency, and bloody stool (all p&amp;lt;0.001). There was a trend towards ileocolonic involvement and penetrating disease in quiescent CD with moderate/severe urgency. General well-being was poorer for those with more severe urgency (p&amp;lt;0.001), and they were more likely to utilize the emergency department (p=0.016). Figure 1 depicts the PROMIS responses. There were significant differences across all domains, and notably those with moderate/severe urgency reported pain (38.8%) and fatigue (60.0%) interfered with enjoyment of life at least some of the time compared to those without urgency (3.9%; 10.0%) or with mild urgency (15.1%; 32,2%). CONCLUSION In this study of patients in SPARC IBD with endoscopic quiescent IBD the overall prevalence of fecal urgency was 65.2% for CD and 53.3% for UC. Fecal urgency was common in quiescent IBD and associated with poorer general well-being and quality of life. Further research is needed to elucidate the pathophysiology for presence of fecal urgency in quiescent IBD and develop personalized management approaches. Table 1 Demographics and IBD characteristics of SPARC IBD patients with quiescent Crohn’s disease (CD) and ulcerative colitis (UC) with symptoms of mild versus moderate/severe fecal urgency. Table 2 Severity of Fecal Urgency on Quality of Life for Patients with Endoscopic Quiescent IBD using PROMIS (Patient-Reported Outcomes Measurement Information System) Scores for Fatigue, Pain Interference† and Social Interference†*. †Responses indicate the degree and frequency of interference with each of the activities listed. *Polarity of Social Interference subscale reversed for consistency and interpretability of the figure.