Inflammatory Bowel Disease Center Research Articles

Impact of a health-system specialty pharmacy on time to upadacitinib initiation.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Upadacitinib has been found to improve symptoms as early as day 1 in patients with inflammatory bowel disease. As a result, early and timely initiation of upadacitinib is paramount to prevent hospital admission for an acute flare. The purpose of this study was to identify the time to initiation of upadacitinib, comparing external specialty pharmacies (ESPs) to a health-system specialty pharmacy (HSSP). This was a single-center, retrospective study at the University of Chicago Medicine (UCM) Inflammatory Bowel Disease Center and included patients initiated on upadacitinib between March 1, 2022, and April 1, 2023. Data collected included demographics, prior authorization information, appeal information, insurance type, date the prescription was sent, and date the patient initiated therapy (patients were called to confirm the date). The primary outcome evaluated was the days from prescribing to patient initiation. Secondary outcomes included the total time to initiation and the time to notification from insurance regarding determination of a prior authorization or appeal. Patients were excluded if they were lost to follow-up, initiated therapy through alternative means, or had previously initiated upadacitinib. A total of 107 patients were initiated on upadacitinib during the study period (n = 18 through the UCM HSSP, n = 89 through an ESP). The median number of days to patient initiation was 3 days (interquartile range, 3-6 days) for the UCM specialty pharmacy vs 9 days (interquartile range, 4-13 days) for ESPs (P = 0.003). A total of 88.9% of patients filling through the UCM specialty pharmacy initiated upadacitinib within 7 days, compared to 47.2% of patients filling through an ESP (P = 0.001). Seven patients needed earlier initiation of therapy to prevent hospital admission. This study validates the ability of HSSPs to initiate therapies earlier than ESPs with a particular focus on upadacitinib.

Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis: data from a retrospective cohort

Background and objectiveThe influence of concomitant prednisolone on clinical outcomes and safety in infliximab-treated ulcerative colitis (UC) patients is unknown.Design, setting, participants and outcome measuresA retrospective cohort study was performed,...

Latent profiles of fatigue in inflammatory bowel disease

IntroductionFatigue is prevalent in people with inflammatory bowel disease (IBD) and has been associated with IBD activity, sleep quality, depression, and anxiety. This study aimed to identify fatigue profiles or clusters through latent profile analysis.MethodsAn online questionnaire was administered through three tertiary IBD centres, social media and through Crohn’s Colitis Australia. Fatigue was assessed via the Functional assessment of chronic illness measurement system fatigue subscale (FACIT-F), a validated assessment of fatigue and its severity. Validated measures of anxiety, depression, IBD activity and sleep quality were also included. Latent profile analysis was performed including fatigue, sleep quality, active IBD, and depression and anxiety. The relationships between profiles and IBD and demographic data were investigated.ResultsIn a cohort of 535 respondents, 77% were female, the median age was 41 years (range 32–52 years), and the majority had Crohn’s disease (62%). Severe fatigue was seen in 62%. Latent profile analysis identified four distinct profiles differing by fatigue score - low fatigue, at-risk profile, active IBD, and a poor mental health profile. Female gender, obesity and opioid usage were associated with higher risk of being in the active IBD and poor mental health profile. Age over 40 was associated with lower risk of being in the poor mental health profile.ConclusionLatent profile analysis identifies four classes of fatigue in an IBD cohort with associations with specific risk factors for fatigue along with specific IBD and demographic attributes. This has implications for the classification of fatigue in IBD and treatment algorithms.

Long-term effectiveness and persistence rate of ustekinumab dose intensification in a South East Asian inflammatory bowel disease center.

Ustekinumab (UST) is an effective biologic for treatment of inflammatory bowel disease (IBD). However, some patients treated with UST have suboptimal clinical response with standard dosing. The aims of this study were to determine the effectiveness of UST dose intensification (DI), identify factors associated with DI, cumulative incidence of DI and persistence of UST among treated patients. Clinical data of patients with Crohn's disease (CD) and ulcerative colitis (UC) who received UST from September 2017 to October 2022 in Singapore General Hospital were collected. Primary outcome was defined as achieving corticosteroid-free clinical remission, biochemical remission, endoscopic healing and/or transmural healing (CD). Statistical analysis was performed to identify factors, which are predictive of UST DI and effectiveness of UST DI. Forty-two patients (34 CD and 8 UC) underwent UST DI to either 6-weekly (n=19, 45.2%) or 4-weekly (n=23, 35.9%) and the median time to intensification was 31.1weeks (17.8-65.7). Presence of perianal disease in CD (HR 4.9; 1.47-16.4) was associated with DI. After DI, 16 (38%) patients achieved primary outcome by week 52. The overall drug persistence rates at 1year and 2years were 75.7% (95% CI 62.9-84.6) and 63.5% (95% CI 49.9-74.3), respectively. Two third of IBD patients underwent DI while on UST treatment and the median time to DI was about 6months after induction. CD patients with perianal disease is more likely to undergo DI. More than one third of dose-intensified patients achieved remission by week 52.

Segmental Colectomy in Ulcerative Colitis.

Segmental colectomy in ulcerative colitis is performed in select patients who may be at increased risk for postoperative morbidity. To identify ulcerative colitis patients who underwent segmental colectomy and assess their postoperative and long-term outcomes. Retrospective case series. A tertiary-care inflammatory bowel disease center. Ulcerative colitis patients who underwent surgery between 1995 and 2022. Segmental colectomy. Postoperative complications, early and late colitis, metachronous cancer development, completion proctocolectomy-free survival rates and stoma at follow-up. Fifty-five patients were included [20 (36.4%) female; 67.8 (57.4-77.1) years of age at surgery; body mass index 27.7 (24.2-31.1) kg/m2; median follow-up 37.3 months]. ASA score was III in 32 (58.2%) patients, 48 (87.3%) had at least one comorbidity, 48 (87.3%) had Mayo endoscopic subscore of 0-1. Patients underwent right hemicolectomy (28, 50.9%), sigmoidectomy (17, 30.9%), left hemicolectomy (6, 10.9%), low anterior resection (2, 3.6%), or a non-anatomic resection (2, 3.6%) for; endoscopically unresectable polyps (21, 38.2%), colorectal cancer (15, 27.3%), symptomatic diverticular disease (13, 23.6%), and stricture (6, 10.9%). Postoperative complications occurred in 16 (29.1%) patients [7 (12.7%) Clavien-Dindo Class III-V]. Early and late postoperative colitis rates were 9.1% and 14.5%, respectively. Metachronous cancer developed in 1 patient. 4 (7.3%) patients underwent subsequent completion proctocolectomy with ileostomy. Six (10.9%) patients had stoma at the follow-up. Two and 5-year completion proctocolectomy-free survival rates were 91% and 88%, respectively. Retrospective study, small sample size. Segmental colectomy in ulcerative colitis is associated with low postoperative complication rates, symptomatic early colitis and late colitis rates, metachronous cancer development and the need for subsequent completion proctocolectomy. Therefore, it can be safe to consider select patients, such as the elderly with quiescent colitis and other indications for colectomy. See Video Abstract.

Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis.

Real-world data on tofacitinib (TOF) covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis (UC) are scarce. To investigate the long-term efficacy and safety of TOF treatment for UC, including clinical issues. We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center. All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled. Patients were followed up until August 2020. The primary outcome was the clinical response rate at week 8. Secondary outcomes included clinical remission at week 8, cumulative persistence rate of TOF administration, colectomy-free survival, relapse after tapering of TOF and predictors of clinical response at week 8 and week 48. The clinical response and remission rates were 66.3% and 50.5% at week 8, and 47.1% and 43.5% at week 48, respectively. The overall cumulative clinical remission rate was 61.7% at week 48 and history of anti-tumor necrosis factor-alpha (TNF-α) agents use had no influence (P = 0.25). The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8 (30.9% vs 88.1%; P < 0.001). Baseline partial Mayo Score was significantly lower in responders vs non-responders at week 8 (odds ratio: 0.61, 95% confidence interval: 0.45-0.82, P = 0.001). Relapse occurred in 45.7% of patients after TOF tapering, and 85.7% of patients responded within 4 wk after re-increase. All 6 patients with herpes zoster (HZ) developed the infection after achieving remission by TOF. TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-α agents. Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF. Special attention is needed for tapering and HZ.

Burden of Mental Health among Patients with Inflammatory Bowel Disease-A Cross-Sectional Study from a Tertiary IBD Center in Hungary.

Background: Inflammatory bowel diseases (IBDs) are chronic conditions that negatively affect the patient's quality of life. With the spread of the biopsychosocial model, the role of mental health in the activity and course of inflammatory bowel disease is becoming more and more recognized. Our study aimed to assess the prevalence of anxiety and depression in IBD patients in our tertiary referral center and determine the predictive factors of these mental conditions. Methods: A total of 117 patients were included consecutively between 1 December 2021 and 28 February 2022. We used a questionnaire to gather demographic information, disease course, and IBD-specific symptoms. We assessed anxiety symptoms using the GAD-7 and depressive complaints using the PHQ-9 questionnaire. We evaluated disease activity using CDAI and pMayo scores. Results: Of the 117 patients (male/female: 63/54), 88 suffered from Crohn's disease, and 29 were diagnosed with ulcerative colitis. Only 6 patients were taking medication for mood disorders, and 38 individuals sought mental support during their lifetime. A total of 15% of the population suffered from moderate-severe anxiety disorder, and 22% were affected by moderate-severe depression. The GAD-7 and PHQ9 values showed a significant correlation between the number of stools, bloody stools, abdominal pain, number of flare-ups, and CDAI scores. Conclusions: Our study confirmed that there is a high incidence of anxiety and depressive symptoms among IBD patients. Our results highlighted the symptoms that could be associated with mental disorders. It is important to assess the mental status of IBD patients to improve their quality of life.

Patient engagement and satisfaction with early phase cell therapy clinical trials at a tertiary inflammatory bowel disease center

Several clinical trials are underway investigating cell and gene therapy, and while these trials are meant to significantly impact patient care, they rely on patient engagement and participation. Unfortunately, clinical trials generally require extensive commitment by subjects. While several studies are using validated surveys to measure patient-reported outcomes, there is a lack of characterization of the patient experience as a subject in these trials. As such, we surveyed mesenchymal stromal cell (MSC) trial participants to understand their perspective. We found that there exists a reliance on one's gastroenterologist and colorectal surgeons for trial introduction and that time and cost were the main barriers to participation. Overall, participants demonstrated high satisfaction with MSC trial participation, but future protocols could incorporate increased use of virtual appointments to optimize patient experience.

Outcomes of a mandatory non-medical switch of infliximab to a biosimilar for inflammatory bowel disease in British Columbia, Canada

Abstract Background Despite infliximab biosimilars becoming widely used in inflammatory bowel disease (IBD) patients, real-world non-medical switching is sparse. A biosimilar non-medical switch was launched in British Columbia in 2019, the first Canadian province to do so, from Remicade to an approved biosimilar (CT-P13 or SB2). Aims This study aims to obtain real-world evidence evaluating the clinical outcomes of non-medical switching from Remicade to the infliximab biosimilars. Methods This is a retrospective observational study of stable IBD patients from the IBD Centre of BC who underwent the non-medical infliximab switch. The primary outcome is treatment continuation at 12 ± 2 months post-switch. Secondary outcomes include frequency of loss of response, adverse events, and immunogenicity within the first 12 months post-switch. A control group of patients maintained on the originator served as a comparison. Results Patients in the biosimilar switch group (n = 264) and originator group (n = 99), show similar demographics and disease characteristics. There was no difference in infliximab continuation between the biosimilar group (94.9%) and the originator group (90.1%) (P = 0.18). Reasons for discontinuation of infliximab included loss of response (4.04% vs 4.91%), immunogenicity (1.01% vs 0.75%), or adverse effect (1.01% vs 2.3%) in the infliximab originator vs biosimilar switch group, respectively. Similarly, no differences in safety or efficacy were observed between patients switched to CT-P13 or SB2. Conclusions Non-medical biosimilar switch of infliximab demonstrates similar clinical outcomes compared to originator molecule continuation for therapy of IBD. These data support the safety and efficacy of non-medical infliximab switching in IBD patients.

Patient and public involvementin the development of health services: Engagement of underserved populations in a quality improvement programme for inflammatory bowel disease using a community-based participatory approach.

Involving people with lived experience is fundamental to healthcare development and delivery. This is especially true for inflammatory bowel disease (IBD) services, where holistic and personalised models of care are becoming increasingly important. There is, however, a significant lack of representation of underserved and diverse groups in IBD research, and there are significant barriers to healthcare access and utilisation among minority groups in IBD. IBD centres need to be aware of these experiences to address barriers via service changes, improve interactions with local communities and promote meaningful engagement for improved health outcomes. A pragmatic community-based approach was taken to engage with leaders and members of underserved groups across 11 workshops representing Roma, Afro-Caribbean, people of African descent and the wider black, Asian and minority ethnic (BAME) communities, Muslim women, refugee community members, deprived areas of South Yorkshire, LGBTQ+ and deaf populations. Thematic analysis of field notes identified patterns of attention across the community groups and where improvements to services were most frequently suggested. Findings demonstrated several barriers experienced to healthcare access and utilisation, including language accessibility, staff attitudes and awareness, mental health and stigma, continuity of support, and practical factors such as ease of service use and safe spaces. These barriers acted as a lever to co-producing service changes that are responsive to the health and social care needs of these groups. Engaging with people from a range of communities is imperative for ensuring that service improvements in IBD are accessible and representative of individual needs and values. Local community leaders and members of community groups actively participated in the co-design and development of improvements to the IBDservice for a local hospital. Their contributions further informed a pilot process for quality improvement programmes in IBD centres.

A247 THE IMPACT OF BIOLOGICS ON MATERNAL AND NEONATAL OUTCOMES IN PREGNANT PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND THEIR ASSOCIATION WITH THERAPEUTIC DRUG LEVELS

Abstract Background Biologic therapies are at the backbone of managing moderate to severe IBD and maintaining clinical remission. The data on the effects of biologic therapy on maternal and neonatal outcomes continues to be limited. To our knowledge, there have been no previous studies specifically investigating whether biologic therapeutic drug levels in pregnant patients are related to maternal and neonatal outcomes. Aims The objective of this study is to determine whether biologic use in pregnancy is associated with adverse maternal and fetal outcomes, and if those outcomes correlate to specific therapeutic drug levels. Methods In this study, we retrospectively evaluate patients at a high-volume pregnancy and inflammatory bowel disease centre at Mount Sinai Hospital in Toronto between January 1st, 2017 to December 31st, 2022. Primary outcomes include maternal complications, such as induction of labour, cesarean section, peripartum infections, placental abruption, preterm labour and pre-eclampsia. Secondary outcomes include neonatal complications, such as preterm birth, low birth weight (ampersand:003C2500g), congenital anomalies and the presence of neonatal infection. These outcomes will be compared to therapeutic drug levels measured in preconception, during pregnancy and post-partum. Results A total of 312 patients were included in our study, of which 152 were on biologic treatment for IBD. Of the biologics population, the majority of patients are on Remicade, followed by Humira and Stelara (Table 1). Preliminary data analysis reveals that there was no significant difference in the rate of miscarriages (10% vs. 6%, P= 0.1), cesarean section (44% vs. 38%, P=0.3) and preterm deliveries (12% vs. 14%, P=0.7) between the biologics vs. non-biologics patient groups. Next round of analysis will include secondary outcomes and therapeutic drug levels. Conclusions Through this study, we hope to add to the literature on the possible safety of maintaining biologic therapy during pregnancy in those with inflammatory bowel disease. The data on proactive therapeutic drug monitoring in pregnant patients may bring to light the importance of its inclusion in clinical decision-making algorithms. Breakdown of therapies in the biologic patient group Funding Agencies None

Ustekinumab for anti-tumor necrosis factor refractory pediatric ulcerative colitis: a promising approach towards endoscopic healing.

To describe the role of ustekinumab in inducing remission and endoscopic healing in anti-tumor necrosis factor α nonresponsive pediatric ulcerative colitis patients at a tertiary care inflammatory bowel disease center. A retrospective chart review was performed on patients with ulcerative colitis receiving ustekinumab. Primary outcome was steroidfree clinical remission at follow-up. Secondary outcomes were biochemical remission and endoscopic healing. Ten children were analyzed; 7 (70%) had ulcerative colitis, and 3 (30%) had inflammatory bowel disease unspecified with colitis. Median follow-up period was 56 weeks. Nine patients (90%) achieved steroid-free clinical remission and biochemical remission. Seven patients had follow-up colonoscopies, out of which 6 (86%) achieved endoscopic remission, while 1 (14%) underwent colectomy. Out of the 3 patients without a follow-up colonoscopy, fecal calprotectin levels downtrended to < 150 mg/kg in 2 patients and < 400 mg/kg in 1 patient from baseline level of > 2,000 mg/kg. Ustekinumab appears efficacious in achieving not only clinical and biochemical remission but also has promising role in inducing endoscopic healing end point in patients who fail other biologics.

Inadequate pregnancy-specific knowledge among patients with inflammatory bowel disease: A multicenter survey in China.

The perceptions and attitudes of inflammatory bowel disease (IBD) patients towards pregnancy may affect their fertility plan and disease progression. We performed a nationwide multicenter survey of pregnancy-related knowledge among gastroenterologists and IBD patients in China to investigate whether specific educational interventions could improve their understanding and broadly influence fertility plan. A cross-sectional questionnaire regarding pregnancy-specific knowledge was carried out among 63 IBD centers in China. Questionnaires were collected from 185 physicians and 609 patients. The patients then received education regarding pregnancy during IBD and filled in the same questionnaire again. Their knowledge regarding pregnancy during IBD was compared before and after education. Compared to physicians, patients' knowledge regarding fertility (39.1% vs 70.8%), imaging examinations (22.8% vs 72.4%), endoscopy performed during pregnancy (19.9% vs 71.4%), and vaccination for infants (16.6% vs 46.5%) was significantly more limited (all P < 0.001). There was a lack of knowledge among gastroenterologists regarding the delivery mode (36.8%), medications (36.8%), and emergency surgery (26.5%) during pregnancy in patients with IBD. After education, the patients showed significant improvement in knowledge regarding medications (26.7% vs 51.7%), fertility (45.0% vs 63.3%), heritability (40.0% vs 58.3%), indications for emergency surgery (15.0% vs 53.3%), imaging examinations during pregnancy (20.0% vs 40.0%), and vaccinations for infants (26.7% vs 45.0%) (all P < 0.05). Pregnancy-specific IBD knowledge needs to be improved among certain gastroenterologists and patients in China. Educational interventions can partially improve the knowledge levels of the patients.

INCREASING ACCESS TO INTERDISCIPLINARY IBD CARE FOR NEWLY DIAGNOSED IBD PATIENTS USING TELEMEDICINE: AN EXTENSION OF THE COMPASS-IBD PROGRAM

Abstract INTRODUCTION Interdisciplinary care is increasingly being recognized as important in the care of inflammatory bowel disease (IBD) patients. However, access to additional resources to do this are frequently only available in tertiary-care IBD centers. We piloted a telemedicine version of an interdisciplinary care program for recently diagnosed IBD patients. METHODS The Mount Sinai Health system has a well-established IBD center, located at the Mount Sinai Hospital in New York. Patients who were diagnosed with IBD in the last 18 months were identified by a primary gastroenterologist working at a community site within the Mount Sinai health system. Once identified, patients were referred electronically and enrolled in the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD) program. This existing program provides interdisciplinary care to newly diagnosed IBD patients. IBD patients have access to a physician who works at the IBD Center, a nutritionist specializing in IBD diets, an experienced IBD clinical pharmacist and a licensed clinical social worker dedicated to the mental and social needs of patients with IBD. After an initial assessment, these patients were then provided access as needed to the program experts. All appointments were done virtually using telemedicine. After completing intake, recommendations were consolidated and provided to the patient and the patient’s primary gastroenterologist electronically. The patient then followed up with his/her primary gastroenterologist. RESULTS For this pilot study, twelve newly diagnosed inflammatory bowel disease patients were identified at community sites within the Mount Sinai health system. Enrolled patients met with all members of the COMPASS- IBD program team for their initial intake. The referring gastroenterologist received summary recommendations for all patients who completed the intake. Participating patients were overall satisfied with the intervention and use of telemedicine as a primary modality. No major barriers to virtual program implementation were identified. DISCUSSION We demonstrated the feasibility of providing interdisciplinary care via telemedicine for recently diagnosed IBD patients. This supports a “hub and spoke” model for IBD care. We believe our pilot study shows a simple way for health systems to increase access to interdisciplinary IBD care for patients with limited access to tertiary-care IBD Centers. This approach may also help in achieving health equity for underserved IBD patient populations.

DEPRESSION MAY BE A STRONGER UNIQUE PREDICTOR OF FATIGUE THAN SELF-REPORTED IBD DISEASE ACTIVITY

Abstract Fatigue is a frequent and debilitating symptom of inflammatory bowel disease (IBD) and can include mental and physical exhaustion, tiredness, or weakness. Modifiable psychosocial factors, such as depression and anxiety, are associated with fatigue in IBD, and provide insight into potential treatment targets. However, little is known about distinct ways in which psychosocial factors relate to subtypes of fatigue. The current study examined associations between psychosocial factors and 5 fatigue subtypes: general, physical, mental, reduced motivation, and reduced activity. Patients 18 and above from Dartmouth-Hitchcock’s IBD Center with Crohn’s disease or ulcerative colitis were invited to participate in a survey via an electronic medical record system message. Measures included the Patient Reported Outcomes-3, Multidimensional Fatigue Inventory, Pain Catastrophizing Scale, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, Insomnia Severity Index, and Brief Pain Inventory. Five forward linear regressions were performed with step 1 including disease activity, step 2 including covariates (age, gender, IBD diagnosis) and step 3 allowing for the inclusion of insomnia, pain severity, depression, anxiety, and pain catastrophizing. Participants were 312 individuals above the age of 18 (M=48.62, SD=16.10). Participants were 66.3% women and 96.5% White. 60.9% were diagnosed with Crohn’s disease and 39.1% with ulcerative colitis. 54.8% were categorized as having active disease based on self-reported symptoms. For all five subtypes of fatigue, depression emerged as the most influential psychosocial predictor. Depression accounted for 21% of the variance in general fatigue, 14% in physical fatigue, 18% in activity avoidance, 19% in reduced motivation, and 29% in mental fatigue. Regarding differences among subtypes, insomnia was only significant in the model predicting general fatigue, accounting for an additional 2% of the variance, and anxiety was only significant in the model predicting activity avoidance, accounting for an additional 3% of the variance. In comparison, self-reported disease activity accounted for 23% of the variance in general fatigue, 7% in physical fatigue, 8% in activity avoidance, 12% in reduced motivation, and 10% in mental fatigue. Depression is a notable factor associated with all subtypes of fatigue in IBD, especially mental fatigue. There are differences in how psychosocial factors relate to fatigue subtypes such that anxiety is uniquely associated with activity avoidance and severity of insomnia is uniquely associated with general fatigue. Results suggest that assessment of fatigue in IBD should also include assessment of depression as standard of care. Additionally, helping patients engage in behavioral interventions to reduce depression, anxiety, and insomnia may be critical for managing fatigue. Results of forward regressions predicting fatigue subtypes

TELEHEALTH ENHANCES RETENTION OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE WITHIN A TERTIARY CARE INFLAMMATORY BOWEL DISEASE CENTER

Abstract INTRODUCTION Telehealth care in the ambulatory setting has dramatically increased in the COVID and post-COVID period in medicine. Understanding how this may impact the care of patients (pts) with inflammatory bowel disease (IBD) is important. This study aims to evaluate the pattern of use of telehealth care in a tertiary care IBD center. METHODS Pts seen at a tertiary care IBD center from January 2018 to March 2020 and August 2020 to January 2023 were included. Pts seen between March 2020 and July 2020 were excluded as the institution had mandatory telehealth visits during this period. Data was obtained from the Electronic Medical Record after IRB approval. Office visit types were based on billing codes, and office visits were only included in the analysis if seen by an MD or Advanced practice provider (APP). Drive time in minutes (min) was established from pt addresses using Esri geographic information systems (GIS) data, services and software. All new pts seen in the IBD Center are required to be seen in-clinic. After August 2020, pts seen in follow up can be seen at an in-clinic visit or via telehealth at the patient’s preference. Statistical analysis included Pearson Chi Square analysis for categorical variables and z-tests for means comparisons for continuous variables. RESULTS A total of 7,040 pts included. 56% were female. 89% were white, 7% Black or African American, and 76% had commercial health insurance, 17% had Medicare, 4% Medicaid, and 3% had no health insurance. New pts seen in the post-Covid period had shorter drive times than those seen in the pre-Covid period. (Table 1) Pts who had at least one year of follow up were more likely to be seen as a return visit in the post-Covid period vs the pre-Covid period (84% vs 76%, p&amp;lt;0.05). In the post-Covid period, 62% (3,575/5,750) pts had return IBD care by their MD or APP team delivered via telehealth. Pts seen in telehealth had significantly longer drive times than in-clinic-only pts (median 56.3 min [IQR 93.3] vs median 47.9 min [IQR 89.7]), p&amp;lt;0.001. (Table 2) This was significant for both the telehealth pts who had been seen in-clinic in the pre-Covid period as well as pts who were seen only in the post-Covid period. Pts who continued care only with in-clinic visits in the post-Covid period had significantly shorter drive times than pts who were seen in-clinic pre-Covid (38.8 min [IQR 60] vs 54.2 min [IQR 89.9]), p&amp;lt;0.001. CONCLUSION Telehealth is an effective strategy for continued multidisciplinary care at a tertiary care IBD center. More than half of patients continuing to participate in telehealth for follow up care, and patients were more likely to follow up in the post-Covid period. Patients who live farther away are more likely to continue IBD care via telehealth. Table 1 Overall Drive Time for New patients in the Pre- and Post-COVID periods Table 2 Drive Times for Return patients in the Pre-Covid and Post-Covid periods

P838 Determing factors that influence Vedolizumab Response in Inflammatory Bowel Diseases: A Prospective Study

Abstract Background In recent years, the development of biologic agents, including Vedolizumab, has offered new avenues for the treatment of IBD Understanding the factors that influence the response to Vedolizumab therapy is of paramount importance in optimizing patient care and treatment outcomes. However, for a drug like Vedolizumab, the exact concentration indicating the need for optimization and what influences it are still unknown. The aim of this research is to evaluate what parameter has influence on good response to Vedolizumab in patients with inflammatory bowel diseases. Methods 160 patients with Crohn's disease and ulcerative colitis were included in this prospective study, who were treated with Vedolizumab biological therapy from October 2018 to February 2023 at a tertiary center for inflammatory bowel diseases. All patients were followed for a minimum of 14 weeks or until therapy discontinuation. Biochemical parameters (CRP, fecal calprotectin, hemoglobin, ferritin), clinical parameters (MTWS, HBI) were monitored in all patients before and during treatment. Vedolizumab concentration was measured in half of the patients during treatment with this drug. All data were processed using the statistical program SPSS 23.0 (Chicago, IL). Results Of the 160 patients, there was almost an equal distribution between male and female (males, 160/86 (53.7%)), with an average age of 51.5 years (± 16.51 SD). After one year of therapy, a statistically significant reduction in inflammation parameters was observed (FCP- p=0.007, Z= -2.694; CRP- p=0.008, Z= -2.646), as well as a statistically significant clinical response to therapy by reducing the disease activity index (p &amp;lt; 0.000, Z= -4.818). Using logistic regression duration of disease nor disease localization are predictive parameters for response to therapy (p = 0.330, Exp B 1.190) In a group of 80 patients, Vedolizumab concentration was measured in a cross-sectional analysis. Our cohort of patients had a median Vedolizumab concentration of 20.73 µg/ml. Patients who achieved remission had statistically similar Vedolizumab concentrations compared to patients with active endoscopic disease (Vedolizumab concentration UC 25.6541 vs 28.8152; p = 0.614; CD 20.0232 vs 18.3346 µg/ml; p = 0.729). Patients on Vedolizumab who had previously received anti-TNF therapy had a lower mean drug concentration compared to bio-naive patients (16.05 ug/ml / 20.34 ug/ml). Conclusion Previous anti-TNF therapy may have an impact on drug concentration and response to therapy, but it is necessary to determine other parameters that can also independently influence drug concentration

P481 "I’ve been told to drop out of school because I need to focus on my health and that was just devastating to hear.": Experiences of Western Canadian young adults with inflammatory bowel disease transitioning from paediatric to adult care

Abstract Background The incidence of patients diagnosed with inflammatory bowel disease (IBD) in childhood/adolescence is increasing worldwide; therefore, in the upcoming years, more patients will need to transition from paediatric to adult care. A smooth transition is essential to ensure continuity of care; however, transition is a difficult time for patients, when increasing responsibility for disease management needs to be balanced with full-time employment or schooling. This study explores the transition experience of young adults with IBD who have transitioned from paediatric to adult care. Methods We recruited young adults with IBD using purposive sampling from two IBD centres in Western Canada for participation in a semi-structured virtual interview. Eligibility required being transferred to adult care within the previous two years and being diagnosed with IBD at least one year before transferring. Interviews were audio recorded, transcribed verbatim, and then analysed with an inductive thematic analysis approach. Results We interviewed 16 young adults with IBD (Table 1). We grouped features of the transition experience described by participants into the following four major themes (Figure 1): 1) Anticipation and preparedness for adult care; 2) New and existing connections; 3) Skill development for disease management; 4) Comparison of adult care to paediatric care. In the first theme, participants described feeling unprepared for and nervous about adult care. In the second theme, participants described the structure of care and noted that adult care had less appointments and the adult care team took a less holistic approach to their IBD care. Subsequent themes focused on developing relationships with the new care team, the importance of existing social supports, and becoming responsible and independent in disease management. Conclusion The results outline four major themes that describe IBD patients’ transition experience. These themes provide insight into aspects of transition described by patients, which can be used to improve patient care. For example, participants characterized adult care as missing elements that were present in paediatric care, suggesting a potential need to prepare patients for care differences and support them through the care adjustments. Overall, this study provides valuable insights into patients’ transition experiences which can be used to inform the development of transition supports and improve patient-centred care.

P446 Influence of seasonal vitamin D deficit in clinical course of inflammatory bowel disease patients

Abstract Background Vitamin D deficiency is common in healthy subjects and it is even more prevalent in inflammatory bowel disease (IBD). Vitamin D (VitD) may influence disease behavior. Whether a deficient vitamin D status facilitates flares or flares consume vitamin D is still a burning question. Data on seasonal variations of VitD levels in IBD are scarce. The aim of this study was to evaluate VitD deficit in IBD patients compared with general population and the influence of seasonal variation in their evolution. Methods A prospective two center study was performed. Patients with Crohn disease (CD) or ulcerative colitis (UC) and no comorbilities that may have influenced VitD were consecutively included from two IBD centers with geographical proximity (less than 100 kms) in order to have comparable solar radiation. Clinical and biochemical characteristics of patients were recorded. Patients were followed for two consecutive seasons, VitD was measured twice: during winter and during summer. VitD levels from general population were also available. Both hospitals share the same methodology for VitD testing. VitD levels were defined as normal (&amp;gt;30 ng/ml), insufficient (20-30 ng/ml), or deficient (&amp;lt;20 ng/ml). Data were analyzed and Mann-Whitney U test was applied using R to compare subsets of patients. Results 199 patients with IBD were consecutively included (38.7% CD, 61.3% UC). 165 (83%) patients have consecutive determinations of VitD (both in summer and winter). Mean age was 47.1, being 54.8% males and 45.2% females. Median value of VitD in winter was 14 ng/ml, and 21 ng/ml in summer. Lab tests in our center for general population in winter presented a median value was 21.2 ng/ml in winter and 24 ng/ml in summer (Figure 1). According values of our laboratory in winter, just 31% of the general population presented VitD values &amp;gt; 30 ng/ml in summer and 26.7% do so in winter. For our cohort of patients with IBD, the results are more pronounced: only 3.8% presented normal values in winter and 23.2% in summer (Table 1). The average variation in VitD values has been 9.26 ng/ml between the two seasons. No statistically significant relationship was found between the factors analyzed (BMI, location, calprotectin levels or disease duration) and VitD levels, neither in summer nor in winter. Most patients remained in remission despite having low VitD levels (82,8% in winter and 80,3% in summer). Conclusion VitD deficit was frequent in summer and in winter in IBD and more prevalent than in general population. Despite frequent deficit only a small percentage of patients presented disease activity. No relationship was observed between VitD deficit and patients characteristics or calprotectin levels.

P640 Role of vedolizumab trough levels in predicting clinical response in Inflammatory Bowel Disease: a multicentre prospective study

Abstract Background Medical treatment of Inflammatory Bowel Diseases (IBD) has developed aiming at a target-therapy using molecular-targeted drugs, such as vedolizumab (VDZ), recommended in moderate to severe forms of IBD refractory to conventional therapy. Considering the low rate of clinical remission after 12 months of treatment (about 30%) and its cost, it is important to identify predictors of clinical efficacy: therapeutic drug monitoring (TDM) based on measuring VDZ trough levels (TL) and circulating neutralizing antibodies could be useful in this setting. This prospective study aims at evaluating the association between VDZ TLs at week 24 and clinical and biochemical disease activity at the same timepoint and at week 52, in order to identify if these levels can predict 12-months clinical remission Methods The study has included patients who started VDZ treatment from 2016 to 2022 at two IBD centres (Turin and Pisa). Patients were monitored through clinical scores (HBI and PMS) and laboratory tests (haemoglobin, CRP, faecal calprotectin) at the beginning of treatment, at 6, at 12-months; TDM has been performed at month 6; response to the treatment and clinical remission have been defined according to IOIBD criteria after 6 and 12 months Results All of 40 patients included (16 CD, 24 UC) have undergone a follow-up at month 6, while only 35 have been to an annual evaluation. At the beginning of treatment the clinical disease activity was moderate (HBI mean 7.5; PMS mean 4.9), it became mild at the second timepoint (HBI mean 3.5; PMS mean 2.5) and was found to be mild or in remission after a year (HBI mean 3.6; PMS mean 1.5). The response rate (77%) and clinical remission rate (63%) at 6 and 12-months have been steady over time. TDM has found a mean of VDZ TLs of 79.3 μg/ml (SD 51.3) and no anti-VDZ antibodies. 12-months clinical remission has been tested through logistic regression in order to identify predictive factors: it was inversely proportional to PMS (OR 0.47; p 0.02) and abnormal CRP levels (OR 0.24; p 0.04) at 6-months and directly associated with haemoglobin concentration at 0 (OR 2.14; p 0.04) and 6-months (OR 1.86; p 0.02). As to TDM, VDZ TLs at the second timepoint were positive predictors of symptoms remission at the next timepoint (OR 1.02; p 0.03): higher concentrations at 43.1 μg/ml were associated with clinical remission (AUC 0.69; p 0.03) and were positively correlated with laboratory tests, such as haemoglobin (r 0.36; p 0.03) Conclusion Response to VDZ at the end of the year can be predicted after the first 6 months with clinical evaluation and laboratory tests, as well as TDM: lower PMS, higher haemoglobin, quiescent inflammatory biomarkers together with higher VDZ TLs allow to identify who will achieve clinical remission.