Inflammatory Bowel Disease Center Research Articles

Pregnancy outcomes among women with inflammatory bowel disease: A UK tertiary centre experience.

Optimal management of inflammatory bowel disease (IBD) in pregnancy is associated with better pregnancy outcomes. We describe management of IBD during pregnancy and maternal and fetal outcomes of patients from a tertiary UK IBD centre. This is a retrospective observational cohort study of all pregnancies occurring between 2015 and 2021 in a large tertiary IBD centre in the UK. IBD activity and management prior to, during and after pregnancy were recorded along with pregnancy and neonatal outcomes. Associations between IBD-focused interventions and any adverse pregnancy outcomes, as well as the association between IBD severity and treatments and adverse maternofetal outcomes were assessed. Pregnancies in 130 women with IBD were included for analysis. The mean maternal age at delivery was 30.5 (± 4.7) years. At conception, 73 women (56.2%) were in clinical remission and 24 (18.4%) were treated with a biologic agent. Active disease during pregnancy, measured by physician global assessment, was less frequent in women who were in clinical remission at conception, compared to those not in remission at conception (16/73 21.9% vs. 39/49 79.6%; data insufficient for eight women). Active IBD at conception was associated with pre-term birth (p = 0.04). Maternal corticosteroid use in any trimester was associated with low birth weight (T1 p = 0.02; T2 p = 0.005; T3 p = 0.007). Active disease (p = 0.008) and steroid use in the third trimester (p = 0.05) were both associated with neonatal infections up to sixmonths after birth. Women in clinical remission at the time of conception have favorable outcomes, consistent with prospective observational studies. Our observations emphasize the importance of high quality IBD care for women pre and post-partum in line with international recommendations.

Dietary habits in Italian children with inflammatory bowel disease: A case-control multicenter study.

Patients with inflammatory bowel disease (IBD) tend to self-modify their dietary habits according to disease activity and symptoms. This study aimed to assess the adequacy of the usual diet in Italian children with IBD in comparison to a control group and to the recommended dietary allowances (RDA). Dietary habits of IBD children and age- and gender-matched healthy controls were investigated using a validated Food Frequency Questionnaire in five Italian pediatric IBD centers. Adherence to the Mediterranean diet (MD) was assessed using the KID-MED test. Energy (EI), macro, and micronutrients intakes were compared between the two groups, to the RDA and the predicted total energy expenditure (EI/total energy expenditure [TEE]%). IBD subjects (n = 110) reported a lower EI, EI/RDA%, and EI/TEE% compared to controls (n = 110) (p = 0.012, p < 0.0002, and p = 0.014), lower total protein and fat intakes (p = 0.017, p < 0.0001) and lower minerals/RDA, vitamins/RDA and micronutrients/RDA ratio (%). Poor adherence to the MD was more frequent in IBD children compared to controls (p = 0.013). The total EI and carbohydrate intake were inversely correlated with higher disease activity. Italian children with IBD report an inadequate diet in terms of energy, macro, and micronutrients and have a low adherence to a high-quality MD pattern.

Navigating Progress: Eight-Year Single-Center Experience With Minimally Invasive Proctectomy and Ileal Pouch-Anal Anastomosis.

Ileal pouch-anal anastomosis has become the gold standard for treating ulcerative colitis, familial adenomatous polyposis, and selected cases of Crohn's colitis. Robotic surgery promises improved postoperative outcomes and decreased length of stay. However, few studies have evaluated the benefits of robotic ileal pouch-anal anastomosis compared to laparoscopy. To compare short-term 30-day postoperative outcomes of robotic versus laparoscopic proctectomy with ileal pouch-anal anastomosis and diverting loop ileostomy. Retrospective observational study from a single, high-volume center. Mayo Clinic, Rochester, MN (tertiary referral center for inflammatory bowel disease). All adult patients undergoing minimally invasive proctectomy with ileal pouch-anal anastomosis and DLI between January 2015 and April 2023. Thirty-day complications, hospital length of stay, estimated blood loss, conversion rate, 30-day readmission, and 30-day reoperation. Two hundred seventeen patients were included in the study; 107 underwent robotic proctectomy with ileal pouch-anal anastomosis and diverting loop ileostomy, while 110 had laparoscopic proctectomy with ileal pouch-anal anastomosis and diverting loop ileostomy. Operating time was significantly longer in the robotic group (263 ± 38 minutes versus 228 ± 75 minutes, p < 0.0001); estimated blood loss was lower in the robotic group (81.5 ± 77.7 ml vs. 126.8 ± 111.0 ml, p = 0.0006) as well as the number of conversions (0% versus 8.2%, p = 0.003). Patients in the robotic group received more intraoperative fluids (3099 ± 1140 ml versus 2472 ± 996 ml, p = 0.0001). However, there was no difference in length of stay, 30-day morbidity, 30-day readmission, 30-day reoperation, rate of diverting loop ileostomy closure at three months, and surgical ileal pouch-anal anastomosis complication rate after ileostomy closure. Retrospective design, single-center study, potential bias due to the novelty of robotic approach, lack of long-term and quality-of-life outcomes. Robotic proctectomy with ileal pouch-anal anastomosis and diverting loop ileostomy may offer advantages in terms of estimated blood loss and conversion rate, while maintaining the benefits of minimally invasive surgery. Further research is needed to evaluate long-term outcomes. See Video Abstract.

Upper Gastrointestinal Involvement in Crohn's Disease as an Independent Predictor of New-Onset Strictures: Insights from an Extensive Retrospective Cohort Analysis.

Crohn's Disease (CD) can affect the entire gastrointestinal tract, including the upper sections (UGI), which is often overlooked, especially in Asian populations. There's a notable gap in research regarding the impact of UGI involvement on the intricate landscape of ensuing complications. This study aims to address this gap. Conducting a retrospective study at Chang Gung Memorial Hospital from January 2001 to September 2023, we compared CD patients with UGI (Montreal L4) involvement against non-L4 counterparts, focusing on baseline characteristics, post-diagnosis complications, and overall outcomes. Routine UGI endoscopy was performed around the time of diagnosis in all patients followed in our inflammatory bowel disease (IBD) center, and all CD patients with adequate follow-up were included in this study. The study included 212 CD patients, 111 in the L4 group and 101 in the non-L4 group, with an average follow-up of 40.8 ± 15.1months. At baseline, individuals in the L4 category demonstrated elevated smoking rates, increased Crohn's Disease Activity Index scores, a higher prevalence of strictures, and a more prevalent usage of biologics and proton pump inhibitors. Moreover, this group was characterized by reduced albumin levels. Upon concluding the follow-up, those with L4 involvement continued to show escalated CDAI scores and hospitalization frequencies, alongside heightened C-reactive protein levels and diminished albumin concentrations. Additionally, the occurrence of UGI involvement, stricturing disease at the time of diagnosis, and a younger age at the onset of CD were pinpointed as independent predictors for the development of new-onset strictures. CD patients with UGI involvement exhibit elevated disease activity and serve as independent predictors for the development of intestinal strictures. Thorough UGI evaluations at the time of diagnosis, coupled with assertive treatment strategies, are essential for managing these patients effectively.

Effect of Overweight and Obesity on the Response to Anti-TNF Therapy and Disease Course in Children With IBD.

This study aimed to evaluate the effect of overweight and obesity at the start of anti-TNF therapy on treatment response and relapse rate in children with inflammatory bowel disease (IBD). This multicenter, retrospective cohort study included 22 IBD centers in 14 countries. Children diagnosed with IBD in whom antitumor necrosis factor (anti-TNF) was introduced were included; those who were overweight/obese were compared with children who were well/undernourished. Six hundred thirty-seven children (370 [58%] males; mean age 11.5 ± 3.5 years) were included; 140 (22%) were in the overweight/obese group (OG) and 497 (78%) had BMI ≤1 SD (CG). The mean follow-up time was 141 ± 78 weeks (median 117 weeks). There was no difference in the loss of response (LOR) to anti-TNF between groups throughout the follow-up. However, children in OG had more dose escalations than controls. Male sex and lack of concomitant immunomodulators at the start of anti-TNF were risk factors associated with the LOR. There was no difference in the relapse rate in the first year after anti-TNF introduction; however, at the end of the follow-up, the relapse rate was significantly higher in the OG compared with CG (89 [64%] vs 218 [44%], respectively, P < .001). Univariate and multivariate analysis revealed that being overweight/obese, having UC, or being of male sex were factors associated with a higher risk for relapse. Overweight/obese children with IBD were not at a higher risk of LOR to anti-TNF. Relapse in the first year after anti-TNF was introduced, but risk for relapse was increased at the end of follow-up.

A real-life pediatric experience of Crohn's disease exclusion diet at disease onset and in refractory patients.

We aimed to appraise the real-life efficacy of Crohn's disease exclusion diet (CDED) coupled with partial enteral nutrition (PEN) in inducing clinical and biochemical remission at disease onset and in patients with loss of response to biologics and immunomodulators. We retrospectively gathered data of patients aged less than 18 years of age with a diagnosis of Crohn's disease (CD), who received CDED coupled with PEN at a tertiary level pediatric inflammatory bowel disease center. Sixty-six patients were identified. Forty (60.6%) started CDED plus PEN at disease onset and 26 (39.4%) received CDED with PEN as add-on therapy. Forty-six (69.7%) patients achieved clinical remission (weighted Pediatric Crohn's Disease Activity Index < 12.5) at the end of Phase 1, 44 (66.7%) normalized c-reactive protein levels (<0.5 mg/dL) and 18 (27.2%) patients normalized calprotectin levels (<150 microg/g). Nine of 19 (47.3%) of patients with clinically severe disease (defined by Physician Global Assessment) achieved clinical remission at the end of Phase I. Patients with extraintestinal manifestations had statistically lower clinical response rates to the dietary regimen (p = 0.018). Among patients who received CDED + PEN as add-on treatment, a previous successful course of Exclusive Enteral Nutrition was associated with statistically higher clinical remission rates at Week 8 (p = 0.026). Clinical response at Week 4 was an independent predictor of clinical remission and fecal calprotectin normalization at Week 8 (p = 0.002). CDED with PEN confirmed its efficacy in a real-life setting, proving to be effective also in refractory patients and those with severe disease. Early clinical response predicts clinical remission at the end of Phase 1.

Efficacy, drug sustainability, and safety of ustekinumab treatment in Crohn’s disease patients over three years

Long-term data on ustekinumab in real-life Crohn’s disease patients are still missing, though randomized controlled trials demonstrated it as a favorable therapeutic option. We aimed to evaluate ustekinumab's clinical efficacy, drug sustainability, and safety in a prospective, nationwide, multicenter Crohn’s disease patient cohort with a three-year follow-up. Crohn’s disease patients on ustekinumab treatment were consecutively enrolled from 9 Hungarian Inflammatory Bowel Disease centers between January 2019 and May 2020. Patient and disease characteristics, treatment history, clinical disease activity (Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (Simple Endoscopic Score for Crohn’s Disease (SES-CD)) were collected for three-years’ time. A total of 148 patients were included with an overall 48.9% of complex behavior of the Crohn’s disease and 97.2% of previous anti-TNF exposure. The pre-induction remission rates were 12.2% (HBI), and 5.1% (SES-CD). Clinical remission rates (HBI) were 52.2%, 55.6%, and 50.9%, whereas criteria of an endoscopic remission were fulfilled in 14.3%, 27.5%, and 35.3% of the subjects at the end of the first, second, and third year, respectively. Dose intensification was high with 84.0% of the patients on an 8-weekly and 29.9% on a 4-weekly regimen at the end of year 3. Drug sustainability was 76.9% during the follow-up period with no serious adverse events observed. Ustekinumab in the long-term is an effective, sustainable, and safe therapeutic option for Crohn’s disease patients with severe disease phenotype and high previous anti-TNF biological failure, requiring frequent dose intensifications.

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 patients with ulcerative colitis who underwent segmental colectomy and assess their postoperative and long-term outcomes. Retrospective case series. A tertiary care IBD center. Patients with ulcerative colitis 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%] women; age 67.8 (57.4-77.1) years at surgery; BMI 27.7 (24.2-31.1) kg/m 2 ; median follow-up 37.3 months). Thirty-two patients (58.2%) had ASA score of 3, 48 (87.3%) had at least 1 comorbidity, and 48 (87.3%) had Mayo endoscopic subscores of 0 to 1. Patients underwent right hemicolectomy (n = 28; 50.9%), sigmoidectomy (n = 17; 30.9%), left hemicolectomy (6; 10.9%), low anterior resection (n = 2; 3.6%), or a nonanatomic resection (n = 2; 3.6%) for endoscopically unresectable polyps (n = 21; 38.2%), colorectal cancer (n = 15; 27.3%), symptomatic diverticular disease (n = 13; 23.6%), and stricture (n = 6; 10.9%). Postoperative complications occurred in 16 patients (29.1%; n = 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. Four patients (7.3%) underwent subsequent completion proctocolectomy with ileostomy. Six patients (10.9%) had a stoma at follow-up. Two- and 5-year completion proctocolectomy-free survival rates were 91% and 88%, respectively. Retrospective study and 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 . ANTECEDENTES:La colectomía segmentaria en la colitis ulcerosa se realiza en pacientes seleccionados que pueden tener un mayor riesgo de morbilidad posoperatoria.OBJETIVO:Identificar pacientes con colitis ulcerosa sometidos a colectomía segmentaria y evaluar sus resultados postoperatorios y a largo plazo.DISEÑO:Serie de casos retrospectivos.AMBIENTE:Un centro de atención terciaria para enfermedades inflamatorias intestinales.PACIENTES:Pacientes con colitis ulcerosa intervenidos quirúrgicamente entre 1995 y 2022.INTERVENCIÓN(S):Colectomía segmentaria.PRINCIPALES MEDIDAS DE RESULTADO:Complicaciones postoperatorias, colitis temprana y tardía, desarrollo de cáncer metacrónico, tasas de supervivencia sin proctocolectomía completa y estoma en el seguimiento.RESULTADOS:Se incluyeron cincuenta y cinco pacientes [20 (36,4%) mujeres; 67,8 (57,4-77,1) años de edad al momento de la cirugía; índice de masa corporal 27,7 (24,2-31,1) kg/m2; mediana de seguimiento 37,3 meses]. La puntuación ASA fue III en 32 (58,2%) pacientes, 48 (87,3%) tenían al menos una comorbilidad y 48 (87,3%) tenían una subpuntuación endoscópica de Mayo de 0-1. Los pacientes fueron sometidos a hemicolectomía derecha (28, 50,9%), sigmoidectomía (17, 30,9%), hemicolectomía izquierda (6, 10,9%), resección anterior baja (2, 3,6%) o resección no anatómica (2, 3,6%) para; pólipos irresecables endoscópicamente (21, 38,2%), cáncer colorrectal (15, 27,3%), enfermedad diverticular sintomática (13, 23,6%) y estenosis (6, 10,9%). Se produjeron complicaciones postoperatorias en 16 (29,1%) pacientes [7 (12,7%) Clavien-Dindo Clase III-V]. Las tasas de colitis posoperatoria temprana y tardía fueron del 9,1% y el 14,5%, respectivamente. Un paciente desarrolló cáncer metacrónico. A 4 (7,3%) pacientes se les realizó posteriormente proctocolectomía completa con ileostomía. Seis (10,9%) pacientes tenían estoma en el seguimiento. Las tasas de supervivencia sin proctocolectomía completa a dos y cinco años fueron del 91% y 88%, respectivamente.LIMITACIONES:Estudio retrospectivo, tamaño de muestra pequeño.CONCLUSIONES:La colectomía segmentaria en la colitis ulcerosa se asocia con bajas tasas de complicaciones postoperatorias, tasas de colitis sintomática temprana y tasas de colitis tardía, desarrollo de cáncer metacrónico y la necesidad de una posterior proctocolectomía completa. Por lo tanto, puede ser seguro considerar pacientes seleccionados, como los ancianos con colitis inactiva y otras indicaciones de colectomía. (Traducción-Dr. Yolanda Colorado ).

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.

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.