Outcomes In Inflammatory Bowel Disease Patients Research Articles

Outcomes of patients with prior biologic intolerance are better than those with biologic failure in clinical trials of inflammatory bowel disease

Abstract Background and Aims Inflammatory bowel disease (IBD) trials often stratify patients by prior biologic exposure, including prior biologic failure or intolerance. This study aimed to assess clinical outcomes in IBD patients with prior biologic failure versus intolerance treated with ustekinumab or vedolizumab. Methods A post-hoc analysis of ulcerative colitis (UC) and Crohn’s disease (CD) clinical trials for ustekinumab (UNITI, UNIFI) and vedolizumab (GEMINI-1, GEMINI-2) was performed. Clinical response, clinical remission, and endoscopic improvement (for UC) were compared among biologic naïve, biologic-failure, and biologic intolerant patients. Statistical analyses, including chi-square tests and logistic regression, were performed. Results 1178 UC and 1439 CD patients received either ustekinumab or vedolizumab. In UC, biologic intolerant patients exhibited higher clinical response (54.7% vs. 38.8%, aOR 1.87 [95% CI 0.93-3.73]), clinical remission (25.0% vs. 11.0%, aOR 2.84 [95% CI 1.47-5.49]), and endoscopic improvement (40.6% vs. 24.8%, aOR 2.76 [95% CI 1.28-5.94]) compared to biologic failure, with outcomes similar to biologic naïve patients. In biologic-intolerant CD patients, clinical response was similar between prior biologic failure and intolerance (34.2% vs 32.8%), but after adjustment for potential confounders, biologic intolerance was associated with higher odds of clinical response (aOR: 1.67, 95% CI 1.09-2.55), with no significant difference observed for clinical remission (aOR: 1.48, 95% CI 0.88-2.49). Conclusion Improved treatment outcomes were generally observed in patients with biologic intolerance compared to failure, especially in UC, where outcomes were similar to biologic naïve patients. Future clinical trials should meticulously differentiate prior biologic failure versus intolerance to mitigate potential bias.

Subcutaneous versus intravenous infliximab therapy - a real-world study: toward higher drug concentrations.

Recently, a formula of subcutaneous infliximab (SC-IFX) has been approved for inflammatory bowel disease (IBD), demonstrating a better pharmacokinetic and immunogenic profiles, compared to intravenous infliximab (IV-IFX), with similar efficacy and safety. The aim of this study is to evaluate the clinical, biochemical, and pharmacological outcomes of IBD patients in clinical remission, who switched from IV-IFX to SC-IFX, with a follow-up period of 6 months. Retrospective cohort study, including IBD patients in clinical remission, previously medicated with IV-IFX, who switched to SC-IFX 120 mg every other week. Biochemical parameters were evaluated before the switch and 6 months after, namely infliximab serum concentrations, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and fecal calprotectin. Included 41 patients in clinical remission, 32 with Crohn's disease (78.0%) and 9 with ulcerative colitis (22.0%). All patients maintained clinical remission during the 6 months after the switch, with a treatment persistence rate of 100%, and no patients requiring corticosteroid therapy, switching back to IV-IFX, or IBD-related hospitalization. The mean infliximab serum concentrations were significantly higher after 6 months of SC-IFX (17.3 ± 6.6 vs. 9.1 ± 5.5 µg/ml, P < 0.001). However, there were no differences between values of ESR, CRP, and fecal calprotectin, before and after the switch (P = 0.791, P = 0.246, and P = 0.639). Additionally, none of the patients developed antibodies to infliximab. Switching from IV-IFX to SC-IFX in IBD patients in clinical remission is effective and leads to higher infliximab serum concentrations, regardless of the combination with immunomodulatory therapy.

The impact of cognitive functions, psychological disorders, and coping strategies on quality of life and disease outcomes in patients with inflammatory bowel diseases: A cross-sectional study.

Quality of life (QoL) in patients with inflammatory bowel disease (IBD) is influenced by several factors, many of which may also impact cognitive function. However, the extent of the interaction among these factors, QoL, and disease outcomes in IBD patients remains unknown. We thus aim to characterize the relationships among psychological disorders, coping mechanisms, cognitive function, and the overall impact on QoL and disease outcomes in patients with IBD. This cross-sectional observational study was conducted at an academic care center. QoL was evaluated using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and disease severity was evaluated using the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). We also used the Hospital Anxiety and Depression scale (HADS). Regression models were used to test the associations among QoL, number of hospitalizations, disease severity, cognitive functioning (working memory [WM] and reaction time), and coping strategies while controlling for anxiety and depressive symptoms, age, and sex. This study included 41 patients (24 patients with CD and 17 with UC) whose mean age was 28.2 (±8.4) years (23 males) and mean SIBDQ score was 51.5 (±10.0). Patients with more WM errors had lower QoL scores (P = .041), whereas patients with higher anxiety levels had lower QoL and more active UC (P = .008 and P = .016, respectively). The use of avoidant coping mechanisms was associated with a significantly higher number of hospitalizations (P = .038), and patients who adopted more emotion-focused coping strategies had a longer illness duration (P = .021). Finally, patients with higher education levels were found to use more active coping mechanisms than others. These results confirm the impact of cognitive, psychological, and coping factors on QoL and disease outcomes in patients with IBD; however, the mechanisms by which these factors interrelate remain unclear. Therapies aimed at improving both cognitive functions and psychological conditions may thus be effective at improving QoL and disease outcomes in IBD patients, and education may play a positive role in promoting the adoption of more effective coping strategies among IBD patients.

Cytomegalovirus Infection in Adult Patients with Inflammatory Bowel Disease: A Literature Review.

Human cytomegalovirus (HCMV) is classified within the Herpesvirales order and is prevalent in 50%‒80% of the general population. Most carriers experience this infection without noticeable clinical symptoms. HCMV causes a lifelong latent infection that can be reactivated due to immune disorders and inflammation. The reactivation of HCMV becomes particularly significant when it coincides with inflammatory bowel disease (IBD). While cytomegalovirus (CMV) colitis in IBD patients was identified years ago, the role of CMV in triggering flare-ups, acute severe colitis, treatment resistance, and other outcomes in IBD patients experiencing CMV reactivation remains a subject of ongoing debate. In this review, we aim to address an updated insight into aspects related to the CMV colitis in IBD patients including epidemiology, risk factors, clinical features, diagnostic tests, histology, place of immunosuppressants and indications for antiviral treatment. We suggest for personalized and thorough assessment based on the disease phase and colitis severity when prescribing drugs to these patients. Furthermore, we emphasize the importance of regular patient follow-up to monitor drug side effects, ensuring treatment success, and minimizing the risk of colectomy.

Comparison of different sources of mesenchymal stem cells: focus on inflammatory bowel disease.

Inflammatory bowel disease (IBD) poses a significant challenge in modern medicine, with conventional treatments limited by efficacy and associated side effects, necessitating innovative therapeutic approaches. Mesenchymal stem cells (MSC) have emerged as promising candidates for IBD treatment due to their immunomodulatory properties and regenerative potential. This thesis aims to explore and compare various sources of MSC and evaluate their efficacy in treating IBD. This study comprehensively analyses MSC derived from multiple sources, including bone marrow, adipose tissue, umbilical cord, and other potential reservoirs. Core elements of this investigation include assessing differences in cell acquisition, immunomodulatory effects, and differentiation capabilities among these MSC sources, as well as comparing their clinical trial outcomes in IBD patients to their therapeutic efficacy in animal models. Through meticulous evaluation and comparative analysis, this thesis aims to elucidate disparities in the efficacy of different MSC sources for IBD treatment, thereby identifying the most promising therapeutic applications. The findings of this study are intended to advance our understanding of MSC biology and offer valuable insights for selecting the most effective MSC sources for personalized IBD therapy. Ultimately, this research endeavor will optimise therapeutic strategies for managing inflammatory bowel disease through the utilization of MSC.

Racial and ethnic disparities in clinical presentation, management, and outcomes of patients with inflammatory bowel disease: a narrative review.

Inflammatory bowel disease (IBD) is a chronic condition that has been increasing in prevalence and incidence worldwide. Although, most cases are described in Caucasian populations, there has been a rise in IBD diagnosis among other populations. In this article, we will discuss the disparities in the presentation, management, medical and surgical outcomes of IBD patients among different racial and ethnic groups. A literature search was conducted in PubMed, Medline, and Google Scholar. The search strategy included targeted keywords to identify specific studies that provided the current literature on disparities in IBD presentation and management. Articles for presentation were selected by the authors, in accordance with a narrative review format, favoring population-based studies, systematic reviews and meta-analysis over single or multicenter reports. Epidemiological data has shown that there is an increasing incidence in IBD diagnosis among Black, Asian, and Hispanic populations over the past decade. Differences in genetic predispositions have been observed, however it is difficult to ascertain if the minor differences in presentation and medical/surgical management reported are due to innate differences or due to confounding factors such as access to health care. Differences in genetic predisposition, and clinical presentation have been observed to exist among IBD non-Caucasian populations. There were also differences observed in both surgical and medical management, but it is difficult to ascertain if these were innate differences or due to societal factors.

Comparative effectiveness and safety of ustekinumab at different intervals of maintenance phase in inflammatory bowel disease: a systematic review and meta-analysis.

Ustekinumab has two alternative drug maintenance intervals for inflammatory bowel disease (IBD), every 8 weeks (Q8W) and every 12 weeks (Q12W). The current study aimed at evaluating the comparative efficacy and safety of the two maintenance intervals in patients with IBD. A systematic search on PubMed, Web of Science, Cochrane Library, and EMBASE was carried out. The relative risk (RR) was pooled for efficacy and safety outcomes between the two intervals at various follow-up time points, categorized as short term (less than 44 weeks), medium term (about 92 weeks), and long term (about 152 weeks). A total of 14 studies with 1448 patients were included. Q8W didn't result in a remarkably higher proportion of clinical remission compared to Q12W at short term (RR, 0.99; 95% CI, 0.83-1.16), medium term (RR, 1.05; 95% CI, 0.91-1.20), and long term (RR, 1.07; 95% CI, 0.91-1.26). Similarly, no substantial differences exist at short term in clinical response (RR, 1.00; 95% CI, 0.85-1.17), endoscopic remission (RR, 0.97; 95% CI, 0.26-3.69), and histologic improvement (RR, 1.13; 95% CI, 0.93-1.36) between the two intervals. For safety outcomes, the RR values for any adverse events in the short, medium, and long term were 1.10 (95% CI, 1.00-1.21), 1.14 (95% CI, 1.08-1.20), and 1.12 (95% CI, 1.07-1.17) for Q8W versus Q12W. Finally, we conclude that ustekinumab maintenance therapy administered every 8 and 12 weeks showed similar effectiveness in achieving efficacy outcomes in IBD patients, and most safety outcomes were significantly better for Q12W during the maintenance phase.

N18 The experience of the IBD patients with a permanent or temporary stoma: update of the literature

Abstract Background Surgery is indicated in selected patients with inflammatory bowel disease (IBD).Annually, 2000 (0.66%) of these individuals in the UK and an estimated 24,000 (1.5%) in the USA undergo surgery resulting in a permanent or temporary stoma. The audience of patients undergoing a stoma surgery is very broad and consists of not only elderly people, but also young adults, fertile or pregnant women.Fear of having a stoma is a major concern for people with IBD. And this aspect goes beyond the simple therapeutic aspect but it encroaches upon the psychological, occupational, relational, educational, financial and domestic area.This study aims to analyze the Quality of Life (QoL) outcomes of IBD patients with temporary or permanent stoma Methods To identify, evaluate and synthesis the lived experiences of IBD patients having a stoma, a meta-synthesis has been performed following the Sandelowski and Barroso guidelines (2007).Studies included: primary studies in English language, conducted using qualitative methodology that explore the subjective experience of IBD patients having a temporary or permanent stoma; studies that debated the experiences lived during the period of having a stoma; studies published from January 2013 to October 2023. The instrument Critical Appraisal Skills Program (CASP) has been used for the qualitative evaluation of the included studies (Image 1) Results Sixteen studies have been analyzed and the most of them involved more than one medical or research institution. The included studies described different areas of the perceived experience of 3046 IBD patients with a stoma. A total of 30 labels have been classified into 12 sub-themes, grouped in a total of five themes. (a) Surgery is a trigger for possible psychological disorders such as PTSD and (b) the positive perception of the stoma as an effective therapy in the management of IBD symptoms are the most frequent labels in the studies (Table 1) Conclusion The results of this study contributed to provide evidence about the experience of stoma-bearing IBD patients.Healthcare providers should offer improved interdisciplinary counselling earlier in the course of IBD so as to inform and enpower the patient and allow for shared decision-making. Patient information, education and support groups are crucial when managing IBD patients and optimizing patient-reported outcomes.This counts especially for young subjects that would be less prone to accept a stoma.Taken together, these findings provide further proof of the complex interplay between various psychological aspects.Our findings are consistent with previous research, which suggest, in terms of direction for psychological operations,that an increased focus in the educational and management of the disease is crucial

P1179 Long-term impact of COVID-19 on the disease course of IBD: a meta-analysis

Abstract Background Viral infections have been implicated in the exacerbation of immune-mediated inflammatory diseases like inflammatory bowel disease (IBD). The COVID-19 pandemic, therefore, sparked interest in whether infection with the virus has an adverse effect on the course of IBD. Since the existing evidence is conflicting and limited by a small sample size, we performed the very first meta-analysis to study the long-term impact of SARS-CoV-2 infection on the disease course of IBD. Methods We performed a systematic literature search in MEDLINE and EMBASE for studies that explored the risk of adverse IBD outcomes following a SARS-CoV-2 infection. We used the random effects model meta-analysis to calculate the pooled hazard ratio for the risk of IBD flares following the acute phase of COVID-19. Subgroup meta-analysis was carried out for the risk of the outcomes by IBD subtype. Meta-regression was carried out for sex and duration of follow-up. The ROBINS-E tool for observational studies was used to assess the quality of the studies. Results A total of 5 studies were included in the meta-analysis. The studies were based on cohorts from Denmark, Italy, the US, and a cohort from a consortium of the EU comprising a total of 34977 SARS-CoV-2 positive IBD patients and 53270 IBD patients without the infection as controls. Two of the studies had a high risk of bias according to the quality assessment tool. The meta-analysis did not show an increased risk of IBD-related outcomes in IBD patients who contracted a SARS-CoV-2 infection compared to those who did not (HR: 1.0514, CI: 0.7547- 1.4646, p= 0.7671). There was substantial heterogeneity between the included studies (91%, p&amp;lt;0.01). There was no significant difference between CD and UC patients in terms of disease flare (CD- HR: 0.9134, CI: 0.8163-1.0220; UC- HR: 0.8257, CI: 0.7549-0.9032). Neither sex nor the duration of follow-up was a predictor of the overall effect size. Conclusion In this group of patients, SARS-CoV-2 infection does not increase the risk of adverse outcomes related to IBD. High-quality studies with longer follow-up duration are required to understand the long-term impact of SARS-CoV-2 infection on IBD prognosis.

P504 Prevalence of gastrointestinal infections in ulcerative colitis patients assessed with QIASTAT-DX® GASTROINTESTINAL PANEL 2

Abstract Background In inflammatory bowel disease (IBD), an acute clinical flare may be due to either disease exacerbation or an enteric infection. Thus, it is recommended to exclude infections before escalating IBD therapy. In this setting, conventional tests identify only a minimal proportion of infections (i.e. 10%). Whether nucleic acid multiplex tests can expand the range of detected pathogens and increase the overall prevalence is still a matter of debate. Methods We performed a single-center transversal prospective study at Fondazione IRCCS Policlinico Ca’ Granda. Stool samples from consecutive ulcerative colitis (UC) patients experiencing a disease flare and a group of patients in clinical remission were enrolled between February and October 2023 and tested with QIAstat-Dx Gastrointestinal Panel 2 (Qiagen GmbH, Hilden, Germany) for simultaneous qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites. Clinically active disease was defined as a Partial Mayo Score (PMS) of ≥2. Results Overall, 85 UC patients were enrolled. Demographics and clinical features are displayed in Table 1. Median age was 42 (18-79), 52% were males. The two most common treatment regimens were mesalamine (54%) and biologic/small molecule treatment (35%). 66 (78%) patients were clinically active, while 19 (22%) were in remission. In the active group, median bowel movements were 5 (3-15), 58 (88%) patients had loose stool, 32 (49%) reported abdominal pain, 40 (61%) urgency, 10 (15%) overnight symptoms, 6 (9%) fever. Median PMS was 5 (2-8). Median hemoglobin was 13.8 (8.2-16.4) g/dL, fecal calprotectin 508 (&amp;lt;5-4980) ug/g. Prevalence of gastrointestinal infections with QIAstat-Dx was 30 vs. 10% (p=0.13) in active vs. remission group, respectively. The most common infections were: C.Difficile infection (CDI) (4 cases), Cytomegalovirus (CMV) (4 cases) and enteropathogenic E.Coli (EPEC) (4 cases). Regarding viral and E. Coli infections, clinical remission (PMS &amp;lt;2) occurred spontaneously. As for CMV, Campylobacter spp., and CDI, all patients except one achieved remission following specific antimicrobial treatment. In one patient CMV infection led to hospital admission (circulating CMV DNA 35,395 IU/mL). The remaining patient did not receive specific antiviral therapy since sigmoidoscopy only detected isolated CMV+ cells, and remission was achieved with UC treatment escalation. Conclusion In UC patients experiencing a clinical flare, prevalence of gastrointestinal infections with QIAstat-Dx® Gastrointestinal Panel 2 is numerically higher than patients in remission. Further studies are needed to investigate whether increased detection could influence the clinical outcomes of IBD patients and time and costs for the healthcare system.

Advancements in Endoscopic Resection for Colitis-Associated Colorectal Neoplasia in Inflammatory Bowel Disease: Turning Visible into Resectable.

Patients suffering from inflammatory bowel disease (IBD) face a two to three-fold higher risk of developing colorectal cancer (CRC) compared to the general population. In recent years, significant progress has been made in comprehending the natural history of IBD-associated CRC (IBD-CRC) and refining its treatment strategies. The decreased incidence of IBD-CRC can be attributed to improved therapeutic management of inflammation, advancements in endoscopy, and early detection of precancerous lesions via surveillance programs. Advanced imaging technologies have made previously undetectable dysplasia visible in most cases, allowing for a much more precise and detailed examination of the mucosa. Additionally, new tools have facilitated the endoscopic resection (ER) of visible lesions in IBD. Particularly, the key to effectively manage colitis-associated colorectal neoplasia (CAN) is to first identify it and subsequently guarantee a complete ER in order to avoid surgery and opt for continuing surveillance. Advanced ER techniques for CAN include endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and hybrid ESD-EMR (h-ESD). This narrative review aims to consolidate the current literature on IBD-CRC, providing an overview of advanced techniques for ER of CAN in IBD, with a particular emphasis on the impact of ESD on the long-term outcomes of IBD patients.

Pregnancy Outcomes in a Cohort of Patients with Inflammatory Bowel Disease: Data from a Multidisciplinary Clinic in a Tertiary Center.

Inflammatory bowel disease (IBD) can have an impact on pregnancy outcomes due to the effect of the disease activity and medication use. This study aimed to evaluate the pregnancy outcomes in IBD patients treated at a multidisciplinary clinic. This study was a retrospective cohort study including consecutive pregnant patients with IBD having a singleton gestation attending a multidisciplinary clinic between 2012 and 2019. The IBD activity and management throughout gestation were assessed. The pregnancy outcomes included: adverse neonatal and maternal outcomes, mode of delivery, and three integrative outcomes: (1) a favorable pregnancy outcome, (2) a poor pregnancy outcome, and (3) an unfavorable maternal outcome. The IBD pregnant cohort was compared with a cohort of non-IBD pregnant women delivering at the same shift. Multivariable logistic regression was used for risk assessment. Pregnant women with IBD (141) and without (1119) were included. Mean maternal age was 32 [±4] years. Patients with IBD had a higher rate of nulliparity (70/141 (50%) vs. 340/1119 (30%), p < 0.001) and lower BMI (21.42 kg/m2 (19.18-23.44) vs. 22.48 (20.31-25.59), p = 0.002). All the other characteristics were comparable. Most patients with IBD 124/141 (88%) were in clinical remission at conception; with maintenance therapy in 117/141 patients (83%). A third of the patients, 43/141 (30.5%), were treated with biologics. Exacerbation occurred during pregnancy in 51/141 (36%). The majority of the maternal and neonatal outcomes and all the composite outcomes were comparable between the patients with IBD and the women without IBD. Cesarean delivery was more frequent in patients with IBD (49/141 (34.8%) vs. 270/1119 (24.1%), p = 0.021). IBD was not associated with composite outcomes. In pregnant patients with IBD followed at a multidisciplinary clinic, the pregnancy outcomes were encouraging and comparable to those of the women without IBD.

Inflammatory bowel disease is associated with an increased risk of adverse events in patients undergoing joint arthroplasty.

The present study aimed to investigate whether patients with inflammatory bowel disease (IBD) undergoing joint arthroplasty have a higher incidence of adverse outcomes than those without IBD. A comprehensive literature search was conducted to identify eligible studies reporting postoperative outcomes in IBD patients undergoing joint arthroplasty. The primary outcomes included postoperative complications, while the secondary outcomes included unplanned readmission, length of stay (LOS), joint reoperation/implant revision, and cost of care. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using a random-effects model when heterogeneity was substantial. Eight retrospective studies involving 29,738 patients with IBD were included. Compared with non-IBD controls, patients with IBD were significantly more likely to have overall complications (OR 2.11 (95% CI 1.67 to 2.66), p < 0.001), medical complications (OR 2.15 (95% CI 1.73 to 2.68), p < 0.001), surgical complications (OR 1.43 (95% CI 1.21 to 1.70), p < 0.001), and 90-day readmissions (OR 1.42 (95% CI 1.23 to 1.65), p < 0.001). The presence of IBD was positively associated with the development of venous thromboembolism (OR 1.60 (95% CI 1.30 to 1.97), p < 0.001) and postoperative infection (OR 1.95 (95% CI 1.51 to 2.51), p < 0.001). In addition, patients with IBD tended to experience longer LOS and higher costs of care. The findings suggest that IBD is associated with an increased risk of postoperative complications and readmission after joint arthroplasty, resulting in longer hospital stay and greater financial burden. Surgeons should inform their patients of the possibility of adverse outcomes prior to surgery and make appropriate risk adjustments to minimize potential complications.

One-Year Clinical Outcomes of Subcutaneous Infliximab Maintenance Therapy Compared With Intravenous Infliximab Maintenance Therapy in Patients With Inflammatory Bowel Disease: A Prospective Cohort Study.

Although the pharmacokinetic profile of subcutaneous (SC) infliximab (IFX) is superior to conventional intravenous (IV) IFX, long-term efficacy and safety of SC IFX in patients with inflammatory bowel disease (IBD) have not been reported yet. This study aimed to evaluate long-term clinical outcomes of IBD patients treated with SC IFX compared with those of IBD patients treated with IV IFX during maintenance therapy. This prospective cohort study enrolled 61 IBD patients in clinical remission who received scheduled IFX maintenance therapy. Of them, 38 patients were switched to SC IFX, while 23 patients continued IV IFX with dose optimization. Enrolled patients were followed up for 1 year. The primary outcome was durable remission defined as clinical remission (Crohn's disease, Harvey-Bradshaw index <5; ulcerative colitis, partial Mayo score <2) and biochemical remission (C-reactive protein <0.5 mg/dL) with IFX trough level ≥3 µg/mL throughout the follow-up period. One-year clinical remission, 1-year biochemical remission, and mucosal healing did not differ between the IV and SC IFX groups (n = 20 of 23 vs 33 of 38; P = 1.000; n = 22 of 23 vs 34 of 38; P = .641; and n = 10 of 18 vs 17 of 25; P = .414, respectively). During follow-up, the number of patients with IFX trough level <3 μg/mL was significantly lower in the SC IFX group (n = 0 of 38, 0%) than in the IV IFX group (n = 10 of 23, 43%) (P < .001). The SC IFX group showed higher 1-year durable remission than the IV IFX group (n = 31 of 38, 82% vs n = 11 of 23, 48%; P = .013). The incidence of IFX-related adverse events did not differ significantly between both groups (26% vs 39%; P = .446). The SC IFX switch induced a higher 1-year durable remission rate than continuing IV IFX in patients with IBD during scheduled maintenance therapy, showing similar safety.

What Should I Eat? Dietary Recommendations for Patients with Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic disorder thought to be caused by enteric inflammation in a genetically susceptible host. Although the pathogenesis of IBD is largely unknown, it is widely accepted that dietary components play an important role. Human and animal-based studies have explored the role of various dietary components such as meat, artificial sweeteners and food additives in causing enteric inflammation. Several diets have also been studied in patients with IBD, specifically their role in the induction or maintenance of remission. The most well-studied of these include exclusive enteral nutrition and specific carbohydrate diet. A diet low in FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols), typically prescribed for patients with irritable bowel syndrome, has also been studied in a specific subgroup of patients with IBD. In this review, we describe the current evidence on how various dietary components can induce enteric and colonic inflammation, and the clinical-epidemiological evidence exploring their role in predisposing to or protecting against the development of IBD. We also discuss several special diets and how they affect clinical outcomes in IBD patients. Based on the available evidence, we provide guidance for patients and clinicians managing IBD regarding the best practice in dietary modifications.

Depression and anxiety are associated with poor outcomes in patients with inflammatory bowel disease: A nationwide population-based cohort study in South Korea

BackgroundPrevalence of depression and anxiety are known to be increased in patients with inflammatory bowel disease (IBD), but it is unclear whether such elevations adversely affect IBD outcomes. ObjectiveWe aimed to investigate the association between depression or anxiety and clinical outcomes of IBD. MethodUsing claims data from the South Korean National Health Insurance Service (NHIS), patients with IBD were identified by codes of the International Classification of Disease, 10th Revision (ICD-10) and the Rare/Intractable Disease (RID) registration program for years 2010 to 2017. ICD-10 codes were also used to identify depression and anxiety in this population. Primary study endpoints were IBD-related outcomes, including emergency room (ER) visits, hospitalizations, and surgeries during the follow-up period. ResultsOur cohort included 32,867 patients with IBD, of whom 3794 (11.5%) experienced depression and anxiety during the 6-year median follow-up period. In multivariate analysis, comorbid depression and anxiety were associated with increased risks of ER visits (hazard ratio [HR] = 1.34, 95% confidence interval [CI]: 1.19–1.51) and hospitalizations (HR = 1.24, 95% CI: 1.12–1.37), whereas surgical risk was not different for IBD patients with and without depression and anxiety. There was no differential effect of depression and anxiety on outcomes in IBD patients, but depression was more closely associated with outcomes in CD patients and anxiety in UC patients. ConclusionIn patients with IBD, comorbid depression and anxiety are associated with increased risks of ER visits and hospitalizations, but not surgery. These associations are more pronounced for depression in CD patients and for anxiety in UC patients.

P747 The impact of COVID-19 on patients with Inflammatory Bowel Disease: A population-based study using artificial intelligence

Abstract Background Coronavirus disease 2019 (COVID-19) has been a pandemic that is still very prevalent. Patients with Inflammatory Bowel Disease (IBD) represent a special population considering their already altered immune system and their exposure to several immunosuppressive therapies. We pretend to study the impact of COVID-19 on IBD patients in our community, Castilla-La Mancha (a region in central Spain). Methods Retrospective observational study using an artificial intelligence with natural language processing capability, the SAVANA manager, we analyzed data from 1 808 010 patients with Electronic Medical Records (EMR) within the public health system of Castilla-La Mancha from March 1st 2020 to January 1st 2021. Data on demographic characteristics, hospitalization, ICU admission and mortality were collected. We compared COVID outcomes between IBD and non-IBD patients. We compared COVID outcomes in IBD patients according to their treatment (comparing each treatment group to those IBD patients with no treatment); we considered: immunomodulators (azathioprine, mercaptopurine, methotrexate), antiTNF alone or combined with immunomodulator, vedolizumab, ustekinumab and tofacitinib; mesalazine and corticosteroids were not analyzed. Results 2 243 patients with IBD suffered COVID-19, compared to COVID-19 cases without IBD there were less females, they suffered more arterial hypertension, diabetes mellitus, dyslipidemia, obesity, or tabacco use (TABLE 1). And yet, despite these being proven risk factors for worse outcomes for COVID-19, no differences were appreciated in hospitalization rate, ICU admission, or mortality between those with or without IBD (TABLE 2). COVID-19 was more frequent in IBD patients (32.59 vs 13.28%). Comparing IBD patients with COVID-19 according to their treatments (TABLE 3), vedolizumab is the only treatment with a higher risk for COVID-19 infection, however the hospitalization risk for vedolizumab is lower than for those without it. Immunomodulators do also have a lower hospitalization risk both alone or in combination with antiTNF, no differences were found for antiTNF monotherapy, ustekinumab or tofacitinib. ICU rate and mortality are no different between treatments, except for tofacitinib (0.00% ICU rate, 10.00% mortality), however the small number of patients using this treatment may bias this result. Conclusion COVID-19 in IBD patients is no different in hospitalization, ICU admission or mortality compared to non-IBD population. IBD patients exposed to immunomodulators and vedolizumab have less hospitalization risk than those not exposed, no differences were found for antiTNF alone or ustekinumab. The impact of tofacitinib in COVID outcomes requires further investigation.

P659 Continuing or stopping 5-aminosalicylate in patients with Inflammatory Bowel Disease under anti-TNF therapy: A nationwide population-based study

Abstract Background The clinical impact of continuing or stopping 5-aminosalicylate (5-ASA) after escalating to treatment with an anti-tumour necrosis factor (TNF) agent in patients with inflammatory bowel disease (IBD) is currently unclear. We aimed to compare the outcomes of IBD patients who stopped or continued 5-ASA after starting anti-TNF therapy. Methods We analysed data obtained from the Korean National Health Insurance claims database between 2007 and 2020. Our analysis included IBD patients already on 5-ASA treatment who started anti-TNF treatment. We compared the prognosis of patients who stopped 5-ASA within 90 days of anti-TNF initiation with those who continued 5-ASA. The primary outcome was any adverse clinical event defined as a composite of intestinal surgery, IBD-related hospitalization, or new corticosteroid use. Kaplan-Meier method and Cox proportional hazards models at landmark time were used to calculate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs). Results Among 62,262 patients diagnosed with IBD during the study period, 7,442 patients were included for analysis. A total of 1,037 (13.9%) patients discontinued 5-ASA within 90 days of starting anti-TNF therapy (Figure 1). Among the included patients, 4,479 (60.2%) had Crohn’s disease, while 2,963 (39.8%) had ulcerative colitis (Table 1). Discontinuation of 5-ASA was not associated with an increased risk of any adverse clinical events, as well as its component outcomes of intestinal surgery, IBD-related hospitalization, and corticosteroid use, with aHRs of 1.011 (95% CI, 0.934 to 1.095), 0.954 (95% CI 0.760 to 1.198), 0.995 (95% CI 0.894 to 1.107), and 0.969 (95% CI, 0.890 to 1.056), respectively (Table 2). In addition, the cumulative incidence of each adverse clinical event, as well as the composite outcome, were not significantly different between the two groups (all, p &amp;gt; 0.05) (Figure 2). Subgroup analysis by sex, IBD type, the timeframe of anti-TNF use, pre-anti-TNF 5-ASA use duration, pre-anti-TNF corticosteroid use, pre-anti-TNF hospitalizations, pre-anti-TNF emergency department visits, and anti-TNF agent type also showed no significant difference in the development of adverse clinical events between the two groups. Conclusion In this nationwide population-based study, we observed that discontinuing 5-ASA after starting anti-TNF therapy was not associated with an increased risk of adverse clinical events.

Combination therapy is not associated with improved rates of clinical or endoscopic remission in patients with inflammatory bowel disease treated with ustekinumab or vedolizumab: a retrospective study.

Management of inflammatory bowel disease (IBD) involves biological agents, often in combination with thiopurines or methotrexate. The aim of our study was to compare clinical and endoscopic outcomes in IBD patients treated with vedolizumab or ustekinumab, as monotherapy or in combination with thiopurines or methotrexate. We conducted a retrospective cohort study of all patients aged ≥18 years with a diagnosis of ulcerative colitis or Crohn's disease, commenced on vedolizumab or ustekinumab between October 2015 and March 2022. Primary outcome was clinical remission or response calculated by partial Mayo score (remission: <3; response: improvement >1) for ulcerative colitis or Harvey-Bradshaw index (<5, >2 respectively) for Crohn's disease over 1 year. Secondary endpoints were treatment failure, relapse, endoscopic remission at 1 year. Statistical analysis was done using 2-sample Student's t and chi-square tests. A total of 159 IBD patients were included in the study, 85 (53%) on vedolizumab and 74 (47%) on ustekinumab. For those on vedolizumab, 61 (72%) patients had ulcerative colitis, and 24 (28%) has Crohn's disease. All patients on ustekinumab had Crohn's disease. Mean disease duration in was 9.4 and 13.5 years respectively. There was no difference in clinical response or remission for vedolizumab or ustekinumab monotherapy compared to combination therapy at 1 year. There was also no difference in treatment failure, relapse or endoscopic remission. Combining vedolizumab or ustekinumab with an immunomodulator is not superior to monotherapy in terms of clinical response or endoscopic remission up to 1 year in IBD.

Active tuberculosis in inflammatory bowel disease patients: a case–control study

Background/Aims: Anti-tumor necrosis factor (anti-TNF) drugs have been the mainstay therapy for moderate to severe inflammatory bowel disease (IBD) over the past 25 years. Nevertheless, these drugs are associated with serious opportunistic infections like tuberculosis (TB). Brazil is ranked among the 30 countries with the highest incidence of TB in the world. This study aimed at identifying risk factors for the development of active TB and describing clinical characteristics and outcomes in IBD patients followed at a tertiary referral center in Brazil. Methods: We conducted a retrospective, case–control study between January 2010 and December 2021. Active TB cases in IBD patients were randomly matched 1:3 to controls (IBD patients with no previous history of active TB) according to gender, age, and type of IBD. Design: This was a retrospective, case–control study. Results: A total of 38 (2.2%) cases of TB were identified from 1760 patients under regular follow-up at our outpatient clinics. Of the 152 patients included in the analysis (cases and controls), 96 (63.2%) were male, and 124 (81.6%) had Crohn’s disease. Median age at TB diagnosis was 39.5 [interquartile range (IQR) 30.8–56.3]. Half of the active TB cases were disseminated (50%). Overall, 36 patients with TB (94.7%) were being treated with immunosuppressive medications. Of those, 31 (86.1%) were under anti-TNF drugs. Diagnosis of TB occurred at a median of 32 months after the first dose of anti-TNF (IQR 7–84). In multivariate analysis, IBD diagnosis older than 17 years and anti-TNF therapy were significantly associated with the development of TB ( p &lt; 0.05). After the TB treatment, 20 (52.7%) patients received anti-TNF therapy, and only one developed ‘de novo’ TB 10 years after the first infection. Conclusions: TB remains a significant health problem in IBD patients from endemic regions, especially those treated with anti-TNFs. In addition, age at IBD diagnosis (&gt;17 years old) was also a risk factor for active TB. Most cases occur after long-term therapy, suggesting a new infection. The reintroduction of anti-TNFs agents after the anti-TB treatment seems safe. These data highlight the importance of TB screening and monitoring in IBD patients living in endemic areas.