Inflammatory Bowel Disease Patients Research Articles

Enhanced Transcription of Human Endogenous Retroviruses and TRIM28 Downregulation in Patients with Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) includes patients affected by Crohn's disease or ulcerative colitis. IBD is thought to be a chronic immune-mediated disease, but its origin remains elusive, and this limits new therapeutic approaches. Human endogenous retroviruses (HERVs) originate from ancestral infections and represent 8% of the human genome. HERVs are no longer infectious, but some retroviral sequences can be activated, and their aberrant expressions have been implicated in inflammatory and autoimmune disorders. HERV transcription is regulated by TRIM28 and SETDB1, which are also directly involved in epigenetic processes and modulation of the immune response. Using a PCR real-time Taqman amplification assay, we assessed, for the first time, the transcription levels of pol genes of HERV-H, -K, and -W families of env genes of syncytin 1 (SYN1), SYN2, and HERV-W, as well as of TRIM28 and SETDB1 in the whole blood of 48 patients with Crohn's disease (CD), 20 with ulcerative colitis (UC), and in healthy controls (HC) of comparable age. The transcriptional levels of HERV-H-pol (p = 0.0003) and HERV-K-pol (p = 0.001) were significantly higher in IBD patients compared with HC, with no differences between patients with CD and UC. No significant differences were found for the remaining HERVs between IBD patients and HC. The transcript levels of TRIM28 were significantly downregulated in IBD patients (p < 0.001), without differences between CD and UC, while the SETDB1 levels were preserved. The enhanced transcription of HERV-H-pol and HERV-K-pol, as well as the impaired activation of TRIM28, were not influenced by clinical disease activity and type of treatment. The overexpression of HERVs and impaired transcription of TRIM28 in patients affected by CD or UC suggest that they might be the main actors in the pathophysiology of IBD, opening the way to innovative targeted interventions.

Oral health in patients with inflammatory bowel disease: A cross-sectional survey in Sweden.

The aim of this cross-sectional survey was to assess oral health, including prevalence of periodontitis and rate of tooth loss, in a Swedish cohort of patients with inflammatory bowel disease (IBD). A questionnaire on general anamnestic and socio-economic aspects, IBD diagnosis, and various oral health aspects was distributed online. The analyses focused on the comparison between patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) as well as on factors associated with self-reported severe periodontitis and tooth loss. Analyses were based on answers from 786 patients; 415 with UC, 371 with CD, 74% female. In both disease entities, high prevalence of severe periodontitis (i.e., 38.5%) was reported, and about 19% of the population had less than 20 remaining teeth and 6.5% a poor oral health-related quality of life. CD patients tended to be more severely affected than UC patients (p > 0.05 in the adjusted analysis). Almost 90% of CD patients were aware of being entitled to a bi-annual governmental financial support for dental care due to IBD; however, 1 out of 4 UC patients did not. Furthermore, IBD patients largely believe that the interest of their physicians in any oral lesions due to IBD diagnosis is low. Severe periodontitis and high rate of tooth loss are frequent in Swedish IBD patients. Even though IBD patients receive bi-annually some special financial support for dental care, it seems this is still not sufficient and more preventive measures appear necessary.

Multimedia: Multimodal Mediation Analysis of Microbiome Data.

Mediation analysis has emerged as a versatile tool for answering mechanistic questions in microbiome research because it provides a statistical framework for attributing treatment effects to alternative causal pathways. Using a series of linked regressions, this analysis quantifies how complementary data relate to one another and respond to treatments. Despite these advances, existing software's rigid assumptions often result in users viewing mediation analysis as a black box. We designed the multimedia R package to make advanced mediation analysis techniques accessible, ensuring that statistical components are interpretable and adaptable. The package provides a uniform interface to direct and indirect effect estimation, synthetic null hypothesis testing, bootstrap confidence interval construction, and sensitivity analysis, enabling experimentation with various mediator and outcome models while maintaining a simple overall workflow. The software includes modules for regularized linear, compositional, random forest, hierarchical, and hurdle modeling, making it well-suited to microbiome data. We illustrate the package through two case studies. The first re-analyzes a study of the microbiome and metabolome of Inflammatory Bowel Disease patients, uncovering potential mechanistic interactions between the microbiome and disease-associated metabolites, not found in the original study. The second analyzes new data about the influence of mindfulness practice on the microbiome. The mediation analysis highlights shifts in taxa previously associated with depression that cannot be explained indirectly by diet or sleep behaviors alone. A gallery of examples and further documentation can be found at https://go.wisc.edu/830110.

Concurrent chronic kidney disease in patients with inflammatory bowel disease, a systematic review and meta-analysis.

Inflammatory bowel disease (IBD) is a multi-organ autoimmune disease that commonly affects the gastrointestinal tract, but can also affect other organs throughout the body. Less is known, however, about kidney involvement in IBD. Although IBD has been associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD), these results have been inconsistent. The present study analyzed the prevalence of concurrent CKD and ESRD in patients with IBD. PubMed, Cochrane, Web of Science, and Embase were searched for studies published through October 2023 on IBD patients with concurrent CKD or ESRD. Outcomes included the incidence rates and odds ratios (OR) of concurrent CKD and ESRD in IBD patients. The quality of included studies was assessed using the Newcastle-Ottawa Scale, and sequential sensitivity was analyzed. Publication bias was evaluated using Egger's test. Nine studies were included in this meta-analysis. The combined results of eight studies, which included 239,042 IBD patients, showed that the prevalence of CKD in IBD patients was 5% (95% confidence interval [CI]: 1-9%). The combined results of two studies, which included 40,341 IBD patients, showed that the prevalence of ESRD in IBD patients was 0.2% (95% CI: -0.08-0.12%). The combined results of six case-control studies reported that the risk of CKD was significantly higher in patients with than without IBD (OR 1.36, 95% CI: 1.08-1.70, p = 0.008). Although studies have shown an increased risk of CKD in IBD, due to the small number of included studies and high heterogeneity across studies, it is not enough to definitively conclude that CKD is more common in patients with IBD. But patients with IBD should be regularly monitored for CKD. https://www.crd.york.ac.uk/PROSPERO/.

Epithelial neutrophil localization and tight junction Claudin-2 expression are innovative outcome predictors in inflammatory bowel disease.

Patients with inflammatory bowel disease (IBD) in clinical and endoscopic remission may still experience disease relapse. Therefore, there is a need to identify outcome predictors. Recently, the role of neutrophils in predicting outcomes in ulcerative colitis (UC) has been highlighted. Furthermore, the impairment of intestinal barrier plays a key role in forecasting disease outcomes in IBD. This observational study aimed to assess the predictive role of neutrophils according to tissue localization and intestinal barrier protein expression in IBD. IBD patients in clinical remission who underwent colonoscopy between January 2020 and June 2022 at two tertiary referral centres were enrolled. Patients with Mayo Endoscopic Score ≤1 (UC) and Simple Endoscopic Score ≤6 (Crohn's disease) were included. Histological activity was assessed using validated scores. Experienced pathologists evaluated neutrophil localization in the epithelium and lamina propria and immunohistochemical expression of Claudin-2 and junctional adhesion molecule A (JAM-A). Of 60 UC and 76 CD patients, 59.7% had histological activity. 25.8% of patients developed an adverse outcome within 12months. Neutrophils in the epithelium predicted adverse outcomes for UC (hazard ratio [HR] 5.198, p=0.01) and CD (HR 4.377, p=0.03) patients in endoscopic remission. Claudin-2 expression correlated with endoscopic and histological activity and predicted outcomes in UC. Similar results were found for JAM-A in CD despite this protein showing less specificity as a barrier predictor of outcome. This study highlights the potential role of epithelial neutrophil localization and Claudin-2 'leaky gut' expression as tools for predicting IBD outcomes and guiding further patient-tailored therapy.

Validation of the Portuguese Version of IBD-Control Questionnaire and Comparison with IBD-Disk

Introduction: The IBD-Control questionnaire and IBD-Disk are two patient-reported outcome measures designed to evaluate the impact of inflammatory bowel disease (IBD) on different health domains. Unlike IBD-Disk, there is no fully published validated Portuguese version of IBD-Control. Furthermore, the two instruments have not yet been compared. We aimed to translate and validate IBD-Control in Portugal and compare it with IBD-Disk. Methods: After translation into Portuguese, the IBD-Control was administered to IBD patients, at baseline (T0), after 1–4 weeks (T1), and >3 months (T2). Patients also completed the Portuguese versions of the PRO2, EQ-5D, SIBDQ, and IBD-Disk. We assessed the reliability, validity, responsiveness, and interpretability of IBD-Control. We compared the usability (3 questions) and the ability to identify good disease control (area under the curve [AUC]) of IBD-Control and IBD-Disk. Results: At T0, the IBD-Control was completed by 142 patients (108 Crohn’s disease, 34 ulcerative colitis). At T1 and T2, 68 and 101 patients completed the questionnaire, respectively. Factor analysis confirmed the one-dimensionality of the scale with 8 items (IBD-Control-8). Internal consistency (Cronbach’s alpha) was 0.80. Test-retest reproducibility for stable patients (n = 54) was high (intraclass correlation coefficient-0.86). IBD-Control-8 significantly correlated (r between 0.55 and 0.82; p ≤ 0.001) with PRO2, EQ-5D, SIBDQ and IBD-Disk. The variation in IBD-Control-8 between T0 and T2 correlated significantly (r between 0.48 and 0.53; p ≤ 0.01) with the variation in PRO2 (only for Crohn’s disease), SIBDQ and IBD-Disk. The IBD-Control-8 significantly discriminated between well and poorly controlled disease (15 ± 2 vs. 11 ± 4; p < 0.001). No significant differences were observed between IBD-Control-8 and IBD-Disk regarding usability and the ability to identify good disease control (AUC: −0.79 vs. 0.76, respectively). Conclusions: The IBD-Control is reliable and valid for measuring disease control from the perspective of patients with IBD in Portugal, presenting no significant differences regarding usability and assessment of disease control when compared to IBD-Disk.

A booster dose of SARS-COV-2 vaccine improves suboptimal seroconversion rates in patients with inflammatory bowel disease. Results of a prospective multicenter study of GETECCU (VACOVEII study)

BackgroundThe response to SARS-CoV-2 vaccination decreases in inflammatory bowel disease (IBD) patients, specially under anti-TNF treatment. However, data on medium-term effectiveness are limited, specially using new recommended seroconversion rate (>260BAU/mL). Our aim was to evaluate the 6-month>260 BAU-seroconversion rate after full vaccination and after booster-dose. MethodsVACOVEII is a Spanish multicenter, prospective study promoted by GETECCU. IBD patients full vaccinated against SARS-CoV-2 and without previous COVID-19 infection, treated or not with immunosuppressants, were included. The booster dose was administered 6 months after the full vaccination. Seroconversion was set at 260BAU/mL, according to most recent recommendations and was assessed 6 months after the full vaccination and 6 months after booster-dose. ResultsBetween October 2021 and March 2022, 313 patients were included (124 no treatment or mesalazine; 55 immunomodulators; 87 anti-TNF; 19 anti-integrin; and 28 ustekinumab). Most patients received mRNA-vaccines (86%). Six months after full vaccination, overall seroconversion rate was 44.1%, being significantly lower among patients on anti-TNF (19.5%, p<0.001) and ustekinumab (35.7%, p=0.031). The seroconversion rate after booster was 92%. Again, anti-TNF patients had a significantly lower seroconversion rate (67%, p<0.001). mRNA-vaccine improved seroconversion rate (OR 11.720 [95% CI 2.26–60.512]). ConclusionThe full vaccination regimen achieves suboptimal response in IBD patients, specially among those anti-TNF or ustekinumab. The booster dose improves seroconversion rate in all patients, although it remains limited in those treated with anti-TNF. These results reinforce the need to prioritize future booster doses in patients on immunosuppressants therapy, specially under anti-TNF, and using mRNA-vaccines.

The impact of achieving remission in inflammatory bowel disease on plasma matrix -carboxyglutamate protein levels

Matrix -carboxyglutamic acid (MGLA) protein is a vitamin K dependent peptide which contributes to the immunomodulatory activity of mesenchymal stromal cells. There is a possible association between MGLA protein and inflammatory bowel disease (IBD) which is divided into Crohn’s disease (CD) and ulcerative colitis (UC). However, little is known about the clinical utility of MGLA protein in IBD patients. This study aimed to assess the impact of achieving remission on the serum MGLA protein levels in IBD patients. This prospective observational study included 60 newly diagnosed IBD patients. All patients were subjected to full clinical, laboratory, radiological, and histopathological assessment of IBD at baseline and six months after initiating treatment. Serum MGLA protein level was assessed using an enzyme-linked immunosorbent assay. There were 29 (48.3%) UC cases and 31 (51.67%) CD cases. We observed a significant decrease in serum MGLA protein levels after 6 months of treatment compared to pretreatment values in UC patients (120.490 ± 26.273 vs. 26.320 ± 17.378 nmol/L, p&lt;0.001) and CD patients (125.576 ± 28.208 vs. 28.520 ± 18.443 nmol/L, p&lt;0.001). Serum MGLA protein levels were significantly higher in non-remittent patients compared to remittent UC patients before treatment (142.556 ± 17.096 vs. 110.560 ± 23.659 nmol/L, p&lt;0.001) and after six months of treatment (51.222 ± 4.410 vs. 15.114 ± 3.302 nmol/L, p&lt;0.001). Serum MGLA protein levels were significantly higher in non-remittent patients compared to remittent CD patients before treatment (150.727 ± 7.198 vs. 111.743 ± 25.718 nmol/L, p&lt;0.001) and after six months of treatment (52.182 ± 5.269 vs. 15.506 ± 4.475 nmol/L, p&lt;0.001). This response was irrespective of the therapeutic modality. In conclusion, achievement of remission in IBD patients resulted in a significant decrease in serum MGLA protein levels.

Real-World Experience of the Association of HLADQA1*05 Allele With Loss of Response to Anti-TNF Inhibitors.

Antitumor necrosis factor (anti-TNF) biologics have revolutionized the treatment of inflammatory bowel disease (IBD). Previously, studies have shown an association between the HLADQA1*05 allele and the development of antibodies and were predictive of loss of response. We sought to investigate the rate of the HLADQA1*05 allele in patients with IBD at a New England center and its association with antibody development and discontinuation of anti-TNF therapy. A single center retrospective cohort study with patients on anti-TNF inhibitor therapy being followed at our IBD clinic who had testing performed for the HLADQA1*05 allele were identified and separated into 2 different groups: HLADQA1*05 positive (HLA carriers) or HLADQA1*05 negative (HLA noncarriers). Persistence of remaining on anti-TNF therapy, measurement of drug/antibody levels, and need for dose escalation were collected and stratified amongst the 2 groups. The prevalence of the HLADQA1*05 allele among all IBD patients followed was 53%. We identified 67 IBD patients being treated with anti-TNF medications, 46 (69%) patients with Crohn's disease and 21 (31%) with ulcerative colitis. Most of the HLA carriers (85%) and HLA noncarriers (92%) remained on anti-TNF therapy at the end of the study period. Thirty-six (84%) patients had therapeutic drug monitoring performed during maintenance therapy. Three patients in the HLA carrier group had meaningful antidrug antibody levels necessitating cessation of therapy compared to one patient in the HLA noncarrier group (P = .61). Only 3 (13%) of HLA carriers and 4 (21%) of HLA noncarriers were on combination therapy with an immunomodulator. 65% of HLA carriers required dose escalation compared to 50% of HLA noncarriers (P = .70). The prevalence of the HLADQA1*05 allele was 53% in our New England IBD patient population, similar to what has previously been reported in European studies. The majority of patients remained on anti-TNF therapy at the end of the study period despite carrier status. While there was a trend toward increased need for dose escalation among HLA carriers, this was not statistically significant. Future studies are needed to determine if the presence of the HLADQA1*05 allele leads to antibody development against anti-TNF inhibitors and treatment failure in patients with IBD.

Impact of Obesity on Outcome for Inflammatory Bowel Disease Patients From 2008 Through 2020.

The incidence and prevalence of obesity have been rising in the U.S. It is known to affect the course and treatment of a variety of gastrointestinal disorders. It has been proposed to particularly worsen the symptoms of inflammatory bowel disease (IBD) and put patients at risk of treatment failure. Our study seeks to understand better the impact of obesity on morbidity, mortality, hospital length of stay (LOS), and charges in patients with IBD. The National Inpatient Sample (NIS) from 2008 to 2020 was used to identify patients over 18 diagnosed with IBD using the International Classification of Disease (ICD) 9 and 10 codes. Records were weighted per the NIS algorithm to produce accurate population estimates. Patients were classified by obesity status and then analyzed for baseline characteristics such as age, gender, race, insurance status, and various comorbidities. Various primary outcomes were analyzed. Outcomes were compared between groups, and odds ratios (ORs) were calculated using weighted logistic regression. ORswere adjusted for common co-founders. A weighted total of 2,105,418 patients admitted for IBD were included in this study. Of these, 170,475 were obese, and 1,934,943 were not obese. Obese patients were older, more complex (Charlson comorbidity index [CCI] 2.03 vs. 1.53), and more likely to be female (p<0.01) than non-obese patients. Compared to non-obese patients, IBD patients with obesity had a higher prevalence of coronary artery disease (11.35% vs. 7.87%), hyperlipidemia (29.27% vs. 15.09%), hypertension (45.38% vs. 25.60%), diabetes mellitus type 2 (27.15% vs. 9.38%), congestive heart failure (4.58% vs. 2.35%), gastroesophageal reflux disease (30.73% vs. 17.98%), and CCI (2.03% vs. 1.53%). Obese IBD patients had slightly higher odds of shock (OR 1.228, p<0.05), acute myocardial infarction (AMI, OR 1.692, p<0.01), acute kidney injury (AKI, OR 1.187, p<0.01), and chronic steroid treatment (OR 1.149, p<0.01). Conversely, obese IBD patients had lower odds of intestinal fistula (OR 0.837, CI 0.77-0.91, p<0.001). Obesity poses a diverse set of complications in IBD patients. Our study found that obese patients admitted with IBD had significantly higher odds of shock, AKI, and chronic steroid treatment. Interestingly, these patients were less likely to develop intestinal fistulas. These findings suggest further research into how obesity affects the disease course.

S1152 The Clinical Course of Inflammatory Bowel Disease in Patients Receiving Cancer Therapy

S1152 The Clinical Course of Inflammatory Bowel Disease in Patients Receiving Cancer Therapy

S1417 Risk of De-Novo Inflammatory Bowel Disease in Patients After an Episode of Diverticulitis: A Propensity-Matched Multi-Network Analysis

S1417 Risk of De-Novo Inflammatory Bowel Disease in Patients After an Episode of Diverticulitis: A Propensity-Matched Multi-Network Analysis

S1177 Outcomes in Inflammatory Bowel Disease in Patients Undergoing Coronary Artery Bypass Grafting: A Nationwide Analysis

S1177 Outcomes in Inflammatory Bowel Disease in Patients Undergoing Coronary Artery Bypass Grafting: A Nationwide Analysis

Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study

IntroductionCrohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier...

Clinical Approach to STRIDE-II in Real-Life Settings: Analysis and Practical Recommendations.

We aimed to (1) analyze the applicability of the updated Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE-II) recommendations in real-world clinical practice, (2) identify barriers to their implementation, and (3) propose practical measures to overcome these obstacles. This qualitative study was based on a survey, a literature review, and expert opinions. Nine inflammatory bowel disease (IBD) experts identified 7 areas likely to be controversial or potential implementation barriers in daily clinical practice: endoscopy, histology, ultrasound, quality of life, biomarkers, symptom control, and patient-reported outcomes (PROs). Based on this, a survey was carried out among educational course participants. The experts discussed the literature review and survey results and proposed several statements and practical actions. A total of 55 gastroenterologists answered the survey. The reported difficulty level in reaching STRIDE-II treatment goals in clinical practice was high. Only 22% of participants performed clinical remission assessments using clinical indexes and PROs. Seventy percent of responders did not use fecal calprotectin cutoffs and considered changes from the previous levels instead. Mucosal healing as a long-term therapeutic goal was considered necessary to be individualized in specific patient subgroups (eg, elderly/fragile patients, multiple treatment failures, and last-line therapies). Other barriers, like the lack of access to imaging techniques or insufficient knowledge and skills among healthcare professionals, were detected. The experts suggested adding less stringent treatment goals and measurements, patient stratification, local adaptations, educational activities, and research. STRIDE-II recommendations face various implementation barriers needing careful evaluation in order to enhance their adoption in clinical practice, and ultimately improve outcomes in IBD patients.

LRRK2; Communicative Role in the Treatment of Parkinson's Disease and Ulcerative Colitis Overlapping.

Involvement of gastrointestinal inflammation in Parkinson's disease (PD) pathogenesis and movement have progressively emerged. Inflammation is involved in the etiology of both PD and inflammatory bowel disease (IBD). Transformations in leucine-rich recurrent kinase 2 (LRRK2) are among the best hereditary supporters of IBD and PD. Elevated levels of LRRK2 have been reported in stimulated colonic tissue from IBD patients and peripheral invulnerable cells from irregular PD patients; thus, it is thought that LRRK2 directs inflammatory cycles. Since its revelation, LRRK2 has been seriously linked in neurons, albeit various lines of proof affirmed that LRRK2 is profoundly communicated in invulnerable cells. Subsequently, LRRK2 might sit at a junction by which stomach inflammation and higher LRRK2 levels in IBD might be a biomarker of expanded risk for inconsistent PD or potentially may address a manageable helpful objective in incendiary sicknesses that increment the risk of PD. Here, we discuss how PD and IBD share covering aggregates, especially regarding LRRK2 and present inhibitors, which could be a helpful objective in ongoing treatments. English data were obtained from Google Scholar, PubMed, Scopus, and Cochrane library studies published between 1990-December 2022. Inhibitors of the LRRK2 pathway can be considered as the novel treatment approaches for IBD and PD treatment. Common mediators and pathways are involved in the pathophysiology of IBD and PD, which are majorly correlated with inflammatory situations. Such diseases could be used for further clinical investigations.

Increased Risk of Chronic Respiratory Disease among Individuals with Inflammatory Bowel Disease in a Prospective Cohort Study

BackgroundCross-sectional evidence suggests a higher burden of chronic respiratory diseases in people with inflammatory bowel disease, but there is a lack of prospective evidence to clarify the direction of their associations. We aimed to investigate the association of inflammatory bowel disease with the risk of 2 major chronic respiratory diseases, chronic obstructive pulmonary disease, and asthma. MethodsWe included 430,414 participants from UK Biobank and followed them from recruitment (2006-2010) to 2021. Chronic obstructive pulmonary disease and asthma cases were obtained from inpatient data and death register. Using Cox proportional hazards models, we estimated the multivariable-adjusted hazard ratios (HR) of developing chronic obstructive pulmonary disease and asthma in participants with inflammatory bowel disease compared with inflammatory bowel disease-free groups. We also investigated the association among Crohn's disease and ulcerative colitis with the risk of chronic obstructive pulmonary disease and asthma. ResultsOver a median follow-up of 11.9 years, there were 11,196 incidents of chronic obstructive pulmonary disease and 9831 asthma cases. The adjusted HRs of developing chronic obstructive pulmonary disease (HR 1.54; 95% confidence interval [CI], 1.33-1.79) and asthma (HR 1.52; 95% CI, 1.29-1.79) were higher for those with inflammatory bowel disease when compared with inflammatory bowel disease-free participants. Participants with Crohn's disease and ulcerative colitis were also found to have a higher risk of chronic obstructive pulmonary disease (Crohn's disease: HR 1.71; 95% CI, 1.36-2.15; ulcerative colitis: HR 1.45; 95% CI, 1.20-1.75) and asthma (Crohn's disease: HR 1.73; 95% CI, 1.33-2.25; ulcerative colitis: HR 1.41; 95% CI, 1.15-1.73) when compared with those free of inflammatory bowel disease. ConclusionsThis study suggested that individuals with inflammatory bowel disease have a higher risk of developing chronic obstructive pulmonary disease and asthma, highlighting the importance of preventing chronic respiratory diseases among inflammatory bowel disease patients.

Comparative evaluation of point of care assay with ELISA techniques for quantifying serum concentrations of ustekinumab in inflammatory bowel disease patients

ObjectivesTo evaluate the analytical performance and clinical utility of the POC-AFIAS assay in comparison with two ELISA established assays for quantifying serum concentrations of ustekinumab. MethodsA prospective study was conducted. Consecutive serum samples from adult patients undergoing treatment with ustekinumab were collected. Three analytical techniques were compared for the quantification of ustekinumab serum concentrations: the AFIAS-10® POC assay (POC-AFIAS), the Promonitor® ELISA assay (ELISA-PRO), and the ELISA Ridascreen® assay (ELISA-RDSC). Ustekinumab concentrations were evaluated within three therapeutic ranges: <1μg/mL, 1–4.5μg/mL, and >4.5μg/mL. Statistical analysis included Pearson correlation, intra-class correlation coefficient, and Bland–Altman analysis. ResultsA total of 104 patients were included in the study. The median ustekinumab concentrations measured were 5.22μg/mL (POC-AFIAS), 3.99μg/mL (ELISA-PRO), and 4.50μg/mL (ELISA-RDSC). Strong correlations were observed between techniques (POC-AFIAS and ELISA-PRO: r=0.921, POC-AFIAS and ELISA-RDSC: r=0.940, ELISA-PRO and ELISA-RDSC: r=0.976). The Bland–Altman analysis revealed a bias difference of 1.81μg/mL between POC-AFIAS and ELISA-PRO, and 1.27μg/mL between POC-AFIAS and ELISA-RDSC. Agreement rates varied by therapeutic range, with the highest agreement observed within the therapeutic range (97.3%) and lower agreement for supra-therapeutic concentrations (74.6%). ConclusionThis study demonstrated that the POC-AFIAS assay provides comparable results to established ELISA techniques for quantifying serum concentrations of ustekinumab, particularly within the therapeutic range. The findings suggest that the POC-AFIAS assay offers a rapid and effective tool for managing ustekinumab therapy in clinical practice.

S1048 Respiratory Syncytial Virus Vaccine is Associated With Better Outcomes in Inflammatory Bowel Disease Patients over 60 Years Old: A US Propensity-Matched Study

S1048 Respiratory Syncytial Virus Vaccine is Associated With Better Outcomes in Inflammatory Bowel Disease Patients over 60 Years Old: A US Propensity-Matched Study

S1045 Fecal Microbiota Transplantation (FMT) With Bezlotoxumab Was Not Better Than FMT Alone in Inflammatory Bowel Disease Patients and Recurrent Clostridioides difficile Infection: Results from a Randomized Controlled Trial

S1045 Fecal Microbiota Transplantation (FMT) With Bezlotoxumab Was Not Better Than FMT Alone in Inflammatory Bowel Disease Patients and Recurrent Clostridioides difficile Infection: Results from a Randomized Controlled Trial