INTRODUCTION:The coronavirus disease 2019 pandemic accelerated use of remote consultations as an alternative to in-person inflammatory bowel disease (IBD) care. However, factors associated with preference for remote or in-person follow-up remain poorly understood. METHODS:We undertook a retrospective analysis of an electronic follow-up survey completed by patients who had previously used an online IBD self-assessment tool during the early pandemic. Respondents with prior experience of remote consultations were included. Preference for future consultation modality was categorised as strong in-person preference ('Never by telephone or video'), strong remote preference ('Mostly by telephone or video'), or no preference. Survey domains included sociodemographics, comorbidities, home restriction, mobility, support, IBD-Control Questionnaire, patient reported outcome-2 symptoms, and satisfaction with IBD care. Associations with preference were examined using binary logistic regression and ordinal logistic regression across ordered preference categories from remote to no preference to in-person. RESULTS:Among 5833 eligible respondents, 65% reported no preference, 25% a strong remote preference, and 10% a strong in-person preference. Stronger in-person preference was associated with older age, male gender, greater area deprivation, Asian ethnicity compared with White ethnicity, two or more comorbidities, Crohn's disease compared with ulcerative colitis, poorer IBD-specific patient-reported outcome measures, higher patient reported outcome-2 symptom scores, and dissatisfaction with care. Associations with strong remote preference were generally opposite, including younger age, lower deprivation, fewer comorbidities, ulcerative colitis, better patient reported outcome measure scores, and greater satisfaction; gender and ethnicity were not significant. Home restriction, mobility, and support were not significantly associated. Negative IBD-Control-8 responses increased progressively from remote preference to no preference to in-person preference. CONCLUSION:Sociodemographic and clinical factors influence consultation preferences in IBD. These findings may support equitable integration of remote care models.
Background: VEST was a multi-centre study of real-world use of vedolizumab in inflammatory bowel disease (IBD) in routine practice in the United Kingdom. Objectives: To describe real-world indications, effectiveness, patient-reported outcomes and safety. Design: Prospective observational cohort study at 22 centres. Methods: Patients receiving vedolizumab as part of standard care were included. Data were collected at infusion visits for activity indices (Harvey–Bradshaw Index (HBI) or partial Mayo Score (PMS)), physician global assessment (PGA), patient-reported quality-of-life and treatment perception (IBD-Control Questionnaire) and adverse events. Clinical response (Wk14) was defined as a reduction in HBI ⩾3 or PMS ⩾2, clinical remission as HBI ⩽4 or PMS ⩽1 and analysed using non-responder imputation. One-year persistence was defined as continuing on vedolizumab after an infusion at ⩾48 weeks. Biomarker and endoscopic data were not available. Results: 364 patients, mean age: 48 years; 132 (36%) with Crohn’s disease (CD), 224 (62%) with UC and 8 (2%) with IBD-U; 174 (48%) male; 142 (39%) receiving steroids at baseline (Wk0); 141 (39%) bio-naïve. At baseline, 279 (77%) had “active” disease. One-year persistence: 58% overall (54% for active disease). Among persistent cases ( n = 212), median (IQR) IBD-Control-8 scores improved from 6 (3–10) at baseline to 14 (10–16) at post-induction (Wk14) and 1 year ( p < 0.001 vs baseline). Corresponding scores for IBD-Control-VAS were: 50 (30–70), 80 (65–90) and 85 (70–95), respectively ( p < 0.001 vs baseline). Each domain of IBD-Control-8 showed improvement. Baseline and post-induction health status (activity index, PGA or IBD-Control) were associated with 1-year persistence, but no significant associations were observed for disease type, duration, bio-naïve status or baseline steroids. Of those with active disease at Wk0, clinical remission rates were 29%, 30% and 38% for CD, UC and IBD-U, respectively, and steroid-free remission rates were 26%, 27% and 38%. Similar remission rates were observed at 1 year. Possible adverse events leading to treatment cessation were rare (3%). Conclusion: In routine clinical practice in the UK, vedolizumab demonstrated high levels of persistence. Similar rates of clinical response, remission and 1-year persistence were seen in UC and CD patients, and in bio-experienced versus naïve cases. Persistent cases experienced significant and sustained improvements in quality of life and treatment perception. Persistence does not imply anti-inflammatory efficacy, as biomarker data were not available.
Background Small bowel Crohn’s disease is increasingly treated with biological therapies. Although many patients do not achieve response or remission, this is unpredictable. Motility magnetic resonance imaging reliably measures Crohn’s disease inflammation, but its predictive ability for longer-term response to biologic therapies is unknown. Objectives Primary: to determine if motility magnetic resonance imaging at weeks 12–30 is superior to C-reactive protein for the prediction of response or remission at 1 year in patients commencing biologics for small bowel Crohn’s disease. Secondary: to determine if motility magnetic resonance imaging changes can predict patient quality of life at 1 year; to determine if diffusion-weighted magnetic resonance imaging is predictive of response or remission; to compare the predictive ability of motility magnetic resonance imaging with that of faecal calprotectin; to investigate the effect of body composition on response or remission; to determine the relationship between plasma gut peptide and cytokine levels, patient symptoms and bowel dysmotility. Design and methods Prospective multicentre cohort study. Setting and participants Thirteen National Health Service hospitals with established inflammatory bowel disease and magnetic resonance imaging practices. Participants with active non-stricturing small bowel Crohn’s disease requiring biological therapy. Interventions Motility magnetic resonance imaging (test under evaluation) and C-reactive protein (comparator). Faecal calprotectin as secondary comparator. Diffusion-weighted magnetic resonance imaging and plasma gut peptide/cytokine level measurement in a subset. Main outcome measures Comparative accuracy of motility magnetic resonance imaging, C-reactive protein and faecal calprotectin to predict response or remission at 1 year, defined using a combination of clinical factors and structural magnetic resonance enterography scores, and measures of quality of life at 1 year, using EuroQol-5 Dimensions, five-level version and disease-specific patient-reported outcome measures. Motility magnetic resonance imaging interobserver variability. Post hoc confirmatory analysis of motility magnetic resonance imaging correlation with magnetic resonance enterography-defined disease activity. Results Two hundred and nineteen participants were screened, of whom 199 were treated. Ninety-three participants were excluded prior to their first visit, with a further 20 lost to follow-up subsequently. Eighty-six participants completed all assessments. Stable or improved motility magnetic resonance imaging post induction was more sensitive than normalisation of C-reactive protein for 1-year response or remission (motility magnetic resonance imaging: 71.0%, 95% confidence interval 52.0 to 85.8; C-reactive protein: 45.2%, 95% confidence interval 27.3% to 64.0%; p = 0.008) but less specific (motility magnetic resonance imaging: 30.9%, 95% confidence interval 19.1 to 44.8; C-reactive protein: 67.3%, 95% confidence interval 53.3% to 79.3%; p < 0.001). There was no significant difference in area under the receiver operating characteristic curve (motility magnetic resonance imaging: 0.48; C-reactive protein: 0.53, p = 0.65). Similar results were obtained for faecal calprotectin. None of motility magnetic resonance imaging, C-reactive protein or faecal calprotectin predicted patient quality of life at 1 year. Diffusion-weighted magnetic resonance imaging was also not predictive of response or remission. Interobserver variability of motility magnetic resonance imaging quantified by intraclass correlation coefficients was 0.75–0.83. We confirmed prior work that motility magnetic resonance imaging is negatively correlated with small bowel Crohn’s disease activity (correlation coefficient [rho]= −0.34). Baseline magnetic resonance imaging-measured body composition was not associated with 1-year response or remission. Patient symptoms, gut peptide and cytokine levels and overall small bowel dysmotility were not consistently correlated. Limitations Loss to follow-up was high, mainly due to the coronavirus disease discovered in 2019 (COVID-19) pandemic. Response assessment using ileocolonoscopy was not possible. Conclusions Although improved motility magnetic resonance imaging is more sensitive than C-reactive protein and faecal calprotectin to predict response or remission at 1 year, it is less specific. None of these factors predict patient quality of life. Motility magnetic resonance imaging measurements are reliable between readers, and it remains a marker of disease activity at a given time point. Future work Impact of motility magnetic resonance imaging on therapeutic management decisions and clinician confidence in Crohn’s disease. Utility of motility magnetic resonance imaging in phenotyping stricturing Crohn’s disease. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme as award number 14/201/16. Plain language summary Crohn’s disease is a condition that causes inflammation of the bowels, and this inflammation can eventually lead to irreversible bowel damage. Powerful treatments that suppress inflammation called biologic drugs are now available, but it is not possible to give these to all patients because of side effects, costs and patient inconvenience. Also, they do not always work, but we cannot predict this reliably. In this study, we tested if a novel scanning technique using magnetic resonance imaging that measures bowel motion (called motility magnetic resonance imaging) can help predict which patients are likely to benefit in the longer term from these biologic drugs. The study recruited 86 patients from 13 National Health Service centres, all of whom had motility magnetic resonance imaging before and after starting their biologic treatment. After 1 year, we checked to see if the biologics had worked for each patient. We tested how good motility magnetic resonance imaging was at predicting whether or not the biologics were going to work, and compared this with other simple blood and faeces tests. We also tested some other magnetic resonance imaging techniques called diffusion-weighted imaging and body composition measurements. We found that none of the tests (motility magnetic resonance imaging, blood tests or faeces tests) were better than chance at predicting if biologics were going to work or not. Diffusion-weighted imaging and body composition measurements were not useful either. We did confirm some previous work that motility magnetic resonance imaging is good at telling us if the bowel is inflamed or not, and we also found that many different doctors (not just experts) can measure it reliably. The study means that motility magnetic resonance imaging and diffusion-weighted imaging are not useful ways to predict which patients are likely to benefit from biologic drugs. It can still be used to measure if the bowel is inflamed or not.
Background:The ability to predict whether patients with a new diagnosis of Crohn's disease will develop disabling disease is an unmet clinical need. Magnetic resonance enterography is a first-line investigation for Crohn's disease, but its role in prognostication is unknown. Objective(s):To improve prediction of disabling Crohn's disease within 5 years of diagnosis by developing and internally evaluating a multivariable prediction model comprising clinical predictors and adding magnetic resonance enterography scores (Magnetic resonance Enterography Global Score, Simplified Magnetic Resonance Index of Activity and Lémann Index). To estimate the healthcare costs incurred within 5 years of Crohn's disease diagnosis and to explore factors driving costs. Design:A multicentre diagnostic inception cohort. Setting:Nine National Health Service hospitals. Participants:Aged ≥ 16 years with newly diagnosed Crohn's disease. Main outcome measures:Comparative predictive ability of prognostic models, including magnetic resonance enterography scores (Magnetic resonance Enterography Global Score, Simplified Magnetic Resonance Index of Activity and Lémann Index) versus a model based on clinical predictors alone for the development of modified Beaugerie disabling Crohn's disease within 5 years of diagnosis. Statistical analysis:We censored development of modified Beaugerie disabling disease ≤ 90 days from diagnosis, and utilised time-to-event models using Royston-Parmar flexible parametric models. Risk group definitions were prespecified; for risk group definition 1, the high-risk patients were the top 40% with the greatest predicted risk, and the high-risk patients had an absolute risk ≥ 10% for risk group definition 2. The absolute risk cut-off was calculated by sorting patients by predicted risk and using the risk of the eighth (10% of 81) patient who developed modified Beaugerie disabling disease. Results:We studied 194 patients, median age 29, interquartile range 22-44 years. Within 5 years from diagnosis, 42% (81/194) developed modified Beaugerie disabling disease. There was a univariable association between initial need for steroid therapy and developing modified Beaugerie disabling disease [hazard ratio 2.11 (95% confidence interval 1.36 to 3.26)]. Using risk group definition 1, the baseline clinical model had 49% (95% confidence interval 39 to 60) sensitivity and 66% (95% confidence interval 57 to 74) specificity for predicting the development of modified Beaugerie disabling disease. There was no difference in sensitivity and specificity between models incorporating Magnetic resonance Enterography Global Score, Simplified Magnetic Resonance Index of Activity and Lémann Index compared to the baseline clinical model. Using risk group definition 2, the model, including magnetic resonance enterography predictors, had 86% (95% confidence interval 77 to 92) sensitivity and 35% (95% confidence interval 27 to 45) specificity for predicting the development of modified Beaugerie disabling disease. There was no difference in sensitivity between the clinical model and models incorporating Magnetic resonance Enterography Global Score, Simplified Magnetic Resonance Index of Activity and Lémann Index, but specificity was significantly lower for models incorporating Magnetic resonance Enterography Global Score [29% (95% confidence interval 22 to 38)] and Lémann Index [29% (95% confidence interval 22 to 38)]. The mean total 5-year per-patient cost of health care was £24,267 (standard deviation £33,108). Mean 5-year costs were £29,763 (standard deviation £38,278) compared to £20,327 (standard deviation £28,368) for those with and without disabling disease, respectively. The largest contributor to costs was biologic use. Age under 40 years, presence of perianal disease and presence of severe endoscopic disease were associated with higher costs. Limitations:Liège and Montreal criteria for disabling disease could not be studied due to an insufficient event rate. Conclusions:Addition of magnetic resonance enterography scores to a multivariable model comprising existing clinical predictors did not improve prediction of modified Beaugerie disabling disease. Healthcare costs were increased in those aged under 40 years and patients with perianal and severe endoscopic disease. Future work:Testing the predictive ability of magnetic resonance enterography against alternative definitions for disabling Crohn's disease. Trial registration:This trial is registered as ISRCTN76899103. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/59/17) and is published in full in Health Technology Assessment; Vol. 30, No. 18. See the NIHR Funding and Awards website for further award information.
Background Gastrointestinal (GI) bleeding is a common event that can be life-threatening. Mussetto et al demonstrated the feasibility of panenteric capsule endoscopy (PCE) in patients with melaena and a negative oesophagogastroduodenoscopy (OGD)—the bleeding source was identified in 80% of patients and colonoscopy was avoided in 50%. However, there are no large prospective trials and limited real-world data. At two tertiary centres in the UK, we retrospectively evaluated the outcomes of patients who underwent an inpatient PCE following a negative OGD for suspected upper GI bleeding. Methods Capsule databases at each institution were reviewed from 2021 to 2024. The inclusion criteria were patients who had a suspected upper GI bleed (melaena and haemoglobin drop of >10 g/L) and underwent an inpatient PCE following a negative OGD. Data was extracted from the patient’s electronic health records. Results 23 patients met the inclusion criteria. The mean age was 56 years. The median time from OGD to capsule ingestion was 4 days. The source of bleeding was identified by PCE in 70% of cases. A small bowel source was identified in 43%. PCE prevented unnecessary lower GI endoscopy in 70%. Capsule retention occurred in 1 patient and was managed conservatively. Rebleeding rates at 30 days, 6 months and 12 months were 9%, 4% and 0%. Conclusion PCE is an option for patients presenting with melaena and has a negative upper GI endoscopy. The findings from this study are promising with a diagnostic yield of 70%. Large, multi-centre randomised studies are required to further investigate this strategy.
BACKGROUND:Small bowel Crohn's disease (SBCD) is increasingly treated with biological therapies. Predicting response or remission (RoR) for individual patients is difficult and complicates treatment strategy. We aimed to determine if motility magnetic resonance imaging (mMRI) is superior to CRP and fecal calprotectin (FC) for the prediction of RoR at 1 year in patients commencing biologics for SBCD. METHODS:Prospective, multicenter (n = 13) cohort study of patients with active non-stricturing SBCD requiring anti-TNFα or anti-IL-12/23 treatment. We measured mMRI and CRP at baseline and post-induction (visit 2: 12-30 weeks), and FC in a subset. RoR was assessed at 1 year using clinical and structural magnetic resonance enterography parameters. We compared sensitivity, specificity, and area under the receiver operating characteristic curve (ROC-AUC) of changes in mMRI and CRP to predict RoR at 1 year. Secondary outcomes compared mMRI with FC, and prediction of improved quality of life (QoL). RESULTS:Eighty-six participants completed all assessments. Stable or improved mMRI at visit 2 was more sensitive than normalization of CRP for RoR (mMRI:71.0%, 95%CI 52.0-85.8; CRP:45.2%, 95%CI 27.3-64.0%, P = .008) but less specific (mMRI:30.9%, 95%CI 19.1-44.8; CRP:67.3%, 95%CI 53.3-79.3%, P < .001). There was no significant difference in ROC-AUC (mMRI:0.48; CRP:0.53, P = .65). Similar results were obtained for FC. None of mMRI, CRP, or FC predicted patient QoL at 1 year. CONCLUSIONS:Although improved mMRI is more sensitive than CRP and FC to predict RoR at 1 year, it is less specific. No factor predicted patient QoL. Motility MRI remains a marker of disease activity at given timepoints.
Objectives Predicting longer-term response to biological therapy for small bowel Crohn's disease (SBCD) is an unmet clinical need. Diffusion-weighted magnetic resonance (MR) imaging (DWI) may indicate disease activity, but its predictive ability, if any, is unknown. We investigated the prognostic value of DWI for 1 year response or remission (RoR) in SBCD patients commencing biologic therapy, including incremental value over C-reactive protein (CRP) and faecal calprotectin (FC).Methods A subset of participants in a prospective, multicentre study investigating the predictive ability of motility MRI for 1-year RoR in patients starting biologic therapy for active SBCD, underwent additional DWI at baseline and post-induction (12-30 weeks). CRP and FC were collected in a subgroup. RoR at 1 year was evaluated using clinical and morphological MR enterography (MRE) parameters. We calculated sensitivity and specificity to predict RoR and quality of life (QoL) at 1 year, comparing apparent diffusion coefficient (ADC) value, Clermont score, and CRP using multivariable logistic regression.Results A total of 25 participants were included (mean 36.9 years, 32% female). ADC changes and Clermont score had poor sensitivity (30.0% [95% CI, 6.7-65.2] and 40.0% [95% CI, 12.2-73.8], respectively) and poor-to-modest specificity (50.0 [95% CI, 27.2-72.8] and 65.0% [95% CI, 40.8-84.6]) for RoR. None of Clermont score, CRP, or FC predicted QoL.Conclusions DWI has inadequate sensitivity and specificity for RoR at 1 year. There is no significant incremental prognostic value of DWI over CRP and FC to predict RoR and/or QoL at 1 year.Advances in knowledge Early post-induction DWI has no prognostic value for RoR at 1 year.
Background: Selection of second-line therapy in Crohn’s disease (CD) patients after failure of first-line TNFα-inhibitor (TNFi) therapy to optimise outcomes remains challenging in real-world clinical practice. Objectives: This study aimed to provide real-world outcomes of CD patients who failed first-line TNFi therapy and switched to either another TNFi or to a biologic with a different mechanism of action. Patients were stratified as to whether they switched because of primary non-response or secondary loss of response to initial TNFi. Design: Retrospective cohort study. Methods: CD patients whose first biologic therapy was a TNFi and switched to another biologic therapy between 26 August 2015 and 31 March 2021 were identified in records held by the UK IBD Registry. Patients were enrolled at study sites, and data were validated by clinical teams. Patients were grouped as within-class switchers (WCS) if their second-line (index) biologic therapy was another TNFi, or out-of-class switchers (OCS) if their index therapy was vedolizumab or ustekinumab. Patients were followed up for at least 1 year. Time to drug discontinuation and outcomes at 1 year after index therapy start were analysed using Cox regression and binary logistic regression models, before and after baseline covariate adjustment through inverse probability of treatment weighting. Results: A total of 180 adult CD patients were included in the study. OCS were less likely to discontinue index therapy in both unweighted analysis (hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.42–0.96, p = 0.03) and weighted analysis (HR: 0.58, 95% CI: 0.38–0.90, p = 0.01), and more likely to show index drug persistence at 1 year in both unweighted analysis (adjusted odds ratio (aOR): 3.66, 95% CI: 1.81–7.67, p < 0.001) and weighted analysis (aOR: 3.95, 95% CI: 2.04–7.89, p < 0.001). These findings were consistent across all secondary endpoints of steroid-free and/or surgery-free index drug survival at 1 year. Conclusion: Patients switching from a TNFi to either vedolizumab or ustekinumab exhibited significantly higher rates of drug persistence compared to those switching to another TNFi, particularly among those experiencing primary non-response to the initial TNFi.
Abstract Background Small bowel capsule endoscopy (SBCE) has the highest sensitivity and specificity for identifying Crohn’s disease (CD) affecting the small bowel. The recent CURE-CD study demonstrated that proactive treatment optimisation with SBCE monitoring led to improved outcomes. [1] We performed a retrospective cohort study at a tertiary centre in the UK to evaluate the impact of SBCE in the management of Crohn’s disease. Methods We reviewed the capsule database from December 2021 – December 2022. 181 SBCE were performed in this time period. We included patients who were either newly diagnosed with CD following SBCE or patients with known CD undergoing SBCE as part of disease reassessment. All patients included had no/minimal changes on imaging and/or endoscopy to justify treatment initiation/escalation for ongoing symptoms. Data was extracted from their electronic health record. Correlations were analysed using Spearman’s ranked test. Results 96 patients met the inclusion criteria. 67 patients (69.8%) with known CD underwent SBCE as part of disease reassessment and 29 patients (30.2%) were newly diagnosed with CD following SBCE. Their baseline demographics pre-SBCE are illustrated by table 1. Small bowel visualisation was adequate in 93 (96.8%) and the median transit time for a SBCE study was 4hrs and 36 minutes. The median Lewis Score (LS) was 423. 71 (73.9%) patients had active SB Crohn’s disease (defined as a LS >135). Of these, 26 (36.6%) had moderate to severe disease (LS>790). There was a poor correlation between inflammatory biomarkers and symptoms of diarrhoea/abdominal pain with active CD on SBCE with none of these reaching a correlation level greater than 0.3. The impact of SBCE on the management of patients is showed by figure 1. 47 (48.9%) had a repeat SBCE for disease reassessment with a median time of 449 days between the first and second SBCE. The median LS for the repeat SBCE was 112. There was a significant reduction in moderate-to-severe active disease at the follow-up SBCE (baseline 26/96, 27.1% to follow-up 8/47, 17%). Repeat SBCE identified more patients in remission defined as LS <135 (baseline SBCE remission 25/96, 26% vs repeat SBCE remission 27/47, 57.4%, p=0.005). No cases of capsule retention occurred. Conclusion In a large cohort of patients with minimal/no changes on conventional investigative modalities for Crohn’s disease, SBCE led to a change in treatment in 63.5%. Repeat SBCE showed significantly higher proportion of patients in endoscopic remission. Conventional non-invasive markers of inflammation and symptoms correlated poorly with activity on SBCE further highlighting the importance for clinicians to consider SBCE in both the workup and reassessment of disease activity in patients with Crohn’s disease. References 1.S Ben-Horin, A Lahat, B Ungar, O Ukashi, D Yablecovitch, M M Amitai, Y Haberman, L Selinger, A Talan-Asher, O Kriger-Sharabi, T Naftali, Y Ron, H Yanai, I Dotan, U Kopylov, R Eliakim, The Israeli IBD Research Nucleus (IIRN), DOP29 Capsule endoscopy-guided proactive treatment versus standard treatment of patients with quiescent Crohn’s Disease: The CURE-CD randomized controlled trial, Journal of Crohn’s and Colitis, Volume 18, Issue Supplement_1, January 2024, Pages i125–i126,
Magnetic resonance enterography (MRE) is a first-line investigation to diagnose Crohn’s disease (CD), but its role for prognostication is unknown. Accordingly, we assessed the predictive ability of prognostic models including MRE scores (MRE Global Score (MEGS), simplified MR Index of Activity (sMARIA), and Lémann index (LI)) against models using clinical predictors alone for the development of modified Beaugerie disabling CD (MBDD) within 5 years of diagnosis. This was a multicentre, diagnostic inception cohort of patients with newly diagnosed CD across 9 UK hospitals, followed for 4 years or more. We censored development of MBDD ≤ 90 days from diagnosis, and used time-to-event models using Royston-Parmer flexible parametric models. We included 194 patients, median age 29, IQR 22–44 years, 52
Abstract Background Intestinal ultrasound is an accurate tool for assessing inflammatory bowel disease activity1. Previous studies showed point-of-care ultrasound (POCUS) can impact treatment decisions in 48% of appointments2. Early diagnosis and treatment improves outcomes in Crohn’s disease (CD). We aimed to investigate if POCUS in the IBD clinic led to earlier initiation of advanced therapies using a randomised controlled trial. Methods Patients attending an IBD clinic at a UK tertiary referral centre with known or suspected IBD (with a high likelihood) were eligible. During the primary clinic appointment clinicians’ investigation and treatment decisions were recorded. Immediately following this they were randomised 1:1 to POCUS or standard of care (SOC). The POCUS group then had further review with an option to alter treatment decisions. The primary end-point was time to initiating definitive therapy (in days) (new/changed immunomodulator, advanced therapy or surgery only). Secondary end-points included clinical score (HBI, SCCAI), calprotectin and patient tolerability. Patients were followed for 12 months. Results 122 patients were enrolled between 1st June and 1st November 2023. Median age was 25 years (16-79) and 50% male with a final diagnosis of 87 CD, 23 UC, 4 IBD-U and 8 non IBD (new referrals). 63 had POCUS and 59 SOC. POCUS was performed by one of two sonographers (one gastroenterologist and one radiologist). 65 (53%) were on advanced therapy or immunomodulators at baseline. 99 (81%) had advanced therapy, immunomodulators or surgery during the study period. Mean time to definitive treatment decision was 43 days with POCUS compared to 92 days in SOC (p<0.01). 65 (53%) patients had a change of, or started a new therapy and mean time to treatment initiation was also significantly shorter in the POCUS group, 75 days, compared to SOC, 131 days (p=0.033). In a sub-group of 20 new referrals, 12 were diagnosed with IBD. Mean time to treatment initiation was shorter with POCUS (82 vs 151 days). Steroid prescriptions at the baseline appointment were significantly higher in the POCUS group, 11/63 vs 2/59 (p = 0.012). Any change to treatment in the POCUS group occurred in 29/63 (46%) patients. Scans took an average of 7.5 minutes with 100% patient acceptability. Conclusion POCUS leads to earlier IBD-related decision making which translates into earlier initiation of effective therapy. This should, in turn, lead to improved care with shorter time to remission and reduced complications. Pathways to incorporate POCUS into routine clinical practice to optimise its effectiveness need further evaluation. This will require collaborative training and working across multiple specialties to effectively deliver this service. References (1)Taylor SA, Mallett S, Bhatnagar G, et al. Diagnostic accuracy of magnetic resonance enterography and small bowel ultrasound for the extent and activity of newly diagnosed and relapsed Crohn’s disease (METRIC): a multicentre trial. Lancet Gastroenterol Hepatol. 2018;3(8):548-558. doi:10.1016/S2468-1253(18)30161-4 (2)Bots S, De Voogd F, De Jong M, et al. Point-of-care Intestinal Ultrasound in IBD Patients: Disease Management and Diagnostic Yield in a Real-world Cohort and Proposal of a Point-of-care Algorithm. J Crohns Colitis. 2022;16(4):606-615. doi:10.1093/ecco-jcc/jjab175
OBJECTIVES:Altered body fat and muscle mass in Crohn's disease (CD) have been linked to adverse disease course and outcomes. Prediction of treatment response or remission (RoR) of small bowel CD (SBCD) to biologic therapy remains challenging. We aimed to establish the prognostic value of body composition parameters measured using MR enterography (MRE) for RoR at 1 year in patients with SBCD commencing biologic therapy. METHODS:Participants were identified from those recruited to a prospective, multicentre study investigating the predictive ability of motility MRI for 1 year RoR in patients starting biologic therapy for active SBCD (MOTILITY trial). Myopenia, skeletal muscle:fat and visceral:subcutaneous fat were measured from baseline MRE. RoR at 1 year was judged using a composite of clinical and morphological MRE parameters. We compared the likelihood of RoR in patients with and without myopenia or low skeletal muscle:fat using logistic regression models. RESULTS:Ninety-six participants were included (mean age 38.2 years; 40 (42%) female). There were 34 (35%) responders. There was no significant difference in RoR at 1 year between those patients with and without skeletal muscle myopenia (OR: 0.85, 95% CI: 0.27, 2.66, p-value: 0.78), or those with or without low skeletal muscle:fat (OR: 0.71, 95% CI: 0.19, 2.71, p-value: 0.62). CONCLUSIONS:Body composition parameters demonstrated no value for predicting therapeutic RoR in patients commencing biologic therapy for SBCD. CRITICAL RELEVANCE STATEMENT:Prediction of response to biologic therapy in small bowel Crohn's disease (SBCD) remains challenging. Body composition parameters cannot predict biologic therapeutic response or remission for SBCD reliably. KEY POINTS:Altered body fat and muscle mass in Crohn's disease have been linked to adverse outcomes. Prediction of response to biologic therapy in small bowel CD (SBCD) would be useful for treatment optimisation. Body composition parameters measured using MRI cannot reliably predict biological therapeutic response or remission for SBCD.
Abstract Background The characteristics and outcomes of patients treated with vedolizumab in routine healthcare settings have not been widely evaluated in the UK. Methods Prospective, multicentre observational study of 364 patients started on vedolizumab in UK practice from January 2017 until February 2019 using the UK IBD Registry clinical web-based tool. For the present analysis, the primary outcome was drug survival (persistence) at 1-year, defined as attendance for infusion ≥48 weeks after the first dose. Secondary outcomes were: Clinical remission (CR, based on partial Mayo score [≤1] or Harvey Bradshaw index [≤4]), physician global assessment (PGA), IBD-Control Questionnaire (IBD-Control-8, IBD-Control-VAS and individual item scores), laboratory parameters and adverse events. Results Age (mean): 44 yrs; Males: 48%; IBD duration (mean): 6 yrs; Prev. resection: 18%; Steroids at baseline: 39%; Outcomes are summarized in Table 1. 37% of CD patients were assessed as being in clinical remission at baseline. Overall, 210 (58%) continued treatment beyond 48 weeks. At 1 year, 67.1% and 52.3% of CD and UC patients were in clinical remission with a clear improvement in QoL as assessed by IBD-Control -8. There were significant improvements across each IBD-Control-8 domain, including fatigue, with few patients considering switching treatment at that point (Figure 1). Conclusion Vedolizumab was effective in clinical practice with 58% of patients remaining on treatment at one-year. Baseline status differed significantly from those recruited into RCTs. Patient reported outcomes demonstrated significant and meaningful improvements across physical, psychological, social and treatment domains.
Abstract Background Small bowel & colon capsule endoscopy have been established in their use to visualise the gastrointestinal (GI) tract. The Panenteric Crohn’s Capsule (PCC) is an evolution of these capsules enabling simultaneous assessment of both the small & large bowel with dual cameras for expanded mucosal coverage. This study investigates the use of PCC in patients suspected for inflammatory bowel disease (IBD), specifically Crohn's disease (CD), and in reassessing patients with established CD. The primary objective is to evaluate the impact of PCC results on patients’ management. Methods All consecutive patients who had PCC for suspected or established CD were included in the study. Those at risk of capsule retention (previous surgery, obstructive symptoms, stricturing disease) underwent a patency capsule, unless MR enterography was done within six months of PCC. Data was collected prospectively and included demographics, indication, procedural information such as completion rates, bowel cleansing & need for subsequent colonoscopy. PCC findings were recorded and the clinical outcome based on those was assessed at the subsequent clinic follow up. Results In this prospective single-centre study, 95 patients (average age 34 years, range 14-84) underwent PCC from November 2020 to May 2023, 61 were females (64%). 43 procedures were conducted remotely, 52 in-hospital, & 5 as inpatients. The primary indications were suspicion of IBD (n=54, 57%) and reassessment of established CD (n=41, 43%). Among the 95 patients,68 (72%) had successful PCC procedures. 18% (17/95) required a subsequent colonoscopy, primarily for biopsy (7,7.4%). PCC findings revealed inflammation in 41 patients (43.2%), diverticular disease in 13 (13.7%), & polyps in 15 (15.8%). The data demonstrated a 51% change in management post-PCC, including treatment escalation (15.8%), treatment de-escalation due to IBD remission (10.5%), exclusion of IBD with redirection for other pathologies or IBS diagnoses (15.8%), new IBD diagnoses (5.3%), & discharged due to normal investigation without need of further investigation (3.2%). Particularly in patients undergoing PCC for CD reassessment, 66% experienced a change in the treatment plan (14 escalated treatment, 7 de-escalated treatment due to remission, 3 achieved IBD treatment response & 3 treated for symptoms found to be caused by other pathologies). Conclusion PCC is a single, one-stop, non-invasive GI examination, ideal for suspected or established CD patients requiring pan-gut assessment. Despite suboptimal completion rates, PCC spared a colonoscopy in 82% of patients and resulted in change of management in over half of the patients and in 2/3 of those with established CD, suggesting a promising future role in diagnosing and monitoring CD.
Background: The IBD-Control Questionnaire is a simple, generic measure of patient-perceived disease control used increasingly in clinical practice and research. We aimed to address knowledge gaps in its psychometric performance, to ensure that it can be used with confidence in a variety of contexts. Methods: We analysed 7341 responses to the IBD Registry COVID-19 survey, sent to 40 911 patients who completed an online self-assessment tool during the pandemic. Questions covered demographics, comorbidities, inflammatory bowel disease [IBD] sub-type, and IBD-Control Questionnaire and symptom scores [CD-PRO2 or UC-PRO2]. Psychometric properties of IBD-Control-8 were tested overall and within subgroups (Crohn's disease [CD], ulcerative colitis [UC] and IBD unclassified; male and female; <= 65 and >65 years; number of co-morbidities; deprivation status). Results: Internal consistency was very strong overall [alpha: 0.84, omega: 0.89] and for each subgroup [alpha range: 0.81-0.85; omega: 0.86-0.90]. Construct validity was demonstrated by moderate correlation of each item with global rating [VAS] [r s range: 0.47-0.65], strong correlation between IBD-Control-8 score and VAS [r(s) = 0.74], moderate-to-strong with PRO2 scores [CD: r(s) = -0.718; UC: r(s) = -0.602] and significantly higher IBDControl-8 scores for PRO2-remission vs PRO2-active, consistent across subgroups. Exploratory and confirmatory factor analyses demonstrated a two-factor model (items loading onto 'Health-related Quality of Life' [HRQoL] or 'Treatment' domains). Extensive tests for factorial invariance confirmed consistency. Conclusions: IBD-Control-8 is a psychometrically robust scale which can be used across a range of populations. It offers a quick, reliable, and valid method of assessing patient-perceived control. The construct of 'control' includes traditional HRQoL and a novel domain relating to treatment perception.
Background:Ustekinumab was approved in 2016 for the treatment of moderate–severe Crohn’s disease (CD). Clinical trials and real-world studies have suggested ustekinumab to be a safe and effective treatment; however, studies to date infrequently use imaging techniques to predict response to biologics in CD.Objectives:We assessed the 2-year real-world effectiveness and safety of ustekinumab in a tertiary CD cohort with the use of novel imaging techniques.Design:Retrospective cohort study.Methods:Retrospective data were collected between 2016 and 2021. Study end points included ustekinumab persistence, biological and/or clinical response and remission at 12, 18 and 24 months. Statistical analysis included demographic and inferential analyses.Results:In all, 131 CD patients [57.3% female, median age of 26.0 (21.0–37.0)] were included. Patients were non-bio naïve, and the majority received ustekinumab as third- or fourth-line treatment. At 24 months, 61.0% (80/131) persisted with ustekinumab [52.7% (69/131) steroid free]. Clinical response was reported in 55.2% (37/67), clinical remission in 85.7% (57/67), biological response in 46.8% (22/47) and biological remission in 31.9% (15/47) of patients at 24 months. The low outcome numbers were attributable to missing data. Improvements in routine disease markers, including C-reactive protein and Harvey–Bradshaw Index, were also reflected in magnetic resonance imaging-derived disease scores. The presence of penetrating CD, an -ostomy and sarcopenia were all predictors of poorer ustekinumab outcomes ( p < 0.05).Conclusion:Ustekinumab is effective in non-bio-naïve CD patients with non-stricturing, non-penetrating disease with an unremarkable safety profile but may be less effective in those with penetrating disease, -ostomies and sarcopenia.
Background and aimsHealthcare quality improvement (QI) is the systematic process to continuously improve the quality of care and outcomes for patients. The landmark Inflammatory Bowel Disease (IBD) UK National Audits provided a means to measure the variation in care, highlighting the need to define the standards of excellence in IBD care. Through a consensus approach, we aimed to establish key performance indicators (KPIs), providing reliable benchmarks for IBD care delivery in UK. MethodsKPIs that measure critical aspects of a patient journey within an IBD service were identified though stakeholder meetings. A two-stage Delphi consensus was then conducted. The first involved a multidisciplinary team of IBD clinicians and patients to refine definitions and methodology. The second stage assessed feasibility and utility of the proposed QI process by surveying gastroenterology services across UK. ResultsFirst, the four proposed KPIs were refined and included time from primary care referral to diagnosis in secondary care, time to treatment recommendation following a diagnosis, appropriate use of steroids and advanced therapies prescreening and assessment. Second, the Delphi consensus reported >85% agreement on the feasibility of local adoption of the QI process and >75% agreement on the utility of benchmarking of the KPIs. ConclusionsThrough a structured approach, we propose quantifiable KPIs for benchmarking to improve and reduce the individual variation in IBD care across the UK.
Introduction Intestinal ultrasound (IUS) is gathering interest around the UK but currently its use is not widely available. Our institution has considerable access to IUS with up to five lists a week performed by consultant GI radiologists. We wanted to compare our use of IUS with MRI small bowel (MRSB) for new patients being investigated for gastrointestinal symptoms. Methods We reviewed the electronic medical records of all IUS and MRSB performed during a six-month period from 1st September 2020 to 28thFebruary 2021 and analysed those performed as part of the initial work up of new gastrointestinal symptoms. Results 347 scans were performed during this period, 120 (34.6%) IUS and 227 (65.4%) MRSB. Baseline demographics were significantly different between the groups: IUS Median age 27.5 years (IQR 19–38), female 69.2% and MRSB 36 years (IQR 26–49), female 63.0% (p<0.001). IUS patients were more likely to have had both bloods and a calprotectin sent prior to the imaging request (68.3% vs 33.5%, p<0.001). For those who had a calprotectin performed, values were similar between modality (Mean 553 vs 514, p=0.42). The indication for scans were different between the groups, with MR scans more often performed in patients following endoscopic findings (20.3% vs 6.7%, p<0.001) and IUS was more likely in patients with an indication of a raised calprotectin (37.5% vs 12.3%, p<0.001). Significant findings were similar between the two groups: IUS 16 (13.3%) vs MRSB 45 (19.8%) (p=0.066). False positives or equivocal findings were also similar: IUS 10 (8.3%) and MRSB 13 (5.7%), p=0.18. Incidental findings were low in both groups, 3 and 6, with none being clinically significant. Limitations were less common for IUS, 14 (11.7%), compared with MRSB, 66 (29.1%) (p<0.001). Ultrasound limitation was mainly due to body habitus and MRI due to underdistension of the distal and terminal ileum (TI), which would limit detection of more subtle TI disease. 30 patients had both MRSB and IUS and none of these showed any significant differences that had a clinical impact. Conclusions Intestinal ultrasound has a clear role as an imaging modality for gastrointestinal symptoms. We regularly use it for patients with a possible new diagnosis of IBD as well as reassurance for those with suspected irritable bowel syndrome. Even though it is used in a slightly different cohort of patients, pathology detection is similar to MRSB and IUS is less likely to have reported limitations. More training in IUS is required around the UK as it is well tolerated by patients and considerably cheaper than MRSB. Opportunities for both radiologists and gastroenterologists are needed so this technique can become mainstream within the UK.