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ObjectivesWe aimed to determine whether changes in acute severe colitis (ASC) management have translated to improved outcomes and to develop a simple model predicting steroid non-response on admission.DesignOutcomes of 131 adult ASC admissions (117 patients) in Oxford, UK between 2015 and 2019 were compared with data from 1992 to 1993. All patients received standard treatment with intravenous corticosteroids and endoscopic disease activity scoring (Ulcerative Colitis Endoscopic Index of Severity (UCEIS)). Steroid non-response was defined as receiving medical rescue therapy or surgery. A predictive model developed in the Oxford cohort was validated in Australia and India (Gold Coast University Hospital 2015–2020, n=110; All India Institute of Medical Sciences, New Delhi 2018–2020, n=62).ResultsIn the 2015–2019 Oxford cohort, 15% required colectomy during admission vs 29% in 1992–1993 (p=0.033), while 71 (54%) patients received medical rescue therapy (27% ciclosporin, 27% anti-tumour necrosis factor, compared with 27% ciclosporin in 1992–1993 (p=0.0015). Admission C reactive protein (CRP) (false discovery rate, p=0.00066), albumin (0.0066) and UCEIS scores (0.015) predicted steroid non-response. A four-point model was developed involving CRP of ≥100 mg/L (one point), albumin of ≤25 g/L (one point), and UCEIS score of ≥4 (1 point) or ≥7 (2 points). Patients scoring 0, 1, 2, 3 and 4 in the validation cohorts had steroid response rates of 100, 75.0%, 54.9%, 18.2% and 0%, respectively. Scoring of ≥3 was 84% (95% CI 0.70 to 0.98) predictive of steroid failure (OR 11.9, 95% CI 10.8 to 13.0). Colectomy rates in the validation cohorts were were 8%–11%.ConclusionsEmergency colectomy rates for ASC have halved in 25 years to 8%–15% worldwide. Patients who will not respond to corticosteroids are readily identified on admission and may be prioritised for early intensification of therapy.

Background Patient-reported outcome measures [PROMs] are key to documenting outcomes that matter most to patients and are increasingly important to commissioners of health care seeking value. We report the first series of the ICHOM Standard Set for Inflammatory Bowel Disease [IBD]. Methods Patients treated for ulcerative colitis [UC] or Crohn’s disease [CD] in our centre were offered enrolment into the web-based TrueColours-IBD programme. Through this programme, e-mail prompts linking to validated questionnaires were sent for symptoms, quality of life, and ICHOM IBD outcomes. Results The first 1299 consecutive patients enrolled [779 UC, 520 CD] were studied with median 270 days of follow-up (interquartile range [IQR] 116, 504). 671 [52%] were female, mean age 42 years (standard deviation [sd] 16), mean body mass index [BMI] 26 [sd 5.3]. At registration, 483 [37%] were using advanced therapies. Median adherence to fortnightly quality of life reporting and quarterly outcomes was 100% [IQR 48, 100%] and 100% [IQR 75, 100%], respectively. In the previous 12 months, prednisolone use was reported by 229 [29%] patients with UC vs 81 [16%] with CD, p 3 months. An IBD-related intervention was reported by 174 [13%] patients, and 80 [6%] reported an unplanned hospital admission. There were high rates of fatigue [50%] and mood disturbance [23%]. Conclusions Outcomes reported by patients illustrate the scale of the therapeutic deficit in current care. Proof of principle is demonstrated that PROM data can be collected continuously with little burden on health care professionals. This may become a metric for quality improvement programmes or to compare outcomes.

Adherence to evidence-based management is variable in inflammatory bowel disease (IBD), which leads to worse patient outcomes and higher healthcare utilization. Solutions include electronic systems to enhance care, but these have often been limited by lack of clinician design input, poor usability, and low perceived value. A cloud-based IBD-specific clinical management software - 'Crohn's Colitis Care' (CCCare) was developed by Australia and New Zealand Inflammatory Bowel Disease Consortium clinicians and software developers to improve this.CCCare captures patient-reported disease activity and medical assessment, medication monitoring, cancer screening, preventative health, and facilitates communication with the IBD team and referring doctor. De-identified longitudinal data are stored separately in a clinical quality registry for research. CCCare was tested for feasibility and usability in routine clinical settings at two large Australian hospitals. Users' experience was evaluated with System Usability Scale (SUS). Value to clinicians and patients was assessed by qualitative feedback. Security was assessed by penetration testing.Users (Initial evaluation demonstrates CCCare is usable, secure, and valued in clinical use. It is designed to measure outcomes of clinical care, including efficacy, quality, cost, and complications for individuals, and to audit these at hospital and national level.

We report a unique case of a 34-year-old man with ulcerative colitis, previously in complete remission with intravenous vedolizumab monotherapy, who developed an urticarial injection-site reaction on switching to a subcutaneous preparation and thereafter experienced a new hypersensitivity reaction on switch back to intravenous vedolizumab, necessitating complete discontinuation from this drug. This case highlights the need for vigilance on switching back to intravenous preparations of vedolizumab, in response to injection-site reactions with a subcutaneous preparation, even if the intravenous preparation had been previously well tolerated by the patient.

Ulcerative colitis (UC) is a major form of inflammatory bowel disease with increasing global incidence. There is significant phenotypic heterogeneity defined by a range of clinical variables including age of onset and disease extent. Clinical outcomes range from long-term remission on minimal therapy to surgical resection. Close to 70% of UC risk can be attributed to genetics and understanding the genetic mechanisms contributing to this risk and disease heterogeneity is vital for understanding disease pathogenesis and improving patient outcomes through targeted screening and therapies. This study aims to characterise the genetic heterogeneity of UC by identifying genomic risk variants specific to mild and/or severe forms of UC, exploring variations in the effect size of known risk variants and assessing the clinical value of a genetic risk score (GRS). We conducted genome-wide association (GWA) analyses in 287 patients with mild UC, 311 patients with severe UC and 583 age- and gender-matched controls. Odds ratios (OR) for mild vs control, severe vs control and combined mild and severe UC vs control were calculated. Using the combined UC data, two independent loci in the HLA region reached genome-wide significance. An additional genome-wide significant signal on chromosome 1 was identified in severe cases only. OR for known risk loci varied between mild and severe patients and were similar to previously published results. Effect estimates from the most recent UC GWA meta-analysis were used to calculate a GRS for each individual. A higher mean GRS was observed in both mild and severe UC cases compared to controls however, there was no difference between the mean GRS for mild and severe UC. Heterogeneity in effect sizes of UC associated variants between mild and severe disease burden suggests the presence of genetically distinct signatures. While large consortium data are needed to identify genome-wide significant variants, additional risk loci may be identified by targeted recruitment of individuals with a history of severe disease.Author SummaryUlcerative colitis (UC) is a chronic and often debilitating form of inflammatory bowel disease affecting approximately 0.3% of the population in industrialized economies. The disease displays significant clinical heterogeneity including age at presentation, disease severity, and the propensity to develop disease-related complications. Several previous studies have demonstrated the heritability of UC, identifying over 30 loci specific to the disease. The majority of these loci have small to modest effect sizes other than those within the Human Leucocyte Antigen (HLA) region on chromosome 6. Using stringent clinical criteria for defining mild and severe forms of UC in an extremes of phenotype approach, we undertook a genome wide association study in a dataset of 1222 participants to investigate genetic heterogeneity in this disease. We demonstrated substantial differences in genetic associations in severe UC as compared to mild UC. While over 2,000 SNPs achieved genome-wide significance in the severe UC analysis, none reached significance for mild UC. These results were reflected in significant differences in odds ratios. We identified Complement Factor B (CFB) as a potential susceptibility gene for severe UC in the Caucasian population with additional tissue gene expression demonstrating a positive correlation with disease severity.

We read with great interest the recent publication from Ungaro and colleagues,1 reporting the latest data from the Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry. These data, while raising concerns regarding the use of thiopurine and corticosteroid therapy in the SARS-CoV-2 pandemic, also provide valuable reassurance that monotherapy with anticytokine therapies, in particular those directed against tumour necrosis factor (TNF), are not associated with adverse outcomes in patients with IBD developing COVID-19. It has been postulated that anticytokine therapies may ameliorate or abrogate the ‘cytokine storm’ associated with severe COVID-19,2 with anti-IL6 strategies now approved for use.3 We have assessed the SARS-CoV-2 antibody seroprevalence in patients with IBD, receiving either intravenous anti-TNF therapy, or anti-integrin therapy, during the first wave of the pandemic in the UK. Sera from 640 patients attending for maintenance infliximab or vedolizumab infusions between April and June 2020 at the John Radcliffe Hospital (Oxford, UK) and Royal London Hospital (London, UK) were tested using the Abbott SARS-CoV-2 IgG assay. Adults (180) and paediatric (56) patients were included from London. Demographic and clinical data are summarised (online supplemental tables 1, 2). Key differences between the Oxford and London adult cohorts included ethnicity, smoking, comorbidities, disease type, concomitant thiopurines and biologic; in our data set, patients attending Royal London Hospital had significantly greater evidence for deprivation than Oxford (deprivation score 4 (3–6.3) vs 8 (6–9.3), p

Background & aimsWe aimed to determine whether changes in ulcerative colitis management have translated to improved outcomes, in order to develop a simple model to predict steroid non-response on admission.MethodsOutcomes of 131 adult ASC admissions (117 patients) in Oxford, UK between 2015-19 were compared with prospectively collected data from 1992-3. All patients received standard treatment with intravenous corticosteroids and endoscopic disease activity scoring (UCEIS). Steroid non-response was defined as receiving rescue medical therapy or surgery. A predictive model created in the Oxford cohort was validated in Australia and India (110 hospitalised patients Gold Coast University Hospital 2015-20; 62 hospitalised patients AIIMS, New Delhi 2018-20).ResultsIn the 2015-19 Oxford cohort, 71 (54%) patients received medical rescue therapy (27% ciclosporin, 27% anti-TNF), compared to 27% ciclosporin in 1992-3, p=0.0015. Only 15% required colectomy during admission vs 29% in 1992-3 (p=0.033). Admission CRP, albumin, and UCEIS scores predicted steroid non-response (FDR p=0.00066, 0.0066 and 0.015). A four-point model was developed involving CRP ≥100mg/L (1 point), albumin ≤25g/L (1 point), UCEIS ≥4 (1 point) or ≥7 (2 points). Scoring 0 or 4 was 100% predictive of steroid response and non-response, respectively, in all three cohorts. Patients scoring 3-4 had 83% risk of steroid non-response in Oxford and 84% (0.70-0.98) in the validation cohorts – OR 11.9 (10.8-13).ConclusionColectomy rates for ASC have halved in 25 years, while use of rescue medical therapy has doubled. Patients who are highly unlikely to respond to parenteral steroid treatment alone may be readily identified on admission, to be prioritised for early intensification of therapy.WHAT YOU NEED TO KNOWBackground and contextAcute severe colitis (ASC) requires hospitalisation and, frequently, colectomy. The accepted management of ASC is three-five days of intravenous steroids followed by protocolised response assessment.New findingsMedical rescue therapy has doubled and the colectomy rate halved in 25 years. A predictive index identifying steroid non-response was derived and validated in three independent centres in three countries.LimitationsA need remains to demonstrate that earlier rescue medical therapy for patients predicted to be steroid non-responders will further improve outcomes.ImpactThe outcome of ASC has substantially improved in the past 25 years, with the potential for further improvement by identifying patients on admission for early escalation of therapy.

Background & Aims Barrett’s epithelium measurement using widely accepted Prague C&M classification is highly operator dependent. We propose a novel methodology for measuring this risk score automatically. The method also enables quantification of the area of Barrett’s epithelium (BEA) and islands, which was not possible before. Furthermore, it allows 3-dimensional (3D) reconstruction of the esophageal surface, enabling interactive 3D visualization. We aimed to assess the accuracy of the proposed artificial intelligence system on both phantom and endoscopic patient data. Methods Using advanced deep learning, a depth estimator network is used to predict endoscope camera distance from the gastric folds. By segmenting BEA and gastroesophageal junction and projecting them to the estimated mm distances, we measure C&M scores including the BEA. The derived endoscopy artificial intelligence system was tested on a purpose-built 3D printed esophagus phantom with varying BEAs and on 194 high-definition videos from 131 patients with C&M values scored by expert endoscopists. Results Endoscopic phantom video data demonstrated a 97.2% accuracy with a marginal ± 0.9 mm average deviation for C&M and island measurements, while for BEA we achieved 98.4% accuracy with only ±0.4 cm2 average deviation compared with ground-truth. On patient data, the C&M measurements provided by our system concurred with expert scores with marginal overall relative error (mean difference) of 8% (3.6 mm) and 7% (2.8 mm) for C and M scores, respectively. Conclusions The proposed methodology automatically extracts Prague C&M scores with high accuracy. Quantification and 3D reconstruction of the entire Barrett’s area provides new opportunities for risk stratification and assessment of therapy response.

Background The SCCAI was designed to facilitate assessment of disease activity in ulcerative colitis (UC). We aimed to interrogate the metric properties of individual items of the SCCAI using item response theory (IRT) analysis, to simplify and improve its performance. Methods The original 9-item SCCAI was collected through TrueColours, a real-time software platform which allows remote entry and monitoring of patients with UC. Data were securely uploaded onto Dementias Platform UK Data Portal, where they were analysed in Stata 16.1 SE. A 2-parameter (2-PL) logistic IRT model was estimated to evaluate each item of the SCCAI for its informativeness (discrimination). A revised scale was generated and re-assessed following systematic removal of items. Results SCCAI data for 516 UC patients (41 years, SD = 15) treated in Oxford were examined. After initial item deletion (Erythema nodosum, Pyoderma gangrenosum), a 7-item scale was estimated. Discrimination values (information) ranged from 0.41 to 2.52 indicating selected item inefficiency with three items ) or non-endorsement of the trait (disease activity). Conclusion Reduction of the SCCAI from the original 9-item scale to a 4-item scale provides optimum trait information that will minimise response burden. This new 4-item scale needs validation against other measures of disease activity such as faecal calprotectin, endoscopy and histopathology.

Introduction Tofacitinib is an oral partially selective Janus kinase inhibitor approved for the treatment of refractory moderate to severe ulcerative colitis (UC). Real-world experience of patients with UC treated with tofacitinib is however limited, and safety concerns over the risk of venous thromboembolism (VTE) have recently emerged. Further, factors linked to primary non-response remain poorly defined. We therefore sought to define the effectiveness and safety of tofacitinib in a real-world cohort. Methods We conducted a retrospective observational cohort study of 134 patients with UC (64% male; median age 37 years [range 16–81]; 83% patients had previously received at least one biologic) treated with tofacitinib from October 2018 to October 2019 in four UK centres. Disease activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI) or Partial Mayo Score (PMS) depending on study site. Response and remission were defined as a reduction in SCCAI or PMS of ≥3, and SCCAI ≤2 or PMS ≤1, respectively. Results Overall, 74% (88/119; 95% CI 65–81%) patients responded to tofacitinib at week 8 and steroid free remission was observed in 44% (47/108; 95% CI 34%-53%) patients at week 26 (figure 1). Endoscopy was undertaken in 90 patients (67%) at baseline with routine follow-up endoscopy in 11 patients at week 8 and 34 patients at week 14. Median baseline UCEIS was 5 (IQR 4–6) falling to 2 (1–6) at week 8 and 2 (1–4) at week 14. Primary non-response was independently associated with younger age (p=0.014) and higher baseline CRP (p=0.004). Prior biologic exposure did not influence response or remission rates. Continuing tofacitinib in the setting of primary non-response was rarely helpful. Dose escalation recaptured response in 9/19 patients who lost response. Dyslipidaemia was observed in 20% (27/134; 95% CI 14%-28%) of patients but no major adverse cardiovascular events occurred. Seven patients had serious infections, with herpes zoster in 3 patients. Overall, adverse events that curtailed treatment were uncommon and no VTE occurred. Conclusions In this multi-centre real-world cohort, tofacitinib was well tolerated and clinically effective in a treatment refractory UC population.

Introduction Acute severe ulcerative colitis (ASUC) is a common medical emergency, with up to 25% of patients with ulcerative colitis experiencing at least one severe attack in their life-time. Since first Randomized control of efficacy of intravenous steroids published in 1954, many drugs have been discovered and used in management of acute severe colitis either as rescue therapy(Ciclosporin/Infliximab) or maintenance agents( 5-ASA, Immunomodulator (Azathioprine/6-Mercaptopurine), Biologic( Infliximab/Adalimumab/Vedolizumab) and small molecules( Tofacitinib).What is not known if these drugs have materialized into better outcomes in acute severe colitis. Methods We analysed outcomes from different papers from Oxford representing different cohorts of different era i.e Dinesen et al(1953–2007), Travis et al( 1996) and Corte et al( 2015).We compared the outcomes with most recent cohort from 2015–2019. Results Consecutive 131 admissions (117 patients) between 2015–9 were analysed. All satisfied modified TW definition of ASUC. Sixty-eight patients (58%) were female, index presentation 38 (29%),median age at presentation 40 years (16–76),median disease duration 1 year (1–43), median follow up 23 months (1–49).Seventy-one (54%) received rescue therapy (ciclosporin 35/71 and anti-TNF 36/71).Colectomy rates were 15% (19/131) during same admission and 26% (30/117) within 1 year of follow up. We compared the outcomes in different cohorts. We observed that colectomy rates have been decreasing significantly with better treatment (Image 1). We also observed that readmissions with acute severe colitis have also reduced (better maintenance) with only 12% patients requiring readmission in first year. Seventy percent of patients in current cohort have been maintained on biologic or Tofacitinib leading to colectomy free survival for median follow up of 2 years. Conclusion Availability of multiple drug options and improvement in healthcare have led to improved outcomes in acute severe colitis justifying the cost associated with these drugs.

Introduction Immune checkpoint inhibitors (ICIs) have revolutionised the treatment of various cancers. They improve survival but this comes at the cost of immune-related adverse events like ICI-colitis. First line treatment is steroids and refractory cases can be treated with infliximab, vedolizumab or faecal microbiota transplant (FMT). We describe our experience of FMT, alongside cytometric/transcriptomic analysis of the GI immune response, and whole stool metabolomic analysis pre- and post-FMT. Methods 150 ml FMT was delivered to the caecum by colonoscopy. 5 pairs of colon pinch biopsies were collected pre- and week 6 post-FMT. Gut mononuclear cells (GMNC) were isolated from the biopsies by enzymatic/mechanical digestion. GMNC were analysed using a 21-parameter flow cytometry panel on the Cytek Aurora Spectral Analyser and a 780-plex Nanostring panel. Stool pre- and post-FMT, and that of the FMT donor, was subjected to whole metabolome analysis. Results Two patients with refractory ICI-colitis were treated with FMT (same donor). Characteristics are shown in Table 1: Patient 1’s symptoms of diarrhoea and abdominal pain resolved fully. Week 6 sigmoidoscopy and biopsies were normal. Pre-FMT, there were high levels of activation (as measured by co-expression of HLA-DR and CD38) on CD4, CD8 and MAIT cell subsets as well as high Ki-67 and low expression of Bcl-2. Post FMT, there was reduced expression of HLA-DR and CD38 and lower expression of Ki-67 with high/homeostatic levels of Bcl-2 and an increased proportion of Tregs. The bowel frequency of patient 2 demonstrated some clinical improvement, but week 6 sigmoidoscopy showed an unchanged UCEIS score and Nancy histological index. Pre FMT, there were similar levels of activation as seen in patient 1, but post-FMT responses were muted. We will present an analysis of the GI immune response and of the stool whole metabolome, in these two patients with dichotomous clinical outcomes. Conclusions We report the first use of FMT to treat ICI-colitis in the UK, demonstrating that it is effective in a subset of patients. Although both patients received stool from the same donor, they experienced contrasting treatment responses. We will present the salient GI immune and stool metabolomic differences to reveal mechanistic insights.

BackgroundThe SCCAI was designed to facilitate assessment of disease activity in ulcerative colitis (UC). We aimed to interrogate the metric properties of individual items of the SCCAI using item response theory (IRT) analysis, to simplify and improve its performance. MethodsThe original 9-item SCCAI was collected through TrueColours, a real-time software platform which allows remote entry and monitoring of patients with UC. Data were securely uploaded onto Dementias Platform UK Data Portal, where they were analysed in Stata 16.1 SE. A 2-parameter (2-PL) logistic IRT model was estimated to evaluate each item of the SCCAI for its informativeness (discrimination). A revised scale was generated and re-assessed following systematic removal of items. ResultsSCCAI data for 516 UC patients (41 years, SD=15) treated in Oxford were examined. After initial item deletion (Erythema nodosum, Pyoderma gangrenosum), a 7-item scale was estimated. Discrimination values (information) ranged from 0.41 to 2.52 indicating selected item inefficiency with three items ) or non-endorsement of the trait (disease activity). Conclusion Reduction of the SCCAI from the original 9-item scale to a 4-item scale provides optimum trait information that will minimise response burden. This new 4-item scale needs validation against other measures of disease activity such as faecal calprotectin, endoscopy and histopathology.

BackgroundThere has been great concern amongst clinicians and patients that immunomodulatory treatments for IBD may increase risk of SARS-CoV-2 susceptibility or progression to severe disease.MethodsSera from 640 patients attending for maintenance infliximab or vedolizumab infusions between April and June 2020 at the John Radcliffe Hospital (Oxford, UK) and Royal London Hospital (London, UK) were tested using the Abbott SARS-CoV-2 IgG assay. Demographic and clinical data were collated from electronic patient records and research databases.ResultsSeropositivity rates of 3.0% (12/404), 7.2% (13/180), and 12.5% (7/56) were found in the Oxford and London adult IBD cohorts and London paediatric IBD cohorts respectively. Seroprevalence rates in the Oxford adult IBD cohort were lower than that seen in non-patient facing health-care workers within the same hospital (7.2%). Seroprevalence rates of the London paediatric IBD cohort were comparable to a contemporary healthy cohort collected at the same hospital (54/396, 13.6%).ConclusionsSARS-CoV-2 seropositivity rates are not elevated in patients with IBD receiving maintenance infliximab or vedolizumab infusions. There is no rationale based on these data for elective interruption of maintenance therapy, and we recommend continuation of maintenance therapy. These data do not address the efficacy of vaccination in these patients.

Background Tofacitinib is a partially selective Janus kinase inhibitor approved for the treatment of refractory moderate to severe ulcerative colitis [UC]. We sought to define the effectiveness and adverse effects of tofacitinib in a real-world cohort. Methods We conducted a retrospective observational cohort study of 134 patients with UC [64% male; median age 37 years [range 16–81]; 83% of patients had previously received at least one biologic] treated with tofacitinib from October 2018 to October 2019 in four UK centres. Disease activity was assessed using the Simple Clinical Colitis Activity Index [SCCAI] or partial Mayo score [PMS], depending on study site. Response and remission were defined as a reduction in SCCAI or PMS of ≥3and SCCAI ≤2 or a PMS ≤1, respectively. Results Overall, 74% (88/119; 95 confidence interval [CI] 65–81%] patients responded to tofacitinib at Week 8 and steroid-free remission was observed in 44% [47/108; 95% CI 3453%] patients at Week 26. Primary non-response was independently associated with younger age [p = 0.014] and higher C-reactive protein [CRP] levels at baseline [p = 0.004]. Only 23% [3/13] of patients who continued tofacitinib in the setting of primary non-response were in steroid-free remission at Week 26. Prior biologic exposure did not influence response or remission rates. Dose escalation, however, recaptured response in approximately half of patients who had lost response. Dyslipidaemia was observed in 20% [27/134; 95% CI 1428%] of patients, but adverse events necessitating drug withdrawal were uncommon and no venous thromboembolic events occurred. Conclusions In this multicentre real-world cohort, tofacitinib was well tolerated and clinically effective in a treatment-refractory UC population.

Background Real time monitoring of patients with Crohn’s disease (CD) gives us the opportunity to examine disease trajectory. We have demonstrated the feasibility of using a monitoring platform with patient reported data, collected prospectively and routinely in clinical practice. The question is whether it can be used for specific drugs Methods TrueColours-IBD (TC-IBD)is a real time, web based platform that through email prompts linked to questionnaires, collects longitudinal patient reported outcome measures (for CD, symptoms measured by Harvey Bradshaw Index (HBI) and quality of life by IBD Control-8). It is routinely used by >2000 patients in Oxford. This study examined 114 patients with Crohn’s: 45 males (median age 36, IQR 28–51) and 69 females (median age 34.8, IQR 28–47), treated with ustekinumab for a maximum of 16 months (range -2 months to 14 months). A linear mixed-effects model was used to approximate longitudinal trends of HBI and IBD Control-8. 3 individual items of the HBI scale (general well-being, abdominal pain & stool frequency) were also assessed. The TC-IBD platform has the capacity to analyse and show patients’ data automatically, using customised models and algorithms through the feedback loop (Fig 1). Model coefficients, intercept and slope were estimated using the restricted maximum likelihood (REML) approach. The intercept corresponds to the expected cohort mean value of the scale (e.g. HBI, IBD Control-8) at baseline (time zero) and the slope describes the rate of the change over time Results The models’ coefficients, the intercept and slope of both HBI and IBD Control-8 scales were statistically significant and are summarised in Table 1 with confidence intervals. Both linear trends (slopes) describing HBI (p Conclusion Patient reported data through the TC-IBD platform can be used for statistical analyses and continuous monitoring of drug effect over time. This analysis is limited by a lack of comparator group, but the models may be used with the TrueColours platform as a decision support tool for other drugs

Background Immunosuppressed IBD patients have an increased risk of HZV infection. The existing live-attenuated HZV vaccine is contraindicated in some of these patients and can only be used with caution in others. Aims To describe characteristics of IBD patients suffering HZV to enable implementation of risk mitigation strategies for those at highest risk. Methods Gastroenterologists completed a proforma for IBD patients who experienced HZV infection: IBD phenotype, details of HZV infection, immunosuppression and any change to treatment upon diagnosis of HZV. Results Thirty cases were identified: Crohn's disease (CD) (n = 25) and ulcerative colitis (UC) (n = 5). Eighty percent (20/25) of the CD patients had penetrating, stricturing or perianal disease. Time from commencement of immunosuppression to HZV infection was highly variable (range 3 months to over 10 years). Ninety percent (27/30) of patients were on at least one immunosuppressive therapy; of those one third were on monotherapy (9/27) and two thirds (18/27) on dual therapy. Eighty-nine percent (24/27) of immunosupressed patients were on a thiopurine (monotherapy (6/27) or in combination (18/27)). Complications of HZV occurred in 27% (8/30) of patients. Conclusions Our series is consistent with existing epidemiological analysis that identified more severe IBD and the use of multiple immunosuppressive therapies as risk factors for HZV. If the promise of an investigational subunit HZV vaccine is realised in immunocompromised patients, better protection may be possible in the future. Thiopurine medications were the most commonly used immunosuppressant in this series. Age and duration of immunosuppressive therapy do not appear to predict HZV infection.

Summary Background The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis. Methods We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia. We randomly allocated patients with active ulcerative colitis (Mayo score 4–10) in a 1:1 ratio, using a pre-established randomisation list, to either faecal microbiota transplantation or placebo colonoscopic infusion, followed by enemas 5 days per week for 8 weeks. Patients, treating clinicians, and other study staff were unaware of the assigned treatment. Faecal microbiota transplantation enemas were each derived from between three and seven unrelated donors. The primary outcome was steroid-free clinical remission with endoscopic remission or response (Mayo score ≤2, all subscores ≤1, and ≥1 point reduction in endoscopy subscore) at week 8. Analysis was by modified intention-to-treat and included all patients receiving one study dose. We performed 16S rRNA stool analysis to assess associated microbial changes. This trial is registered with ClinicalTrials.gov, number NCT01896635. The trial has ended; this report presents the final analysis. Findings From November, 2013, to May, 2015, 85 patients were enrolled to our trial, of whom 42 were randomly assigned faecal microbiota transplantation and 43 were allocated placebo. One patient assigned faecal microbiota transplantation and three allocated placebo did not receive study treatment and were excluded from the analysis. The primary outcome was achieved in 11 (27%) of 41 patients allocated faecal microbiota transplantation versus three (8%) of 40 who were assigned placebo (risk ratio 3·6, 95% CI 1·1–11·9; p=0·021). Adverse events were reported by 32 (78%) of 41 patients allocated faecal microbiota transplantation and 33 (83%) of 40 who were assigned placebo; most were self-limiting gastrointestinal complaints, with no significant difference in number or type of adverse events between treatment groups. Serious adverse events occurred in two patients assigned faecal microbiota transplantation and in one allocated placebo. Microbial diversity increased with and persisted after faecal microbiota transplantation. Several bacterial taxa were associated with clinical outcome; in particular, the presence of Fusobacterium spp was associated with lack of remission. Interpretation Intensive-dosing, multidonor, faecal microbiota transplantation induces clinical remission and endoscopic improvement in active ulcerative colitis and is associated with distinct microbial changes that relate to outcome. Faecal microbiota transplantation is, thus, a promising new therapeutic option for ulcerative colitis. Future work should focus on precisely defining the optimum treatment intensity and the role of donor–recipient matching based on microbial profiles. Funding Broad Medical Research Program, Gastroenterological Society of Australia, Mount Sinai (New York) SUCCESS fund, University of New South Wales.

BACKGROUND: Active inflammatory bowel disease (IBD) adversely affects pregnancy outcomes. Little is known about the risk of relapse after stopping anti-tumor necrosis factor (anti-TNF) treatment during pregnancy. We assessed the risk of relapse before delivery in women who discontinued anti-TNF treatment before gestational week (GW) 30, predictors of reduced infant birth weight, a marker associated with long-term adverse outcomes, and rates and satisfaction with counseling.METHODS: Pregnant women with IBD receiving anti-TNF treatment were prospectively invited to participate in an electronic questionnaire carried out in 22 hospitals in Denmark, Australia, and New Zealand from 2011 to 2015. Risk estimates were calculated, and birth weight was investigated using t tests and linear regression.RESULTS: Of 175 women invited, 153 (87%) responded. In women in remission, the relapse rate did not differ significantly between those who discontinued anti-TNF before GW 30 (1/46, 2%) compared with those who continued treatment (8/74, 11%; relative risk, 0.20; 95% confidence interval [CI], 0.02 to 1.56; P = 0.08). Relapse (P = 0.001) and continuation of anti-TNF therapy after GW 30 (P = 0.007) were independently associated with reduced mean birth weight by 367 g (95% CI, 145 to 589 g; relapse) and 274 g (95% CI, 77 to 471 g; anti-TNF exposure after GW 30). Of 134 (88%) women who received counseling, 116 (87%) were satisfied with the information provided.CONCLUSIONS: To minimize fetal exposure in women in remission, discontinuation of anti-TNF before GW 30 seems safe. Relapse and continuation of anti-TNF therapy after GW 30 were each independently associated with lower birth weight, although without an increased risk for birth weight

© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)., Currently, the main targets of drug therapy for ulcerative colitis [UC] are endoscopic and clinical remission. However, there is active discussion about the additional advantages of including histological remission as a target. Accumulating evidence indicates that microscopic activity persists in endoscopically quiescent UC, that histological changes may lag behind clinical remission after treatment, and that absence of histological activity predicts lower rates of relapse, hospitalization, surgery and subsequent neoplasia. Obtaining useful information from mucosal biopsies in this setting depends on accurate and consistent evaluation of histological features. However, there is no standardization of biopsy procedures, histological sample processing technique or histological scoring systems, and there is no agreement on the definitions of histological remission, response or activity. Accordingly, a consensus expert panel convened by the European Crohn's and Colitis Organisation [ECCO] reviewed the literature and agreed a number of position statements regarding harmonization of UC histopathology. The objective was to provide evidence-based guidance for the standardization and harmonization of procedures, definitions and scoring systems for histology in UC, and to reach expert consensus where possible. We propose the absence of intraepithelial neutrophils, erosion and ulceration as a minimum requirement for the definition of histological remission. For randomized control trials we recommend the use of the Robarts histopathology index [RHI] or the Nancy index [NI]. For observational studies or in clinical practice we recommend the use of the NI. To predict the risk of future neoplasia in UC, cumulative histological scores over time are more useful than single scores.

Background Disease activity assessment in UC is most accurately evaluated by endoscopy and biopsy, which often correlates poorly with current symptoms. We investigated whether a machine learning classification algorithm using patient-reported Simple Clinical Colitis Activity Index (SCCAI) over 14 days and signature features could reliably distinguish endoscopic and histopathologic activity from remission. Methods The TrueColours ulcerative colitis (UC) monitoring platform was used to collect symptoms (SCCAI, daily) and endoscopic/histopathological activity, as per the UCEIS and Nancy indices (twice in 6 months) in 233 patients. The longitudinal data may be seen as a trajectory. The signature is a collection of statistics which efficiently summarises the trajectory and serves as a non-parametric hierarchical method for longitudinal data representation. Signature features were used as input to the extreme gradient boosting classification algorithm to categorise subjects into remission or active disease groups. Remission: UCEIS ≤1 AND Nancy ≤1; Active disease: UCEIS ≥4 AND Nancy ≥2. The advanced signature-based approach was compared with a baseline model with manually constructed features (mean SCCAI score over 14 days preceding endoscopy). Cross-validation was used to report metrics, Table 1. Results Disease activity classification with signature features significantly outperformed mean-SCCAI based approach (AUC 0.87 vs. AUC 0.79 correspondingly, p = 0.011, Figure 1). All other statistical metrics (including sensitivity (0.89), specificity (0.78), PPV (0.82) and NPV) demonstrated the same trend, favouring the signature method. The decision-tree-based ensemble gradient boosting classification algorithm (XGBoost) has the intrinsic ability to rank feature importance. The signature feature of the fourth item within the SCCAI (blood in stool) dominated, followed by cross-correlation between the first (daily bowel frequency) and fourth item. Conclusion Gradient boosting classification algorithm with signature features extracted from the longitudinal six-item symptoms of the SCCAI, reliably identified subjects with endoscopic and histopathological disease activity. The developed algorithm may be used with the TrueColours platform as a decision support tool.

Background Demand for outpatient clinic appointments for ulcerative colitis (UC) often exceeds capacity, since spaces are frequently assigned to routine follow-up of patients who are well. Demand might better be managed by targeting appointments for patients in need of therapeutic decisions. The TrueColours UC (TCUC) Escalation of Therapy or Intervention (ETI) calculator is a potential enabling tool. Methods TCUC is a web-based programme based on email prompts linked to validated, disease-specific indices. The ETI Calculator was created after logistic regression showed that patient-reported symptoms (Simple Clinical Colitis Activity Index) and quality of life (IBD Control-8) could calculate the probability of therapy escalation or an urgent intervention during an outpatient appointment (OPA, Figure 1). From June 2018 to August 2019, all OPA for 650 patients using TCUC and under standard OPA follow-up were examined. The probability of escalation at each OPA was calculated using the most recent prior SCCAI and IBD-Control scores (within 2 weeks of appointment). Clinic letters were assessed to determine whether treatment escalation or intervention had occurred during the OPA. Results Of 650 patients, 236 had a total of 403 OPAs. 210/403 (52%) of these OPAs resulted in no treatment escalation; 159/403 (40%) had escalation and 34/410 (8%) had de-escalation. An ETI calculator threshold set at 5% estimated probability of treatment escalation would have correctly identified 143/159 (90%) escalation events. 16/159 (10%) escalations were not correctly predicted: 12/16 were escalations of medication (oral 5-aminosalicylic acid, n = 3), azathioprine (2), methotrexate (1), increase infliximab dose (2), adalimumab (3), tofacitinib (1). Other escalations were endoscopy requests (2), dermatology/rheumatology referrals (2). Importantly, 6/16 (38%) had taken steroids within 1 month of data collection. 143/403 (35%) of OPAs could have been deferred using a 5% ETI threshold. In contrast, increasing the ETI threshold to 25% would have allowed 274/403 (68%) OPAs to be deferred but would have resulted in missing an additional 53 escalations. Conclusion A model that predicts the likelihood of treatment escalation or intervention during an OPA, based on real-time data entered by patients, has the potential to improve outpatient clinic resource utilisation. The calculator may not be valid to triage patients recently on steroids.

Background Faecal calprotectin [FCal] levels are used as a surrogate marker for mucosal inflammation, but thresholds for defining endoscopic or histological disease activity in ulcerative colitis [UC] remain unclear. Methods Using validated indices, prospective measurements of FCal, symptoms [Simple Colitis Clinical Activity Index, SCCAI], endoscopic [Ulcerative Colitis Endoscopic Index of Severity, UCEIS] and histological activity [Nancy index] were made over 6 months in patients enrolled into the TrueColours UC web-based monitoring programme. Repeated measurements correlation was performed between FCal and SCCAI, UCEIS, and Nancy indices using definitions for remission and active disease [UCEIS: remission ≤1, active ≥4; Nancy: remission ≤1, active ≥2; combined criteria: remission UCEIS ≤1 and Nancy ≤1, active UCEIS ≥4 and Nancy ≥2]. Receiver operating characteristic curves investigated FCal thresholds after maximising sensitivity for active disease. Results In 39 patients followed prospectively for 6 months, correlation coefficients between FCal and SCCAI, UCEIS, and Nancy indices were 0.271 (95% confidence interval [CI] 0.114–0.415), 0.741 [95% CI 0.289–0.922], and 0.876 [95% CI 0.605–0.965], respectively. Median FCal thresholds for remission using endoscopic, histological, or combined criteria were 71 μg/g [range 8–624], 91 μg/g [range 8–858], and 67 μg/g [range 8–479], respectively. The FCal threshold above which active disease was confirmed was 187 μg/g for UCEIS (area under the curve [AUC] 0.915), 72 μg/g for Nancy [AUC 0.824], and 187 μg/g for combined endoscopic and histological criteria [AUC 0.936]. Conclusions Correlation between FCal and symptoms in UC is weak. In contrast, the correlation between FCal and endoscopic or histological activity is strong. An FCal ≥72 μg/g indicates histological inflammation [Nancy ≥2] and ≥187 μg/g indicates endoscopically active disease [UCEIS ≥4], whether combined with histopathology or not.

Background & Aims Fecal microbiota transplantation (FMT) can induce remission in patients with ulcerative colitis (UC). In a randomized controlled trial of FMT in patients with active UC, we aimed to identify bacterial taxonomic and functional factors associated with response to therapy. Methods We performed a double-blind trial of 81 patients with active UC randomly assigned to groups that received an initial colonoscopic infusion and then intensive multidonor FMT or placebo enemas, 5 d/wk for 8 weeks. Patients in the FMT group received blended homogenized stool from 3–7 unrelated donors. Patients in the placebo group were eligible to receive open-label FMT after the double-blind study period. We collected 314 fecal samples from the patients at screening, every 4 weeks during treatment, and 8 weeks after the blinded or open-label FMT therapy. We also collected 160 large-bowel biopsy samples from the patients at study entry, at completion of 8 weeks of blinded therapy, and at the end of open-label FMT, if applicable. We analyzed 105 fecal samples from the 14 individual donors (n = 55), who in turn contributed to 21 multidonor batches (n = 50). Bacteria in colonic and fecal samples were analyzed by both 16S ribosomal RNA gene and transcript amplicon sequencing; 285 fecal samples were analyzed by shotgun metagenomics, and 60 fecal samples were analyzed for metabolome features. Results FMT increased microbial diversity and altered composition, based on analyses of colon and fecal samples collected before vs after FMT. Diversity was greater in fecal and colon samples collected before and after FMT treatment from patients who achieved remission compared with patients who did not. Patients in remission after FMT had enrichment of Eubacterium hallii and Roseburia inulivorans compared with patients who did not achieve remission after FMT and had increased levels of short-chain fatty acid biosynthesis and secondary bile acids. Patients who did not achieve remission had enrichment of Fusobacterium gonidiaformans, Sutterella wadsworthensis, and Escherichia species and increased levels of heme and lipopolysaccharide biosynthesis. Bacteroides in donor stool were associated with remission in patients receiving FMT, and Streptococcus species in donor stool was associated with no response to FMT. Conclusions In an analysis of fecal and colonic mucosa samples from patients receiving FMT for active UC and stool samples from donors, we associated specific bacteria and metabolic pathways with induction of remission. These findings may be of value in the design of microbe-based therapies for UC. ClinicalTrials.gov, Number NCT01896635

Electronic health (eHealth) data collection is increasingly used in many chronic illnesses, to track pattern of disease. eHealth systems have the potential to revolutionize care. Inflammatory bowel disease (IBD) is a paradigm for such an approach: this is a chronic disease that usually affects young and technologically literate patient population, who are motivated to be involved in their own care. A range of eHealth technologies are available for IBD. This review considers the strengths and weaknesses of 7 platforms that focus on patient-provider interaction. These have been developed in Denmark, United States, the Netherlands, and the United Kingdom, demonstrating an international interest in this form of technology and interaction. Not only do these technologies aim to improve care but they also have the potential to collect large amounts of information. Information includes demographics and patient reported outcomes (symptoms, quality of life), quality of care (steroid use, among other metrics) and outcomes such as hospitalization. These data could inform quality improvement programmes to improve their focus. eHealth technology is also open to machine learning to analyze large data sets, through which personalized algorithms may be developed.

Background The efficacy of infliximab has been demonstrated in patients with both acute severe and moderate-severe ulcerative colitis (UC). However, there is a need for ‘real-life data’ to ensure that conclusions from trial settings are applicable in usual care. We therefore examined the national experience of anti-tumour necrosis factor-α (TNF-α) therapy in UC. Methods Case notes review of patients with UC who had received compassionate access (CA) anti-TNF-α therapy from prospectively maintained inflammatory bowel disease databases of six Australian adult teaching hospitals. Results Patients either received drug for acute severe UC (ASUC) failing steroids (n = 29) or for medically refractory UC (MRUC) (n = 35). In ASUC, the treating physicians judged that anti-TNF-α therapy was successful in 20/29 patients (69%); in these cases, anti-TNF-α was able to be discontinued (after 1–3 infusions in 19/20 responders) as clinical remission was achieved. Consistent with this perceived benefit, only 7/29 (24%) subsequently underwent colectomy during a median follow up of 12 months (interquartile range (IQR) 5–16). Eight of the 35 patients with MRUC (23%) required colectomy during a median follow up of 28 months (IQR 11–43). The majority of these patients (20/35 or 57%) had anti-TNF-α therapy for ≥4 months, whereas, 27/29 (93%) of ASUC patients had CA for ≤3 months. Conclusions These data show an excellent overall benefit for anti-TNF-α therapy in both ASUC and MRUC. In particular, only short-duration anti-TNF-α was required in ASUC. These real-life data thus support the clinical trial data and should lead to broader use of this therapy in UC.

Background ‘Dose tailoring’ of anti-tumour necrosis factor alpha (TNF-α) therapy in Crohn disease (CD), by dose escalation, or shortening of dosing intervals, has been suggested to regain clinical response following a flare in a proportion of patients. However, reported outcome data are sparse and none exists from Australia. Method In an observational multicentre, retrospective study, the impact of anti-TNF-α dose tailoring on corticosteroid use, the need for surgery and physician perception of clinical efficacy was examined in a real-world setting at six Australian adult teaching hospitals. Demographics, disease characteristics, medications, indication for and duration of dose tailoring were documented. Results Fifty-five CD patients were identified as requiring dose tailoring and secondary loss of response was the indication in 96%. Either adalimumab (64%) or infliximab (36%) was dose escalated for a median of 5 months (range 1–47), with a median of 20 months follow up (range 3–65). At 3 months, dose tailoring reduced the mean number of days on high-dose corticosteroids (45 vs 23, P = 0.01). Most (78%) patients remained resection free, and 73% of physicians reported good clinical efficacy of dose tailoring. Of those who de-escalated therapy due to induction of remission, long-term (>12 months) follow up and complete data on steroid use were available in 15/28, with 12/15 (80%) remaining steroid free at 1 year. Conclusion Short-term dose tailoring regains disease response in the majority of patients with CD. Of these, most will remain free of corticosteroids at 1 year after de-escalating therapy.

Background Ulcerative colitis (UC) or Crohn’s disease (CD) are associated with symptoms that lead to reduced quality of life and increased healthcare utilisation. The patient reported outcome (PRO) tools are key to documenting outcomes that matter most to patients and are increasingly important to commissioners of health care seeking value. We report the first series of the ICHOM Standard Set for inflammatory bowel disease (IBD). Methods Patients treated for UC or CD in our tertiary referral centre are offered enrolment into the TrueColours IBD web-based PRO collection programme. This functions through email prompts, directly linked to validated questionnaires. Prompts for symptoms (daily SCCAI for UC and HBI for CD); quality of life (fortnightly IBD-Control); and other outcomes (baseline and 3 monthly ICHOM Standard Set), including data on steroid use, hospital admission and other measures through internationally agreed criteria. Results The first 500 consecutive patients enrolled (401 UC, 99 CD) were studied. 274 (55%) were female, mean age 40 years (sd 15), and mean BMI 26 (sd 6). 22/500 (5%) were current smokers. Baseline medications at the time of registration were no therapy 6%, topical therapies 21%, 5ASA 49%, thiopurines 24%, methotrexate 6%, budesonide 3%, prednisolone 10%, advanced therapies 37%. (adalimumab 13%, golimumab 3 months. 61 (12%) patients reported requiring an IBD-related intervention (11% UC vs. 17% CD) and 25 (5%) reported an unplanned hospital admission (4% UC vs. 8% CD). Eighty-one (16%) participants had required at least one hospital admission in the preceding year, exceeded by 101 (20%) requiring at least one emergency department presentation in the same period. There were high rates of fatigue (53%) and mood disturbance (26%). Eighty-two (16%) felt they needed a treatment change, and 136 (27%) felt their current treatment was not useful for their IBD. Conclusion Outcomes reported by patients illustrate the scale of the therapeutic deficit in current care. The ICHOM Standard Set acts as a benchmark for comparing outcomes between institutions.

Background Tofacitinib is a partially selective Janus kinase inhibitor that was approved for the treatment of refractory moderate to severe ulcerative colitis (UC) in 2018. We report the real-world clinical effectiveness and adverse effects of tofacitinib in UC. Methods We conducted a retrospective observational cohort study of tofacitinib-treated patients with UC between October 2018 to October 2019 from 4 UK centres. Disease activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI) or Partial Mayo Score (PMS) depending on the study site. Response and remission were defined at week 8 and 26 as a reduction in SCCAI or PMS of ≥3, and SCCAI Results We included 140 patients (65% M; median age 37y [range 16–81]) with a median disease duration of 5.5y (IQR 2.2–11.8). Forty-six per cent (65/140) were receiving corticosteroids at baseline and 83% (116/140) had previously received at least one biologic (62 anti-TNF, 4 vedolizumab, 50 both). Median (IQR) serum CRP and faecal calprotectin levels at baseline were 4 mg/l (1.6–15) and 540 µg/g (316–1175). Response and remission rates were 73% (81/111) and 56% (62/111) respectively at week 8 (median ΔSCCAI of −3 [IQR -6 to -1], median ΔPMS −4 [−6 to −1]) and 48% (39/82) and 39% (32/82) respectively at week 26 (median ΔSCCAI −3 [IQR −7 to –1], median ΔPMS −4 [−6 to –1]). Steroid-free remission was seen in 47% (52/111) and 37% (30/82) patients at week 8 and 26. Patients with response or remission had a significantly lower CRP (p = 0.02) but not calprotectin (p = 0.38) levels at baseline. Response and remission rates were no different stratified by prior biologic use (p = 0.56). Treatment was discontinued after a median of 3 months (IQR 2–4) in 43 patients: 32 with primary non-response, 9 loss of response and in 1 each because of an adverse drug reaction (headache) and patient choice. 7/17 patients had a clinical response to dose re-escalation following a loss of response on dose reduction. The median time to dose de-escalation was 67 (IQR 25–240) days. Seven patients were hospitalised and 5 underwent colectomy. Six serious infections were noted including 2 herpes zoster infections but there were no venous thromboembolic events. Median total cholesterol, low-density lipoprotein and high-density lipoprotein increased from 4.4 mmol/l (IQR 3.7–5.2), 2.47 (1.9–2.9) and 1.5 (1.1–1.9) to 4.8 mmol/l (4.1–6.0), 2.8 (2.13.5) and 1.7 (1.4–1.9) respectively after 8 weeks of tofacitinib. Conclusion Clinical effectiveness and side-effect profile of tofacitinib in UC in this multi-centre real-world cohort were similar to that reported in the pivotal OCTAVE clinical trials.

Background & aims The burden of ulcerative colitis (UC) in relation to disease severity is not well documented. This study quantitatively evaluated the relationship between disease activity and quality of life (QoL), as well as health care utilization, cost, and work-related impairment associated with UC in an Australian population. Methods A cross-sectional, noninterventional, observational study was performed in patients with a wide range of disease severity recruited during routine specialist consultations. Evaluations included the Assessment of Quality of Life–8-dimension (AQoL-8D), EuroQol 5-dimension, 5-level (EQ-5D-5L), the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ), and the Work Productivity and Activity Impairment (WPAI) instrument. The 3-item Partial Mayo Score was used to assess disease severity. Health care resource utilization was assessed by chart review and patient questionnaires. Results In 175 patients, mean (SD) AQoL-8D and EQ-5D-5L scores were greater for patients in remission (0.80 [0.19] and 0.81 [0.18], respectively) than for patients with active disease (0.70 [0.20] and 0.72 [0.19], respectively, both P s < 0.001). IBDQ correlated with both AQoL-8D ( r = 0.73; P < 0.0001) and EQ-5D-5L (0.69; P < 0.0001). Mean 3-month UC-related health care cost per patient was AUD $2914 (SD = $3447 [mean for patients in remission = $1970; mild disease = $3736; moderate/severe disease = $4162]). Patients in remission had the least work and activity impairment. Conclusions More severe UC disease was associated with poorer QoL. Substantial health care utilization, costs, and work productivity impairments were found in this sample of patients with UC. Moreover, greater disease activity was associated with greater health care costs and impairment in work productivity and daily activities.