scholarly journals Treatment Targets in Ulcerative Colitis: Is It Time for All In, including Histology?

2021 ◽  
Vol 10 (23) ◽  
pp. 5551
Author(s):  
Panu Wetwittayakhlang ◽  
Livia Lontai ◽  
Lorant Gonczi ◽  
Petra A. Golovics ◽  
Gustavo Drügg Hahn ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Current Evidence ◽  
Treat To Target ◽  
Therapeutic Goal ◽  
Treatment Targets ◽  
Patient Reported ◽  
Clinical Biomarker ◽  
Endoscopic Score ◽  
Histological Remission

The main therapeutic goal of ulcerative colitis (UC) is to induce and maintain remission to prevent long-term disease progression. Treat-to-target strategies, first introduced by the STRIDE consensus and updated in 2021, have shifted focus from symptomatic control toward more stringent objective endpoints. Today, patient monitoring should be based on a combination of biomarkers and clinical scores, while patient-reported outcomes could be used as short-term targets in monitoring disease activity and therapeutic response. In addition, endoscopic healing was the preferred long-term goal in UC. A Mayo endoscopic score (MES) ≤ 1 can be recommended as a minimum target. However, recent evidence suggests that more stringent endoscopic goals (MES of 0) are associated with superior outcomes. Recently, emerging data support that histological remission (HR) is a superior prognostic factor to endoscopic healing in predicting long-term remission. Despite not yet being recommended as a target, HR may become an important potential therapeutic goal in UC. However, it remains questionable if histological healing should be used as a routine assessment in addition to clinical, biomarker, and endoscopic targets in all patients. Therefore, in this review, our aim was to discuss the current evidence for the different treatment targets and their value in everyday clinical practice.

‘Treat to Target’ in Mild to Moderate Ulcerative Colitis: Evidence to Support this Strategy

2020 ◽  
Vol 22 (1) ◽  
pp. 117-125
Author(s):  
Arianna Dal Buono ◽  
Giulia Roda ◽  
Marjorie Argollo ◽  
Kristine Paridaens ◽  
Laurent PeyrinBiroulet ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Practice ◽  
Mucosal Healing ◽  
Current Evidence ◽  
Treat To Target ◽  
Pubmed Search ◽  
Objective Outcomes ◽  
Histological Remission ◽  
Approved Drugs

Background: The management of chronic conditions, above all rheumatic disease and diabetes has adopted a "treat to target" strategy where treatment aims to achieve objective outcomes; this has emerged as applicable in ulcerative colitis (UC) as well. Targets are demonstrated to prevent end-organ disfunction, specifically bowel damage and its complications, lastly colorectal cancer. Recently, the scientific community has tried to define further targets beyond those currently recommended, namely mucosal healing and clinical remission. Studies that prospectively investigated this approach in UC are scanty and a treat-to-target (T2T) algorithm is not routinely inserted in daily clinical practice. Objective: We aim to review current evidence on T2T in UC and to discuss its adoption in routine clinical practice as well as in clinical trials. Methods: A PubMed search was conducted in February 2020 to identify published papers investigating targets’ achievement rates in UC. Results: Different targets can be achieved through approved drugs for mild to moderate UC; histological remission is emerging as a robust target with respect to long-term outcomes. Conclusion: Further studies to compare a T2T strategy to the traditional care are needed, particularly in the mild to moderate spectrum of disease.

scholarly journals OP09 Patient reported outcomes reflect histologic disease activity in patients with Ulcerative Colitis: Interim analysis of the APOLLO study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S008-S009
Author(s):  
B Verstockt ◽  
C Jorissen ◽  
E Hoefkens ◽  
N Lembrechts ◽  
L Pouillon ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Remission Rate ◽  
Stool Frequency ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
Histological Remission ◽  
General Wellbeing

Abstract Background Treating beyond endoscopic remission, aiming for histological remission, has shown to reduce relapse and hospitalization rates in patients with ulcerative colitis (UC). However, very little is known on how histological remission associates with patient reported outcomes (PROMs). Methods PROMs (Simple clinical colitis activity index [SCCAI], IBD disk and Visual Analogue Scales [VAS]) were prospectively collected through a digital questionnaire in all patients with UC undergoing colonoscopy between July 21st 2020-Jan 21st 2021. Mayo endoscopic sub score and UCEIS were determined, as well as the Nancy histologic index (NHI) of the most affected area. Endoscopic remission was defined as Mayo endoscopic sub score 0 and UCEIS 0; histologic remission as NHI 0, absence of active inflammation as NHI ≤ 1. PRO2 remission was defined as stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1–2 stools more than usual) and rectal bleeding score of 0. Results Fifty-six paired assessments were collected in 48 unique patients (Table 1), with a histologic, endoscopic and PRO-2 remission rate of 23.2%, 28.6% and 38.2% respectively. Patients with histologic remission or absence of histologic inflammation had a significantly lower overall IBD disability (p=0.007, p=0.003) and disease activity score (p=0.003, p<0.001), as compared to patients without. In line, NHI correlated with the overall IBD disk (r=0.40, p=0.002) and SCCAI score (r=0.50, p<0.001). Many individual components of both scores (abdominal pain, arthralgia, impact on education and work/interpersonal interactions/sexual function, regulation of defecation, blood loss, general wellbeing, joint pain, numbers of stools during night/day, urgency) differed significantly between patients with and without histologic remission. VAS scores assessing general wellbeing (r=0.33, p=0.01), impact on daily activities (r=0.41, p=0.002), UC-related symptoms (r=0.42, p=0.001) and worries (r=0.40, p=0.002) correlated with histology. Quartile analysis of the overall IBD disk and SCCAI scores confirmed the highest likelihood for histologic remission in patients with the lowest scores (Q1-Q2 vs Q3-Q4 39.3% vs 7.1%, p=0.01; 40.0% vs 9.7%, p=0.01) (Figure 1). Nevertheless, the overall accuracy of the IBD disk (0.75) or SCCAI score (0.76) for histologic remission is lower (p<0.05) than the accuracy of the Mayo endoscopic (0.90) or UCEIS (0.90) score. Table 1: Baseline features Abstract OP09 – Figure 1: Quartile analysis Conclusion In patients with UC, PROMs for disability and clinical disease activity reflect histologic disease activity and should therefore be further explored in (trial) endpoint discussions. However, they cannot fully replace endoscopic and histologic findings, and should be considered complementary.

scholarly journals P545 Calprotectin at week 12 is a predictor for histological remission in ulcerative colitis patients treated with Vedolizumab

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S515-S516
Author(s):  
D Rubstov ◽  
P Kakkadasam Ramaswamy ◽  
J Edwards ◽  
D Shukla ◽  
L Willmann ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Real World Setting ◽  
Endoscopic Remission ◽  
Endoscopic Score ◽  
Histological Activity ◽  
Maintenance Of Remission ◽  
Histological Remission ◽  
Endoscopic Assessment

Abstract Background Vedolizumab (VDZ) is a gut-specific α4β7 integrin antagonist that has demonstrated efficacy for induction and maintenance of remission in moderate to severe ulcerative colitis (UC). The aim of this study was to assess the rates of histological remission (HR) in a real-world setting and to identify predictors for histological remission. Methods Retrospective cohort study of all UC patients (≥18 years) initiated on VDZ from 2016 to 2020 was completed. Clinical, biochemical, endoscopic and histologic data were collected. All patients received standard induction therapy with VDZ 300 mg IV at Weeks 0, 2, and 6 and maintained on an 8-weekly regimen. Dose was escalated to a every 4-weekly regimen as per physician’s discretion. A 52-week follow-up was completed on all patients. Endoscopic assessment was carried out between 24 and 52 weeks after commencing VDZ. Histological activity was graded as per Nancy index and histological remission was defined as Nancy grade 0. Endoscopic remission was defined as Mayo endoscopic score = 0. Clinical remission was defined as SCCAI ≤ 5. Results A total of 51 patients [55% female, median age 48 years (IQR 35–60)] were included. 16/51 (34%) were anti-TNF exposed. In 30/51 (59%) patients VDZ was combined with steroids at induction and by week 12 steroids were completely tapered in 14/30 (46.7%) patients. At weeks 12, 24 and 52, 89.6%, 87% and 97.5% of patients, respectively, were in clinical remission. 19/37 (51.3%) patients were in endoscopic remission at end of follow up. Median Nancy score prior to commencing VDZ was 3 (IQR: 2–4) and the median Nancy score at end of follow up was 1 (IQR: 0–2). 19/37 (51.3%) patients achieved HR; 3 patients who were in HR at the time of commencement of VDZ remained in HR at the end of follow up. Median baseline faeces calprotectin (FC) was 320 mcg/g (IQR 45–1000) and was similar in patients who achieved HR and those who did not. Median FC at 12 weeks was 155 mcg/g (45–720) and was significantly lower in patients who achieved HR when compared to patients who did not achieve histological remission (45 vs 420, p 0.028). FC at week 12 predicted histological remission (AUC =0.8667). FC ≥ 200mcg/g at week 12 predicted failure to achieve HR with sensitivity 70%, specificity 100%, PPV 100%, NPV 75%, accuracy 84%. Conclusion Vedolizumab is effective in achieving histological remission and FC ≥ 200 mcg/g at week 12 accurately predicts failure to achieve HR in patients treated with VDZ.

Interactive remote patient monitoring devices for managing chronic health conditions: systematic review and meta-analysis (Preprint)

2021 ◽  
Author(s):  
Donato Giuseppe Leo ◽  
Benjamin J.R. Buckley ◽  
Mahin Chowdhury ◽  
Stephanie L. Harrison ◽  
Masoud Isanejad ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Usual Care ◽  
Current Evidence ◽  
Long Term Conditions ◽  
Increased Risk ◽  
Patient Reported ◽  
Meta Analyses

BACKGROUND Telemedicine is an expanding and feasible approach to improve medical care for patients with long-term conditions. However, there is a poor understanding of patients’ acceptability of this intervention and their rate of uptake. OBJECTIVE To systematically review the current evidence on telehealth in the management of patients with long-term conditions, and to evaluate the patients’ uptake and acceptability of this technology. METHODS MEDLINE, SCOPUS, and CENTRAL were searched from date of inception to 5 February 2021, with no language restrictions. Studies were eligible for inclusion if they reported any of the following outcomes: (i) intervention uptake and adherence; (ii) study retention; (iii) patient acceptability, satisfaction and experience using intervention: (iv) changes in physiological values; (v) all-cause and cardiovascular related hospitalization; (vi) all-cause and disease specific mortality; (vii) patient-reported outcome measures; (viii) quality of life. Two reviewers independently assessed articles for eligibility. This systematic review was registered on PROSPERO (CRD42021236291). RESULTS Ninety-six studies were included and fifty-eight were pooled for meta-analyses. Meta-analyses showed reduction in mortality (RR= 0.71, 95% CI 0.56 to 0.89, P=0.003, I2=0%); and improvements in BP (MD -3.85 mmHg, 95% CI -7.03 to -0.68, P<.02, I2= 100%) and HbA1c (MD -0.33, 95% CI -0.57 to -0.09, P=.008, I2= 99%); but no significant improvements in quality of life (MD 1.45, 95% CI -0.10 to 3, P=.07, I2=80%); and increased risk of hospitalization (RR 1.02, 95% CI 0.85 to 1.23, P=.81, I2=79%) with telehealth compared to usual care. CONCLUSIONS Telehealth is a valid alternative to usual care, reducing mortality and improving self-management of the disease, with patients reporting good satisfaction and adherence. Further studies are required to address some potential concerns regarding higher hospitalisation rates and a lack of a positive impact on patients’ quality of life.

Fecal Calprotectin Thresholds to Predict Endoscopic Remission Using Advanced Optical Enhancement Techniques and Histological Remission in IBD Patients

2020 ◽  
Author(s):  
Rosanna Cannatelli ◽  
Alina Bazarova ◽  
Davide Zardo ◽  
Olga Maria Nardone ◽  
Uday Shivaji ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Surrogate Marker ◽  
Fecal Calprotectin ◽  
Cross Sectional Study ◽  
Mucosal Healing ◽  
Cross Sectional ◽  
Endoscopic Techniques ◽  
Endoscopic Remission ◽  
Endoscopic Score ◽  
Histological Remission

Abstract Background Fecal calprotectin (FC) is a common surrogate marker of mucosal healing (MH) in patients with ulcerative colitis (UC) and Crohn’s disease (CD). We investigated the optimum FC thresholds for defining endoscopic remission (ER) and histological remission (HR) using advanced endoscopic techniques. Patients and Methods In this cross-sectional study, we collected clinical, endoscopic, histological data, and FC from 76 UC and 41 CD patients. Receiver operating characteristic curves were created to evaluate the optimum cut-off of FC to predict ER evaluated by Mayo Endoscopic Score (MES), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and modified PICaSSO (Paddington International Virtual Chromoendoscopy Score) for UC patients and Simple Endoscopic Score (SES-CD) in CD patients; and HR was scored by the Robarts Histology Index (RHI) and Nancy Index for UC and modified Riley for CD. Results In UC patients, the best thresholds of FC to identify ER calculated with MES, UCEIS, and modified PICaSSO were 112, 148, and 161 mcg/g with accuracy of 86.9% 86.8%, and 81.6%, respectively. The best value of FC to predict HR was 112 mcg/g and 172 mcg/g with accuracy of 84.2% and 81.6% for RHI and Nancy Index, respectively. In CD patients, the best cut-off of FC to predict ER was 96 mcg/g with accuracy of 82.9%. The HR was best predicted by an FC value of 225 mcg/g with accuracy of 75.6%. Conclusions The FC value threshold between 112 and 172 mcg/g could identify ER and HR in UC patients, whereas a value under 225 mcg/g should be considered for CD patients.

scholarly journals The Ulcerative Colitis Endoscopic Index of Severity More Accurately Reflects Clinical Outcomes and Long-term Prognosis than the Mayo Endoscopic Score

2015 ◽  
Vol 10 (3) ◽  
pp. 286-295 ◽  
Author(s):  
Kentaro Ikeya ◽  
Hiroyuki Hanai ◽  
Ken Sugimoto ◽  
Satoshi Osawa ◽  
Shinsuke Kawasaki ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcomes ◽  
Endoscopic Score ◽  
Index Of Severity ◽  
Long Term Prognosis

scholarly journals Ultra-high Magnification Endocytoscopy and Molecular Markers for Defining Endoscopic and Histologic Remission in Ulcerative Colitis—An Exploratory Study to Define Deep Remission

2021 ◽  
Author(s):  
Marietta Iacucci ◽  
Louisa Jeffery ◽  
Animesh Acharjee ◽  
Olga Maria Nardone ◽  
Davide Zardo ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Molecular Markers ◽  
Partial Least Square ◽  
Least Square ◽  
High Magnification ◽  
Gene Expressions ◽  
Endoscopic Score ◽  
Histological Remission ◽  
Cell Adhesion Molecule 1 ◽  
Culture Supernatants

Abstract Background Endoscopic and histological remission are both important treatment goals in patients with ulcerative colitis (UC). We aimed to define cellular architecture, expression of molecular markers, and their correlation with endoscopic scores assessed by ultra-high magnification endocytoscopy (ECS) and histological scores. Methods Patients with UC (n = 29) were prospectively recruited. The correlation among ECS score (ECSS), Mayo endoscopic score (MES), and histological scores were determined. Area under curve were plotted to determine the best thresholds for ECSS that predicted histological remission by Robarts (RHI) and Nancy Histological Index (NHI). Soluble analytes relevant to inflammation were measured in serum and mucosal culture supernatants using ProcartaPlex Luminex assays and studied by partial least square discriminant analysis and logistic model. Mucosal RNA sequencing and bioinformatics analysis were performed to define differentially expressed genes/pathways. Results Endocytoscope scoring system correlated strongly with RHI (r = 0.89; 95% CI, 0.51–0.98) and NHI (r = 0.86; 95% CI, 0.42–0.98) but correlated poorly with MES (r = 0.28; 95% CI, 0.27–0.70). We identified soluble brain-derived neurotrophic factors (BDNF), macrophage inflammatory proteins (MIP-1 α) and soluble vascular cell adhesion molecule 1 (sVCAM-1) predicted histological remission. Mucosal biopsy cultures also identified sVCAM-1 associated with healed mucosa. RNA-seq analysis identified gene expressions shared between ECSS, RHI, or NHI defined healing. A number of gene expressions and pathways were identified including inflammation and metabolic and tumor suppressors that discriminated healed from nonhealed mucosa. Conclusions Endocytoscopy represents an interesting tool that may sit between endoscopy and histology—but closer to the latter—identifying gene expression markers and pathways that are also identified by histology.

scholarly journals Long-term patient-reported outcome measures after injury: National Trauma Research Action Plan (NTRAP) scoping review protocol

2020 ◽  
Vol 5 (1) ◽  
pp. e000512
Author(s):  
Juan Pablo Herrera-Escobar ◽  
Manuel A Castillo-Angeles ◽  
Samia Y Osman ◽  
Claudia P Orlas ◽  
Mahin B Janjua ◽  
...  
Keyword(s):  
Scoping Review ◽  
Patient Reported Outcomes ◽  
Action Plan ◽  
Current Evidence ◽  
Trauma Research ◽  
National Trauma ◽  
Patient Reported ◽  
Research Action ◽  
Outcome Metrics

BackgroundA significant proportion of patients who survive traumatic injury continue to suffer impaired functional status and increased mortality long after discharge. However, despite the need to improve long-term outcomes, trauma registries in the USA do not collect data on outcomes or care processes after discharge. One of the main barriers is the lack of consensus regarding the optimal outcome metrics.ObjectivesTo describe the methodology of a scoping review evaluating current evidence on the available measures for tracking functional and patient-reported outcomes after injury. The aim of the review was to identify and summarize measures that are being used to track long-term functional recovery and patient-reported outcomes among adults after injury.MethodsA systematic search of PubMed and Embase will be performed using the search terms for the population (adult trauma patients), type of outcomes (long-term physical, mental, cognitive, and quality of life), and measures available to track them. Studies identified will be reviewed and assessed for relevance by at least two reviewers. Data will be extracted and summarized using descriptive statistics and a narrative synthesis of the results. This protocol is being reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines.DisseminationThis scoping review will provide information regarding the currently available metrics for tracking functional and patient-reported outcomes after injury. The review will be presented to a multi-disciplinary stakeholder group that will evaluate these outcome metrics using an online Delphi approach to achieve consensus as part of the development of the National Trauma Research Action Plan (NTRAP). The results of this review will be presented at relevant national surgical conferences and published in peer-reviewed scientific journals.

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