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.

Role of Faecal Microbiota Transplantation for Maintenance of Remission in Patients With Ulcerative Colitis: A Pilot Study

2019 ◽  
Vol 13 (10) ◽  
pp. 1311-1317 ◽  
Author(s):  
Ajit Sood ◽  
Ramit Mahajan ◽  
Arshdeep Singh ◽  
Vandana Midha ◽  
Varun Mehta ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Clinical Remission ◽  
Faecal Microbiota ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Secondary Endpoints ◽  
Maintenance Of Remission ◽  
Histological Remission

Abstract Objectives To study the role of faecal microbiota transplantation [FMT] in maintenance of remission in ulcerative colitis [UC]. Methods In this pilot study, patients with UC in clinical remission achieved after multi-session FMT were randomly allocated to either maintenance FMT or placebo colonoscopic infusion every 8 weeks, for 48 weeks. The standard of care [SOC] therapy was continued in all patients. The primary endpoint was maintenance of steroid-free clinical remission [Mayo score ≤2, all subscores ≤1] at Week 48. Secondary endpoints were achievement of endoscopic remission [endoscopic Mayo score 0] and histological remission [Nancy grade 0, 1] at Week 48. Results In all, 61 patients in clinical remission were randomised to receive either FMT [n = 31] or placebo [n = 30]. The primary outcome was achieved in 27/31 [87.1%] patients allocated FMT versus 20/30 [66.7%] patients assigned placebo [p = 0.111]. Secondary endpoints of endoscopic remission (FMT: 18/31 [58.1%] versus placebo: 8/30 [26.7%], p = 0.026) and histological remission (FMT: 14/31 [45.2%] versus placebo: 5/30 [16.7%], p = 0. 033) were achieved in a significantly higher number of patients with FMT. Three patients receiving FMT [9.7%] and 8 patients on placebo [26.7%] relapsed. There were no serious adverse events necessitating discontinuation in patients on FMT; one patient who relapsed on placebo required colectomy. Conclusions Maintenance FMT in patients who are in clinical remission may help sustain clinical, endoscopic and histological remission in patients with UC.

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 prognostic value of histology in ulcerative colitis in clinical remission with mesalazine

2017 ◽  
Vol 10 (10) ◽  
pp. 749-759 ◽  
Author(s):  
Giuseppe Frieri ◽  
Brigida Galletti ◽  
Mirko Di Ruscio ◽  
Rachele Tittoni ◽  
Annalisa Capannolo ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Logistic Regression Analysis ◽  
Clinical Remission ◽  
Prognostic Value ◽  
Activity Index ◽  
Multivariate Logistic Regression Analysis ◽  
Histological Activity

Background: The aim of the study was to compare the prognostic value of histological and endoscopic activity in patients with ulcerative colitis (UC). Methods: Patients in clinical remission for 1 year under treatment with mesalazine underwent a planned colonoscopy with biopsies. Histological activity was scored using the histological activity index (HAI). Endoscopic activity was scored using the Mayo endoscopic subscore (MES). The clinical course was evaluated measuring relapses needing steroids during a follow up of 3 years. Results: A total of 52 patients were enrolled into the study and followed up for 3 years. At baseline 29 patients (55.77%) had no endoscopic lesions, and 17 patients (32.69%) showed no histological alteration. At 3 years of follow up, overall, 26 patients (50%) were still in steroid-free remission. Using univariate logistic regression analysis, both histological (HAI ⩾ 1) and endoscopic activity (MES ⩾ 1) were significantly associated with outcome, showing, respectively, a relapse risk (odds ratio [OR]) 16.4 times higher than histological remission (HAI 0) (96% confidence interval [CI]: 3.2–84.3) and 6.3 times higher with respect to endoscopic remission (MES 0) (96% CI: 1.9–21.3). After multivariate logistic regression analysis, histological activity was the only factor significantly associated with outcome (OR 10.2; 95% CI: 1.7–59.4). Conclusions: Histological activity has the most powerful prognostic value in predicting the need for steroids in patients with UC in stable clinical remission on mesalazine. It could be considered as a target of therapy in UC.

scholarly journals Histological Remission in Ulcerative Colitis in Deep Remission under Treatment with Adalimumab

2021 ◽  
Vol 30 (1) ◽  
pp. 55-58
Author(s):  
Antonio Tursi ◽  
Rosanna Nenna ◽  
Giovanni Musci ◽  
Walter Elisei ◽  
Marcello Picchio
Keyword(s):  
Ulcerative Colitis ◽  
Biopsy Specimens ◽  
Histological Activity ◽  
Hematoxylin And Eosin ◽  
The Mean ◽  
Histological Remission ◽  
Four Quadrant ◽  
Hematoxylin And Eosin Stain ◽  
First Time

Background and Aims: Histological remission (HR) has been recently demonstrated as the last therapeutic goal in ulcerative colitis (UC), but it is unknown whether and how it may occur. Our aim was to assess the histology during the follow-up of an UC population in deep remission under treatment with adalimumab (ADA). Methods: We performed a retrospective study on 22 UC patients who were in deep remission and followed-up while receiving therapy with ADA. Colonoscopy in those patients was performed every year. Four-quadrant biopsies every 10 cm were obtained during each colonoscopy and assessed by hematoxylin and eosin stain. Histological activity was classified using the Geboes scale. Results: A total of 22 patients were enrolled in the study. The mean follow-up of those patients was 28±7 months, and 2,592 biopsy specimens in total were taken during 108 colonoscopies performed during the follow-up. At the beginning of the follow-up, histological inflammation was found in 15/22 (68.2%) of patients in deep remissio while receiving maintenance ADA therapy, 8/22 (36.4%) of them with Geboes score ≥3.1. At the end of the follow-up, when patients were still in deep remission while receiving maintenance ADA therapy, only 4 patients (18.2%) had at least one biopsy specimen with evidence of any histological inflammation during the follow-up; only two patients (9.1%) had Geboes score ≥3.1. Conclusions: Our study shows for the first time that UC patients in deep remission under ADA may reach HR, but it seems slower than other clinical or endoscopic goals.

Faecal Calprotectin Predicts Endoscopic and Histological Activity in Clinically Quiescent Ulcerative Colitis

2019 ◽  
Vol 14 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Lara Hart ◽  
Mallory Chavannes ◽  
Omar Kherad ◽  
Chelsea Maedler ◽  
Nathalie Mourad ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Clinical Remission ◽  
Roc Analysis ◽  
Surrogate Marker ◽  
Area Under The Curve ◽  
Faecal Calprotectin ◽  
Mayo Score ◽  
Endoscopic Score ◽  
Histological Activity

Abstract Introduction Faecal calprotectin [FC] is a reliable surrogate marker for disease activity in ulcerative colitis [UC]; however, there are no consensus cut-off values for remission. The study aim was to correlate FC with Mayo Endoscopic Score [MES] and histological disease activity of UC patients in clinical remission. Methods Our study recruited adult UC patients at the McGill IBD Center between 2013 and 2017. Patients in clinical remission [partial Mayo score ≤2], undergoing endoscopy for disease activity or dysplasia surveillance, were enrolled. Before bowel preparation, FC was collected. MES was documented during colonoscopy. Biopsies were taken; histological activity was assessed using Geboes score and the presence of basal plasmacytosis. Results A total of 185 patients were recruited. The area under the curve [AUC] in receiver operating characteristic [ROC] analysis to predict MES 1–3 [from 0] was 0.743 [95% CI 0.67–0.82; p <0.001] with an FC cut-off value 170 µg/g [64% sensitivity, 74% specificity], and to predict MES 2–3 [from 0–1] was 0.722 [95% CI 0.61–0.83; p <0.001] with an FC cut-off value 170 µg/g [69% sensitivity, 65% specificity]. To differentiate MES 0 from MES 1, an FC value 130 µg/g yields a 70% sensitivity and 68% specificity. The AUC in ROC analysis to predict Geboes <3.1 was 0.627 [95% CI 0.55–0.71; p = 0.003], with an FC value 135 µg/g [54% sensitivity, 69% specificity]. Conclusions In this large study, FC ≥170 µg/g predicts endoscopic activity and FC ≥135 µg/g predicts histological activity. Therefore in clinical practice, lower faecal calprotectin thresholds can be chosen to optimise identification of patients with ongoing endoscopic and histological disease activity.

Endocytoscopy can be used to assess histological healing in ulcerative colitis

Endoscopy ◽  
2017 ◽  
Vol 49 (06) ◽  
pp. 560-563 ◽  
Author(s):  
Yoshihiro Nakazato ◽  
Makoto Naganuma ◽  
Shinya Sugimoto ◽  
Rieko Bessho ◽  
Mari Arai ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Diagnostic Accuracy ◽  
White Light ◽  
High Accuracy ◽  
Biopsy Specimens ◽  
Endoscopic Remission ◽  
Endoscopic Score ◽  
Histological Remission ◽  
Microscopic Inspection

Abstract Background and study aim Endocytoscopy (ECS) is used in the in vivo microscopic inspection of microstructural mucosal features and enables endoscopists to assess the histological severity of ulcerative colitis (UC). The aim of this study was to assess histological healing in UC patients by using ECS. Patients and methods A total of 64 patients in clinical and endoscopic remission who underwent ECS were selected. The correlation between the ECS score and Geboes score at the rectum was evaluated in patients with a Mayo endoscopic score (MES) of 0. The diagnostic accuracy of the ECS score for histological remission (Geboes score ≤ 2) was also assessed. Results The ECS score ranged from 0 to 5 in patients with endoscopic remission on conventional white-light images (MES of 0). The agreement between histological remission regarding the ECS score and the Geboes score had a κ value of 0.72, and the ECS score showed high accuracy for histological remission, with a sensitivity of 0.77, a specificity of 0.97, and a diagnostic accuracy of 0.86. Conclusion ECS can be used to assess histological healing in patients with UC without the need for biopsy specimens.

scholarly journals Narrow band imaging efficiency in evaluation of mucosal healing/relapse of ulcerative colitis

2018 ◽  
Vol 06 (05) ◽  
pp. E518-E523 ◽  
Author(s):  
Seiko Sasanuma ◽  
Kazuo Ohtsuka ◽  
Shin-ei Kudo ◽  
Noriyuki Ogata ◽  
Yasuharu Maeda ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Blood Vessels ◽  
Narrow Band ◽  
Narrow Band Imaging ◽  
Mucosal Healing ◽  
Current Treatment ◽  
Mayo Score ◽  
Histological Activity ◽  
Histological Remission

Abstract Background and study aims Mucosal healing is a current treatment target in ulcerative colitis (UC), while histological remission is another target. The aim of this study was to evaluate the efficiency of magnified narrow band imaging (NBI) findings of mucosal healing and their relationship with histological activity and prognosis. Patients and methods Patients with UC who underwent total colonoscopy between January 2010 and December 2012 with left-sided or total-colitis type UC and achieved clinical remission with an endoscopic Mayo score of 0 or 1 were included. Each colon section was observed with white light and magnified NBI, with the colonoscopy being repeated at 1-year follow-up. We assessed the relationships of magnified NBI with histological disease activity and prognosis. Magnified NBI findings were divided into three categories; honeycomb-like blood vessels (BV-H), blood vessels shaped like bare branches (BV-BB), and blood vessels shaped like vines (BV-V). Results Fifty-two patients were included. The percentage of remitted mucosa with BV-BB was 37 %, while that of mucosa with scars with BV-H was 35 %. BV-H and BV-BB did not show pathological activity (12/292 and 8/299, respectively), while BV-V showed high pathological activity (27/33, 81 %). There was a correlation between magnified NBI findings and pathological findings (P < 0.01). The odds ratio for inflammation activity at 1-year follow-up was 14.2 for BV-BB (95 % CI, 3.3 – 60.9) Conclusion Magnified NBI findings showed a good relationship with histological activity. This suggests that we could estimate histological activity without biopsy, and also the possibility of predicting relapse over the following year.

scholarly journals ECCO Position Paper: Harmonization of the Approach to Ulcerative Colitis Histopathology

2020 ◽  
Vol 14 (11) ◽  
pp. 1503-1511 ◽  
Author(s):  
Fernando Magro ◽  
Glen Doherty ◽  
Laurent Peyrin-Biroulet ◽  
Magali Svrcek ◽  
Paula Borralho ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Scoring Systems ◽  
Processing Technique ◽  
Histological Changes ◽  
Minimum Requirement ◽  
Histological Activity ◽  
Histological Remission ◽  
Definition Of ◽  
Consensus Expert

Abstract 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.

scholarly journals Increased Mucosal IL-12 Expression is Associated with Relapse of Ulcerative Colitis

2021 ◽  
Author(s):  
Kazuhiko Uchiyama ◽  
Tomohisa Takagi ◽  
Katsura Mizushima ◽  
Mariko Kajiwara-Kubota ◽  
Saori Kashiwagi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Mrna Expression ◽  
Real Time Pcr ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Histological Activity ◽  
Rectal Biopsies ◽  
Relapse Group

Abstract Background: The role of IL-12/23 in the pathogenesis of ulcerative colitis (UC) is unclear. We analyzed mucosal IL-12/23 expression and its relationship with endoscopic severity, histological activity, and UC relapse.Methods: Rectal biopsies were collected from 70 UC patients with clinical remission. IL-12, IL-23, IFN-g, IL-17A, and IL-17F mRNA expression was measured by real-time PCR. Endoscopic severity and histological activity were evaluated using the Mayo endoscopic subscore (MES) and the Geboes score, respectively. Results: The longest follow-up period was 51 months. Thirty-four patients relapsed during the study period. Samples from these subsequently relapsed patients formed the “relapse” group, while those from patients that did not relapse formed the “remission” group. IL-12 (P=0.0003) and IL-23 (P=0.014) mRNA expression was significantly higher in the relapse than the remission group. Expression of IL-23 (P=0.015) but not IL-12 (P=0.374) was correlated with MES. However, in patients with an MES of 0 and 1, IL-12 expression was statistically higher in the relapse than the remission group (P=0.0015, P=0.0342). IL-12 and IL-23 expression did not vary significantly between histologically active and inactive mucosa; both were higher in histologically inactive patients in the remission group (IL-12: P=0.0002, IL-23: P=0.046).Conclusions: Rectal IL-12 and IL-23 expression was elevated in the relapse group, but IL-12 was more strongly associated with UC relapse, irrespective of endoscopic severity and histological activity. Mucosal IL-12 was elevated in patients with deep mucosal healing. Our results suggest an important role of IL-12 in UC pathogenesis and the molecular mechanism of UC relapse.

scholarly journals A15 EFFICACY AND SAFETY OF FILGOTINIB AS INDUCTION THERAPY FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2B/3 SELECTION STUDY

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 18-20
Author(s):  
B G Feagan ◽  
E V Loftus ◽  
S Danese ◽  
S Vermeire ◽  
W J Sandborn ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Active Ulcerative Colitis ◽  
Treatment Groups ◽  
Disease Characteristics ◽  
Serious Infections ◽  
Endoscopic Remission ◽  
Induction Study ◽  
Secondary Endpoints

Abstract Aims The SELECTION (NCT02914522) Induction Studies evaluated the efficacy/safety of filgotinib (FIL), a preferential JAK1 inhibitor, as induction therapy for patients (pts) with moderately to severely active ulcerative colitis (UC) who were biologic-naïve but failed conventional therapy (Induction Study A) or failed prior biologics (Induction Study B). Methods Pts were randomized 2:2:1 to once–daily FIL 200mg, FIL 100mg or placebo (PBO). The primary (clinical remission), key secondary (Mayo Clinic Score [MCS] remission, endoscopic remission, and histologic remission), and exploratory endpoints (MCS response and endoscopic improvement) were assessed at Week 10. Results In both studies, baseline demographics and disease characteristics were similar across treatment groups. In Study A, 659 pts were randomized and treated. Baseline mean MCS was 8.6 and 56% had a Mayo endoscopic subscore (ES)=3. A significantly higher proportion of biologic-naïve pts on FIL 200mg achieved clinical remission vs PBO and all key secondary endpoints (Table). In Study B, 689 pts were randomized and treated. Baseline mean MCS was 9.3 and 78% had ES=3. Prior treatment failures were: anti-TNF (86%), vedolizumab (52%) and both (dual-refractory; 43%). A significantly higher proportion of biologic-experienced pts on FIL 200mg achieved clinical remission vs PBO. In Studies A and B, a greater proportion of pts on FIL 200 mg achieved an MCS response and endoscopic improvement vs PBO. The rates of AEs, serious AEs and discontinuations due to AEs were similar across FIL and PBO groups during induction. In the PBO, FIL 100mg and FIL 200mg groups, serious infections occurred in 0.7%, 0.7% and 0.4% pts in Study A and 1.4%, 1.4% and 0.8% pts in Study B; H Zoster occurred in &lt;1% in both groups for both cohorts. Conclusions SELECTION included a high proportion of dual-refractory pts, and pts with severe endoscopic disease. Both doses of FIL were well tolerated. Filgotinib 200mg was effective induction therapy for both biologic-naïve/-experienced pts with moderately to severely active UC. Funding Agencies None

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