Mo1829 HISTOLOGICAL REMISSION DOSE NOT OFFER ADDITIONAL BENEFIT FOR ULCERATIVE COLITIS PATIENTS IN ENDOSCOPIC REMISSION

2020 ◽  
Vol 158 (6) ◽  
pp. S-940
Author(s):  
abdulaziz s. alshahrani ◽  
mona alsaedi ◽  
Ma'ayan Fadida ◽  
Neeraj Narula ◽  
John K. Marshall ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Additional Benefit ◽  
Endoscopic Remission ◽  
Histological Remission

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.

scholarly journals P628 Histological remission does not offer additional benefit for ulcerative colitis patients in endoscopic remission

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S519-S520
Author(s):  
N Narula ◽  
A A Alshahrani ◽  
M Fadida ◽  
M Al-Saedi ◽  
J K Marshall ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Medical Therapy ◽  
Proportional Hazards Model ◽  
Survival Curve ◽  
Additional Benefit ◽  
Cox Proportional Hazards Model ◽  
Significant Difference ◽  
Endoscopic Remission ◽  
Active Colitis ◽  
Time To Relapse

Abstract Background Histologic remission appears to be associated with positive outcomes in ulcerative colitis (UC) patients. However, it is not clear whether UC patients in endoscopic remission have additional benefit from achieving histologic remission. The objective of the study was to assess the relationship between time to relapse and histological activity among UC patients who are in endoscopic remission. Methods This was a retrospective observational study conducted at McMaster University Medical Centre in Hamilton, ON, Canada and University of Chicago Hospital, Chicago, IL. UC patients from an ongoing observational database who had achieved endoscopic remission (Mayo score 0) were included. Index colonoscopy was the first colonoscopy where Mayo 0 was achieved. These patients were classified based on their histologic activity: normal (no architectural changes or evidence of UC), inactive colitis (architectural changes but absence of acute inflammation), or active colitis (neutrophils in epithelium, crypt destruction, and/or erosions/ulcers). The primary outcome was time to relapse (defined as symptomatic flare with escalation of medical therapy, UC-related hospitalisation, colectomy, or development of colorectal cancer/dysplasia). Secondary outcomes included reasons for relapse and the association between other baseline variables and risk of relapse. A Cox proportional hazards model was used to evaluate the association of baseline factors with the outcome of relapse. Results 269 patients with UC and endoscopic remission were included in this study. According to a Kaplan–Meier survival curve analysis, there was no significant difference based on histologic activity with regards to time to relapse (log-rank p = 0.96)(See Figure). Patients with active colitis on histology did not have a higher relapse rate compared with those with inactive colitis (hazard ratio 1.11, p = 0.77), after adjustment for covariates. Older age, 5-aminosalicylate use, and disease location (both left-sided and pan-colitis) were found to be significantly associated with a lower rate of relapse. Symptomatic flare with an escalation of medical therapy accounted for the majority of relapses (80.4%). Conclusion Histologic remission did not impact time to relapse in UC patients who had achieved endoscopic remission. This suggests against targeting histologic remission in patients who have achieved endoscopic remission.

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.

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.

scholarly journals Deep Learning Algorithm for Diagnose Endoscopic and Histological Images With Ulcerative Colitis

2022 ◽  
Author(s):  
Yan Ye ◽  
Xudong Luo ◽  
Qiong Nan ◽  
Yanhong Liu ◽  
Yinglei Miao ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Learning Algorithm ◽  
Computer Assisted ◽  
Diagnosis System ◽  
Endoscopic Images ◽  
Deep Learning Algorithm ◽  
Endoscopic Remission ◽  
Histological Images ◽  
Assisted Diagnosis ◽  
Histological Remission

Abstract The goal of treatment for ulcerative colitis is to achieve histological and endoscopic remission. Aiming at the problem that the observer will be affected by subjective factors in the endoscopic evaluation of ulcerative colitis and the cumbersome diagnosis process of histological images, this paper aims to develop a computer-assisted diagnosis system for real-time, objective diagnosis of endoscopic images and use the trained CNN model to predict histological images of patients with ulcerative colitis. Diagnosing endoscopic remission of ulcerative colitis, the accuracy of the CNN is 97.04% (95% CI,96.26%:97.62%). Diagnosing the severity of endoscopic inflammation in patients with ulcerative colitis, the accuracy of the CNN is 90.15% (95% CI, 89.49%:90.82%). The accuracy of predicting histological remission was 91.28%. The kappa coefficient between the CNN model and the biopsy results was 82.56%. The proposed computer-aided diagnosis system can effectively evaluate the inflammation of endoscopic images of patients with ulcerative colitis and predict the remission of histological images with high accuracy and consistency.

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 P383 Relationship between histo-endoscopic mucosal healing and baseline characteristics in patients with moderately to severely active Ulcerative Colitis receiving filgotinib in the phase 2b/3 SELECTION study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S395-S396
Author(s):  
L Peyrin-Biroulet ◽  
E V Loftus Jr ◽  
T Hibi ◽  
C Birchwood ◽  
C Yun ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Mucosal Healing ◽  
Active Ulcerative Colitis ◽  
Disease Characteristics ◽  
Endoscopic Remission ◽  
Remission Rates ◽  
Baseline Characteristics ◽  
Histological Remission ◽  
To Receive ◽  
Maintenance Study

Abstract Background Filgotinib (FIL), an oral preferential Janus kinase 1 inhibitor, was evaluated for the treatment of ulcerative colitis in the phase 2b/3 double-blind, placebo (PBO)-controlled SELECTION study (NCT02914522). Clinical, histological and endoscopic remission rates at week 58 were significantly greater with FIL 200 mg than with PBO (p < 0.025 for all comparisons). Here, we identify disease characteristics contributing to histo-endoscopic mucosal healing (HEMH; Geboes histological remission and endoscopic subscore ≤ 1) at week 58. FIL 100 mg data are excluded from by-treatment summaries because histological and endoscopic remission rates were not significantly different from PBO in SELECTION. Methods Eligible patients (18–75 years old) with moderately to severely active ulcerative colitis were enrolled in Induction Study A (biologic-naïve) or B (biologic-experienced) and randomized to receive FIL 200 mg, FIL 100 mg or PBO (2:2:1) once daily for up to 11 weeks, with response assessed at week 10. At week 11, FIL responders were re-randomized 2:1 to continue their induction FIL dose or to receive PBO for the 47-week maintenance study. PBO responders continued receiving PBO. For the maintenance study, univariate logistic regression was used to identify baseline and week 10 disease characteristics associated with HEMH (defined as achieving both Geboes histological remission [Grade 0 of ≤0.3, Grade 1 of ≤ 1.1, Grade 2a of ≤ 2A.3, Grade 2b of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0] and an endoscopic subscore of 0 or 1) at week 58 for patients receiving FIL 200 mg; variables with p < 0.05 in the univariate analysis were included in a multivariate analysis. Results Patients had similar characteristics across the treatment groups for both the induction (Table 1) and maintenance studies (Table 2). HEMH was achieved in a greater proportion of patients receiving FIL 200 mg than those receiving respective PBO at week 58 (32.7% vs 10.2%; p < 0.0001). No associations between disease characteristics (at baseline and week 11) and HEMH at week 58 were found (Table 3). Conclusion FIL 200 mg was effective at establishing HEMH compared with PBO at week 58; there were no baseline characteristics identified to be associated with HEMH at week 58.

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