Endoscopic and Histological Assessment, Correlation, and Relapse in Clinically Quiescent Ulcerative Colitis (MARQUEE)

2020 ◽  
Author(s):  
Mark T Osterman ◽  
Frank I Scott ◽  
Franz F Fogt ◽  
Erin D Gilroy ◽  
Susan Parrott ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Clinical Remission ◽  
Clinical Relapse ◽  
High Prevalence ◽  
Histological Indices ◽  
Index Of Severity ◽  
Multicenter Prospective Study ◽  
Multicenter Prospective Cohort Study ◽  
Research Alliance

Abstract Objective It is difficult to predict relapse in quiescent ulcerative colitis (UC), but newer endoscopic and histological indices could improve this. This study aimed to determine in UC patients in clinical remission (1) the prevalence of active endoscopic and histological disease; (2) the correlation between endoscopic and histological scores; and (3) the predictive power of these scores for clinical relapse. Design This multicenter prospective cohort study conducted by the Crohn’s and Colitis Foundation Clinical Research Alliance included 100 adults with UC in clinical remission undergoing surveillance colonoscopy for dysplasia. Endoscopic activity was assessed using the Mayo endoscopic score (MES), ulcerative colitis endoscopic index of severity (UCEIS), and ulcerative colitis colonoscopic index of severity (UCCIS). Histology was assessed with the Riley index subcomponents, total Riley score, and basal plasmacytosis. Results Only 5% of patients had an MES of 0, whereas 38% had a score of 2 to 3; using the UCEIS, the majority of patients had at least mild activity, and 15% had more severe activity. Many patients also had evidence of histological disease activity. The correlations among endoscopic indices, histological subcomponents, and total score were low; the highest correlations occurred with the subcomponent architectural irregularity (ρ = 0.43–0.44), total Riley score (ρ = 0.35–0.37), and basal plasmacytosis (ρ = 0.35–0.36). Nineteen patients relapsed clinically over 1 year, with the subcomponent architectural irregularity being the most predictive factor (P = 0.0076). Conclusions This multicenter prospective study found a high prevalence of both endoscopic and histological disease activity in clinically quiescent UC. The correlations between endoscopy and histology were low, and the power to predict clinical relapse was moderate.

scholarly journals Further research on the clinical relevance of the ulcerative colitis colonoscopic index of severity for predicting 5-year relapse

2021 ◽  
Author(s):  
Natsuki Ishida ◽  
Shunya Onoue ◽  
Takahiro Miyazu ◽  
Satoshi Tamura ◽  
Shinya Tani ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Colonic Mucosa ◽  
Rank Test ◽  
Clinical Relapse ◽  
Characteristic Analysis ◽  
Log Rank Test ◽  
Index Of Severity ◽  
Time To Relapse ◽  
Free Rate

Abstract Purpose The ulcerative colitis colonoscopic index of severity (UCCIS) evaluates the state of the entire colonic mucosa in ulcerative colitis. However, no cut-off values of scores for predicting clinical relapse in patients with ulcerative colitis have been established. This study aimed to determine the cut-off values for predicting clinical relapse in patients with ulcerative colitis. Methods The endoscopic scores (sum of Mayo endoscopic subscores (S-MES) and UCCIS) of 157 patients with ulcerative colitis experiencing clinical remission and their subsequent clinical course were retrospectively reviewed. The optimal cut-off values for predicting relapse and relapse-free rates were analyzed by receiver operating characteristic analysis. Results Forty patients with ulcerative colitis experienced relapse within 24 months. The median UCCIS for these patients at the time of study enrollment was significantly higher than that for patients with clinical remission (P < 0.001). The cut-off value of the UCCIS for predicting relapse was 9.8. The relapse-free rate was significantly lower in patients with UCCIS ≥ 9.8 than in those with UCCIS < 9.8 (log-rank test P < 0.001). For patients who experienced relapse within 5 years, the optimal cut-off values for the UCCIS and S-MES were 10.2 and 1, respectively (P = 0.004). Conclusions The data from this study indicate that the USSIC is a more relevant score than the S-MES for predicting the time to relapse in patients with ulcerative colitis in remission.

scholarly journals P233 Evaluating the association between faecal calprotectin and endoscopic outcomes in ulcerative colitis using the HICKORY open-label induction cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S259-S259
Author(s):  
W Reinisch ◽  
B El Azzouzi ◽  
R Li ◽  
S Lacey ◽  
M Daperno ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Disease Activity ◽  
Clinical Remission ◽  
Area Under The Curve ◽  
Percentage Change ◽  
Open Label ◽  
Faecal Calprotectin ◽  
Using Data ◽  
Factor Α

Abstract Background In clinical practice, faecal calprotectin (FC) is used to monitor disease activity in ulcerative colitis (UC); however, there is no consensus on optimal cut-off values of FC for predicting endoscopic outcomes. FC performance has not been extensively assessed in the context of clinical trials using central endoscopy. This study aimed to evaluate the association between FC and endoscopic disease activity and to propose a meaningful cut-off FC value to predict endoscopic outcomes using data from the open-label induction (OLI) cohort of HICKORY (NCT02100696). Methods HICKORY is a Phase 3 study evaluating etrolizumab in anti-tumour necrosis factor α-experienced patients with moderate-to-severe UC. The study included patients who received ≥1 dose of etrolizumab 105 mg subcutaneously every 4 weeks during a 14-week induction period. Percentage change in FC was calculated at week 14. The endoscopic activity was measured by Mayo Clinic score (MCS) endoscopic subscore (ES) using a robust central-reading model. Endoscopic improvement was defined as ES=0/1; clinical remission as MCS ≤2 and no individual subscore &gt;1. FC analysis was performed by Covance® (Bühlman FC ELISA assay). Receiver operator characteristic (ROC) curve analyses were used to calculate cut-off FC values. Results A total of 97 patients (mean age [standard deviation], 41.2 ± 13.4 years) were included in the analysis. Median (interquartile range [IQR]) baseline duration of disease was 6.3 (3.2–12.3) years with a median (IQR) MCS of 9 (8–10). Median (IQR) baseline FC and ES were 254 (156–455) µg/g and 3 (3-3). At week 14, median (IQR) FC percentage change was −13 (−57 to 112). A numerical association between changes in FC level and ES was observed (Table). A cut-off FC value of 159 µg/g was observed to predict endoscopic improvement with &gt;70% sensitivity and specificity; ROC area under the curve was 0.78 (Figure). Similar results were observed for clinical remission. Conclusion In this exploratory analysis using HICKORY OLI cohort data, changes in FC appear to associate with changes in ES. A cut-off FC value of 159 µg/g predicted endoscopic improvement. In UC, FC may be a useful non-invasive biomarker for ascertaining endoscopic disease activity in clinical trials; however, further clinical studies validating FC cut-offs against centrally read endoscopy are needed.

scholarly journals Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density

Gut ◽  
2020 ◽  
Vol 69 (10) ◽  
pp. 1778-1786 ◽  
Author(s):  
Peter Bossuyt ◽  
Hiroshi Nakase ◽  
Séverine Vermeire ◽  
Gert de Hertogh ◽  
Tom Eelbode ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Objective Evaluation ◽  
Second Phase ◽  
Endoscopic Images ◽  
Severity Scores ◽  
Computer Based ◽  
Index Of Severity ◽  
Using Data ◽  
Histological Factors

BackgroundThe objective evaluation of endoscopic disease activity is key in ulcerative colitis (UC). A composite of endoscopic and histological factors is the goal in UC treatment. We aimed to develop an operator-independent computer-based tool to determine UC activity based on endoscopic images.MethodsFirst, we built a computer algorithm using data from 29 consecutive patients with UC and 6 healthy controls (construction cohort). The algorithm (red density: RD) was based on the red channel of the red-green-blue pixel values and pattern recognition from endoscopic images. The algorithm was refined in sequential steps to optimise correlation with endoscopic and histological disease activity. In a second phase, the operating properties were tested in patients with UC flares requiring treatment escalation. To validate the algorithm, we tested the correlation between RD score and clinical, endoscopic and histological features in a validation cohort.ResultsWe constructed the algorithm based on the integration of pixel colour data from the redness colour map along with vascular pattern detection. These data were linked with Robarts histological index (RHI) in a multiple regression analysis. In the construction cohort, RD correlated with RHI (r=0.74, p<0.0001), Mayo endoscopic subscores (r=0.76, p<0.0001) and UC Endoscopic Index of Severity scores (r=0.74, p<0.0001). The RD sensitivity to change had a standardised effect size of 1.16. In the validation set, RD correlated with RHI (r=0.65, p=0.00002).ConclusionsRD provides an objective computer-based score that accurately assesses disease activity in UC. In a validation study, RD correlated with endoscopic and histological disease activity.

scholarly journals Intestinal ultrasound for monitoring therapeutic response in patients with ulcerative colitis: results from the TRUST&UC study

Gut ◽  
2019 ◽  
Vol 69 (9) ◽  
pp. 1629-1636 ◽  
Author(s):  
Christian Maaser ◽  
Frauke Petersen ◽  
Ulf Helwig ◽  
Imma Fischer ◽  
Alexander Roessler ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Sigmoid Colon ◽  
Therapeutic Response ◽  
Bowel Wall ◽  
Activity Index ◽  
Point Of Care ◽  
Clinical Relapse ◽  
Short Term Treatment ◽  
Descending Colon

ObjectiveProspective evaluation of intestinal ultrasound (IUS) for disease monitoring of patients with ulcerative colitis (UC) in routine medical practice.DesignTRansabdominal Ultrasonography of the bowel in Subjects with IBD To monitor disease activity with UC (TRUST&UC) was a prospective, observational study at 42 German inflammatory bowel disease-specialised centres representing different care levels. Patients with a diagnosis of a proctosigmoiditis, left-sided colitis or pancolitis currently in clinical relapse (defined as Short Clinical Colitis Activity Index ≥5) were enrolled consecutively. Disease activity and vascularisation within the affected bowel wall areas were assessed by duplex/Colour Doppler ultrasonography.ResultsAt baseline, 88.5% (n=224) of the patients had an increased bowel wall thickness (BWT) in the descending or sigmoid colon. Even within the first 2 weeks of the study, the percentage of patients with an increased BWT in the sigmoid or descending colon decreased significantly (sigmoid colon 89.3%–38.6%; descending colon 83.0%–42.9%; p<0.001 each) and remained low at week 6 and 12 (sigmoid colon 35.4% and 32.0%; descending colon 43.4% and 37.6%; p<0.001 each). Normalisation of BWT and clinical response after 12 weeks of treatment showed a high correlation (90.5% of patients with normalised BWT had symptomatic response vs 9.5% without symptomatic response; p<0.001).ConclusionsIUS may be preferred in general practice in a point-of-care setting for monitoring the disease course and for assessing short-term treatment response. Our findings give rise to the assumption that monitoring BWT alone has the potential to predict the therapeutic response, which has to be verified in future studies.

scholarly journals P807 UCEIS is associated with PRO2, partial Mayo and SCCAI remission in UC: preliminary results from a prospective study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S631-S631
Author(s):  
P A Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
W Afif ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Roc Analysis ◽  
Clinical Decision Making ◽  
Activity Index ◽  
Operating Characteristics ◽  
Faecal Calprotectin ◽  
Patient Reported ◽  
Index Of Severity ◽  
Active Disease

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine the operating characteristics of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), to quantify the cut off most closely correlated with clinical remission or activity and determine agreement with the Mayo endoscopic subscore (MES), Baron score, clinical scores and biomarkers. Methods 136 patients were included prospectively (age: 48 (IQR38-61) years, duration 12 (4–19)years, 63 females, 53.7% extensive disease, 40.4% on biologicals) at the time of the colonoscopy. Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Mayo endoscopic subscore (MES), Baron scores were calculated, as well as the2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI). CRP and faecal calprotectin (FCAL) was available in 58.1 and 33.8% of patients. 20.7% had clinical flare, treatment was escalated in 17.8% of patients. ROC analysis and K-statistics were performed and Spearman’s correlation was calculated. Results UCEIS was strongly associated to PRO2 SF (AUC:0.866), RBS (AUC:0.921), PRO2 combined remission (AUC:0.905), partial MAYO (AUC:0.956) and SCCAI (AUC:0.907) remission in a ROC analysis. A UCEIS of ≤3 was identified as the best cut-off to identify RBS subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission, while a UCEIS≥4 identified active disease frequently needing change in medical therapy. A moderate agreement was found between UCEIS and MES (K=0.451) or Baron (K=0.499) scores. Correlation between FCAL and UCEIS (coeff:0.743, p &lt; 0.0001) was strong, while modest only with CRP (coeff:0.333, p = 0.01). Conclusion A UCEIS was strongly associated with clinical remission defined as PRO2, SF, RBS, partial Mayo or SCCAI with best agreement with RBS and partial Mayo remission. A UCEIS of ≤3 was identified as a cut-off for quiescent disease, while a UCEIS≥4 identified active disease, which can support clinical decision-making based on endoscopic findings. Agreement between UCEIS and FCAL was strong, while agreement with UCEIS and MES/Baron scores was moderate.

scholarly journals P696 The usefulness to treatment enhancement for the patients of ulcerative colitis with clinical remission diagnosed as Mayo endoscopic subscore 1

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S564-S564
Author(s):  
M Kubota Kajiwara ◽  
K Uchiyama ◽  
Y Azuma ◽  
R Yasuda ◽  
S Takayama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Treatment Group ◽  
Clinical Remission ◽  
Clinical Symptoms ◽  
Mucosal Healing ◽  
Endoscopic Examination ◽  
Clinical Relapse ◽  
Oral Medicine ◽  
Clinical Background ◽  
Observation Period

Abstract Background In many clinical trials of ulcerative colitis (UC), Mayo endoscopic subscore (MES) has been used to diagnose mucosal healing to evaluate the effectiveness of various treatment. Although both MES 0 and MES 1 were defined as the endoscopic mucosal healing, several studies reported that the risk of clinical relapse was significantly higher in the patients diagnosed as MES 1 compared with MES 0. However, it has not been established the beneficial effect to escalate the treatment for the patients diagnosed as MES 1 to avoid clinical relapse. In the present study, we retrospectively investigated the effectiveness about the escalation of treatment for UC patients with clinical remission diagnosed as MES 1. Methods A total of 68 patients with UC diagnosed as clinical remission (4 and under of Lichtiger CAI score) between April 2014 to October 2019 were enrolled in this study. All patients were endoscopically diagnosed as MES 1 and observation period was 12 months from the time of endoscopy. Relapse of UC was defined as the need for more aggressive treatment for UC due to aggravation of clinical symptoms or endoscopic findings. The relapse ratio was compared between the patients who continued the same treatment and the patients who had enhanced treatment. Enhanced treatment was defined as additional oral medicine or local preparations including enemas, suppositories, and foams within 3 months from endoscopic examination. Results In 68 patients, 12 patients were received enhanced treatment and 56 patients were continued the same treatments. There were no significant differences in clinical background between the two groups such as mean age (enhanced treatment group vs. same treatment group: 47.9 years vs. 42.9 years), disease type, disease duration (110.3 months vs. 94.8 months), and disease activity (Lichtiger CAI score: 2.5 vs. 2.8). The group of the enhanced treatment included 8 patients with oral 5-aminosalicylates escalation and 4 patients with additional local preparations. The relapse ratio was higher in patients with same treatment group (0%) compared with enhanced treatment group (14.3%). Conclusion Our results indicate that the enhancement of the treatment for UC patients with clinical remission diagnosed as MES 1 is effective to avoid relapse.

scholarly journals P225 Using a standardised reporting proforma is associated with improved endoscopic assessment in UC

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S255-S255
Author(s):  
R KADER ◽  
P Middleton ◽  
O Ahmad ◽  
R Dart ◽  
J McGuire ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Site Factors ◽  
Multi Centre Study ◽  
Gi Endoscopy ◽  
Mayo Score ◽  
Chi Squared ◽  
Index Of Severity ◽  
Level Of Training ◽  
Endoscopic Assessment

Abstract Background Repeated endoscopic assessments are an essential part of ulcerative colitis (UC) disease management and current guidelines recommend the use of an endoscopic activity score, either the endoscopic Mayo score or Ulcerative Colitis Endoscopic Index of Severity (UCEIS) as treatment targets. These indices have prognostic value, with endoscopic healing associated with favourable short- and long-term outcomes. This multi-centre study aimed to assess the frequency of using endoscopic disease activity scores in UC patients undergoing lower GI endoscopy. Methods Lower GI endoscopy reports from patients with UC were retrospectively reviewed from 7 sites in London between April and October 2018. Endoscopy reports were assessed based on the BRIDGe endoscopic reporting criteria including the use of Mayo or UCEIS score. The comparison was made between site factors (specialist IBD centres/non-specialist centres, use of reporting proforma), endoscopist speciality (gastroenterology, surgery or nurse endoscopist), level of training (consultant, registrar or nurse endoscopist) and interest in IBD. Chi-squared was used to compare groups. Results 899 lower GI endoscopy reports were reviewed. Mayo or UCEIS was used in 51% of cases (453/899). The use of endoscopic scores were significantly higher in gastroenterologists than in surgeons and nurse endoscopists respectively (401/762 (53%) vs. 22/54 (41%) vs. 30/83 (36%)), and higher in registrar trainees than consultants and nurse endoscopists (175/251 (70%) vs. 248/565 (44%) vs. 30/83 (36%)) and in those with a specialist interest in IBD compared with those without (237/409 (58%) vs. 216/490 (44%), p &lt; 0.0001). The use of endoscopic scores was more frequent in specialist IBD centres than in non-specialist centres (417/728 (58%) vs. 36/172 (21%), p &lt; 0.001). One centre used a reporting proforma which was associated with a significantly higher frequency of score use compared with centres without a proforma (202/260 (78%) vs. 251/639 (39%), p &lt; 0.0001). Conclusion Reporting of endoscopic disease activity using a standardised scoring system occurs in only half of cases from this large multi-centre cohort. Frequency of use is higher in specialist IBD centres and when performed by gastroenterology specialists. Endoscopy reports from a site that used a standardised reporting proforma were significantly more likely to include an endoscopic index as well as a range of other reporting items. This suggests, at least in part, that endoscopy reporting may be optimised by the introduction of a proforma. Integration of a standardised proforma into reporting software would target all endoscopists performing UC endoscopies regardless of speciality, site or IBD interest.

scholarly journals DOP18 UCEIS is associated with PRO2, partial Mayo and SCCAI remission in UC: Final results from a prospective study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S056-S057
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglas ◽  
C Verdon ◽  
S Pundir ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Roc Analysis ◽  
Clinical Decision Making ◽  
Activity Index ◽  
Clinical Decision ◽  
Operating Characteristics ◽  
Patient Reported ◽  
Index Of Severity ◽  
Active Disease

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine the operating characteristics of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), to quantify the cut off most closely correlated with clinical remission or activity and determine agreement with the Mayo endoscopic subscore (MES), Baron score, clinical scores and biomarkers. Methods 171 patients were included prospectively and consecutively (age: 49 (IQR: 38–61) years, duration 12 (4–19)years, 79 females (46.2%), 57.3% extensive disease, 42.7% on biologicals) at the time of the colonoscopy. Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Mayo endoscopic subscore (MES), Baron scores were calculated, as well as the 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI). C reactive Protein (CRP) and fecal calprotectin (FCAL) was available in 83 and 45.6% of patients. 17.0% had clinical flare, treatment was escalated in 14.6% of patients. Sensitivity, specificity, PPV and NPV values were calculated, ROC analysis and K-statistics were performed. Results UCEIS was strongly associated to PRO2 SF (AUC:0.863), RBS (AUC:0.924), PRO2 combined (AUC:0.898), partial MAYO (AUC:0.945) and SCCAI (AUC:0.901) remission in a ROC analysis. A UCEIS of ≤3 was identified as the best cut-off to identify RBS subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission, while a UCEIS≥4 identified active disease frequently needing change in medical therapy. A moderate agreement was found between UCEIS &lt;4 and MES 0 (K=0.471) or Baron 0 (K=0.414)/Baron 0–1 (K=0.353). Correlation between FCAL and UCEIS (coeff:0.701, p&lt;0.0001) was strong, while modest only with CRP (coeff:0.248, p=0.01). Conclusion UCEIS was strongly associated with clinical remission defined as PRO2, SF, RBS, partial Mayo or SCCAI with best agreement with RBS and partial Mayo remission. A UCEIS of ≤3 was identified as a cut-off for quiescent disease, while a UCEIS≥4 identified active disease, which can support clinical decision-making based on endoscopic findings. Agreement between UCEIS and FCAL was strong, while agreement with UCEIS and MES/Baron scores was moderate.

scholarly journals Serum anti-proteinase 3 anti-neutrophil cytoplasmic antibody in ulcerative colitis: a potential marker of disease activity that predicts steroid therapy failure

2020 ◽  
Author(s):  
Yuki Aoyama ◽  
Tomoki Inaba ◽  
Sakuma Takahashi ◽  
Hisae Yasuhara ◽  
Sakiko Hiraoka ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Clinical Significance ◽  
Steroid Therapy ◽  
Clinical Remission ◽  
Active Phase ◽  
Proteinase 3 ◽  
Characteristic Analysis ◽  
Therapy Failure ◽  
Potential Marker

Abstract Background Serum anti-proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) is a disease-specific antibody against granulomatosis with polyangiitis. Some patients with ulcerative colitis (UC) have positive results for PR3-ANCA but the clinical significance of PR3-ANCA is not clear. Thus, we conducted a multicenter, retrospective, observational study to elucidate the clinical significance of PR3-ANCA in UC.Methods In total, 150 patients with UC underwent colonoscopy and serum PR3-ANCA measurements. Activity was evaluated using the Mayo Endoscopic Subscore (MES), and the relationship between activity and PR3-ANCA was analyzed.Results Twenty-six of the 150 patients who met the exclusion criteria were eliminated; 124 patients were included. A positive correlation was observed between MES and PR3-ANCA (r = 0.42; p < 0.001). Receiver-operating characteristic analysis showed that the cut-off value for calculations was 4.1 U/mL. Of 108 patients with active-phase UC, 58 (53.7%) were positive for PR3-ANCA. Furthermore, patients for whom steroid therapy was ineffective had a significantly higher rate of being PR3-ANCA positive (p = 0.045). Of 21 patients who reached clinical remission with PR3-ANCA-positive active-phase UC, 13 had an MES ≥ 1 and 8 patients had an MES 0. For MES 0 cases, the reduction of PR3-ANCA levels was significant (p = 0.012) when comparing the active-phase and clinical remission. All cases with MES 0 were negative for PR3-ANCA. Only 4 of 13 cases with MES ≥ 1 were negative for PR3-ANCA.Conclusions Approximately half of UC cases are PR3-ANCA-positive during the acute phase, indicating that PR3-ANCA is a potential marker of disease activity that predicts steroid therapy failure.Trial registration This study was registered in the UMIN Clinical Trials Registry System (000039174). Retrospectively registered on 16th Jan. 2020.

scholarly journals P198 Practical deep learning tool for the scoring of ulcerative colitis disease activity in central reading

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S263-S264
Author(s):  
M Byrne ◽  
J East ◽  
M Iacucci ◽  
S Travis ◽  
R Kalapala ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Disease Activity ◽  
Video Quality ◽  
Opinion Leaders ◽  
Subject Matter Experts ◽  
Web Based ◽  
Software Interface ◽  
Index Of Severity

Abstract Background Central Reading Org.& the pharma industry employ subject matter experts(SMEs)to score videos from sites participating in clinical trials for Ulcerative Colitis(UC).As we are developing Artificial Intelligence(AI)models for scoring purposes,we need to build a new software interface that can incorporate these AI models to aid SMEs,making their determination of the scores for each segment of the video & for the video as a whole.We propose a system that reduces the time for SMEs to review & score videos,improving the accuracy of scoring,with the help of our AI models. Methods We built a web-based interface supported by our AI models which can read,write multiple databases & data stores to read & display videos to be scored by a central reader, as well as the associated metadata required to improve the process.User interface shows a timeline with markers for the segments of the colon,with sections that are blurry,poorly prepped,or unscorable highlighted in different colours.While we could also highlight sections of the video with the precise score assigned to it by the AI,this would bias the central reader’s opinion.We hide the precise score generated by our AI models & instead display 3 colours for low,medium or high disease activity.When a video is loaded to be read by the user,the playback marker is set to the first high disease activity section based on known medical indexes such as the Mayo Endoscopic Subscore(MES) & UCEIS(Ulcerative Colitis Endoscopic Index of Severity),usually consists of a few seconds of video & that video is played back continuously in a loop until the reader selects the appropriate score for that section.When the reader saves the section,the software immediately moves the video cursor to the highest scored section of the video.That way the central reader can review only the relevant portions of the video to confirm the score assigned to each segment.If the central reader’s scores do not align well with the AI scores then the software continues to show more sections of the video to the user,including sections it may have labeled as unscorable,that may be scorable. Results The review of the system by 3 key opinion leaders,user experience was positive.Not only does the system allow the reader’s attention to be more efficiently used,but the interface allows both AI & central reader scores to be saved,allowing for the latter to be used iteratively to re-train & improve the underlying AI model(s).Our tool was also used by a gastroenterologist specialist in order to perform video quality assessment & colon sections scoring. Conclusion We developed an AI tool that can be used to improve the efficiency & accuracy of the central reading process in clinical trials for UC.Further work is ongoing to improve the interface.

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