scholarly journals P689 Patient-reported outcomes (PRO-2) and intestinal ultrasound in ulcerative colitis patients: subanalysis of the TRUST&UC study cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S560-S561
Author(s):  
C Maaser ◽  
U Helwig ◽  
I Fischer ◽  
S Rath ◽  
S Kolterer ◽  
...  

Abstract Background Patient-reported Outcomes (PRO) are gaining increasing acceptance as new tools to evaluate clinical activity, especially in the context of clinical trials and evaluation of drug efficacy. However, data to support the relevance of these endpoints and their correlation to objective markers of inflammation is still lacking.1 Recently published data demonstrated the feasibility of intestinal ultrasound (IUS) as a routine monitoring technique in clinical practice for Crohn’s disease (CD) and ulcerative colitis (UC) patients.2 Thus, the importance and significance of IUS, as a patient-centric and non-invasive technique has emerged over the last years and will become more relevant in the future.With this sub-analysis of the TRUST&UC study, we aimed to investigate the correlation between improvement in ultrasound parameters and PRO-2 in UC patients. Methods TRUST&UC is a prospective, observational study including 244 patients with an increased bowel wall thickness (BWT) at baseline and active UC (SCCAI ≥ 5). These patients were analysed for the Simple Clinical Colitis Activity Index (SCCAI) subscores stool frequency, urgency and rectal bleeding. These parameters were documented for up to 4 visits (baseline, an optional visit at week 2, week 6 and week 12). Pathological stool frequency was defined as a stool frequency of ≥1 point (≥ 4 stools/day) and pathological rectal bleeding was defined as ≥1 point (traces of blood in stool); the combination of both subscores was defined as PRO-2. Results We found a positive moderate correlation between BWT and the investigated SCCAI-subscores (rectal bleeding and BWT at W12 r = 0.417; stool frequency and BWT at W12, r = 0.483; PRO-2 and BWT at W12, r = 0.518) and even W6, which is in accordance with previously reported correlations of various PROs and endoscopy in UC-patients.3 We demonstrate that patients with normalisation of BWT (sigmoid colon < 4.0 mm) had a significantly higher chance of a non-pathological PRO-2 (pathological PRO-2 yes/no: 4.25 mm and 3.20 mm for week 6 (p < 0.001) and 4.45 mm and 3.00 mm (p < 0.001) for week 12). Conclusion With this sub-analysis of the TRUST&UC study we demonstrated that bowel wall thickness, assessed by intestinal ultrasound, had a moderate correlation with normalisation of patient-reported outcomes as early as week 6 and 12. Furthermore, patients with non-pathological PRO-2 had significantly decreased bowel wall thickness. This again supports the value of intestinal ultrasound in routine medical practice. References

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S196-S196
Author(s):  
P Dulai ◽  
S Singh ◽  
V Jairath ◽  
C Ma ◽  
N Narula ◽  
...  

Abstract Background We aimed to quantify the prevalence of endoscopic improvement (EI) and remission (ER) amongst ulcerative colitis patients with various permutations of patient reported outcomes (PRO) following treatment with biologic agents or tofacitinib. Methods Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab, and tofacitinib were pooled to estimate the prevalence of EI (Mayo endoscopic sub-score [MES] 0 or 1) and ER (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6–8 weeks) and maintenance (30–54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring. Results Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of EI and ER was highest among participants with a RBS 0 + SFS 0 post induction (EI: 81%, [95% CI 78–84]; ER: 29% [26–33]) and during maintenance (EI: 91% [87–93]; ER: 57% [52–62]). Prevalence estimates were lower for more recently performed trials (p < 0.01). In comparison to locally scored endoscopy, when using central endoscopy scoring the prevalence of EI and ER were lower post-induction (EI 57% [50–64], p < 0.001; ER 15% [11–21], p = 0.09) and during maintenance (EI 74% [67–81], p = 0.001; ER 31% [24–38], p = 0.001) for participants achieving a RBS 0 + SFS 0. Conclusion Approximately eight out of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Moataz Mohamed Sayed ◽  
Kamal El-Deen Abdelrahman El-Atrebi ◽  
Tari Magdy Aziz George ◽  
Hazem Mohamed Abd Elazim Marey

Abstract Background Ulcerative colitis, a type of inflammatory bowel disease that merely affects the mucosa and submucosa of colon in the form of inflammatory ulcers. Colonoscopy is the gold standard for its diagnosis. For optimal monitoring of disease activity in UC patients, colonoscopy should be performed on a regular basis. However, repeated colonoscopies represent a logistic and economic challenge, as well as significant burden for the patients. Objectives Our study aimed to provide an extensive overview of the main pathologic features of gut wall vessels and bowel wall thickness at US examination of UC. Patients and Methods This prospective case control study was done on 40 patients confirmed to have UC attending to Outpatient Clinics of Internal Medicine and Gastroenterology Department – Ain-Shams University from October 2018 to Augost 2019. They were divided into two groups: Relapse group: Include 20 patients with active UC disease. Remission group: Include 20 patients with inactive UC disease (in remission state). These two groups were matched with 20 healthy individuals, matched for age and gender and considered to be a control group. Disease activity was categorized according to the endoscopic Mayo score.Ultrasound and endoscopic findings were compared for each colon segment except for the rectum. Results The peak incidence of affected patients was 30–40 years of age. Female predominance compared to male with a ratio of 2.6:1. 20% of remission patients complaining from 1-2 bowel movement while 45% and 50% of relapsing patients suffer from 3-4 and 5 bowel movement respectively. 100%, 100%, 20% and 15% of relapsing patients suffer from bleeding per rectum, abdominal pain, tenesmus and urgency. Higher ESR and CRP and lower hemoglobin in relapsing compared to remission group. Furthermore, The last group has higher value of ESR and CRP and lower value of hemoglobin compared to control group. BWT was significantly thicker in relapse group (4.8±0.7 mm) than of remission (3.55±0.5 mm) compared to control group (1.6±0.5) (p value <0.001). BWT at a cut-offs > 4 mm discriminating between cases with relapse from those with remission and at a cut-offs >4 mm discriminating between mild endoscopic severity from moderate and severe UC. Furthermore, BWT at a cut-offs >4.6 mm discriminating between mild and moderate endoscopic severity from severe UC. Vascular signal number at a cut-offs >1 discriminating between cases with relapse from those with remission and at a cut-offs >2 discriminating between mild and moderate endoscopic severity of UC. Conclusion Abdominal ultrasound is a widely available non-invasive method for imaging of UC. It provides a high sensitivity, specificity and accuracy in diagnosis and monitoring of UC activity.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S008-S009
Author(s):  
B Verstockt ◽  
C Jorissen ◽  
E Hoefkens ◽  
N Lembrechts ◽  
L Pouillon ◽  
...  

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.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S315-S317
Author(s):  
F de Voogd ◽  
E Van Wassenaer ◽  
A Mookhoek ◽  
S Bots ◽  
S Van Gennep ◽  
...  

Abstract Background To assess disease activity in ulcerative colitis (UC) intestinal ultrasound (IUS) highly correlates with endoscopic outcomes. However, data on treatment response evaluated with IUS is limited. In this study we aim to evaluate bowel wall thickness (BWT) at follow-up to determine treatment effectiveness in moderate-severe UC patients treated with tofacitinib according to central read endoscopy and histology. Methods Patients with moderate-severe UC (endoscopic Mayo score (EMS)≥2) starting tofacitinib 10 mg bid were included. Disease activity was evaluated by recorded IUS cine-loops and video-taped endoscopies with biopsies from the sigmoid (SC) and descending colon (DC) at baseline and at 8 weeks. BWT and EMS were assessed per segment (SC and DC). Histology was scored for the SC with the Robarts Histology Index (RHI). BWT, EMS and RHI were centrally read and for IUS there was a second reader. Endoscopic remission (ERem) was defined as EMS=0, endoscopic improvement (EI) as EMS≤1 and endoscopic response (ERes) as a decrease of EMS≥1. For statistical analysis a Wilcoxon signed-rank and Spearman’s test were used. Area under the ROC was used to determine optimal cut-off values. Inter-observer agreement was analyzed by intra-class correlation coefficient (ICC). Results 29 patients were included and started tofacitinib. 10% reached complete ERem after 8 weeks, respectively. Per-segment analysis for EMS showed 22% and 53% reaching ER and 40% and 60% having EI in the SC and DC, respectively. BWT in SC and DC correlated highly with the EMS (rho=0.68, rho=0.75, both p<0.0001) and moderately with RHI (rho=0.49, p=0.002). Patients with EMS≥2 after 8 weeks had an increased BWT (SC: 4.32 ± 1.57 mm, DC: 4.38 ± 1.58 mm) when compared to ERem (SC: 2.10 ± 0.67 mm, DC: mean: 2.00 ± 1.18 mm, both p<0.0001) and EI (SC: 2.29 ± 0.76 mm, DC: 2.56 ± 1.38 mm, both p<0.0001) in the similar segment (Figure 1 and 2). BWT decreased after 8 weeks when there was ERes (SC: mean: -2.59 ± 1.44 mm, DC: -1.82 ± 1.01 mm, both p=0.007) and did not when there was no ERes (Figure 3). BWT cut-off values for ERem are reported in Figure 4. Furthermore, agreement for BWT in the SC and DC was excellent (ICC: 0.92 and ICC: 0.89), respectively. Conclusion BWT reduction showed early endoscopic remission, improvement and response after 8 weeks of tofacitinib treatment and correlated with histology in this central read cohort. Furthermore, accurate and reliable cut-off values for BWT in SC and DC were found for endoscopic remission and improvement. Therefore, IUS should be incorporated in the standard follow-up and close monitoring of UC patients.


2011 ◽  
Vol 43 ◽  
pp. S436
Author(s):  
A. Montemaggi ◽  
L. Tasciotti ◽  
M. Basile ◽  
M. De Maurizio ◽  
M. Paci ◽  
...  

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S486-S487
Author(s):  
F de Voogd ◽  
R Wilkens ◽  
K Gecse ◽  
M Allocca ◽  
K Novak ◽  
...  

Abstract Background Gastrointestinal ultrasound (GIUS) is increasingly performed in inflammatory bowel disease to assess disease activity and treatment response. It is promising as an effective point-of-care imaging tool since it correlates well with endoscopy and other cross-sectional imaging modalities. Previous studies showed moderate to substantial interobserver agreement in Crohn’s disease. However, in ulcerative colitis (UC) inter-observer agreement for GIUS has not yet been evaluated. Therefore, we conducted a study to assess inter-observer agreement in UC. Methods Thirty patients with UC (five with clinically quiescent and 25 with active disease) were included in this study. Cine-loops were recorded for the sigmoid colon (SC) in a longitudinal and cross-sectional axis in B-mode and in colour Doppler mode. Cine-loops were scored by five independent raters blinded for clinical disease activity. The cine-loops were scored for bowel wall thickness (BWT), Doppler activity (0=no activity, 1=small spots limited to the bowel wall, 2=long stretches within the bowel wall, 3=long stretches within and outside of the bowel wall), inflammatory fat, bowel wall stratification, loss of haustration and lymph nodes (present or absent). The intraclass correlation coefficient was used for the assessment of bowel wall thickness. Fleiss’ kappa was used for all nominal variables and weighted Cohen’s kappa was used for all ordinal variables. Results Inter-observer agreement was good for bowel wall thickness (ICC: 0.7, 95% CI: 0.51–0.83, p < 0.0001) [1] and moderate for Doppler signal (k=0.57, 95% CI: 0.37–0.77, p < 0.0001) [2]. When Doppler signal was interpreted as absent (0) or present (1–3) the observed agreement was almost perfect (k=0.81, 95% CI: 0.69–0.92). For inflammatory fat the observed agreement was moderate (k=0.42, 95% CI: 0.29–0.58, p < 0.0001). Inter-observer agreement was fair for the presence of lymph nodes (k=0.35, 95% CI:0.20–0.49, p < 0.0001) and loss of stratification (k=0.22 95% CI: 0.09–0.35, p < 0.001). Agreement was slight for loss of haustrations (k=0.15, 95% CI: 0.00–0.29, p = 0.046). Conclusion GIUS is a reliable imaging modality with good to moderate interobserver agreement for BWT, vascularisation and fatty wrapping in UC. These ultrasonographic parameters are important features to distinguish active from quiescent disease. References


2020 ◽  
Author(s):  
Masahiro Takahara ◽  
Sakiko Hiraoka ◽  
Masayasu Ohmori ◽  
Kensuke Takei ◽  
Eriko Yasutomi ◽  
...  

Abstract Background: Transabdominal ultrasonography (TUS) is a non-invasive method that can be performed repeatedly. Although the usefulness of TUS in ulcerative colitis (UC) has been reported, no well-established data exist yet. This study aimed to determine the usefulness of TUS, compared with colonoscopy (CS), in detecting the presence of mucosal inflammation in each segment of the colon among patients with UC. Methods: Eighty UC patients who underwent US within 14 days after CS were retrospectively registered. We divided the colon into five segments and measured the bowel wall thickness (BWT) using TUS. The results were then compared with the Mayo endoscopic subscore classification (MES) in order to determine their accuracy.Result: We evaluated a total of 268 lesions for each segment among 80 UC patients. The proportion of BWT decreased with an increase in the MES of each segment (p < 0.0001, Cochran-Armitage trend test). The sensitivity, specificity, and accuracy of positive BMT (BWT >2 mm) for detecting mucosal inflammation (MES >0) of each segment were 0.85-1.00, 0.78-0.93, and 0.87-0.98, respectively. Conclusion: This study concluded that TUS was a useful method for detecting the presence or absence of inflammation sites among UC patients due to its high accuracy when BMT >2 mm was considered as a positive finding. This non-invasive method may help control the disease activity of UC.


2021 ◽  
Author(s):  
April N Naegeli ◽  
Theresa Hunter ◽  
Yan Dong ◽  
Ben Hoskin ◽  
Chloe Middleton-Dalby ◽  
...  

Abstract Background Understanding ulcerative colitis (UC) disease activity assessed via the full, modified or partial Mayo Score may help clinicians apply results from clinical trials to practice and facilitate interpretation of recent and older studies. Methods Mayo Score variables were assessed in a cross-sectional study of 2608 UC patients. Results Permutations of Mayo Scores were highly correlated, and models predicting the omitted variable from each permutation demonstrated significant agreement between predicted and observed values. Conclusions Partial/modified Mayo Scores may be used to predict endoscopic and Physician's Global Assessment scores, and serve as proxies for the full Mayo Score in clinical practice/trials.


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