scholarly journals The value of abdominal ultrasonography compared to colonoscopy and faecal calprotectin in following up paediatric patients with ulcerative colitis

2021 ◽  
Author(s):  
Ioana Fodor ◽  
Oana Serban ◽  
Daniela Elena Serban ◽  
Dorin Farcau ◽  
Otilia Fufezan ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Activity Index ◽  
Endoscopic Examination ◽  
Observer Agreement ◽  
Pathological Findings ◽  
Abdominal Ultrasonography ◽  
Faecal Calprotectin ◽  
Paediatric Patients ◽  
Active Disease

Aim: To evaluate the value of abdominal ultrasonography (US) in the follow-up of paediatric patients with ulcerative colitis (UC) compared to faecal calprotectin (FC) and colonoscopy. Material and method: In this retrospective study we enrolled 30 paediatric patients previously diagnosed with UC, examined by abdominal US and colonoscopy within the same week. FC was also determined during the same week. Disease activity was established using the paediatric ulcerative colitis activity index (PUCAI). The global endoscopic activity was evaluated using the Mayo endoscopic subscore. Results: Endos-copy revealed pathological findings of active disease in 27 out of 30 patients; 3 patients were in endoscopic remission. Only 18 of them had clinical active disease (PUCAI >10), [sensitivity (Se) 66.7% and specificity (Sp) 33% of PUCAI in detecting endoscopic active disease). Twenty-three (76.7%) patients had FC >250 mcg/g, but in 2 of these cases the colonoscopy was normal (Se 77.8% and Sp 33.3% in detecting active disease). At US examination, pathological findings (increased bowel wall thickness, hypervascularity, lymphadenopathies, and/or mesenteric inflammatory fat) were found in 27 patients (90%), all with endoscopic active disease (agreement US - colonoscopy, at patient level, k=1.0, p<0.001, Se 100% and Sp 100%). At seg-ment level (totally 180 bowel segments examined by US), the overall agreement between US and colonoscopy was k=0.767, p<0.001, Se 86.5%, Sp 90.1%. Of the 27 patients with US pathological findings in any of colonic segments, 23 had FC >250 mcg/g (85.1%). The inter-observer agreement for the US measurements had an overall ICC of 0.926 with p<0.001. Conclusion: Abdominal US findings demonstrate a good to excellent concordance with endoscopic examination and are correlated with elevated FC levels. Therefore, US appears as an accurate technique in assessing activity in patients with UC and might replace colonoscopic evaluation for the follow-up.

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.

THU0356 DISEASE ACTIVITY ASSESSMENT IN SYSTEMIC SCLEROSIS PATIENTS BASED ON THE CURRENTLY AVAILABLE ACTIVITY INDICES AND THE PHYSICIAN GLOBAL ASSESSMENT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 409.1-409
Author(s):  
T. Minier ◽  
V. Lóránd ◽  
Z. Bálint ◽  
D. Komjati ◽  
G. Nagy ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Activity Assessment ◽  
One Year ◽  
Active Disease ◽  
The Eu ◽  
Disease Activity Assessment ◽  
Activity Indices

Background:Disease activity assessment is crucial in defining the appropriate therapy and to monitor the efficacy of treatment in systemic sclerosis.Objectives:We aimed to test the performance of the ’old’ European Scleroderma Trials and Research Group (EUSTAR) Activity Index (old-AI) (1), the ’new’ EUSTAR activity index (new-AI) (2), and the scleroderma activity index derived from the old-AI (Pecs-AI) (3). We compared the three indices to the disease activity based on the physician’s global assessment (PGA). We also assessed the correlations with the change in modified Rodnan Skin Score (MRSS), FVC and arthritis after one year follow-up.Methods:We evaluated 77 patients (50 diffuse /dcSSc/ and 27 limited cutaneous SSc /lcSSc/ patients) from a single tertiary clinical center. Cohort enrichment was performed to increase the number of patients with early disease and dcSSc. Seventy-two patients were re-evaluated after one year. Nine patients had overlap syndromes: rheumatoid arthritis (n=3), Sjögren syndrome (n=2), polymyositis (n=2), and mixed connective tissue disease (n=2). The overall disease activity was evaluated using both composite indices (old-AI, Pecs-AI, new-AI) and the PGA of disease activity, based on the blinded evaluation of a single physician (LV). In addition to the minimal essential data from the EUSTAR database we also performed detailed assessment of the musculoskeletal involvement evaluating measures of hand function, DAS28 scores, and the Clinical Disease Activity Index (CDAI) (4).Results:Three times more patients with active disease were identified by the new-AI compared to the old-AI at baseline investigation (n=37, 48.7%, vs. n=11, 14.3%). Two patients (18%) with active disease based on the old-AI were missed by the new-AI. Pecs-AI index identified 15 patients (19.5%) with active disease (cut-off >2.75 points). Active disease was equally frequent in dcSSc and lcSSc patients based on old-AI, but was more frequent in dcSSc patients based on the new-AI in the whole cohort, and also after excluding overlap cases.Patients with active disease based on the old-AI had more frequently rheumatoid factor (6/9, vs. 12/45, p=0.047), and DLCO<70% (11/11, vs. 36/65, p<0.01). Active disease based on the new-Al was associated with current cyclophosphamide treatment (9/37, vs.2/39, p=0.023), and diabetes mellitus (7/30, vs. 0/39, p<0.01). The PGA correlated moderately at both baseline and one year follow-up examination with the old-AI (rho: 0.519, and rho: 0.692, respectively, p<0.001), the new-AI (rho: 0.401, and rho: 0.429, respectively, p<0.001), and the Pecs-AI (rho: 0.425, and rho: 0.593, respectively, p<0.001).CDAI correlated significantly with the old-AI (rho: 0.345, and rho: 0.283, respectively, p<0.05) and the Pecs-AI (rho: 0.363, and rho: 0.324, respectively, p<0.05) at both the baseline and one-year follow-up investigations, but showed no consistent correlation to the new-AI or PGA.Conclusion:The two validated disease activity indices indentify different patient groups. Joint involvement is potentially underrepresented in the new EUSTAR activity index. Active disease is also present in lcSSc and should be assessed regularly in these patients.References:[1]Valentini G, et al. Ann Rheum Dis 2003; 62: 901-3.[2]Valentini G, et al. Ann Rheum Dis 2017;76:270–276.[3]Minier T, et al. Rheumatology (Oxford) 2010;49(6):1133-45.[4]Lorand V, et al. Rheumatology (Oxford). 2016;55(10):1849-58.Acknowledgments:This work was supported by the EU Seventh Framework Program [FP7/2007-2013] under Grant Agreement n° 305495 (DeSScipher), by the Hungarian Scientific Research Fund (contract n°: 112939), and the EU under the Grant Agreement n° PEPSYS GINOP-232-15-2016-00050.Disclosure of Interests:Tünde Minier Speakers bureau: Actelion, Abbvie, MSD, Pfizer, Lilly, Roche, Veronika Lóránd: None declared, Zsófia Bálint: None declared, Dalma Komjati: None declared, Gabriella Nagy Speakers bureau: MSD, Antonietta Kovács: None declared, Orsolya Koncz: None declared, Cecília Varjú Consultant of: Boehringer Ingelheim RCV GmbH & Co KG, Speakers bureau: Lilly, László Czirják Consultant of: Actelion, BI, Roche-Genentech, Lilly, Medac, Novartis, Pfizer, Bayer AG, Gabor Kumanovics Consultant of: Boehringer, Teva, Speakers bureau: Roche, Lilly, Novartis, Balazs Nemeth: None declared

scholarly journals Development of Mucosal PNAd+ and MAdCAM-1+ Venules during Disease Course in Ulcerative Colitis

Cells ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. 891
Author(s):  
Britt Roosenboom ◽  
Ellen G. van Lochem ◽  
Jos Meijer ◽  
Carolijn Smids ◽  
Stefan Nierkens ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
High Endothelial Venules ◽  
Cell Homing ◽  
Colonic Biopsy ◽  
T Cell Homing ◽  
N 93 ◽  
Active Inflammation ◽  
Active Disease

PNAd and MAdCAM-1 addressins on venules are of importance in T-cell homing and potential therapeutic targets in ulcerative colitis (UC). Normally, PNAd+ high endothelial venules (HEVs) are only present in lymphoid organs, whereas small numbers of MAdCAM-1+ venules can be seen in non-lymphoid tissue. We aimed to study their presence in the intestinal mucosa of UC patients at diagnosis and during follow-up, and their correlation with disease activity. Colonic biopsy specimens of 378 UC patients were analyzed by immunohistochemistry for CD3, CD20, ERG, MECA-79 (PNAd) and MECA-376 (MAdCAM-1) and compared to healthy controls (HC). The proportion of PNAd+HEVs in UC at diagnosis was 4.9% (IQR 2.0%–8.3%), while none were detected in HC. During follow-up, PNAd+HEVs completely disappeared in remission (n = 93), whereas the proportion in active disease was similar to baseline (n = 285, p = 0.39). The proportion of MAdCAM-1+venules in UC at baseline was 5.8% (IQR 2.6–10.0). During follow-up, the proportion in remission was comparable to diagnosis, but upregulated (7.5% (IQR 4.4–10.9), p = 0.001) in active disease. In conclusion, PNAd+HEVs appear in UC during active inflammation which could thus serve as a marker for disease activity, whereas MAdCAM-1+venules remain present after inflammation is resolved and increase after subsequent flares, reflecting chronicity and potentially serving as a therapeutic target.

scholarly journals P562 5-ASA in ulcerative colitis: Are they really needed in the biological therapy era?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S474-S474
Author(s):  
C Arieira ◽  
F Dias de Castro ◽  
T Cúrdia Gonçalves ◽  
M J Moreira ◽  
J Cotter
Keyword(s):  
Colorectal Cancer ◽  
Ulcerative Colitis ◽  
Biologic Therapy ◽  
Fecal Calprotectin ◽  
Inflammatory Biomarkers ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Maintenance Of Remission ◽  
Treatment Escalation

Abstract Background Biologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. Methods Retrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collected inflammatory biomarkers were faecal calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). The occurrence of complications was defined as the need of hospitalisation, need of corticosteroids or other top-up therapy, surgery and the occurrence of dysplasia or colorectal cancer. Results We included 65 patients with UC, 56.9% female with a mean age of 32.8 (±12.8) years. The median follow-up was 30 (6–132) months. Regarding extension, 61.5% were E3, 35.4% E2 and 3.1% E1. While 44 patients (67.7%) were on 5-ASA and biologics (infliximab = 32, adalimumab = 6, vedolizumab = 6), 21 (32.3%) were on biologics alone (infliximab = 13, adalimumab = 3, vedolizumab = 5). The median duration of biologic therapy was 30 (6–126) months. Regarding baseline characteristics, including age, gender, duration of the disease or biologic therapy and age at UC diagnosis, there were no differences between groups. No differences regarding inflammatory biomarkers were observed – fecal calprotectin (p = 0.39), CRP (p = 0.9) and ESR (p = 0.61). No differences were found regarding complications, namely the need of hospitalisation (p = 0.06) or need of corticosteroids (p = 0.89). Only one patient developed dysplasia (under infliximab and 5-ASA). Any of the included patients needed surgery or developed colorectal cancer. Conclusion About two-thirds of the UC patients under biologics are co-treated with 5-ASA. No differences between UC patients under combination biologics+5-ASA vs. biologics alone were found regarding inflammatory biomarkers or the occurrence of complications. These results raise the question if continuing 5-ASA in UC patients under biologics is really necessary.

scholarly journals P430 Feasibility and reliability of gastrointestinal ultrasound in pregnant inflammatory bowel disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S391-S393
Author(s):  
F de Voogd ◽  
H Joshi ◽  
E Van Wassenaer ◽  
G D’Haens ◽  
K Gecse
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Terminal Ileum ◽  
Bowel Disease ◽  
Activity Index ◽  
Third Trimester ◽  
Faecal Calprotectin ◽  
Gastrointestinal Ultrasound ◽  
Inflammatory Bowel ◽  
Active Disease

Abstract Background Disease activity during pregnancy in women with inflammatory bowel disease (IBD) is associated with miscarriage, preterm delivery and low birth weight. Monitoring disease activity throughout the pregnancy is therefore important. Gastrointestinal ultrasound (GIUS) has a high potential as a point-of-care tool for monitoring disease activity in IBD as it has been shown to correlate well with endoscopy and magnetic resonance imaging. However, data are scarce on the use of GIUS in IBD throughout pregnancy. The aim of this prospective study is to determine the feasibility and reliability of GIUS in pregnant IBD patients. Methods Patients were included when visiting the outpatient IBD pregnancy clinic. At each trimester, clinical and biochemical disease activity was evaluated and GIUS was performed. Feasibility was assessed by the ability to visualise each bowel segment (terminal ileum (TI), ascending (AC), transverse (TC), descending (DC) and sigmoid colon (SC)). Reliability was evaluated by using clinical and biochemical disease activity as a gold standard. This was defined as a Harvey–Bradshaw Index ≥4 in Crohn’s disease (CD) or a Simple Clinical Colitis Activity Index ≥5 in ulcerative colitis and a faecal calprotectin (FCP)³ 250 mg/g. Bowel wall thickness (BWT) of &gt; 3 mm in the colon and &gt; 2mm in the terminal ileum was considered as signs of active inflammation on ultrasound. A Mann–Whitney U-test and chi-square were used for statistical analysis. Results Thirty-two IBD patients (54% CD) were studied. Both a GIUS and FCP was available in 18, 11 and 6 patients for the first, second and third trimester, respectively. Eleven of 32 (34%) patients had clinically active disease at least at one time point during the pregnancy. Table 1 shows the visibility per segment. When the active disease was defined as an FCP ≥ 250 mg/g, GIUS could distinguish active from the non-active disease in the first, second and third trimester with a sensitivity of 80%, 75% and 75% and specificity of 85%, 86% and 100%, respectively. FCP levels were significantly higher in patients with an active disease on GIUS regardless of the trimester (mean 1095.5 ± 1453.8 mg/g vs. 265.25 ± 649.8 mg/g, p &lt; 0.0001). Conclusion GIUS is accurate to distinguish active from the quiescent disease in pregnancy. Feasibility to visualise the TI and the SC decreased during the second and third trimester, although active disease could still be detected. Consequently, GIUS is feasible and reliable to assess disease activity throughout pregnancy in IBD.

scholarly journals Increased abundance of proteobacteria in aggressive Crohn’s disease seven years after diagnosis

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
M. K. Vester-Andersen ◽  
H. C. Mirsepasi-Lauridsen ◽  
M. V. Prosberg ◽  
C. O. Mortensen ◽  
C. Träger ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Activity Index ◽  
Aggressive Disease ◽  
Intestinal Dysbiosis ◽  
Inflammatory Bowel ◽  
Microbiota Diversity ◽  
Active Disease

Abstract Intestinal dysbiosis in inflammatory bowel disease (IBD) patients depend on disease activity. We aimed to characterize the microbiota after 7 years of follow-up in an unselected cohort of IBD patients according to disease activity and disease severity. Fifty eight Crohn’s disease (CD) and 82 ulcerative colitis (UC) patients were included. Disease activity was assessed by the Harvey-Bradshaw Index for CD and Simple Clinical Colitis Activity Index for UC. Microbiota diversity was assessed by 16S rDNA MiSeq sequencing. In UC patients with active disease and in CD patients with aggressive disease the richness (number of OTUs, p = 0.018 and p = 0.013, respectively) and diversity (Shannons index, p = 0.017 and p = 0.023, respectively) were significantly decreased. In the active UC group there was a significant decrease in abundance of the phylum Firmicutes (p = 0.018). The same was found in CD patients with aggressive disease (p = 0.05) while the abundance of Proteobacteria phylum showed a significant increase (p = 0.03) in CD patients. We found a change in the microbial abundance in UC patients with active disease and in CD patients with aggressive disease. These results suggest that dysbiosis of the gut in IBD patients is not only related to current activity but also to the course of the disease.

scholarly journals P471 What is the appropriate cut-off value of CRP to predict endoscopic remission in ulcerative colitis patients with clinical remission?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S415-S415
Author(s):  
J Shin ◽  
G Seong ◽  
J H Song ◽  
S M Kong ◽  
T J Kim ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Sensitivity And Specificity ◽  
Clinical Remission ◽  
Activity Index ◽  
Area Under The Curve ◽  
Endoscopic Evaluation ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Endoscopic Remission ◽  
Low Sensitivity

Abstract Background A noninvasive and reliable markers for predicting endoscopic remission (ER) in ulcerative colitis (UC) patients with clinical remission (CR) provide important information in predicting disease progression and in determining treatment. Faecal calprotectin test is known to be the most accurate to predict ER, but patients are reluctant to handle faecal materials. C-reactive protein (CRP) is one of the surrogate markers for assessing disease activity, but it is known to have low sensitivity and specificity of normal CRP value (&lt;0.3 mg/dl). The sensitivity of the CRP test has been improved, and even fine values within the normal range can be measured. The aim of this study was to determine appropriate CRP cut-off values for the prediction of ER in UC patients with CR even though within normal CRP range. Methods A total of 132 UC patients who underwent endoscopic evaluation in CR were retrospectively reviewed. Serum biomarkers including haemoglobin, leukocytes, platelets, erythrocyte sedimentation rate, and CRP were evaluated within 1 week period from endoscopic evaluation. The clinical and endoscopic activity was measured by simple clinical colitis activity index and endoscopic Mayo subscore. Results In UC patient with CR, CRP level was significantly lower in ER (median 0.05, 0.03–2.57) vs. non-ER (median 0.11 0.03-2.81). (p &lt; 0.005) The proportion of males in non-ER was slightly higher than in ER (24, 72.7% vs. 52, 52.5 %; p = 0.042), and only gender and CRP showed statistical differences in baseline clinical characteristics. CRP had predictive value of ER [Area under the curve (AUC = 0.760)] and the sensitivity was 71.4%, specificity was 71.7 % at cut-off value of 0.09mg/dl. In contrast, the sensitivity and specificity of normal CRP (0.3mg/dl) were low. (sensitivity 27.3%, specificity 90.9%). Conclusion Norma CRP cut-off values are not sufficient to reflect ER. It may be helpful to change the CRP cut-off value that predicts ER in CR to value other than 0.3 mg/dl.

DOP71 Efficacy, safety, and tolerability of ustekinumab in paediatric patients with moderately to severely active Crohn’s disease: Results from, UniStar, a phase 1 study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S107-S108
Author(s):  
J Rosh ◽  
D Turner ◽  
A Griffiths ◽  
D Jacobstein ◽  
O Adedokun ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Opportunistic Infections ◽  
Activity Index ◽  
Phase 1 ◽  
Double Blind ◽  
Faecal Calprotectin ◽  
Adequate Treatment ◽  
Safety And Efficacy ◽  
Paediatric Patients

Abstract Background Ustekinumab (UST) is approved for the treatment of adults with moderate to severe Crohn’s disease (CD). The objective of this study was to evaluate the pharmacokinetics (PK), safety, and efficacy of UST in paediatric patients with moderately to severely active CD who had failed treatment with corticosteroids (CS) and/or immunomodulators (IM) and/or anti-tumour necrosis factor (TNF) therapies. Here, we report the safety and efficacy results through Week 16; PK results are reported separately. Methods This was a Phase 1, multicentre, 16-week, double-blind induction dose-ranging study (NCT02968108) in patients aged 2 to &lt;18 years (body weight [BW] ≥10 kg) with a Paediatric CD Activity Index (PCDAI) score &gt;30 and at least an abnormal C-reactive protein &gt;3.0 mg/l or faecal calprotectin &gt;250 µg/g), or ulcerations in the ileum or colon upon ileocolonoscopy despite adequate treatment with CS ± IM ± anti-TNF therapy. Patients were randomised (1:1) and stratified by weight and prior anti-TNF use for induction to one of 2 weight range-based intravenous (IV) doses: 130mg vs. 390 mg if BW ≥40 kg and 3 mg/kg vs. 9 mg/kg if BW &lt;40 kg. At week 8, all patients received a single subcutaneous (SC) UST maintenance dose of 90mg if BW ≥40 kg or 2 mg/kg if BW &lt;40 kg. Results Forty-four patients (59% ≥40kg BW; &gt;90% anti-TNF exposed) were randomised (n = 23 lower dose; n = 21 higher dose) and treated with UST. Baseline characteristics are summarised in Table 1. At week 16, in the lower dose and higher dose groups, 52%/52% achieved clinical response (reduction in PCDAI ≥15) and 22%/29% had clinical remission (PCDAI ≤10), respectively (Table 2). In addition, 32% and 28% of patients showed endoscopic response (reduction in Simple Endoscopic Score for CD of ≥50%), respectively. Through week 16, 73% of patients reported ≥1 adverse event (AE; 82.6% lower dose vs. 62% higher dose); 2 discontinued due to AEs (1 in each group). Serious AEs occurred in 16% of patients (26% lower dose and 5% higher dose, with CD exacerbation being the most frequent (13%/5%, respectively). Infections occurred in 41% of patients (1 was serious, which was intestinal abscess that spontaneously resolved with sequelae). No injection site reactions, opportunistic infections, malignancies, or deaths were reported. No antibodies to UST were observed. Conclusion As early as 3 weeks and through 16 weeks, both the lower and higher doses of UST (IV week 0 and SC at week 8) improved clinical and endoscopic disease activity in this previously treatment-refractory group of children with CD. The safety profile was consistent with that for UST in adults with CD.

scholarly journals MODERATE TO SEVERE ENDOSCOPIC INFLAMMATION IS FREQUENT AFTER ACHIEVING CLINICAL REMISSION IN PEDIATRIC ULCERATIVE COLITIS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S13-S13
Author(s):  
Chen Sarbagili-Shabat ◽  
Dror Weiner ◽  
Joram Wardi ◽  
Lee Abramas ◽  
Michal Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Residual Disease ◽  
Activity Index ◽  
Final Analysis ◽  
Mucosal Healing ◽  
Sustained Remission ◽  
High Relapse Rate ◽  
Mayo Score

Abstract Background Pediatric ulcerative colitis (UC) is characterized by low sustained remission rates and frequent extension of disease even if clinical remission is obtained with therapy. Moderate to severe endoscopic activity is a risk factor for relapse while evidence regarding early mucosal healing or persistence of inflammation after remission in children is not available. Our aim was to evaluate if persistence of significant inflammation is common and could explain the high relapse rate in pediatric UC. Methods Pediatric UC patients with clinical remission, defined as pediatric UC activity index (PUCAI) scores &lt; 10, were prospectively assessed for mucosal healing by endoscopy 3–5 months after remission was documented. Mayo score was assessed for each segment by a blinded adult gastroenterologist using central reading. Symptomatic patients prior to sigmoidoscopy were excluded Sustained remission was assessed retrospectively at 18 months follow-up. Results Forty-six children were enrolled, 28 children in continuous clinical remission at time of sigmoidoscopy were included in the final analysis. Mayo 0 was present in 12/28 (42.86%), Mayo 1 in 2/28 (7.1%) and Mayo 2–3 in 14/28 (50.0%) endoscopies. Among 23/28 patients with follow-up through 18 months, remission was sustained in 2/11 (18.18%) of patients with Mayo 2 and 3 versus 6/12 (50.0%) with Mayo score 0–1. Conclusion Over 50% of children assessed for mucosal healing 3–5 months after clinical remission is obtained have residual disease activity, primarily moderate to severe inflammation which was associated with lower sustained remission. Early sigmoidoscopy after clinical remission for assessment of mucosal disease should be considered in pediatric UC.

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.

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