scholarly journals Physician Global Assessments or Blood tests do not Predict Mucosal Disease Activity in Ulcerative Colitis

2014 ◽  
Vol 28 (6) ◽  
pp. 325-329 ◽  
Author(s):  
Mayur Brahmania ◽  
Charles N Bernstein

BACKGROUND: Mucosal healing has been proposed as the therapeutic end point in the treatment of patients with ulcerative colitis (UC).OBJECTIVE: To investigate the relationship between physician global assessment (PGA) and laboratory blood tests (complete blood count, ferritin, C-reactive protein, albumin) and endoscopic findings in UC to determine whether they could be adequate surrogates for endoscopy.METHODS: A retrospective chart review of patients known to have UC from July 2008 to November 2012 was performed at the Health Sciences Centre, Winnipeg, Manitoba. Patients included individuals with UC who underwent colonoscopy within one month of clinic assessment. Blood tests were standard at the time of colonoscopy. Patients presenting through the emergency department, those with colonoscopies performed outside the authors’ institution, or whose colonoscopies and clinical assessments were undertaken more than one month apart were excluded. The PGA was used to determine disease activity in patients before colonoscopy. The Ulcerative Colitis Endoscopic Index of Severity, a validated scoring system to rate endoscopic disease severity in ulcerative colitis, was adapted.RESULTS: A total of 154 patients (mean [± SD] age 44±15.7 years) with UC were identified including 82 (53%) men. Mean hemoglobin level was 139 g/L, mean platelet level was 296×109/L, mean ferritin level was 102 μg/L, mean C-reactive protein level was 10 mg/L and mean albumin level was 40 g/L. Using endoscopy as the ‘gold standard’ for assessing UC activity (moderate-severe), abnormalities in laboratory parameters and PGA were both highly specific but not sensitive for identifying individuals with at least moderately active endoscopic disease. The PGA had higher positive and negative predictive values than the laboratory parameters.CONCLUSION: Neither blood tests nor PGA could replace endoscopy for assessing mucosal healing. When patients experienced active symptoms and abnormal serum markers, they were highly likely to have abnormal endoscopy. However, inactive symptoms or normal laboratory values did not preclude having active endoscopic disease.

2015 ◽  
Vol 53 (3) ◽  
pp. 253-260
Author(s):  
T. Voiosu ◽  
Andreea Benguş ◽  
P. Bălănescu ◽  
Roxana Dinu ◽  
A. Voiosu ◽  
...  

AbstractBackground and Aims. Serum and fecal biomarkers have been used as noninvasive methods for assessing disease activity in ulcerative colitis. C-reactive protein, serum tumor necrosis factor-α and fecal calprotectin are among the most promising such biomarkers. However, their role in the management of ulcerative colitis patients remains to be clarified. We aimed to evaluate the accuracy of C-reactive protein, fecal calprotectin and tumor necrosis factor-α in detecting clinical and endoscopic activity and predicting disease outcome.Methods. A cohort of ulcerative colitis patients was prospectively evaluated for clinical and endoscopic disease activity using the Mayo score. Serum C-reactive protein and tumor necrosis factor-α levels were measured and a point-of-care method was used for determining Calprotectin levels.Results. Fifty-three patients with ulcerative colitis were followed for a median of 12 months. Fecal calprotectin and C-reactive protein levels were significantly higher in patients with clinically active disease at baseline, but only calprotectin levels correlated with endoscopic activity. Calprotectin values over 300 μg/g had 60% sensitivity and 90% specificity for detecting active endoscopic disease and 61% sensitivity and 89% specificity for predicting mucosal healing.Conclusion. Rapid calprotectin testing is a better predictor of mucosal healing than serum biomarkers and it could improve the management of ulcerative colitis patients by decreasing the need for invasive investigations.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S555-S556
Author(s):  
A Yarur ◽  
M Chiorean ◽  
J Zhang ◽  
W Reinisch ◽  
S Vermeire ◽  
...  

Abstract Background Reliable biomarkers of ulcerative colitis (UC) disease activity may be useful in clinical trials and practice. Etrasimod is an oral, selective, sphingosine 1-phosphate receptor modulator with efficacy in a 12-week, phase 2, double-blind (DB), randomised, controlled trial in adult patients with moderately-to-severely active UC (OASIS; NCT02447302). Patients who completed the DB study were eligible to enrol in an open-label extension (OLE; NCT02536404) and receive etrasimod 2 mg once daily for up to an additional 34 weeks. The aim of this post-hoc analysis was to assess the correlation of sequential faecal calprotectin (FC) and C-reactive protein (CRP) levels throughout the DB study and OLE with clinical and endoscopic outcomes at end of treatment (EOT) in the OLE. Methods In the DB study, patients received etrasimod 1 mg, etrasimod 2 mg or placebo. The OLE evaluable cohort comprised patients who received etrasimod 2 mg throughout the OLE. The modified intention-to-treat (mITT) population comprised patients with non-missing assessments. EOT was the last observation for each patient, occurring at week 46 (OLE week 34) for study completers or at last visit for patients who discontinued or had missing data. Endpoints were modified Mayo Clinic score (mMCS; range 0–9; including endoscopy, rectal bleeding [RB], and stool frequency [SF]); clinical remission (endoscopic subscore ≤1 [with absence of friability], RB ≤1, and SF score ≤1 with ≥1 point decrease from DB baseline); clinical response (clinical remission or decrease in mMCS of ≥2 points and ≥30% decrease from DB baseline, with either a RB decrease of ≥1 or RB score of ≤1); and endoscopic improvement (subscore ≤1). FC and CRP were measured longitudinally to EOT. Comparisons between subgroups were assessed with a Wilcoxon rank-sum test (2-sided P values). Analysis of correlation between variables was conducted using the Spearman’s rank coefficient. Results The evaluable cohort included 105 patients, 31 of whom received etrasimod 2 mg throughout both DB and OLE periods. At EOT 70%, 35% and 45% of patients in the mITT evaluable cohort had clinical response, clinical remission and endoscopic improvement, respectively. Differences in FC and CRP levels between patients with and without clinical remission at EOT are shown in Figures 1 and 2, respectively for patients who received etrasimod 2 mg throughout both the DB and OLE periods. Correlation analyses of FC and CRP with clinical (mMCS) and endoscopic disease activity and with each other are shown in Table 1. Conclusion FC and CRP appear to correlate with clinical and endoscopic outcomes over long-term treatment with etrasimod. Additional validation is needed to determine their utility in treat-to-target management strategies.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Eriko Yasutomi ◽  
Toshihiro Inokuchi ◽  
Sakiko Hiraoka ◽  
Kensuke Takei ◽  
Shoko Igawa ◽  
...  

AbstractLeucine-rich alpha-2 glycoprotein (LRG) may be a novel serum biomarker for patients with inflammatory bowel disease. The association of LRG with the endoscopic activity and predictability of mucosal healing (MH) was determined and compared with those of C-reactive protein (CRP) and fecal markers (fecal immunochemical test [FIT] and fecal calprotectin [Fcal]) in 166 ulcerative colitis (UC) and 56 Crohn’s disease (CD) patients. In UC, LRG was correlated with the endoscopic activity and could predict MH, but the performance was not superior to that of fecal markers (areas under the curve [AUCs] for predicting MH: LRG: 0.61, CRP: 0.59, FIT: 0.75, and Fcal: 0.72). In CD, the performance of LRG was equivalent to that of CRP and Fcal (AUCs for predicting MH: LRG: 0.82, CRP: 0.82, FIT: 0.70, and Fcal: 0.88). LRG was able to discriminate patients with MH from those with endoscopic activity among UC and CD patients with normal CRP levels. LRG was associated with endoscopic activity and could predict MH in both UC and CD patients. It may be particularly useful in CD.


Gut ◽  
2013 ◽  
Vol 63 (1) ◽  
pp. 88-95 ◽  
Author(s):  
Laurent Peyrin-Biroulet ◽  
Walter Reinisch ◽  
Jean-Frederic Colombel ◽  
Gerassimos J Mantzaris ◽  
Asher Kornbluth ◽  
...  

Arthritis ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Faiq I. Gorial ◽  
Ali M. Hassan

Background. Ankylosing spondylitis (AS) is a chronic, progressive inflammatory rheumatic disease that leads to structural damage, functional impairment, and decrease in the quality of life. Red cell distribution width (RDW) is a part of the complete blood count (CBC) and estimates erythrocyte variability. Objective. To analyse RDW in patients with AS and to evaluate the relationships with acute phase reactants (APRs) and disease activity index. Patients and Methods. A total of 100 patients with AS (78 males and 22 females) were diagnosed according to the modified New York classification criteria for AS and 146 (99 males: 47 females) healthy individuals matched in age and sex as controls enrolled in the study. Demographic data, disease activity scores using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), medical history, C-reactive protein (CRP), erythrocytes sedimentation rate (ESR), and complete blood count (CBC) were measured. Results. The mean age for patients and controls was 38.0 ± 9.0 and 35.8 ± 9.0 years, respectively (p=0.057). RDW was significantly higher in patients with AS compared with controls (14.133 ± 1.613 versus 12.299 ± 1.031, p < 0.001). There was a direct correlation of RDW with both ESR and CRP (P < 0.001); RDW had r=0.38 for C-reactive protein (CRP) and r=0.413 for ESR. Also BASDAI was directly correlated with RDW (r=0.326 p<0.001). RDW was a valid measure to differentiate between patients with AS and controls (AUC=0,84, p<0.001) and at optimum cut-off value>13% has highest accuracy (78.9%) with very good sensitivity test (81%) and NPV (85.6%) as well as good specificity (77.4%) and PPV (71.1%). Conclusion. RDW was higher in AS patients compared with controls and was directly correlated with ESR, CRP, and BASDAI. RDW was a valid simple measure with good accuracy to differentiate between patients with AS and controls.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S210-S211
Author(s):  
V Jairath ◽  
W J Lee ◽  
W Zhou ◽  
G Heap ◽  
J Butler ◽  
...  

Abstract Background Several histologic indices are available for evaluating mucosal inflammation activity in ulcerative colitis (UC), although there is no consensus regarding which is the most appropriate for evaluating disease activity in clinical trials. Methods The correlation of three histologic indices, the Geboes Score (GS, range of major grade 0 to 5), Robarts Histopathology Index (RHI, range 0 to 33), and Nancy Index (NI, range grade 0 to grade 4) were evaluated in a Phase 2b, multicenter, randomised, double-blind, placebo-controlled study of upadacitinib in patients with moderately to severely active UC. Biopsy data were collected and centrally read using GS at Baseline and week 8; scores of RHI1 and NI2 were derived based on GS. Descriptive statistics, correlational analyses, and stratified analyses were performed in the pooled study population using as observed data. Results Among 250 UC patients enrolled at Baseline, 224, 214, 209 patients with non-missing values of GS, RHI and NI were observed, respectively. At week 8, the GS, RHI, and NI correlated strongly to each other (r = 0.90 to 0.98), and these 3 indices correlated highly with the subgrade of lamina propria neutrophils, erosion or ulceration, neutrophils in the epithelium, and chronic inflammatory infiltrate (Table 1). The Mayo endoscopic subscore (r = 0.62) was found to have higher correlation with GS, RHI and NI, followed by physician global assessment subscore (r = 0.48 to 0.51), rectal bleeding subscore (r = 0.36 to 0.39) and stool frequency subscore (r = 0.31 to 0.33). Faecal calprotectin (r = 0.47 to 0.50) and C-reactive protein (0.36 to 0.39) and total IBDQ score (r = 0.34 to 0.38) were moderately correlated with GS, RHI, and NI. Over 50% of patients with Mayo endoscopic subscore ≤1 were observed among patients scoring GS = 0 (24/41, 59%), GS = 1 (8/15, 53%), GS = 2 (13/26, 50%), RHI≤3 (45/82, 55%), and NI = 0 (40/69, 58%) at week 8. Conclusion In a moderately to severely active UC population, GS, RHI and NI correlate strongly with each other. Higher correlations were found between histologic scores and endoscopic activity than symptom-related disease activity. Further studies are warranted to evaluate the relationship between histological inflammation and long-term clinical outcomes. References Acknowledgements and Funding statement: Design, study conduct, and financial support for the study were provided by AbbVie; Financial support for the study was provided by AbbVie. AbbVie participated in interpretation of data, review, and approval of the abstract. All authors contributed to development of the abstract and maintained control over final content.


Sign in / Sign up

Export Citation Format

Share Document