Crohn's Disease Endoscopic Index Of Severity Scores Research Articles

Ileal and Rectal Ulcer Size Affects the Ability to Achieve Endoscopic Remission: A Post hoc Analysis of the SONIC Trial.

It is unclear how baseline endoscopic characteristics in Crohn's disease (CD) affect the ability to achieve endoscopic remission (ER). We aimed to determine the endoscopic prognostic factors that influence achieving ER in CD. This post hoc analysis of SONIC (NCT00094458; YODA #2019-3980) evaluated baseline and week 26 endoscopy indices in 172 patients using the CD Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score for CD. The impact of baseline ulcer depth and size on achieving week 26 ER was assessed using multivariate logistic regression models adjusted for confounders. The ER rate of ileal ulcers was significantly lower than ER rates throughout the colon (P < 0.0001). Ileal ulcers >2 cm were less likely to achieve ER compared with smaller ulcers {odds ratio (OR) 0.31 (95% confidence interval [CI] 0.11-0.89), P = 0.03}. Similarly, rectal ulcers >2 cm were associated with reduced odds of week 26 ER (OR 0.26 [95% CI 0.08-0.80], P = 0.02). Ulcer size in other colonic segments did not affect the achievement of week 26 ER. Deep ileal and rectal ulcers >2 cm compared with smaller or superficial ulcers were even less likely to achieve week 26 ER (ileum: OR 0.10, 95% CI 0.02-0.68, P = 0.02; rectum: OR 0.12, 0.02-0.82, P = 0.03). High baseline Simple Endoscopic Score for CD (≥16) or CDEIS scores (≥12) did not affect achieving week 26 ER. Patients with larger and deep ulcers in the ileum or rectum may have difficulty achieving ER. Overall degree of endoscopic inflammation as measured numerically by endoscopic scores does not affect the likelihood of achieving week 26 ER.

Development and Validation of a Simplified Magnetic Resonance Index of Activity for Crohn's Disease.

The magnetic resonance index of activity (MARIA) for Crohn's disease (CD) is used to assess the activity of luminal CD. However, it has a number of practical limitations. We aimed to develop and validate a simplified MARIA to more easily and quickly assess CD activity and response to therapy. We performed a retrospective analysis of magnetic resonance imaging data from 98 participants in 2 studies. We used logistic regression analysis to identify magnetic resonance imaging parameters independently associated with CD endoscopic index of severity (CDEIS) scores (the reference standard). We validated the responsiveness and reliability of the simplified MARIA in an independent cohort of 37 patients who underwent magnetic resonance imaging and endoscopy before and after a therapeutic intervention. Logistic regression analysis showed that dichotomous qualitative assessment of wall thickening (>3 mm), presence of mural edema, perienteric fat stranding, and ulcers were independently associated with CDEIS scores; we used these factors to create a simplified MARIA. Simplified MARIA scores greater than 1 identified segments with active CD with 90% sensitivity and 81% specificity (area under the curve 0.91; 95% confidence interval 0.88-0.94). Simplified MARIA scores of 2 or more detected severe lesions (ulcers) with 85% sensitivity and 92% specificity (area under the curve 0.94; 95% confidence interval 0.91-0.96). For each patient, there was a high level of correlation between simplified MARIA scores and CDEIS scores (r= 0.83) and simplified MARIA scores and original MARIA scores (and r= 0.93) (P < .001). The simplified MARIA score accurately detected changes in lesion severity in response to therapy and was as reliable as endoscopy for the assessment of mucosal healing. We developed and validated a simplified MARIA for easier and faster assessment of CD activity and severity. This index identifies patients with a response to therapy with a high level of accuracy. These findings require confirmation in independent, multireader studies.

Assessing the Variability Between Endoscopic Scoring Indices for Evaluation of Crohnʼs Disease Activity

Introduction: Crohn's disease endoscopic index of severity (CDEIS) and simple endoscopic score for Crohn's disease (SES-CD) are considered as gold standards to assess the state of mucosal disease in CD patients and determine the outcome of clinical trials that utilize mucosal healing as an endpoint. Although a linear offset between CDEIS and SES-CD is widely accepted, a closer look at the accuracy and impact of using the two scoring indices has not been adequately explored.Figure: Contingency tables pre- and post-normalization of CDEIS and SES-CD scores.Methods: Both CDEIS and SES-CD scores were collected at the same time in a centrally read, prospectively collected, longitudinal cohort of 118 CD patients in the TAILORIX clinical trial. Up to 3 endoscopic scores were available from each patient over a period of 1 year. Standard disease severity definitions were applied to both CDEIS and SES-CD scores. CDEIS scores were classified as remission < 3, mild 3-8, moderate 9-12, and severe >12. For SES-CD the same groups were defined as < 3, 3-6, 7-15, and >15, respectively. The two indices were normalized using linear regression and contingency tables were created for both pre- and post-normalization for the categorical outcomes of those endpoints. Results: Using the raw CDEIS and SES-CD scores, a contingency table (Table 1; Non-adjusted Agreement) showed that the overall agreement in disease severity states (Remission, Mild, Moderate and Severe) was only 59% (241/411). 33% (58/175) of the scores deemed as disease in remission by CDEIS were classified as active disease by SES-CD. Likewise, 81/146 (˜56%) of mild disease classifications by CDEIS were suggested to have moderate disease with SES-CD. After applying the observed linear regression equation (CDEIS = 0.25 + 0.69*SESCD; r = 0.92) to normalize the two scores the overall agreement improved to 80% (Table 1; Normalized Agreement). Conclusion: Although CDEIS and SES-CD scores correlate well and are often considered as endoscopic gold standard endpoints, our data demonstrates that the two are not equivalent as their ‘endoscopic categorical calls' are in agreement only 59% of the time. The data further shows that even after accounting for their known offset, their agreement is still only 80%. These results highlight the difference in the two currently accepted gold standards and elucidate the importance and clinical unmet need for establishing a single objective score to assess the mucosal state in patients with CD.

Endoscopic scoring indices for evaluation of disease activity in Crohn’s disease

Endoscopic assessment of mucosal disease activity is widely used to determine eligibility and response to therapy in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently available endoscopic indices remain unclear. A systematic review was undertaken to evaluate the development and operating characteristics of the Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Scale for Crohn's Disease (SES-CD). Electronic searches of the MEDLINE (1966 to December 2015), EMBASE (1980 to December 2015), and Cochrane CENTRAL Register of Controlled Trials (Issue 12, 2015) databases were supplemented by manual reviews of reference listings and conference proceedings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organization). Any study design (e.g. randomized controlled trials, cohort studies, case series) that evaluated either or both the CDEIS or SES-CD in patients with Crohn's disease was considered for inclusion. Eligible participants were adult patients (> 16 years), diagnosed with Crohn's disease using conventional clinical, radiographic, and endoscopic criteria. Two authors (RK, JKM) independently reviewed the titles and abstracts of the studies identified from the literature search. The full texts of potentially relevant citations were reviewed for inclusion and the study investigators were contacted to clarify any unclear data. Any disagreements were resolved by discussion and consensus with a third author. A standardized form was used to assess eligibility of trials for inclusion in the study and for data extraction.Two authors independently extracted and recorded data (RK, SAN). The number of patients enrolled; number of patients per treatment arm; patient characteristics including age and gender distribution; endoscopic index; and outcomes such as intra-rater reliability, inter-rater reliability responsiveness, validity, feasibility, construct validity, and criterion validity were recorded for each trial. Forty-three reports of 30 studies fulfilled the inclusion criteria.For the SES-CD, inter-rater reliability was assessed in four studies. In the development study for the SES-CD (Daperno 2004), the overall ICC (0.9815, 95% CI 0.9705 to 0.9884) and the kappa for the regions is high; however the paired raters were in the same room which introduces the potential for bias.For the CDEIS, inter-rater reliability was assessed in six studies. Daperno 2014 reported that the ICC for the CDEIS was 0.985 (95% CI 0.939-1.000) for average measures of video score and was 0.835 (95% CI 0.540-0.995) for single measures of video score.With respect to validity, correlation between the CDEIS and clinical measures, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), was also reported. The estimates of correlation with CRP were r = 0.521 (Sipponen 2010b), r = 0.553 (Sipponen 2008a) and r = 0.608 (Sipponen 2008c). For the SES-CD, the corresponding values for correlation with CRP ranged from r = 0.46 (Jones 2008) to r = 0.68 (Green 2011).Responsiveness data for the CDEIS were available in nine studies. Seven studies demonstrated statistically significant decreases in the CDEIS score after administration of a treatment of known efficacy. Minimal responsiveness data were available for the SES-CD. Sipponen 2010a and Sipponen 2010b demonstrated statistically significant changes in the SES-CD score after subjects were administered a treatment of known efficacy.No studies were identified that explicitly evaluated the feasibility for either the SES-CD or the CDEIS. The SES-CD requires fewer calculations and may therefore be easier to use than the CDEIS. Although they are used in clinical trials, the CDEIS and SES-CD remain incompletely validated. Future research is required to determine the operating properties and to define the optimal index.

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Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol

ObjectiveTo evaluate the efficacy of certolizumab pegol (CZP) in improving endoscopic lesions in patients with active ileocolonic Crohn's disease (CD).MethodsThis phase IIIB multicentre open-label clinical trial enrolled 89 adult patients...

Circulating Cytokines Reflect Mucosal Inflammatory Status in Patients with Crohn’s Disease

There is a great need for a simple activity assessment tool that can reliably predict activity in patients with Crohn's disease (CD). To investigate the relationship between serum cytokines and endoscopic activity of CD using Crohn's Disease Endoscopic Index of Severity (CDEIS) as a gold standard. We prospectively evaluated 32 firmly established CD patients using ileocolonoscopy, CDEIS score, and Crohn's Disease Activity Index (CDAI) score. Blood samples for cytokine analysis were obtained 1 day prior to procedure. The correlation between CDEIS and CDAI was moderate (r = 0.43; P = 0.01); however, the correlation between CDEIS and inflammatory cytokines was excellent, with the highest coefficients for tumor necrosis factor alpha (TNFalpha) and interleukin-6 (IL-6) (r = 0.96 and r = 0.96, respectively; P < 0.001). CDEIS and anti-inflammatory cytokines were correlated nonlinearly (power function). We identified two separate models for predicting CDEIS value, based on the best performing pro-inflammatory [CDEIS = 0.445 x (IL-6) - 5,143] and anti-inflammatory [CDEIS = 27.478 x (IL-10)(-0.71)] cytokines. Both IL-6 and IL-10 models had high adjusted R(2) values (0.916 and 0.954, respectively). IL-6 had excellent diagnostic accuracy for detecting patients with CDEIS >7 (active disease), with area under the receiver operating characteristic (ROC) curve of 1.0 [95% confidence interval (CI) = 0.89-1.0; P < 0.001]. Serum cytokine levels are excellent predictors of endoscopic activity in patients with CD.