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. 2023 Jul 5;29(7):1089-1097.
doi: 10.1093/ibd/izac183.

Validating the Simplified Endoscopic Mucosal Assessment for Crohn's Disease: A Novel Method for Assessing Disease Activity

Jeremy Adler  1   2 , Richard B Colletti  3 , Lenore Noonan  4 , Tyler M Berzin  5 , Adam S Cheifetz  5 , Laurie S Conklin  4 , Timothy C Hoops  6 , Christopher S Huang  7 , Blair Lewis  8 , Daniel S Mishkin  9 , Kim Hung Lo  4 , Yongling Xiao  10 , Sheri Volger  4
Affiliations

Validating the Simplified Endoscopic Mucosal Assessment for Crohn's Disease: A Novel Method for Assessing Disease Activity

Jeremy Adler et al. Inflamm Bowel Dis. .

Abstract

Background: To demonstrate treatment efficacy in Crohn's disease (CD), regulatory authorities require that trials include an endoscopic remission/response end point; however, standardized endoscopic assessment of disease activity, such as the Simple Endoscopic Score for Crohn's Disease (SES-CD), is not typically recorded by clinicians in practice or outside of clinical trials. The novel Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) was developed to be easy to use in routine clinical practice and as a trial end point. We conducted a study to assess and validate the reliability and feasibility of SEMA-CD as a measure of endoscopic disease activity.

Methods: Pre- and post-treatment ileocolonoscopy videos of pediatric (n = 36) and adult (n = 74) CD patients from 2 ustekinumab clinical trials were each scored with SEMA-CD by 2 to 3 professional central readers, blinded to clinical history and other video scorings; the correlation between SEMA-CD and SES-CD previously completed during the trials was assessed. Sensitivity to change, inter- and intrarater reliability, and comparative ease of scoring were also assessed.

Results: The SEMA-CD strongly correlated with SES-CD (Spearman ρ = 0.89; 95% confidence interval, 0.86-0.92). Pre- to post-treatment changes in SEMA-CD vs in SES-CD were strongly correlated, and the correlation remained strong between the scores when compared by study population (pediatric, adult), disease severity, and video quality. Intra- and inter-rater reliability were good, and SEMA-CD was rated easier than SES-CD to score 63.0% of the time, although slightly more difficult than SES-CD to score <1.0% of the time.

Conclusions: The SEMA-CD is reliable, reproducible, sensitive to change, and easy to use in both pediatric and adult patients with CD.

Keywords: Crohn’s disease; SEMA-CD; SES-CD; endoscopic disease activity; validation.

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Conflict of interest statement

J.A. has received research grants/funding from Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson).

T.M.B. has acted in a consultancy role for Medtronic, Boston Scientific, Docbot AI, and Wision AI.

A.S.C. has acted in a consultancy role for Abbvie, Arena, Artizan (SAB), Artugen, Bacainn, BMS, Equillium, Grifols, Janssen, Pfizer, Procise, Prometheus (SAB), Samsung, and Takeda.

R.B.C. has acted in a consultancy/advisory role for Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson).

L.S.C. is an employee of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson) and owns Johnson & Johnson stock and/or stock options.

T.C.H. is an employee of Immunology Global Medical Affairs, Janssen Pharmaceutical Companies (a subsidiary of Johnson & Johnson) and owns Johnson & Johnson stock and/or stock options.

C.S.H. has no disclosures to report.

B.L. has no disclosures to report.

K.H.L. is an employee of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson) and owns Johnson & Johnson stock and/or stock options.

D.S.M. owns GI Reviewers, LLC.

L.N. is an employee of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson) and owns Johnson & Johnson stock and/or stock options.

S.V. is an employee of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson) and owns Johnson & Johnson stock and/or stock options.

Y.X. is an employee of Cytel, Inc., Waltham, MA, USA, and has acted in a consultancy/advisory role for Janssen Research & Development, LLC.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
Scatter plot demonstrating the correlation of SEMA-CD with SES-CD (ρ = 0.89; 95% CI, 0.86-0.92). Abbreviations: CI, confidence interval; SEMA-CD, Simplified Endoscopic Mucosal Assessment for Crohn’s Disease; SES-CD, Simplified Endoscopic Activity Score for Crohn’s Disease. Each point in the figure corresponds to a video scored using SEMA-CD and SES-CD. For SEMA-CD, each video was scored by 2 readers with a third reader included for adjudication as needed. The median SEMA-CD of all readings for each video was used in the analysis.
Figure 2.
Figure 2.
Scatter plot demonstrating the correlation of change from pre- to post-treatment in SEMA-CD and change from pre- to post-treatment in SES-CD (ρ = 0.84; 95% CI, 0.77-0.89). Abbreviations: CI, confidence interval; SEMA-CD, Simplified Endoscopic Mucosal Assessment for Crohn’s Disease; SES-CD, Simplified Endoscopic Activity Score for Crohn’s Disease. Each point in the figure corresponds to change in scores from pre- to post-treatment that was measured using SEMA-CD and SES-CD for each patient. For SEMA-CD, each video was scored by 2 readers with a third reader included for adjudication as needed. The median SEMA-CD of all readings for each video was used in the analysis.
Figure 3.
Figure 3.
Usability of SEMA-CD vs SES-CD by number of videos scored (percent). Abbreviations: n, number of videos; SEMA-CD, Simplified Endoscopic Mucosal Assessment for Crohn’s Disease; SES-CD, Simplified Endoscopic Activity Score for Crohn’s Disease.
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