To demonstrate the treatment efficacy in Crohn′s disease (CD), regulatory authorities require that trials include an endoscopic remission/response endpoint. However, standardized endoscopic assessment of disease activity, such as the Simple Endoscopic Score for Crohn′s Disease (SES-CD), is not typically documented by clinicians in practice or beyond clinical trials.

The novel Simplified Endoscopic Mucosal Assessment for Crohn′s Disease (SEMA-CD) felicitated the easy use in routine clinical practice and a trial endpoint. A recent study assessed and validated the reliability and feasibility of SEMA-CD as a measure of endoscopic disease activity.

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 professionals. They also assessed the correlation between SEMA-CD and SES-CD previously completed during the trials. Furthermore, they evaluated Sensitivity to change, inter- and intra-rater reliability, and comparative ease of scoring.

The study found-

• A strong correlation between SEMA-CD and SES-CD.
• A strong correlation between Pre- to post-treatment changes in SEMA-CD vs. in SES-CD, which remained strong when compared by study population (pediatric, adult), disease severity, and video quality.
• Good Intra- and inter-rater reliability.
• SEMA-CD 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.

This study proves SEMA-CD to be reliable, reproducible, sensitive to change, and easy to use in pediatric and adult CD patients.

Adler J, Colletti RB, Noonan L, et al. Validating the Simplified Endoscopic Mucosal Assessment for Crohns Disease: A Novel Method for Assessing Disease Activity. Inflamm Bowel Dis. 2022 Sep 1;izac183. doi: 10.1093/ibd/izac183. https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00276-X/fulltext