Clinical trials are required to include an endpoint of endoscopic remission in validating the efficacy of therapies for Crohn disease (CD), but the simple endoscopic score of Crohn disease (SES-CD) “is not typically recorded by clinicians in practice or outside of clinical trials,” Jeremy Adler, MD, from the University of Michigan, explained at the Crohn’s & Colitis Congress 2022 on January 22.

However, he explained, a “previous study demonstrated the Simplified Endoscopic Mucosal Assessment of CD (SEMA-CD) correlates strongly with SES-CD and is a score that can be easily used by clinicians in routine.”

Adler and colleagues conducted a study “to validate the SEMA-CD scored colonoscopy videos in additional populations and to examine the reliability of SEMA-CD over a range of mucosal disease severity in pediatric and adult participants and to evaluate sensitivity to change over time.”

The researchers compared scores on both SEMA-CD and SES-CD of 110 patients on existing pre- and post-treatment colonoscopy videos from the UNISTAR pediatric and SEAVUE adult clinical trials for ustekinumab. Different central readers, blinded to other scores and to clinical histories, separately scored these videos with the SEMA-CD and SES-CD. “Spearman’s rank correlation coefficient was used to evaluate correlation between scores, under different settings by study population (pediatric, adult), disease severity, and video quality. Inter- and intra-rater reliability were assessed with interclass correlation coefficient (ICC),” Adler explained.

“SEMA-CD was highly correlated (rho [95% CI]) with the SES-CD, 0.89 (0.86, 0.92),” the authors wrote in the abstract. “Pre-to post-treatment changes in SEMA-CD scores compared with SES-CD scores were highly correlated 0.84 (0.77, 0.89),” in both pediatric and adult patients, as well as across SES-CD disease severity categories and in videos with both “optimal” and “less than optimal” quality.

The readers also rated the ease of scoring with SEMA-CD using a 7-point Likert scale; SEMA-CD was rated equal to or easier than SES-CD more than 99% of the time.

“This study demonstrated the SEMA-CD is feasible, reliable, reproducible, and sensitive to change in both adult and pediatric patients with CD,” the abstract stated. “SEMA-CD should serve as an easy score for clinicians to record mucosal improvement and provide quality real world evidence for research using data from clinical registries.”

--Rebecca Mashaw

Reference:

Adler J, Colletti R, Noonan L, et al. Validation of the simplified endoscopic mucosal assessment of Crohn’s disease (SEMA-CD); a novel endpoint to assess endoscopic improvement with real world data. Presented at: Crohn’s & Colitis Congress 2022. January 22, 2022. Virtual