Simpler Tool Validated for Endoscopic Assessment in Crohn’s

The simplified endoscopic mucosal assessment for Crohn’s disease (SEMA-CD) was confirmed as a reliable and easier-to-use method for recording mucosal changes, a researcher reported.

In the validation study that relied on colonoscopy videos from pediatric and adult clinical trials, SEMA-CD scores highly correlated (Spearman’s ρ 0.89, 95% CI 0.86-0.92) with the Simple Endoscopic Score for Crohn’s Disease (SES-CD), a tool rarely used in clinical practice, according to Jeremy Adler, MD, MSc, of the University of Michigan in Ann Arbor.

SEMA-CD and SES-CD also highly correlated when it came to evaluating pre- and post-treatment score changes or when looking at different age groups, he reported at the virtual Crohn’s & Colitis Congress (CCC):

• Treatment: ρ 0.84 (95% CI 0.77-0.89)
• Children: ρ 0.94 (95% CI 0.90-0.96)
• Adults: ρ 0.86 (95% CI 0.80-0.89)

“It’s not a surprise that the two correlate with one another, but what is surprising is how well they correlate,” Adler told MedPage Today. “The correlation was very strong — stronger than I expected.” And it remained strong regardless of video quality or SES-CD disease severity, according to his presentation.

While the “gold standard” for Crohn’s disease remission in clinical trials is endoscopic assessment of mucosal improvement, scoring tools are often cumbersome and go unused in clinical practice, leaving registries absent of such useful data for research.

Adler said his group designed the scoring system “specifically to create a simple tool to enable clinicians to record standardized endoscopic findings in these registries.”

“This instrument might have potential for use in future clinical trial designs,” noted Dana Lukin, MD, PhD, of Weill Cornell Medicine in New York City, who was not involved in this study, adding that the scoring system may be easier to use in general practice as well.

Intraclass correlation (ICC) for intra- and inter-reader reliability for SEMA-CD were 0.93 (95% CI 0.88-0.96) and 0.89 (95% CI 0.85-0.91), respectively. And nearly all of the 503 readers rated SEMA-CD as at least as easy to use as SES-CD:

• Much easier for 1.4%
• Somewhat easier for 42.9%
• Slightly easier for 18.7%
• The same for 36.6%

SEMA-CD uses a 5-point scale to rank endoscopic severity of the colon and ileum, ranging from normal (0) to severe disease (4) — defined as widespread large ulcers and non-passable stricture or visible fistula. What makes it easier is not having to pay attention to every little detail and segment of the bowel, Adler explained, eliminating the need to count ulcers or estimate surface area percentages of ulceration.

“We need more tools in our toolbox that are easier for interpretation,” commented CCC session moderator Millie Long, MD, MPH, of the University of North Carolina Health at Chapel Hill.

For their validation study, the researchers examined data from colonoscopy videos of 110 Crohn’s disease patients from two ustekinumab (Stelara) trials: 74 adults from the phase IIIb SEAVUE trial and 36 pediatric patients from the phase I UniStar study. Blinded readers viewed the videos and separately scored them using SEMA-CD and SES-CD. Readers used a 7-point Likert scale to rate ease of scoring.

The main outcomes assessed the correlation of SEMA-CD versus SES-CD based on different study populations (adults/pediatric), video quality, and disease severity.

Average age of patients in the UniStar study was 13 years, about two-thirds were girls, and most were white (86%). For SEAVUE, the average age was 37 years, 88% were white, and roughly half were women.

The authors acknowledged their study was limited by the use of very experienced gastroenterologists as central readers.