A novel method of quantifying disease activity and severity in Crohn's disease that aims to be simpler and easier to use in clinical practice than the current standard appears to offer reliable and reproducible results, suggests a study of clinical trial data.
The Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) was tested on ileocolonoscopy videos taken in more than 100 adult and pediatric patients with Crohn's disease who had participated in two clinical trials of ustekinumab (Stelara).
The novel tool was found to be strongly correlated with the widely used Simple Endoscopic Score for Crohn's Disease (SES-CD) in assessing Crohn's disease activity, regardless of disease severity, video quality, and patient population.
The research also suggested that the SEMA-CD, which was typically rated as easier to use than its predecessor, could reliably track pre- to post-treatment changes.
"SEMA-CD may be a valuable method for assessing both clinically meaningful improvements in mucosal disease activity and the effectiveness of CD treatments," write the researchers.
The findings were published online in Inflammatory Bowel Diseases.
Ready to Put Into Practice
The tool is "ready to be used by physicians," lead author Jeremy Adler, MD, MSc, clinical professor, C.S. Mott Children's Hospital, Michigan Medicine, University of Michigan, Ann Arbor, told Medscape Medical News.
Provation, which produces clinical documentation software for endoscopies, has already included the SEMA-CD in its latest software updates, he noted.
The study population was limited to clinical trial participants, who might not be "reflective of real-world patients," Adler said. "However, the range of severity and findings at the colonoscopies really did mirror what is seen in practice, so I don't expect this to be a problem."
The researchers say that the adequate assessment of mucosal activity in Crohn's disease requires a "simple, standardized method" for quantifying findings on ileocolonoscopy.
Although the SES-CD is "often used" for assessing disease activity and severity on endoscopy in clinical trials, "it can be too complex and time-consuming for clinicians to use in everyday practice," they write.
It requires the endoscopist "to keep a mental note of how ulcerated every segment of the bowel is, how big the ulcers were, and how much inflammation there is separate from ulcers," Adler explained.
"The endoscopist has to basically memorize all this and record all the details at the end of the procedure or dictate to an assistant as they go," he added. "That might work for a clinical trial, but physicians just don't do that in regular day practice."
The researchers therefore developed the SEMA-CD to offer an "easy but accurate" method for quantifying disease activity and severity in real-world practice.
The tool, which scores patients from 0-4 on a scale from endoscopic remission to severe disease, is "much simpler" than the SES-CD, with "no need to keep track of details," Adler said.
"It's a very straightforward recording of mild-moderate-severe, et cetera, and very much the way clinicians think," he added.
Retrospective Analysis of Two Clinical Trials
After a successful pilot study, the researchers conducted a retrospective analysis of two clinical trials of ustekinumab in Crohn's disease:
STELARA, a phase 1, randomized, double-blind, pharmacokinetic in pediatric patients; and
The researchers collated ileocolonoscopy videos and SES-CD scores from all patients in STELARA, also known as the UniStar study, and a random sample of those from SEAVUE. After the videos were anonymized, four central readers scored them using the SEMA-CD.
Thirty-six pediatric patients were included from STELARA, of whom 86.1% were White, 63.9% were female, and 75.0% were aged 12-17 years. The median age at diagnosis was 8.9 years, and the median disease duration was 3.8 years.
In addition, 74 adult patients were included from SEAVUE, among whom 87.8% were white, 51.4% were female, and 71.6% were aged 18-44 years. The median age at diagnosis was 29.9 years, and the median disease duration was 3.4 years.
Across the study population, the median SES-CD score was 13, with 40.9% of patients deemed to have moderate disease and 35.5% severe disease.
The researchers found that scores on the SEMA-CD correlated strongly with those on the SES-CD, at a Spearman correlation coefficient (SCC) of 0.89, and in both pediatric patients (SCC, 0.94) and adult patients (SCC, 0.86).
There was a strong correlation between the two assessment tools when patients were analyzed by disease severity, at an SCC of 0.85 for patients with inactive disease, 0.69 for those with mild disease, 0.72 for those with moderate disease, and 0.83 for patients with severe disease.
The researchers also note a strong correlation between the SEMA-CD and SES-CD in the overall change from pre- to post-treatment scores, at an SCC of 0.84.
In terms of the usability of the SEMA-CD, it was rated as slightly, somewhat, or much easier to use than the SES-CD 63.0% of the time, as equal to the SES-CD in terms of usability 36.6% of the time, and slightly more difficult to use 0.4% of the time.
Finally, there was a strong correlation between the two scores across levels of video quality, at an SCC of 0.88 for readable, but not optimal, videos, and 0.90 for videos deemed to be optimal.
A Need for Better Scoring
Approached for comment, Miguel Regueiro, MD, chair, Digestive Disease & Surgery Institute, Cleveland Clinic, Ohio, told Medscape Medical News that there is "a need for gastroenterologists to better score endoscopic findings in inflammatory bowel disease."
"Currently, many do not use scores, and the description of 'inflammation in the colon' is not precise," he said.
"Personally, I have been using the SES-CD in clinical practice, not just research, for years," Regueiro added. It is "incorporated into our endoscopy reporting system, and easy to click on the different variables."
Consequently, while "not sure" that the introduction of the SEMA-CD "would change practice, if SEMA-CD were validated and this increased the rates of gastroenterologists using the score, I would be all for it," concluded Regueiro.
The study was funded by Janssen Research & Development, LLC. Adler declares a relationship with Janssen Research & Development, LLC. Other authors also declare numerous relationships. Regueiro declares relationships with AbbVie, Janssen, UCB, Takeda, Pfizer, Miraca Labs, Amgen, Celgene, Seres, Allergan, Genentech, Gilead, Salix, Prometheus, Lilly, TARGET Pharma Solutions, ALFASIGMA, S.p.A., BMS, CME Outfitters, Imedex, GI Health Foundation (GiHF), Cornerstones, Remedy, MJH Life Sciences, Medscape, MDEducation, WebMD, and HMPGlobal.
Inflamm Bowel Dis. Published online September 1, 2022. Full text
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Cite this: Novel Tool Aims to Simplify Crohn's Disease Assessment - Medscape - Sep 29, 2022.