Novel endpoint is ‘reliable’ for assessment of endoscopic improvement in Crohn’s
Click Here to Manage Email Alerts
The simplified endoscopic mucosal assessment of Crohn’s disease is highly effective in evaluating endoscopic improvement in patients, according to results presented at the Crohn’s and Colitis Congress.
“SEMA-CD is reliable, it is reproducible, and it is sensitive to change from before to after treatment,” Jeremy Adler, MD, MSc, clinical associate professor of pediatric gastroenterology at C.S. Molt Children’s Hospital at the University of Michigan, told attendees. “It is validated for use in both adult and pediatric patients and is considerably easier to use than SES-CD. Routine use of the SEMA-CD should enhance the quality of real-world evidence recorded in registries and recorded in clinical practice.”
Adler and colleagues compared simple endoscopic scores for CD (SES-CD) with the simplified endoscopic mucosal assessment of CD (SEMA-CD) in 110 patients with existing pre- and post-treatment colonoscopy videos from two ustekinumab clinical trials.
Different central readers, blinded to one another’s score and to clinical history, scored the videos with SEMA-CD and SES-CD. The correlation between scores under different study populations (pediatric vs. adult), disease severity and video quality was assessed with Spearman’s rank correlation coefficient. The 7-point Likert scale was used to rate the ease of SEMA-CD.
Researchers found that SEMA-CD was highly associated with SES-CD (0.86 vs. 0.92). There was a significant association between the pre-and post-treatment changes in SEMA-CD vs. SES-CD (0.77, 0.89), and the relationship remained strong between scores in pediatric (0.94) and adult patients (0.86) and across SES-CD disease severity categories. Both the inter- and intra-reliability were high, 0.93 and 0.89, respectively.
“SEMA-CD should be adopted as an endoscopic endpoint for clinical trials, in addition to registry-based research,” Adler and colleagues concluded.
Collapse
Click Here to Manage Email Alerts