The following is a summary of “Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn’s Disease,” published in the April 2024 issue of Gastroenterology by Khanna, et al.

Regulatory guidance outlines co-primary efficacy endpoints for Crohn’s disease (CD) trials.

Researchers conducted a retrospective study to evaluate the performance of common disease activity assessments used individually and combined.

They analyzed endoscopic and clinical data from 129 participants in the Study of Biologic and Immunomodulator Naïve Patients in the CD trial. Readers evaluated the Simple Endoscopic Score for CD (SES-CD) and the CD Endoscopic Index of Severity (CDEIS) using agreed-upon methods. The reliability of the indices was assessed with intraclass correlation coefficients. Treatment responsiveness was gauged using standardized effect sizes linked to treatment assignments. Outcomes were evaluated to optimize sensitivity to treatment effects.

The results showed strong inter-rater reliability for continuous use of the SES-CD and CDEIS (intraclass correlation coefficient, 0.64; 95% CI, 0.50-0.73; and 0.62, 95% CI, 0.36-0.77), compared to moderate reliability when dichotomized (0.46; 95% CI, 0.26-0.65; and 0.51; 95% CI, 0.00-0.78). SES-CD, CDEIS, patient-reported outcome-2, and CD Activity Index showed similar responsiveness (standardized effect size, 0.43, 95% CI, 0.05-0.81; 0.38, 95% CI, 0.0-0.76; 0.53, 95% CI, 0.15-0.91). A composite outcome of CD Activity Index score <150 and CDEIS score <6 demonstrated the highest sensitivity to treatment effect (28.9%; 95% CI, 11.0%-46.8%; P=.003).

Investigators found endoscopic measures more reliable continuously, while composite outcomes with endoscopy enhanced treatment effect detection.

Source: academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izae089/7658207