Sa467 THE MODIFIED MULTIPLIER SES-CD (MM-SES-CD) PERFORMS BETTER THAN THE SES-CD FOR PREDICTION OF ENDOSCOPIC REMISSION IN CROHN'S DISEASE

Abstract

Background and Aims: The Simple Endoscopic Score for Crohn's disease (SES-CD) is the primary tool for measurement of mucosal inflammation, but its prognostic potential remains unclear. We set to develop and validate a modified multiplier of the SES-CD (MM-SES-CD), which takes into consideration each individual parameter's prognostic value for achieving endoscopic remission (ER) while on active therapy. Method(s): This was a post-hoc analysis of CD clinical trial programs, including the UNITI studies (ClinicalTrials.gov identifiers NCT01369329, NCT01369342, NCT01369355, obtained through the Yale Open Data Access Project #2020-4363 by permission from Janssen Inc), the EXTEND study (NCT00348283, used by permission from Abbvie Inc and obtained through VIVLI Protocol #00005567), and from a clinical trial of patients with active CD comparing biosimilar and originator infliximab (NCT02096861, obtained by permission from Celltrion Inc). A total of 350 patients with baseline SES-CD >= 3 and confirmed ulceration were pooled and randomly split into a 70% training cohort and 30% testing cohort. The MM-SES-CD was designed using weights for individual SES-CD parameters as determined by logistic regression modeling, with one-year ER (SES-CD < 3) being the dependent variable. A cut point score for low and high probability of ER was determined by using the maximum Youden Index and validated in the testing cohort. Result(s): Baseline ulcer size, extent of ulceration, and presence of non-passable strictures had the strongest association with one-year ER as compared to affected surface area, with differential weighting of individual parameters across disease segments being observed during logistic regression. The MM-SES-CD was built using this weighted regression model, and it was demonstrated to strongly discriminate for ER in thetraining dataset (area under the curve [AUC] 0.83, 95% CI 0.78-0.94) and in the validation dataset (AUC 0.82, 95% CI 0.77-0.92). The MM-SES-CD scoring model was more accurate than the original SES-CD score (AUC 0.60, 95% CI 0.55-0.65) for predicting the achievement of ER. The maximum Youden index was 0.66, which corresponded to a cut-off value of 45. Overall, participants with a score 45 had low probability of achieving ER (9/110,8.2%). Participants with a score < 45 had a higher probability of ER (69/240, 28.8%). The diagnostic accuracy of the point system cut points is provided in Table 1. Conclusion(s): We developed and internally validated the MM-SES-CD, which has good discriminative performance for prediction of one-year ER in patients with CD on active therapy (Table Presented)Copyright © 2021 AGA Institute