gMS-Classifier1 Serum Assay Is Associated with Faster Relapsing-Remitting Multiple Sclerosis (RRMS) Disability Progression, Reaching Expanded Disability Status Scale (EDSS) >= 4.0 - A Retrospective Analysis (P02.092)

Objective: Explore association between gMS-Classifier1 status and risk for fast progression to EDSS≥4.0 in RRMS patients. Background Positive gMS-Classifier1 serum immunoassay, based on IgM antibodies against glycan antigens (anti-GAGA panel) was associated with fast progression by EDSS≥1.0 point in the accelerated cure project (ACP) RRMS cohort. We have further explored its association with fast progression to EDSS≥4.0 on an extended ACP cohort. Design/Methods: Selection criteria for frozen sera from ACP: Two EDSS records separated by ≥6 months, first available EDSS record Results: Selection criteria were met by 120 patients, median (IQR) EDSS at first and second visits were 1.5 (1.5-2.0) and 2.0 (1.5-2.5), respectively. Median (IQR) time between first and second records was 1050 (473-1958) days. The 75-percentile time to progress to EDSS≥4.0 was significantly faster for gMS-Classifier1 positive patients (n=36, 2000 days) than negative patients (n=84, did not reach 75-percentiles, HR 11.8 95%CI 1.6-88.7, p=0.005 log-rank). gMS-Classifer1 (HR 13.0, 95%CI 1.3-127.6) and duration of disease (HR 0.66, 95%CI 0.44-0.99) were the only variables staying in the Cox model (p-value=0.0003). Similar associations were found for faster progression to EDSS≥3.0 (HR 3.5, 95%CI 1.2-10.1 p-value=0.02) and for fast progression by EDSS≥1.0 point (HR 4.2, 95%CI 1.3-14.0 p-value=0.02). Conclusions: In this retrospective analysis of RRMS patients, gMS-Classifier1 positive status was an independent variable for association with faster disability progression to EDSS≥4.0. A prospective analysis is required to verify the predictive value of this association. Supported by: Glycominds. Disclosure: Dr. Yarden has received personal compensation for activities with Glycominds Ltd. Dr. Yarden holds stock and/or stock options in Glycominds. Dr. Schmidt has nothing to disclose. Ms. Spector has received personal compensation for activities with Glycominds Ltd as an employee. Ms. Spector holds stock and/or stock options in Glycominds Ltd. Mr. Rimer has received personal compensation for activities with Glycominds as an employee. Dr. Loud has nothing to disclose. Dr. Dotan has received personal compensation for activities with Glycominds Ltd. as an employee.Dr. Dotan holds stock and/or stock options in Glycominds Ltd., which sponsored research in which Dr. Dotan was involved as an investigator.