Symptom stability throughout Ocrelizumab infusion cycle in patients with Multiple Sclerosis: final results of SYMptom Burden on Ocrelizumab, a Longitudinal Study (SYMBOLS) (P7-3.017)

Abstract

<h3>Objective:</h3> To determine whether symptom burden in Ocrelizumab (OCR)-treated MS patients varies over the 6-month infusion cycle. <h3>Background:</h3> OCR is a humanized anti-CD20 antibody therapy for multiple sclerosis (MS) given at 6-month intervals. Some patients report an increase in symptoms toward the end of the infusion cycle (“wearing off”). <h3>Design/Methods:</h3> One-year, prospective, observational, two-center study (NCT04855617) enrolled MS patients aged 18–80 with EDSS scores between 0–7 who were treated with OCR for ≥ 1 year or were initiated on OCR. All patients were followed at NYU MS Care Center (NYU), New York, NY, and the Elliot Lewis MS Center (ELC), Wellesley, MA. Patients completed NeuroQol short forms, SymptoMScreen, work productivity (WPAI:MS), and medical screening questionnaires at 4-, 12-, and 24-weeks post-infusion for two consecutive infusion cycles as well as a post-study completion questionnaire. <h3>Results:</h3> 115 participants were included in the study (n=53 NYU/n=62 ELC); 64% were female; 36% - non-White; baseline age - 46.2±12.5 years; disease duration −15.3±10.7 years; OCR treatment duration - 2.54 ±1.04 years; median (IQR) EDSS - 3.0 (1.5, 5.3); EDSS was &gt;= 4 in 48 patients (42%). Paired Wilcoxon nonparametric tests used to evaluate the changes in outcome scores from pre- to post-infusion showed no significant changes on any NeuroQol and SymptoMScreen scales. Scores on two WPAI-MS subscales (“impairment while working due to health” and “overall work impairment”) increased by 10% during the 2^nd cycle (p-values=0.02 and 0.001) but not the 1^st cycle. On the post-completion questionnaire, the percentage of patients who reported ‘wearing off’ always was 4%, usually - 33%, sometimes - 45%, and never - 17%. <h3>Conclusions:</h3> Although symptom burden remained stable throughout two OCR infusion cycles on multiple scales, most patients reported “wearing off” at least sometimes. We will discuss possible explanations for this discrepancy. <b>Disclosure:</b> Dr. Kister has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech-Roche. The institution of Dr. Kister has received research support from Genentech. Dr. Kister has received publishing royalties from a publication relating to health care. Prof. Oh has nothing to disclose. Ms. Douglas has nothing to disclose. Ms. O’Shea has nothing to disclose. An immediate family member of Tamar Bacon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of an immediate family member of Tamar Bacon has received research support from Gentech. An immediate family member of Tamar Bacon has received publishing royalties from a publication relating to health care. Dr. Bouley has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Banner Life Sciences. Dr. Bouley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Bouley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Bouley has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Bouley has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Bouley has received research support from Novartis. Dr. Lathi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. The institution of Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Theraputics. The institution of Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jansen Pharmaceuticals. The institution of Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viela Bio. The institution of Dr. Katz has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Katz has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sanofi-Genzyme. The institution of Dr. Katz has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. The institution of Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD-Serono.