Abstract Details

Title Real-World Experience with Ocrelizumab

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-059

Objective Evaluate effectiveness, safety and tolerability of ocrelizumab in clinical practice.

Background This study evaluates the generalizability of data from ocrelizumab phase 3 clinical trials to a real-world setting.

Design/Methods This is a prospective longitudinal cohort study. Patients were identified by chart review and data was abstracted from the electronic medical record. Patients had to be 18-75 years old, start ocrelizumab after regulatory approval, be followed clinically for at least 6 months prior to starting ocrelizumab, have a confirmed diagnosis of multiple sclerosis (MS), and have a relapsing-remitting (RR) or primary progressive (PP) disease course. Demographic data, disease duration, prior disease modifying therapies, baseline and monitoring MRIs, screening and monitoring laboratory assessments, infusion-related reactions (IRRs), on-treatment side effects, and quantitative neuroperformance and patient-reported outcomes were collected.

Results As of 5/14/18, 748 patients have been treated with ocrelizumab at our center. We report the results of the first 272 patients with 6-month follow up. 208 had RRMS and 64 had PPMS. Demographics were similar to the clinical trial population: median age 47, 60.0% women, 84.8% white, 11.6% black. Compared to clinical trials, our population had a longer disease duration (13 vs. 7 years) and fewer patients had enhancing lesions at baseline (36% vs. 38-43% for RRMS, 17.6% vs. 27.5% for PPMS). At 6 months, 14 (5.2%) of patients had a CD19 B-cell count within normal range. 10 (3.7%) were treated for a clinical relapse. 9 (3.3%) had a serious adverse event. 57 (21.0%) had an infection, most commonly UTI or URI. 49 (18.0%) had an IRR.

Conclusions Ocrelizumab is a highly effective treatment for MS. Rates of adverse events are lower than reported in clinical trials, possibly due to differences in reporting. Compared to clinical trials, patients at our center had different disease characteristics, with longer disease durations and fewer enhancing lesions at baseline.

Authors/Disclosures
Brandon P. Moss, MD (Cleveland Clinic Mellen Center) PRESENTER	An immediate family member of Dr. Moss has stock in Pfizer. The institution of Dr. Moss has received research support from Novartis. The institution of Dr. Moss has received research support from Genentech.
Erica H. Parrotta, DO (Saint Peters Health Partners MS & Headache Center)	No disclosure on file
Laura E. Baldassari, MD, MHS (US Food and Drug Administration)	No disclosure on file
Jeffrey A. Cohen, MD (Cleveland Clinic)	Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion.
Daniel Ontaneda, MD, PhD, FAAN (Cleveland Clinic)	Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech/Roche. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen Idec. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. The institution of Dr. Ontaneda has received research support from NIH. The institution of Dr. Ontaneda has received research support from PCORI. The institution of Dr. Ontaneda has received research support from NMSS. The institution of Dr. Ontaneda has received research support from Genetech.

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