Abstract Details

Title A Retrospective Chart Review of the Safety and Tolerability in Ocrelizumab in Pediatric and Young-Adult Onset Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 9-003

Objective To determine the safety and tolerability of ocrelizumab in young multiple sclerosis (MS) patients.

Background Pediatric and young adult-onset MS often has a more aggressive course early than adult-onset MS, and evidence is accumulating supporting the use of early highly-effective therapy, such as anti-CD20. While OPERAI/II evaluated adverse events (AE) and infusion related reactions (IRR) with ocrelizumab, the mean age was 37.

Design/Methods The electronic medical record (EMR) in a single comprehensive MS center was queried for patients with MS infused with antiCD20 under the age of 22 from 8/1/2014 to 10/1/2019. AEs were queried in the EMR and classified using the Common Terminology Criteria for Adverse Events version 5.

Results We found 27 patients meeting inclusion criteria, all received ocrelizumab. Median age at diagnosis was 17.5 (range 12.4-21.6; IQR 3.3) and median age at OCR start was 19.2 (range 15-21.9; IQR 3.1). Cumulatively 96 infusions were given, and 22 patients (81%) experienced at least 1 AE. Grade 1 AEs were the most common (86%), then grade 2 (11%) and grade 3 (3%); 0 grade 4 (serious). Of the AEs, 68% were IRRs: 19 patients (70%) with the first infusion. Intervention (alone or in combination) was needed in 6 (14%) cases: infusion rate slowed 3 times, infusion stopped briefly twice, medications given twice, and one ED evaluation. Common IRRs included bradycardia (22%), hypotension (17%), fatigue (13%), headache (10%), throat irritation (9%), with a mean of 2.2 symptoms/patient. The most common non-IRR AEs were fatigue and headache.

Conclusions We found similar rates of AEs but a greater proportion of IRRs in our young population compared to OPERA I/II. The majority of AEs were mild and none prompted discontinuation of therapy. Bradycardia appeared to be a unique and unexpected IRR in these young patients. Overall, ocrelizumab appears to be safe and well tolerated in this population.

Authors/Disclosures
Carolyn Goldschmidt, DO (NorthShore University HealthSystem) PRESENTER	Dr. Goldschmidt has nothing to disclose.
Mary R. Rensel, MD, FAAN	Dr. Rensel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for genentech. Dr. Rensel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG. Dr. Rensel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biogen. Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Rensel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG. Dr. Rensel has stock in Brain Fresh LLC . The institution of Dr. Rensel has received research support from NMSS. The institution of Dr. Rensel has received research support from Roche- Genentech . The institution of Dr. Rensel has received research support from Biogen.
Kedar Mahajan, MD, PhD	Dr. Mahajan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Mahajan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech.
Moein Amin, MD (Cleveland Clinic)	Dr. Amin has nothing to disclose.

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