Abstract Details

Title Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-world Observational Survey (ENAMOR)

Topic Multiple Sclerosis

Presentation(s) P7 - Poster Session 7 (5:00 PM-6:00 PM)

Poster/Presentation
Number 1-015

Objective To describe the tolerability profile of ublituximab infusions in the real-world clinical practice setting.

Background Ublituximab is a novel monoclonal antibody targeting CD20 and is glycoengineered for enhanced antibody-dependent cellular cytolysis. In the ULTIMATE Phase 3 studies, the incidence of IRRs was highest with the first infusion (43%), and markedly decreased with subsequent infusions (10% with the second, 8% with the third infusion, and 7% with the fourth infusion). Premedications prior to each infusion in the studies included an antihistamine and corticosteroid. Acetaminophen was not permitted at the first infusion so as not to confound Day 2 labs but could be utilized for subsequent infusions at the investigator’s discretion.

Design/Methods ENAMOR is a retrospective blinded survey to assess the tolerability profile in people with MS (PwMS) treated with ublituximab in the real-world setting. Clinics completed one survey to collect data on up to twenty PwMS receiving up to four ublituximab infusions for analyses related to the infusion experience, including premedications, incidence of IRRs, and infusion time.

Results A total of twenty-one clinics participated in the ENAMOR survey, collecting data on 401 PwMS. Prior to initiating ublituximab, 127 (31.7%) PwMS were previously on an infusible anti-CD20 therapy. Clinics reported that all infusions were completed in the specified time (median time for the first infusion was 240 minutes, and 60 minutes for infusions 2-4). IRRs occurred in 19.2% of PwMS with the first infusion, 6.9% with the second infusion, 7.7% with the third infusion, and 5.1% with the fourth infusion. All clinics indicated a standardized protocol for premedications and notably all utilized an antipyretic with the first infusion.

Conclusions

Data from the ENAMOR survey supports that ublituximab infusions are well tolerated in the real-world clinical practice setting. Additional data to be presented at the meeting.

Authors/Disclosures
Edward Fox, MD, PhD, FAAN PRESENTER	Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Fox 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. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Fox has received research support from Biogen. The institution of Dr. Fox has received research support from Genentech. The institution of Dr. Fox has received research support from Celgene - BMS. The institution of Dr. Fox has received research support from Chugai. The institution of Dr. Fox has received research support from Novartis. The institution of Dr. Fox has received research support from EMD-Serono. The institution of Dr. Fox has received research support from TG Therapeutics. The institution of Dr. Fox has received research support from AbbVie. The institution of Dr. Fox has received research support from Sanofi Genzyme. The institution of Dr. Fox has received research support from AbbVie.
Peter Sportelli, BS	Mr. Sportelli has received personal compensation for serving as an employee of TG Therapeutics. Mr. Sportelli has stock in TG Therapeutics, Inc.
Hari Miskin (TG therapeutics)	Hari Miskin has received personal compensation for serving as an employee of TG Therapeutics, Inc.. Hari Miskin has stock in TG Therapeutics, Inc..
Chris Garner (TG Therapeutics)	Chris Garner has received personal compensation for serving as an employee of TG Therapeutics Inc.. Chris Garner has stock in TG Therapeutics, Inc..

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