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: